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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| Biomedical Advanced Research and Development Authority | FED |
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ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the local clinics, including remdesivir (provided). The SoC may change during the course of the study based on other research findings. Comparisons of the agents among themselves is not a research objective.
The study population corresponds to moderately and severely ill patients infected with the coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already hospitalized for treatment of COVID-19 infection as well as patients being treated for COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital. Patients both in and out of the ICU are included in the study population.
ACTIV-1 IM is a master protocol designed to evaluate immune modulators for the treatment of moderately or severely ill hospitalized patients infected with COVID-19. Trial participants will be assessed daily while hospitalized. If the participants are discharged from the hospital prior to Day 29, they will have follow-up study visits at Days 8, 11, 15, 22, and 29. For discharged participants, it is preferred that the Day 8, 11, 15, and 29 visits are in person to obtain safety laboratory tests and blood (serum/plasma) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the participant to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The Day 60 assessment will be conducted by phone.
The effectiveness of each therapeutic agent as add-on therapy to SoC plus remdesivir (provided) will be evaluated based on the primary endpoint of time to recovery by Day 29. The sample size requirements are based on the ability to detect a moderate improvement in time to recovery (3-4 fewer days) for each agent. A total of 788 recoveries are required for each comparison to provide approximately 85% power to detect a recovery rate ratio of 1.25. Assuming 73% of participants achieve recovery in 28 days, consistent with the ACTT-1 results, the total sample size to evaluate 1, 2, and 3 agents in ACTIV-1 IM is approximately 1080, 1620, and 2160, respectively. Because each agent is being compared to SoC with no between-agent comparisons, no multiplicity adjustments for multiple agents are planned.
The CVC arm of the study was closed to enrollment on 3-Sep-2021.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care + infliximab or matching placebo | Active Comparator | infliximab (single dose IV 5mg/kg given on day 1) or matching placebo |
|
| Standard of Care + abatacept or matching placebo | Active Comparator | abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) or matching placebo |
|
| Standard of Care + cenicriviroc or matching placebo (closed to enrollment as of 3-Sep-2021) | Active Comparator | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. or matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | study drug or matching placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had Recovered by Day 28 | Time to recovery by day 28. The number of participants who have recovered by day 28. | Days 1-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best) To determine a participant's clinical status using the ordinal scale their clinical status was collected at Day 15 assessing day 14. The scale used in this study is as follows (from worst to best):
|
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Inclusion Criteria:
Admitted to a hospital or awaiting admission in the ED with symptoms suggestive of COVID-19.
Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
Male or non-pregnant female adults ≥18 years of age at time of enrollment.
Has laboratory-confirmed (within 14 days prior to enrollment) SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen.
Ongoing illness of any duration, and at least one of the following:
Women of childbearing potential must agree to either abstinence or use of at least one primary form of contraception not including hormonal contraception from the time of screening through Day 60.
Agrees to not to participate in another interventional trial for the treatment of COVID-19 through Day 60.
Exception 1: Participant may co-enroll in ACTIV-4 (ACTIV-4A and ACTIV-4C). Exception 2: Participants in ACTIV-2 who have been hospitalized may be enrolled in ACTIV-1 as long as ACTIV-2 study therapy has been discontinued. They will remain in ACTIV-2 follow-up.
Exception 3: If participant is already participating in a COVID-19 vaccine trial but develops COVID-19 disease that requires hospitalization, participant is eligible for this study, assuming all other inclusion/exclusion criteria are met.
Exclusion Criteria:
ALT or AST >10 times the upper limit of normal.
Estimated glomerular filtration rate (eGFR) <30 mL/min (including patients receiving hemodialysis or hemofiltration).
Exception: Participants with an eGFR <30 mL/min may enroll as long as their renal insufficiency has been stable without renal replacement therapy for ≥1 month and they are not current candidates for renal replacement therapy. These participants will not receive remdesivir.
Neutropenia (absolute neutrophil count <1000 cells/μL) (<1.0 x 103/μL or <1.0 GI/L).
Lymphopenia (absolute lymphocyte count <200 cells/μL) (<0.20 x 103/μL or <0.20 GI/L)
Pregnancy or breast feeding.
Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
Known allergy to any study medication.
Received cytotoxic or biologictargeted immune-modulator treatments (such as anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], anti-IL-17, or T-cell or B-cell targeted therapies ([e.g., rituximab), tyrosine kinase], JAK inhibitors [including baricitinib,], TNF inhibitors, or interferon) within 4 weeks or 5 half-lives prior to screening., whichever is longer. Steroid dependency, defined as need for prednisone at a dose >10 mg (or equivalent) for >1 month within 2 weeks of screening, is exclusionary. Note Exception 1: Dexamethasone (at a dose of 6 mg per day for up to 10 days) is permitted for the treatment of COVID-19 in patients who are already mechanically ventilated and in patients who require supplemental oxygen at screening, but who are not mechanically ventilated in accordance with national guidelines. Note Exception 2: Infusion of convalescent plasma given for treatment of COVID-19 while on-study is also allowed.
Exception 3: Monoclonal antibody therapy given for COVID-19 treatment at any time prior to enrollment is also allowed.
BasedKnown or suspected history of untreated tuberculosis (TB). TB diagnosis may be suspected based on medical history and concomitant therapies that would suggest TB infection, have suspected clinical diagnosis of current active tuberculosis (TB) or, if. Participants are also excluded if they have known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required).
Based on medical history and concomitant therapies that would suggest infection,Known or suspected serious, active bacterial, fungal, or viral (infection (excepting SARS-CoV-2 and including, but not limited to, active HBV, HCV, or HIV/AIDS). with the latter defined as a CD4 count <200 or an unsuppressed HIV viral load), or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
Note: Broad-spectrum empiric antibiotic usage does not exclude participation.
Have received any live vaccine (that is,or live attenuated) within 3 months before screening, or intend to receive a live vaccine (or live attenuated) during the study. Note Exception: Use of prior non-live (inactivated) vaccinations is allowed for all participants, including any vaccine for COVID-19.
Severe hepatic impairment (defined as liver cirrhosis Child stage C).
CurrentKnown severe heart failure (New York Heart Association [NYHA] III-IV).) or new-onset left-systolic or global cardiac dysfunction in the setting of COVID-19.
Exception: Right-sided heart dysfunction or pulmonary hypertension thought related to COVID-19 is permitted.
In the Investigator's judgment, the patient has any advanced organ dysfunction that would not make participation appropriate.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel K Benjamin, MD, PhD | Duke University | Principal Investigator |
| Bill Powderly, MD | Washington University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Phoenix | Arizona | 85006 | United States | ||
| University of Arkansas Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39610848 | Derived | Lachiewicz AM, Shah M, Der T, Cyr D, Al-Khalidi HR, Lindsell C, Iyer V, Khan A, Panettieri R, Rauseo AM, Maillo M, Schmid A, Jagpal S, Powderly WG, Bozzette SA; ACTIV-1 IM study group members. Resource Use in the Randomized Master Protocol for Immune Modulators for Treating COVID-19 (ACTIV-1 IM): A Secondary Data Analysis. CHEST Crit Care. 2024 Dec;2(4):100095. doi: 10.1016/j.chstcc.2024.100095. Epub 2024 Aug 22. | |
| 38662372 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care + Infliximab | infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care |
| FG001 | Standard of Care + Abatacept | abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 2, 2020 | Dec 8, 2022 |
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ACTIV-1 IM builds upon findings and the model used for other network COVID studies. Including multiple therapeutic agents under a single protocol avoids duplication of effort in terms of infrastructure, trial governance, information systems (EDC, web-based randomization, etc.) and other aspects of study management. Implementation of the master protocol facilitates discontinuation of less promising agents and addition of possibly newly emergent agents that become available after the study begins, without stopping and starting the study itself for extended pauses.
All test agents are evaluated as add-on therapies to the local SoC at each clinic. The master protocol design allows for the efficacy and safety of each agent to be determined based on comparisons with a pooled control group, consisting of patients receiving SoC plus placebo. Sharing control patients across all test agents substantially reduces the sample size requirements for the study.
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Study Drug and Matching Placebo
| Abatacept | Drug | study drug or matching placebo |
|
|
| Remdesivir | Drug | Standard of Care |
|
| cenicriviroc (closed to enrollment as of 3-Sep-2021) | Drug | study drug or matching placebo |
|
| Day 14 |
| Mortality Through 28 Days | mortality at day 28 | Day 1-28 |
| Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best) To determine a participant's clinical status using the ordinal scale their clinical status was collected at Day 29 assessing day 28. The scale used in this study is as follows (from worst to best):
| Day 28 |
| Mortality Through 14 Days | mortality at day 14 | Day 1-14 |
| Number of Participants Who Met a One Point Improvement in One Category From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best). Number of people who met a 1 point improvement. The scale used in this study is as follows (from worst to best):
| Day 1-day 28 |
| Number of Participants Who Met a One Point Improvement in Two Categories From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best). Number of people who met a two category improvement. The scale used in this study is as follows (from worst to best):
| Day 1- day 28 |
| Mean Change in the 8-point Ordinal Scale From Day 0 to Day 2 | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best) | Day 0 to day 2 |
| Mean Change in the 8-point Ordinal Scale From Day 0 to Day 4 | 8 point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) | Day 0 to day 4 |
| Mean Change in the 8-point Ordinal Scale From Day 0 to Day 7 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities=best) | Day 0 to day 7 |
| Mean Change in the 8-point Ordinal Scale From Day 0 to Day 10 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) | Day 0 to day 10 |
| Mean Change in the 8-point Ordinal Scale From Day 0 to Day 14 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) | Day 0 to day 14 |
| Mean Change in the 8-point Ordinal Scale From Day 0 to Day 21 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) | Day 0 to day 21 |
| Mean Change in the 8-point Ordinal Scale From Day 0 to Day 28 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) | Day 0 to day 28 |
| Duration (Days) Alive and Free of Supplemental Oxygen | Days alive and free of supplemental oxygen | Day 1 to day 28 |
| Number of Patients With New Supplemental Oxygen Use | Number of patients with new supplemental oxygen use | Day 1-day 28 |
| Duration (Days) Alive and Free of Non-invasive Ventilation/ High Flow Oxygen | Days alive and free of non-invasive ventilation/ high flow oxygen | Day 1 to day 28 |
| Number of Patients With New Non-invasive Ventilation/High Flow Oxygen Use | Number of patients with new non-invasive ventilation/high flow oxygen use | Day 1-day 28 |
| Duration (Days) Alive and Free of Invasive Mechanical Ventilation or ECMO | Days alive and free of invasive mechanical ventilation or ECMO | Day 1 to day 28 |
| Number of Patients With New Mechanical Ventilation or ECMO Use | Number of patients with new mechanical ventilation or ECMO use | Day 1 to day 28 |
| Duration (Days) Alive and Out of the Hospital | Days alive and out of the hospital | Through day 28 |
| Number of Patients With SAEs Through Day 28 | Cumulative Incidence of SAEs through day 28 | Day 28 |
| Number of Patients With Grade 3 and 4 Adverse Events | Cumulative incidence of adverse events of grade 3 and 4 | Day 28 |
| Number of Patients With Adverse Events Leading to Dose Modification | Number of patients with adverse events (serious and non serious) leading to dose modification | Day 1-28 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Scripps Clinical Medical Group | La Jolla | California | 92037 | United States |
| UCLA - Ronald Reagan Medical Center | Los Angeles | California | 90095 | United States |
| Riverside University | Moreno Valley | California | 92555 | United States |
| UC Irvine Medical Center | Orange | California | 92868 | United States |
| Stanford University Medical Center | Palo Alto | California | 94303 | United States |
| UCLA Medical Center- Santa Monica | Santa Monica | California | 06037 | United States |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| University of Florida-Jacksonville | Jacksonville | Florida | 32218 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60607 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Kansas | Kansas City | Kansas | 66160 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Tulane School of Medicine | New Orleans | Louisiana | 70112 | United States |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| Johns Hopkins Medical Center | Baltimore | Maryland | 21202 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| U Mass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| U Mass University Medical Center | Worcester | Massachusetts | 01655 | United States |
| MidMichigan Medical Center- Gratiot | Alma | Michigan | 48640 | United States |
| MidMichigan Medical Center - Midland | Midland | Michigan | 48670 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| University of Missouri Health Care | Columbia | Missouri | 65212 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Trinitas Hospital | Elizabeth | New Jersey | 07207 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Rutgers New Jersey Medical School | New Brunswick | New Jersey | 08901 | United States |
| NYU Brooklyn | Brooklyn | New York | 11220 | United States |
| University at Buffalo | Buffalo | New York | 14203 | United States |
| Flushing Hospital Medical Center | Flushing | New York | 11355 | United States |
| Jamaica Hospital Medical Center | Jamaica | New York | 11418 | United States |
| NYU Long Island | Long Island City | New York | 10016 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Harlem Hospital Center | New York | New York | 10037 | United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| St Lawrence Health System | Potsdam | New York | 13676 | United States |
| University of Rochester Medical Center-Strong Memorial Hospital | Rochester | New York | 14642 | United States |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Mercy Saint Vincent Medical Center | Toledo | Ohio | 43608 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Reading Hospital Study | Wyomissing | Pennsylvania | 19610 | United States |
| Avera McKennan Hospital | Sioux Falls | South Dakota | 57105 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Methodist Health System Clinical Research Institute | Dallas | Texas | 75203 | United States |
| University of Texas Health Science Center - Houston | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Trinity Mother Frances Hospital | Tyler | Texas | 75701 | United States |
| University of Texas Health Center at Tyler | Tyler | Texas | 75708 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Providence Medical Research Center | Spokane | Washington | 99204 | United States |
| West Virginia University | Morgantown | West Virginia | 26505 | United States |
| Gundersen Health System | La Crosse | Wisconsin | 54601 | United States |
| Hospital Interzonal Dr Jose Penna Bahia Blanca | BahÃa Blanca | Buenos Aires | 8000 | Argentina |
| Sanatorio Ramon Cereijo | CABA | Buenos Aires | C1048 | Argentina |
| Instituto Medico Platense | La Plata | Buenos Aires | B1900 | Argentina |
| Clinica Central S.A. | Villa Regina | RÃo Negro Province | 8336 | Argentina |
| Hospital Ramos Mejia | Buenos Aires | C1221ADC | Argentina |
| Hospital Rawson | Córdoba | 5000 | Argentina |
| Sanatorio Allende | Córdoba | X5000JHGQ | Argentina |
| Sanatorio Britanico | Rosario | 2000 | Argentina |
| Sanatorio Diagnóstico/ Instituto del Buen Aire | Santa Fe | S3000 | Argentina |
| Hospital BrasÃlia | BrasÃlia | Federal District | 71681-603 | Brazil |
| Hospital FelÃcio Rocho | Belo Horizonte | Minas Gerais | 30110-934 | Brazil |
| Instituto DOR de Ensino e Pesquisa Hospital Glória D'Or | Rio de Janeiro | Rio de Janeiro / RJ | 22211-230 | Brazil |
| Hospital Ernesto Dornelles | Porto Alegre | Rio Grande D Sul /RS | 90160-092 | Brazil |
| Hospital de Clinicas de Porto Alegre HCPA | Porto Alegre | Rio Grande Do Sul / RS | 90035-903 | Brazil |
| Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande Do Sul/RS | 90020-090 | Brazil |
| Hospital e Maternidade Celso Pierro - PUC Campinas | Campinas | São Paulo/SP | 13060-904 | Brazil |
| Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca" | Guadalajara | Guadalajara Jalisco | CP 44340 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Nuevo León | Monterrey | 64460 | Mexico |
| Hospital Central FAP | Lima | Lima/Lima | 51 | Peru |
| Hospital Regional Lambayeque | Chiclayo | 1400 | Peru |
| Hospitala Nacional Hipólito Unánue | Lima | 15007 | Peru |
| Hospital Nacional Aezobispo Loayza | Lima | 15082 | Peru |
| Hospital de Chancay y Servicios Basicos de Salud | Lima | 15131 | Peru |
| ClÃnica Belén SANNA | Piura | Peru |
| Derived |
| Balevic SJ, Benjamin DK Jr, Powderly WG, Smith PB, Gonzalez D, McCarthy MW, Shaw LK, Lindsell CJ, Bozzette S, Williams D, Linas BP, Blamoun J, Javeri H, Hornik CP; ACTIV-1 IM Study Group. Abatacept Pharmacokinetics and Exposure Response in Patients Hospitalized With COVID-19: A Secondary Analysis of the ACTIV-1 IM Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e247615. doi: 10.1001/jamanetworkopen.2024.7615. |
| 37428480 | Derived | O'Halloran JA, Ko ER, Anstrom KJ, Kedar E, McCarthy MW, Panettieri RA Jr, Maillo M, Nunez PS, Lachiewicz AM, Gonzalez C, Smith PB, de Tai SM, Khan A, Lora AJM, Salathe M, Capo G, Gonzalez DR, Patterson TF, Palma C, Ariza H, Lima MP, Blamoun J, Nannini EC, Sprinz E, Mykietiuk A, Alicic R, Rauseo AM, Wolfe CR, Witting B, Wang JP, Parra-Rodriguez L, Der T, Willsey K, Wen J, Silverstein A, O'Brien SM, Al-Khalidi HR, Maldonado MA, Melsheimer R, Ferguson WG, McNulty SE, Zakroysky P, Halabi S, Benjamin DK Jr, Butler S, Atkinson JC, Adam SJ, Chang S, LaVange L, Proschan M, Bozzette SA, Powderly WG; ACTIV-1 IM Study Group Members. Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial. JAMA. 2023 Jul 25;330(4):328-339. doi: 10.1001/jama.2023.11043. |
| 36203544 | Derived | Ko ER, Anstrom KJ, Panettieri RA, Lachiewicz AM, Maillo M, O'Halloran JA, Boucher C, Smith PB, McCarthy MW, Segura Nunez P, Mendivil Tuchia de Tai S, Khan A, Mena Lora AJ, Salathe M, Kedar E, Capo G, Rodriguez Gonzalez D, Patterson TF, Palma C, Ariza H, Patelli Lima M, Blamoun J, Nannini EC, Sprinz E, Mykietiuk A, Wang JP, Parra-Rodriguez L, Der T, Willsey K, Benjamin DK, Wen J, Zakroysky P, Halabi S, Silverstein A, McNulty SE, O'Brien SM, Al-Khalidi HR, Butler S, Atkinson J, Adam SJ, Chang S, Maldonado MA, Proscham M, LaVange L, Bozzette SA, Powderly WG; ACTIV-1 IM study group members. Abatacept for Treatment of Adults Hospitalized with Moderate or Severe Covid-19. medRxiv [Preprint]. 2022 Sep 26:2022.09.22.22280247. doi: 10.1101/2022.09.22.22280247. |
| 36172138 | Derived | O'Halloran JA, Kedar E, Anstrom KJ, McCarthy MW, Ko ER, Nunez PS, Boucher C, Smith PB, Panettieri RA, de Tai SMT, Maillo M, Khan A, Mena Lora AJ, Salathe M, Capo G, Gonzalez DR, Patterson TF, Palma C, Ariza H, Lima MP, Lachiewicz AM, Blamoun J, Nannini EC, Sprinz E, Mykietiuk A, Alicic R, Rauseo AM, Wolfe CR, Witting B, Benjamin DK, McNulty SE, Zakroysky P, Halabi S, Butler S, Atkinson J, Adam SJ, Melsheimer R, Chang S, LaVange L, Proschan M, Bozzette SA, Powderly WG; ACTIV-1 IM study group members. Infliximab for Treatment of Adults Hospitalized with Moderate or Severe Covid-19. medRxiv [Preprint]. 2022 Sep 26:2022.09.22.22280245. doi: 10.1101/2022.09.22.22280245. |
| 34473343 | Derived | Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
| FG002 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc (closed to enrollment as of 3-Sep-2021): study drug |
| FG003 | Shared Placebo | Shared placebo Placebo group was shared among up to all 3 arms for which the participant qualified. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care + Infliximab | infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care |
| BG001 | Standard of Care + Abatacept | abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care |
| BG002 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc (closed to enrollment as of 3-Sep-2021): study drug |
| BG003 | Shared Placebo | placebo group placebo group was shared among up to all 3 arms; whichever arms the participant qualified. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Had Recovered by Day 28 | Time to recovery by day 28. The number of participants who have recovered by day 28. | Intent to treat population. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Count of Participants | Participants | Days 1-28 |
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| Secondary | Number of Participants With Clinical Status for Day 14 Using an 8 Point Ordinal Scale | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best) To determine a participant's clinical status using the ordinal scale their clinical status was collected at Day 15 assessing day 14. The scale used in this study is as follows (from worst to best):
| Intention to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Missing data: Infliximab arms 49, Abatacept arms 57, CVC arms 27. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Count of Participants | Participants | Day 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mortality Through 28 Days | mortality at day 28 | Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Count of Participants | Participants | Day 1-28 |
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| Secondary | Number of Participants With Clinical Status for Day 28 Using an 8 Point Ordinal Scale | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best) To determine a participant's clinical status using the ordinal scale their clinical status was collected at Day 29 assessing day 28. The scale used in this study is as follows (from worst to best):
| Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 65, Abatacept arms 69, CVC arms 41. | Posted | Count of Participants | Participants | Day 28 |
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| Secondary | Mortality Through 14 Days | mortality at day 14 | Intention to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Count of Participants | Participants | Day 1-14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Met a One Point Improvement in One Category From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best). Number of people who met a 1 point improvement. The scale used in this study is as follows (from worst to best):
| Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Count of Participants | Participants | Day 1-day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Met a One Point Improvement in Two Categories From Day 0 (Baseline) to Day 28 Using an 8-point Ordinal Scale | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best). Number of people who met a two category improvement. The scale used in this study is as follows (from worst to best):
| Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Count of Participants | Participants | Day 1- day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 2 | 8-point ordinal scale assessing clinical status (1=Death is worst, 8=not hospitalized/no limitations on activities is best) | Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 24, Abatacept arms 22, CVC arms 9. | Posted | Mean | Standard Deviation | units on a scale | Day 0 to day 2 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 4 | 8 point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) | Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.Missing data: Infliximab arms 25, Abatacept arms 32, CVC arms 16. | Posted | Mean | Standard Deviation | units on a scale | Day 0 to day 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 7 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities=best) | Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled.Missing data: Infliximab arms 35, Abatacept arms 43, CVC arms 19. | Posted | Mean | Standard Deviation | units on a scale | Day 0 to day 7 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 10 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) | Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 45, Abatacept arms 51, CVC arms 24. | Posted | Mean | Standard Deviation | units on a scale | Day 0 to day 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 14 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) | Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 49, Abatacept arms 57, CVC arms 27. | Posted | Mean | Standard Deviation | units on a scale | Day 0 to day 14 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 21 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) | Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. Missing data: Infliximab arms 57, Abatacept arms 64, CVC arms 35. | Posted | Mean | Standard Deviation | units on a scale | Day 0 to day 21 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in the 8-point Ordinal Scale From Day 0 to Day 28 | 8-point ordinal scale assessing clinical status (1=death is worst, 8=not hospitalized/no limitations on activities is best) | Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Missing data: Infliximab arms 65, Abatacept arms 69, CVC arms 41. | Posted | Mean | Standard Deviation | units on a scale | Day 0 to day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration (Days) Alive and Free of Supplemental Oxygen | Days alive and free of supplemental oxygen | Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Mean | Standard Deviation | days | Day 1 to day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With New Supplemental Oxygen Use | Number of patients with new supplemental oxygen use | Intent to treat in patients who were not taking any supplemental oxygen at baseline. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Count of Participants | Participants | Day 1-day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration (Days) Alive and Free of Non-invasive Ventilation/ High Flow Oxygen | Days alive and free of non-invasive ventilation/ high flow oxygen | Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Mean | Standard Deviation | days | Day 1 to day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With New Non-invasive Ventilation/High Flow Oxygen Use | Number of patients with new non-invasive ventilation/high flow oxygen use | Intent to treat in patients who were not taking any supplemental or non-invasive/high flow oxygen at baseline. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Count of Participants | Participants | Day 1-day 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration (Days) Alive and Free of Invasive Mechanical Ventilation or ECMO | Days alive and free of invasive mechanical ventilation or ECMO | Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Mean | Standard Deviation | days | Day 1 to day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With New Mechanical Ventilation or ECMO Use | Number of patients with new mechanical ventilation or ECMO use | Intent to treat in patients that were not receiving ECMO at baseline. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Count of Participants | Participants | Day 1 to day 28 |
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| Secondary | Duration (Days) Alive and Out of the Hospital | Days alive and out of the hospital | Intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Mean | Standard Deviation | days | Through day 28 |
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| Secondary | Number of Patients With SAEs Through Day 28 | Cumulative Incidence of SAEs through day 28 | Modified intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Count of Participants | Participants | Day 28 |
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| Secondary | Number of Patients With Grade 3 and 4 Adverse Events | Cumulative incidence of adverse events of grade 3 and 4 | Modified intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Count of Participants | Participants | Day 28 |
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| Secondary | Number of Patients With Adverse Events Leading to Dose Modification | Number of patients with adverse events (serious and non serious) leading to dose modification | Modified intent to treat. This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups. Per master protocol design patients randomized to placebo had the potential to be included in the analyses for infliximab, abatacept, and cenicriviroc based on their eligibility. Therefore, the counts of participants will be higher than the number of participants enrolled. | Posted | Count of Participants | Participants | Day 1-28 |
|
Day 1-60
Adverse events were collected on a modified intent to treat population during hospitalization days and at time of outpatient visits. All-cause mortality was collected on intent to treat population.
This study had a shared placebo group meaning some participants are included in the analysis for multiple placebo comparison groups.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care + Infliximab | infliximab (single dose IV 5mg/kg given on day 1) Infliximab: study drug Remdesivir: Standard of Care | 65 | 531 | 125 | 517 | 18 | 517 |
| EG001 | Standard of Care + Infliximab Matching Placebo | infliximab matching placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care | 85 | 530 | 130 | 516 | 18 | 516 |
| EG002 | Standard of Care + Abatacept | abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care | 74 | 524 | 128 | 509 | 24 | 509 |
| EG003 | Standard of Care + Abatacept Matching Placebo | abatacept matching placebo (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care | 87 | 525 | 136 | 510 | 18 | 510 |
| EG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. cenicriviroc: study drug Remdesivir: Standard of Care cenicriviroc (closed to enrollment as of 3-Sep-2021): study drug | 64 | 360 | 102 | 355 | 13 | 355 |
| EG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1/Loading Dose: 2 tabs in morning and 1 evening Day 2 - 29/Maintenance Dose: BID through Day 29]. Remdesivir: Standard of Care | 49 | 363 | 84 | 354 | 13 | 354 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William G. Powderly MD | Washington University in St. Louis | 314-454-8276 | wpowderly@wustl.edu |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2022 | Dec 16, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 31, 2020 | Feb 11, 2022 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D000069594 | Abatacept |
| C000606551 | remdesivir |
| C506967 | cenicriviroc |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018796 | Immunoconjugates |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Brazil |
|
| Mexico |
|
| Peru |
|
| Recovery Rate Ratio |
| 1.120 |
| 2-Sided |
| 95 |
| .984 |
| 1.275 |
| Superiority |
| Fine-Gray Proportional Hazards Model | 0.9354 | Recovery Rate Ratio | 1.006 | 2-Sided | 95 | 0.862 | 1.176 | Superiority |
| OG001 | Standard of Care + Infliximab Matching Placebo | infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care |
| OG002 | Standard of Care + Abatacept | abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care |
| OG003 | Standard of Care + Abatacept Matching Placebo | abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
|
|
|
abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
|
|
|
| OG001 | Standard of Care + Infliximab Matching Placebo | infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care |
| OG002 | Standard of Care + Abatacept | abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care |
| OG003 | Standard of Care + Abatacept Matching Placebo | abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
|
|
|
abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
|
|
|
| OG001 | Standard of Care + Infliximab Matching Placebo | infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care |
| OG002 | Standard of Care + Abatacept | abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care |
| OG003 | Standard of Care + Abatacept Matching Placebo | abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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| OG001 | Standard of Care + Infliximab Matching Placebo | infliximab placebo (single dose IV 5mg/kg given on day 1) Remdesivir: Standard of Care |
| OG002 | Standard of Care + Abatacept | abatacept (single dose IV 10 mg/kg up to 1,000 mg given on day 1) Abatacept: study drug Remdesivir: Standard of Care |
| OG003 | Standard of Care + Abatacept Matching Placebo | abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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| OG003 | Standard of Care + Abatacept Matching Placebo | abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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| OG003 | Standard of Care + Abatacept Matching Placebo | abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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| OG003 | Standard of Care + Abatacept Matching Placebo | abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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| OG003 | Standard of Care + Abatacept Matching Placebo | abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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| OG003 | Standard of Care + Abatacept Matching Placebo | abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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| OG003 | Standard of Care + Abatacept Matching Placebo | abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1)
Remdesivir: Standard of Care
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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|
| Standard of Care + Abatacept Matching Placebo |
abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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| OG003 |
| Standard of Care + Abatacept Matching Placebo |
abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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| Standard of Care + Abatacept Matching Placebo |
abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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| Standard of Care + Abatacept Matching Placebo |
abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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|
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| Standard of Care + Abatacept Matching Placebo |
abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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| OG003 |
| Standard of Care + Abatacept Matching Placebo |
abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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|
abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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|
| Standard of Care + Abatacept Matching Placebo |
abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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|
|
| Standard of Care + Abatacept Matching Placebo |
abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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| OG003 |
| Standard of Care + Abatacept Matching Placebo |
abatacept matching placebo(single dose IV 10 mg/kg up to 1,000 mg given on day 1) Remdesivir: Standard of Care |
| OG004 | Standard of Care + Cenicriviroc | cenicriviroc [tablet, Day 1/Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
| OG005 | Standard of Care + Cenicriviroc Matching Placebo | cenicriviroc matching placebo [tablet, Day 1:Loading Dose: 450 mg (300mg morning and 150mg evening) Day 2 - 29/Maintenance Dose: 300 mg (150 mg BID) through Day 29]. Remdesivir: Standard of Care cenicriviroc or matching placebo arm closed to enrollment as of 3-Sep-2021 |
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