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an event rate lower than anticipated
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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A multi-center adaptive randomized placebo-controlled platform trial evaluating the efficacy and safety of anti-thrombotic strategies in COVID-19 adults not requiring hospitalization at time of diagnosis
The COVID-19 Outpatient Thrombosis Prevention Trial is a multi-center adaptive randomized double-blind placebo-controlled platform trial to compare the effectiveness of anti-coagulation with anti-platelet agents and with placebo to prevent thrombotic events in patients diagnosed with COVID-19 who have evidence of increased inflammation based on elevated D-dimer and hsCRP levels, yet are not admitted to hospital as COVID-19 related symptoms are currently stable. Participants will all be adults between 40 and 79 years who will be enrolled from approximately 100 facilities, such as emergency rooms and other settings where a physician is present to evaluate the patient for inclusion and exclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban 2.5mg | Active Comparator | Anticoagulation: prophylactic dose Apixaban 2.5mg po bid |
|
| Apixaban 5mg | Active Comparator | Anticoagulation: therapeutic dose Apixaban 5.0mg po bid |
|
| Aspirin | Active Comparator | Antiplatelet agent: low dose aspirin 81mg po qd |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban 2.5 MG | Drug | Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study drug will be shipped to subjects home. Subjects will take Apixaban 2.5 MG twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization for Cardiovascular/Pulmonary Events | The primary outcome will be a composite endpoint of need for hospitalization for cardiovascular/pulmonary events, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, and all-cause mortality for up to 45 days after initiation of assigned treatment. | 45 days |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Sciurba | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Stanford University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37591523 | Derived | Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2. | |
| 37489818 | Derived | Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078. |
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Participants were enrolled from a variety of different facilities where (a) a clinician can evaluate the patient for inclusion and exclusion criteria, and (b) where blood samples can be arranged to be sent for D-dimer, hsCRP, calculated creatinine clearance, and platelet count. COVID-19 testing needs to be confirmed positive within the past 14 days. Serum or urine pregnancy test results will be required for women of childbearing potential before starting study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Apixaban 2.5mg | Anticoagulation: prophylactic dose Apixaban 2.5mg po bid |
| FG001 | Apixaban 5mg | Anticoagulation: therapeutic dose Apixaban 5.0mg po bid |
| 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 | May 31, 2021 | Feb 15, 2022 |
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Double-blind
|
| Apixaban 5MG | Drug | Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study drug will be shipped to subjects home. Subjects will take Apixaban 5 MG twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period. |
|
| Aspirin | Drug | Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study drug will be shipped to subjects home. Subjects will take Aspirin twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period. |
|
| Placebo | Drug | Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study placebo will be shipped to subjects home. Subjects will take placebo twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period. |
|
| Palo Alto |
| California |
| 94304 |
| United States |
| Zuckerberg San Francisco General | San Francisco | California | 94143 | United States |
| Olive View-UCLA Medical Center | Sylmar | California | 91342 | United States |
| Pine Ridge Family Medicine | Colorado Springs | Colorado | 80924 | United States |
| Life Tree Health, Inc. | Washington D.C. | District of Columbia | 20020 | United States |
| Midland Florida Clinical Research Center, LLC | DeLand | Florida | 23720 | United States |
| University of Florida at Gainesville | Gainesville | Florida | 32611 | United States |
| Vital Pharma Research | Hialeah | Florida | 33016 | United States |
| Advanced Research for Health Improvement, LLC | Immokalee | Florida | 34142 | United States |
| University of Floridia at Jacksonville | Jacksonville | Florida | 32209 | United States |
| Lakeland Regional | Lakeland | Florida | 33805 | United States |
| Total Research Group LLC | Miami | Florida | 33126 | United States |
| Jackson Memorial | Miami | Florida | 33136 | United States |
| Well Pharma Medical Research | Miami | Florida | 33173 | United States |
| Innovation Clinical Trials | Palmetto Bay | Florida | 33157 | United States |
| Bond Community Health Center | Tallahassee | Florida | 32301 | United States |
| Tallahassee Memorial | Tallahassee | Florida | 32308 | United States |
| USF Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Alliance Clinical Research | Tampa | Florida | 33615 | United States |
| Hawaii Pacific Health | Honolulu | Hawaii | 96813 | United States |
| Fox Valley Clinical Research Center, LLC | Aurora | Illinois | 60506 | United States |
| UIC - Mile Square | Chicago | Illinois | 60608 | United States |
| Jesse Brown VA | Chicago | Illinois | 60612 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| Olivo Wellness Medical Center | Chicago | Illinois | 60618 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Ascension Via Christi | Wichita | Kansas | 67214 | United States |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | United States |
| Jadestone Clinical Research, LLC | Gaithersburg | Maryland | 20877 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| GFC of Southeastern Michigan | Detroit | Michigan | 48202 | United States |
| SRI International | Plymouth | Michigan | 48170 | United States |
| Metro Health-University of Michigan Health | Wyoming | Michigan | 49519 | United States |
| Raritan Bay Primary Care and Cardiology Associates | Matawan | New Jersey | 07747 | United States |
| G&S Medical Associates, LLC | Paterson | New Jersey | 07514 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| Strong Memorial | Rochester | New York | 14642 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Spinal Pain and Rehab Medicine | Yonkers | New York | 10701 | United States |
| Duke | Durham | North Carolina | 27701 | United States |
| Peters Medical Research | High Point | North Carolina | 27262 | United States |
| The Heart and Medical Center | Durant | Oklahoma | 74701 | United States |
| Ascension St. John Clinical Research Institute | Tulsa | Oklahoma | 74104 | United States |
| UPMC Passavant Cranberry | Cranberry | Pennsylvania | 16066 | United States |
| UPMC McKeesport | McKeesport | Pennsylvania | 15132 | United States |
| UPMC East | Monroeville | Pennsylvania | 15146 | United States |
| UPMC Magee | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC Presby | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC Mercy | Pittsburgh | Pennsylvania | 15219 | United States |
| Preferred Primary Care Physicians | Pittsburgh | Pennsylvania | 15220 | United States |
| UPMC Shadyside | Pittsburgh | Pennsylvania | 15232 | United States |
| UPMC Passavant McCandless | Pittsburgh | Pennsylvania | 15237 | United States |
| Preferred Primary Care Physicians, Inc | Pittsburgh | Pennsylvania | 15243 | United States |
| Preferred Primary Care Physicians | Pittsburgh | Pennsylvania | 15243 | United States |
| Preferred Primary Care Physicians | Uniontown | Pennsylvania | 15401 | United States |
| Pharma Tex Research | Amarillo | Texas | 79109 | United States |
| Ascension Seton Medical Center | Austin | Texas | 78752 | United States |
| Baptist Beaumont | Beaumont | Texas | 77030 | United States |
| McGoven Medical School - UT- Houston | Houston | Texas | 77030 | United States |
| Diversifield Medical Practices | Houston | Texas | 77057 | United States |
| Next Level Urgent Care | Houston | Texas | 77057 | United States |
| Mesquite Regional Internal Medicine | Mesquite | Texas | 75149 | United States |
| University of Texas at Tyler | Tyler | Texas | 75708 | United States |
| University of Texas at Rio Grande Valley | Weslaco | Texas | 78596 | United States |
| Intermountain Healthcare | Murray | Utah | 84107 | United States |
| Community Care of Clay | Clay | West Virginia | 25043 | United States |
| University Healthcare Physicians | Harpers Ferry | West Virginia | 25425 | United States |
| Community Care of Weston | Weston | West Virginia | 26452 | United States |
| Gundersen Health System | La Crosse | Wisconsin | 54601 | United States |
| 37189091 | Derived | Bledsoe J, Woller SC, Brooks M, Sciurba FC, Krishnan JA, Martin D, Hou P, Lin JY, Kindzelski A, Handberg E, Kirwan BA, Zaharris E, Castro L, Shapiro NL, Pepine CJ, Majercik S, Fu Z, Zhong Y, Venugopal V, Lai YH, Ridker PM, Connors JM. Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial. BMC Infect Dis. 2023 May 15;23(1):325. doi: 10.1186/s12879-023-08295-9. |
| 34633405 | Derived | Connors JM, Brooks MM, Sciurba FC, Krishnan JA, Bledsoe JR, Kindzelski A, Baucom AL, Kirwan BA, Eng H, Martin D, Zaharris E, Everett B, Castro L, Shapiro NL, Lin JY, Hou PC, Pepine CJ, Handberg E, Haight DO, Wilson JW, Majercik S, Fu Z, Zhong Y, Venugopal V, Beach S, Wisniewski S, Ridker PM; ACTIV-4B Investigators. Effect of Antithrombotic Therapy on Clinical Outcomes in Outpatients With Clinically Stable Symptomatic COVID-19: The ACTIV-4B Randomized Clinical Trial. JAMA. 2021 Nov 2;326(17):1703-1712. doi: 10.1001/jama.2021.17272. |
| 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 | Asprin | Antiplatelet agent: low dose aspirin 81mg po qd |
| FG003 | Placebo | Only Placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Apixaban 2.5mg | Anticoagulation: prophylactic dose Apixaban 2.5mg po bid |
| BG001 | Apixaban 5mg | Anticoagulation: therapeutic dose Apixaban 5.0mg po bid |
| BG002 | Asprin | Antiplatelet agent: low dose aspirin 81mg po qd |
| BG003 | Placebo | Only Placebo |
| 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 | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Hospitalization for Cardiovascular/Pulmonary Events | The primary outcome will be a composite endpoint of need for hospitalization for cardiovascular/pulmonary events, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, and all-cause mortality for up to 45 days after initiation of assigned treatment. | Posted | Number | 95% Confidence Interval | participants | 45 days |
|
|
|
a 45-day treatment period
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Apixaban 2.5mg | Anticoagulation: prophylactic dose Apixaban 2.5mg po bid | 0 | 165 | 0 | 165 | 9 | 165 |
| EG001 | Apixaban 5mg | Anticoagulation: therapeutic dose Apixaban 5.0mg po bid | 0 | 164 | 0 | 164 | 13 | 164 |
| EG002 | Asprin | Antiplatelet agent: low dose aspirin 81mg po qd | 0 | 164 | 0 | 164 | 6 | 164 |
| EG003 | Placebo | only Placebo | 0 | 164 | 0 | 164 | 3 | 164 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-major Bleeding | Investigations | MedDRA (10.0) | Non-systematic Assessment |
| |
| Admitted for pneumonia | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment |
|
Early termination leads to a small number of subjects being analyzed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frank Sciurba | University of Pittsburgh | 412-648-6494 | sciurbafc@upmc.edu |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2021 | Feb 15, 2022 | SAP_002.pdf |
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| 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 |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|