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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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Blinded, multicenter, placebo-controlled, randomized clinical trial evaluating lopinavir/ritonavir vs placebo in early outpatient treatment of adults with COVID-19
We will conduct an investigator-initiated, multicenter, blinded, placebo-controlled, randomized clinical trial evaluating lopinavir/ritonavir vs placebo for early treatment of adults with COVID-19 in the outpatient setting prior to hospitalization. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Lopinavir/Ritonavir | Active Comparator | Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14) |
|
| Control Group | Placebo Comparator | Placebo unmatched orally twice daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/Ritonavir 400 mg/100 mg | Drug | Lopinavir/Ritonavir tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group) | Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial. | Day 1 to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Modified COVID Ordinal Outcome Scale: Study Day 8 (Group 2 and Placebo Control Group) | Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial. |
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Inclusion Criteria:
Exclusion Criteria:
Prisoner
Pregnancy
Breast feeding
Two individuals from the same household are not enrolled in the study
Unable to randomize within 6 days after onset of acute respiratory infection symptoms
Hospitalization within the 6 days prior to randomization
Inability to swallow oral medications
Refusal or inability to be contacted and participate in daily symptom/safety monitoring in English or Spanish during the two-week follow-up period
Previous enrollment in this trial
Known severe chronic kidney disease requiring dialysis
Known severe liver disease [cirrhosis or >3 times upper limit of normal for aspartate aminotransferase (AST) or alanine aminotransferase (ALT) in medical record if available]
Known hepatitis B or hepatitis C infection
Known history of jaundice
Current heavy alcohol use, defined as 8 drinks or more per week for women or 15 drinks or more per week for men
Known seizure disorder
Known human immunodeficiency virus (HIV) infection
Known history of pancreatitis
Known history of prolonged QT interval [Long QT Syndrome, patient report, or corrected QT interval (QTc) >500 milliseconds on most recently available electrocardiogram within the past 2 years]
Receipt of >1 dose of lopinavir/ritonavir in the 10 days prior to enrollment
Known allergy to lopinavir/ritonavir
Currently prescribed (with planned continuation) or planned administration during 14-day study period of medication at high risk for QT prolongation as follows:
Antiarrhythmics: Amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, procainamide, propafenone, quinidine, sotalol Anti-cancer: Arsenic trioxide, oxaliplatin, vandetanib Antidepressants: Amitriptyline, citalopram, escitalopram, imipramine Antimicrobials: azithromycin, ciprofloxacin, clarithromycin, erythromycin, fluconazole, levofloxacin, moxifloxacin, pentamidine, hydroxychloroquine Antipsychotics: haloperidol, chlorpromazine, droperidol, olanzapine, pimozide, quetiapine, thioridazine, risperidone, ziprasidone Others: cilostazol, cimetidine, cisapride, donepezil, methadone, ondansetron, sumatriptan
Currently prescribed (with planned continuation) or planned administration during 14-day study period of any of the following medications: alfuzosin, apalutamide, astemizole, ergot-containing medicines (including dihydroergotamine mesylate, ergotamine tartrate, methylergonovine), lomitapide, lovastatin, lurasidone, midazolam, phenobarbital, phenytoin, ranolazine, rifampin, sildenafil, simvastatin, St. John's Wort, terfenadine, triazolam. Patients who are on warfarin or fluticasone will be advised to contact their primary care provider to advise them that they are in the trial and possibly receiving lopinavir/ritonavir which can influence levels of either drug and may require more frequent monitoring.
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| Name | Affiliation | Role |
|---|---|---|
| Todd Rice, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | United States | ||
| Beth Israel Deaconess Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32108857 | Background | Del Rio C, Malani PN. COVID-19-New Insights on a Rapidly Changing Epidemic. JAMA. 2020 Apr 14;323(14):1339-1340. doi: 10.1001/jama.2020.3072. No abstract available. | |
| 32109011 | Background | Fauci AS, Lane HC, Redfield RR. Covid-19 - Navigating the Uncharted. N Engl J Med. 2020 Mar 26;382(13):1268-1269. doi: 10.1056/NEJMe2002387. Epub 2020 Feb 28. No abstract available. |
| Label | URL |
|---|---|
| World Health Organization (WHO). WHO R\&D Blueprint: informal consultation on prioritization of candidate therapeutic agents for use in novel coronavirus 2019 infection, Geneva, Switzerland, 24 January 2020. \[Internet\]. \[cited 2020 Mar 19\] | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1- Hydroxychloroquine | Hydroxychloroquine 400 mg orally twice daily for two doses (Day 1), then 200 mg twice daily for subsequent eight doses (Day 2-5), then placebo twice daily for subsequent eighteen doses (Day 6-14). Arm Terminated 6/22/2020 |
| FG001 | Group 2 - Lopinavir/Ritonavir | Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14) Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets |
| FG002 | Placebo Control Group | Placebo Group 1: matched to Hydroxychloroquine orally twice daily for 14 days Placebo Group 2: unmatched orally twice daily for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No difference in overall number of baseline participants and those assigned to study arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1- Hydroxychloroquine | Hydroxychloroquine 400 mg orally twice daily for two doses (Day 1), then 200 mg twice daily for subsequent eight doses (Day 2-5), then placebo twice daily for subsequent eighteen doses (Day 6-14). Arm Terminated 6/22/2020 |
| BG001 | Group 2 - Lopinavir/Ritonavir |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group) | Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial. | Includes all randomized participants, Unknown represents those with no daily surveys submitted over the first 15 study days | Posted | Count of Participants | Participants | Day 1 to Day 15 |
|
Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
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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 | Group 1- Hydroxychloroquine | Hydroxychloroquine 400 mg orally twice daily for two doses (Day 1), then 200 mg twice daily for subsequent eight doses (Day 2-5), then placebo twice daily for subsequent eighteen doses (Day 6-14). Arm Terminated 6/22/2020 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung Infection | Infections and infestations | Systematic Assessment | Lung Infection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Operations Manager | Vanderbilt University Medical Center | (615) 875-3080 | kelly.walsh@vumc.org |
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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 | Jan 26, 2021 | Aug 25, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 23, 2021 | Aug 25, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 21, 2021 | Aug 26, 2022 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| C558899 | lopinavir-ritonavir drug combination |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Blinded, multicenter, placebo-controlled randomized clinical trial
Not provided
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Lopinavir/Ritonavir tablets or unmatched placebo tablets
| Placebo | Other | Unmatched placebo |
|
| on or at Day 8 |
| Modified COVID Ordinal Outcome Scale: Study Day 29 (Group 2 and Placebo Control Group) | Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial. | on or at Day 29 |
| Number of Patients Hospitalized: Day 1 to 29 (Group 2 and Placebo Control Group) | Number of patients hospitalized from Day 1 to 29 (Group 2 and Placebo Control Group) | Day 1 to Day 29 |
| Time to Hospitalization Day 1 to Day 29 (Group 2 and Placebo Control Group) | Number of days from enrollment to hospitalization (Group 2 and Placebo Control Group) | Day 1 to Day 29 |
| Time to Symptom Resolution: Day 1 to Day 29 (Group 2 and Placebo Control Group) | Number of days from enrollment to resolution of COVID-19 symptoms (Group 2 and Placebo Control Group) | Day 1 to Day 29 |
| All-cause, All-location Mortality: Day 1 to Day 29 (Group 2 and Placebo Control Group) | Survival status (All-cause, all-location mortality) from Day 1 to Day 29 (Group 2 and Placebo Control Group) | Day 1 to Day 29 |
| Oxygen-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group) | Number of Days without oxygen Day 1 to Day 29 (Group 2 and Placebo Control Group) | Day 1 to Day 29 |
| Fever-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group) | Number of days without fever from Day 1 to Day 29 (Group 2 and Placebo Control Group) | Day 1 to Day 29 |
| Ventilator-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group) | Number of days without ventilator use from Day 1 to Day 29 (Group 2 and Placebo Control Group) | Day 1 to Day 29 |
| ICU-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group) | Number of days outside the ICU from Day 1 to Day 29 (Group 2 and Placebo Control Group) | Day 1 to Day 29 |
| Hospital-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group) | Number of days outside the hospital from Day 1 to Day 29 (Group 2 and Placebo Control Group) | Day 1 to Day 29 |
| Vasopressor-free Days Through Study Day 29 (Group 2 and Placebo Control Group) | Number of vasopressor-free days through Study Day 29 (Group 2 and Placebo Control Group) | Day 1 to Day 29 |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
| Intermountain | Murray | Utah | 84107 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| 32109013 | Background | Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28. |
| 31822885 | Background | Wang Y, Fan G, Salam A, Horby P, Hayden FG, Chen C, Pan J, Zheng J, Lu B, Guo L, Wang C, Cao B. Comparative Effectiveness of Combined Favipiravir and Oseltamivir Therapy Versus Oseltamivir Monotherapy in Critically Ill Patients With Influenza Virus Infection. J Infect Dis. 2020 Apr 27;221(10):1688-1698. doi: 10.1093/infdis/jiz656. |
| 36581186 | Derived | Kaizer AM, Shapiro NI, Wild J, Brown SM, Cwik BJ, Hart KW, Jones AE, Pulia MS, Self WH, Smith C, Smith SA, Ng PC, Thompson BT, Rice TW, Lindsell CJ, Ginde AA. Lopinavir/ritonavir for treatment of non-hospitalized patients with COVID-19: a randomized clinical trial. Int J Infect Dis. 2023 Mar;128:223-229. doi: 10.1016/j.ijid.2022.12.028. Epub 2022 Dec 27. |
| 35395957 | Derived | Kaizer AM, Wild J, Lindsell CJ, Rice TW, Self WH, Brown S, Thompson BT, Hart KW, Smith C, Pulia MS, Shapiro NI, Ginde AA. Trial of Early Antiviral Therapies during Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19: a summary of the protocol and analysis plan for a decentralized randomized controlled trial. Trials. 2022 Apr 8;23(1):273. doi: 10.1186/s13063-022-06213-z. |
| Woosley R, Heise C, Gallo T, Tate J, Woosley D, Romero K. www.CredibleMeds.org, QTdrugs ListCredibleMeds \[Internet\]. \[cited 2020 Apr 24\] | View source |
| WHO \| Coronavirus disease (COVID-2019) R\&D \[Internet\]. WHO. \[cited 2020 Mar 18\]; | View source |
| Hydroxychloroquine \[Internet\]. In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012 \[cited 2020 Mar 21\]. | View source |
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14) Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets |
| BG002 | Placebo Control Group | Placebo Group 1: matched to Hydroxychloroquine orally twice daily for 14 days Placebo Group 2: unmatched orally twice daily for 14 days |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Group 2 - Lopinavir/Ritonavir | Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14) Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets |
| OG001 | Placebo Control Group | Placebo Group 2: unmatched orally twice daily for 14 days |
|
|
| Secondary | Modified COVID Ordinal Outcome Scale: Study Day 8 (Group 2 and Placebo Control Group) | Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial. | 41 participants did not complete a survey in Group 2 34 participants did not complete a survey in the Placebo Control Group | Posted | Count of Participants | Participants | on or at Day 8 |
|
|
|
| Secondary | Modified COVID Ordinal Outcome Scale: Study Day 29 (Group 2 and Placebo Control Group) | Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial. | 58 participants did not complete a survey in Group 2; 38 participants did not complete a survey in the Placebo Control Group. | Posted | Count of Participants | Participants | on or at Day 29 |
|
|
|
| Secondary | Number of Patients Hospitalized: Day 1 to 29 (Group 2 and Placebo Control Group) | Number of patients hospitalized from Day 1 to 29 (Group 2 and Placebo Control Group) | Posted | Count of Participants | Participants | Day 1 to Day 29 |
|
|
|
| Secondary | Time to Hospitalization Day 1 to Day 29 (Group 2 and Placebo Control Group) | Number of days from enrollment to hospitalization (Group 2 and Placebo Control Group) | Those with a recorded hospitalization | Posted | Median | Full Range | days | Day 1 to Day 29 |
|
|
|
| Secondary | Time to Symptom Resolution: Day 1 to Day 29 (Group 2 and Placebo Control Group) | Number of days from enrollment to resolution of COVID-19 symptoms (Group 2 and Placebo Control Group) | If a respondent did not report symptoms on any survey (e.g., if they resolved before receiving the medication), they were not included in the time to symptom resolution based on how we worded it in the SAP (i.e., time from medication receipt to resolution) | Posted | Median | Inter-Quartile Range | days | Day 1 to Day 29 |
|
|
|
| Secondary | All-cause, All-location Mortality: Day 1 to Day 29 (Group 2 and Placebo Control Group) | Survival status (All-cause, all-location mortality) from Day 1 to Day 29 (Group 2 and Placebo Control Group) | Posted | Count of Participants | Participants | Day 1 to Day 29 |
|
|
|
| Secondary | Oxygen-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group) | Number of Days without oxygen Day 1 to Day 29 (Group 2 and Placebo Control Group) | Participants who never filled out a daily survey were excluded since we could not derive oxygen status. We present the median (IQR), and with almost all participants having no days on supplemental oxygen (or with other outcomes); Median (Q1, Q3) all are 17. 5 participants in Group 2 and 6 participants in the placebo never filled out the daily survey. | Posted | Median | Inter-Quartile Range | days | Day 1 to Day 29 |
|
|
|
| Secondary | Fever-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group) | Number of days without fever from Day 1 to Day 29 (Group 2 and Placebo Control Group) | Related to outcome 6, if symptoms resolved before receiving medication they were not included in this outcome. 13 participants in Group 2 and 6 participants in Placebo Control group did not fill out the data relevant to tracking fever-free days. | Posted | Median | Inter-Quartile Range | days | Day 1 to Day 29 |
|
|
|
| Secondary | Ventilator-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group) | Number of days without ventilator use from Day 1 to Day 29 (Group 2 and Placebo Control Group) | Related to outcome 8, if no daily surveys were completed, we could not derive ventilation status. We present the median (IQR), and with almost all participants having no days on a ventilator; Median (Q1, Q3) all are 17. There was no data for 5 participants in Group 2 and 6 participants in the Placebo Control Group. | Posted | Median | Inter-Quartile Range | days | Day 1 to Day 29 |
|
|
|
| Secondary | ICU-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group) | Number of days outside the ICU from Day 1 to Day 29 (Group 2 and Placebo Control Group) | Related to outcome 8, if no daily surveys were completed, we could not determine ICU-free days. We present the median (IQR), and with almost all participants having no days in the ICU; Median (Q1, Q3) all are 17. | Posted | Median | Inter-Quartile Range | days | Day 1 to Day 29 |
|
|
|
| Secondary | Hospital-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group) | Number of days outside the hospital from Day 1 to Day 29 (Group 2 and Placebo Control Group) | Related to outcome 8, if no daily surveys were completed we could not determine ICU-free days. We present the median (IQR), and with almost all participants having no hospitalized days; Median (Q1, Q3) all are 17. | Posted | Median | Inter-Quartile Range | days | Day 1 to Day 29 |
|
|
|
| Secondary | Vasopressor-free Days Through Study Day 29 (Group 2 and Placebo Control Group) | Number of vasopressor-free days through Study Day 29 (Group 2 and Placebo Control Group) | We present the median (IQR), with almost all participants having vasopressor-free days throughout primary follow-up; Median (Q1, Q3) all are 17. | Posted | Median | Inter-Quartile Range | days | Day 1 to Day 29 |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
| EG001 | Group 2 - Lopinavir/Ritonavir | Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14) Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets | 1 | 221 | 2 | 221 | 203 | 221 |
| EG002 | Placebo Control Group | Placebo Group 1: matched to Hydroxychloroquine orally twice daily for 14 days Placebo Group 2: unmatched orally twice daily for 14 days | 0 | 227 | 1 | 227 | 211 | 227 |
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Adult Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
|
| Multi-Organ Failure | General disorders | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013844 |
| Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| Hospitalized on Supplemental Oxygen |
|
| Hospitalized, Not on Supplemental Oxygen |
|
| Not Hospitalized, Symptomatic, Limitations to Daily Activities |
|
| Not Hospitalized, Symptomatic, No Limitations to Daily Activities |
|
| Not Hospitalized, No Symptoms, No Limitations to Daily Activities |
|
| Unknown (No participant response) |
|
| Hospitalized, Not on Supplemental Oxygen |
|
| Not Hospitalized, Symptomatic, Limitations to Daily Activities |
|
| Not Hospitalized, Symptomatic, No Limitations to Daily Activities |
|
| Not Hospitalized, No Symptoms, No Limitations to Daily Activities |
|
| Unknown (no participant response) |
|
| Unknown |
|