COVID-19
Conditions
Brief summary
Treatments for COVID-19 are urgently needed. Hydroxychloroquine (HCQ) is an antimalarial and immunomodulatory agent being repurposed for COVID-19 therapy based off in vitro data suggesting a possible antiviral effect. However, HCQ's effect on COVID-19 in human infection remains unknown. To fill this knowledge gap, we will enroll 626 adult patients hospitalized with laboratory-confirmed COVID-19 and randomize them 1:1 to a five-day course of HCQ or placebo. Notable exclusion criteria include ICU admission or ventilation on enrollment, prior therapy with HCQ, and baseline prolonged qTC. Our primary endpoint is a severe disease progression composite outcome (death, ICU admission, mechanical ventilation, ECMO, , and/or vasopressor requirement) at the 14-day post-treatment evaluation. Notable secondary clinical outcomes include 30-day mortality, hospital length of stay, noninvasive ventilator support, and cytokine release syndrome (CRS) grading scale. Secondary exploratory objectives will examine SARS-CoV-2 viral eradication at the EOT, changes in COVID-19 putative prognostic markers and cytokine levels, and titers of anti-SARS-CoV-2 antibodies. This randomized trial will determine if HCQ is effective as treatment in hospitalized non-ICU patients with COVID-19.
Interventions
HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)
DRUGPlacebo: Calcium citrate
Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Sponsors
State University of New York - Downstate Medical Center
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double-blind
Intervention model description
Placebo-controlled, Randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Hospitalized adult (≥18 years old) with symptoms consistent with COVID-19 including but not limited to any of the following: fever (documented or subjective), cough, dyspnea, diarrhea, nausea, diffuse myalgias, and/or anosmia 2. Informed consent signed by patient 3. Positive SARS-CoV-2 RT-PCR testing (nasopharyngeal, oropharyngeal, sputum and/or bronchoalveolar lavage) o The testing may: * Occur up to ≤72h prior to informed consent of participation in the study * Be undertaken either on-site or in an external laboratory certified by New York State to run testing for SARS-CoV-2
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study: 1. Presence of the primary endpoint (ICU admission, mechanical ventilation, ECMO, and/or vasopressor requirement) at time of randomization. 2. Treatment with CQ or HCQ within the 30 days prior to the start of the study drug treatment. 3. Participation in a clinical trial to investigate a non-FDA approved drug with the intent to treat SARS-CoV-2 within the 30 days prior to the start of the study drug treatment. 4. Unable to take oral medications. 5. History of allergic reaction or intolerance to CQ or HCQ. 6. Baseline corrected qT interval \>470 milliseconds (male) or \>480 milliseconds (female), history of congenital qT prolongation, and/or history of cardiac arrest. 7. Concomitant therapy with flecainide, amiodarone, digoxin, procainamide, propafenone, thioridazine, or pimozide 8. History of retinal disease including a documented history of diabetic retinopathy. 9. Known history of G6PD deficiency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With SAE Through Day 30 | 30 days | The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100) |
| Percent of Participants With Grade 3 or 4 AEs Through Day 30 | 30 days | The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100) |
| Percent of Participants With Discontinuation of Therapy (for Any Reason) | 30 days | The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100) |
| Percent of Participants Showing a Severe Disease Progression Composite Outcome | 14 days | Including any of the following: mortality, ICU admission, invasive mechanical ventilation, ECMO, and/or hypotension requiring vasopressor support by the 14-day post-treatment evaluation (PTE). The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in White Blood Cell (WBC) Count | Baseline, 6 days | Hematology lab-work will be completed to obtain WBC count (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). |
| Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale | Day 1 | Grade 1 (mild) = able to be managed with nonparenteral supportive care, Grade 2 (moderate) = at least one of the following present (hospitalization needed for management of CRS-related symptoms, parenteral nutrition or supportive care required, signs of moderate/severe organ dysfunction), Grade 3 (severe) = hospitalization needed for management of at least one of the following (hypotension, hypoxia, organ dysfunction, coagulopathy), Grade 4 (life-threatening) = at least one of the following present (hypotension requiring high-dose vasopressors, hypoxia requiring mechanical ventilation). |
| Percent of Subjects With Q-T Interval, Corrected (qTC) Prolongation at End of Treatment (EOT) | 6 Days | (≥470 milliseconds in men; ≥480 milliseconds in women) on electrocardiogram at EOT (Day 6) |
| Percent of Patients Who Resulted in Mortality | 30 days | Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100). |
| Percent of Participants Who Required ICU Admission | 30 Days | Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100). |
| Percent of Participants Who Required Invasive Mechanical Ventilation | 30 Days | Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100). |
| Percent of Participants Who Required Extracorporeal Membrane Oxygenation (ECMO) | 30 Days | Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100). |
| Percent of Participants With Hypotension Requiring Vasopressor Support | 30 Days | Individual component of severe disease progression composite endpoint evaluated. For incidence, the measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100) |
| Percent of Participants With SARS-CoV-2 Viral Eradication From Nasopharyngeal Specimens at EOT | 6 days | Laboratory endpoint, measured by RT-PCR, reported as the percentage of negative results at day 6 |
| Hospital Length of Stay | 30 days | LOS is defined as the interval (in days) that the patient was admitted to a non-rehabilitation floor, categorized as short (\<7 days), moderate (7-10 days), or extended (\>10 days) |
| Change in Aspartate Aminotransferase (AST) Levels | Baseline, 6 days | Biochemistry lab-work will be completed to obtain AST levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). |
| Change in Creatinine Levels | Baseline, 6 days | Biochemistry lab-work will be completed to obtain Creatinine levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). |
| Change in Glucose Levels | Baseline, 6 days | Biochemistry lab-work will be completed to obtain Glucose levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). |
| Change in Hemoglobin Levels | Baseline, 6 days | Hematology lab-work will be completed to obtain hemoglobin levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). |
| Change in Platelet Count | Baseline, 6 days | Hematology lab-work will be completed to obtain platelet count (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). |
| Change in Total Bilirubin Levels | Baseline, 6 days | Biochemistry lab-work will be completed to obtain bilirubin levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). |
| Change in Lactate Dehydrogenase (LDH) Levels | Baseline, 6 days | Biochemistry lab-work will be completed to obtain LDH levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). |
| Change in C-Reactive Protein (CRP) Levels | Baseline, 6 days | Biochemistry lab-work will be completed to obtain CRP levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). |
| Change in Interleukin 6 (IL-6) Levels | Baseline, 6 days | Biochemistry lab-work will be completed to obtain IL-6 levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). |
| Change in Alanine Aminotransferase (ALT) Levels | Baseline, 6 days | Biochemistry lab-work will be completed to obtain ALT levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). |
| Days of Fever | 14 days | Defined as number of days with temperature \>100.4 degrees Fahrenheit. |
| Days of Non-invasive Ventilator Use | 14 days | Defined as days the patient is placed on non-invasive ventilator support (CPAP or BiPAP), excluding routine CPAP use for sleep apnea. |
| Days of Non-rebreather Mask Oxygen Supplementation | 14 days | Defined as the number of days the subject was on a non-rebreather mask. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hydroxychloroquine Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5) | 67 |
| Placebo Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5 | 61 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-Up (Day 14) | 7 | 4 |
| Overall Study | Lost to Follow-Up (Day 30) | 7 | 7 |
Baseline characteristics
| Characteristic | Placebo | Total | Hydroxychloroquine |
|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 16 | 66.2 years STANDARD_DEVIATION 16.2 | 66.5 years STANDARD_DEVIATION 16.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 50 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 78 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 10 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 25 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 25 Participants | 50 Participants | 25 Participants |
| Race (NIH/OMB) White | 18 Participants | 41 Participants | 23 Participants |
| Sex: Female, Male Female | 30 Participants | 52 Participants | 22 Participants |
| Sex: Female, Male Male | 31 Participants | 76 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 67 | 6 / 61 |
| other Total, other adverse events | 32 / 67 | 30 / 61 |
| serious Total, serious adverse events | 10 / 67 | 10 / 61 |
Outcome results
Primary
Percent of Participants Showing a Severe Disease Progression Composite Outcome
Including any of the following: mortality, ICU admission, invasive mechanical ventilation, ECMO, and/or hypotension requiring vasopressor support by the 14-day post-treatment evaluation (PTE). The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100).
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydroxychloroquine | Percent of Participants Showing a Severe Disease Progression Composite Outcome | 18.30 percentage of participants |
| Placebo | Percent of Participants Showing a Severe Disease Progression Composite Outcome | 10.50 percentage of participants |
Primary
Percent of Participants With Discontinuation of Therapy (for Any Reason)
The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100)
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydroxychloroquine | Percent of Participants With Discontinuation of Therapy (for Any Reason) | 23.90 percentage of participants |
| Placebo | Percent of Participants With Discontinuation of Therapy (for Any Reason) | 24.6 percentage of participants |
Primary
Percent of Participants With Grade 3 or 4 AEs Through Day 30
The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100)
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydroxychloroquine | Percent of Participants With Grade 3 or 4 AEs Through Day 30 | 13.40 percentage of participants |
| Placebo | Percent of Participants With Grade 3 or 4 AEs Through Day 30 | 13.10 percentage of participants |
Primary
Percent of Participants With SAE Through Day 30
The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100)
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydroxychloroquine | Percent of Participants With SAE Through Day 30 | 14.90 percentage of participants |
| Placebo | Percent of Participants With SAE Through Day 30 | 16.40 percentage of participants |
Secondary
Change in Alanine Aminotransferase (ALT) Levels
Biochemistry lab-work will be completed to obtain ALT levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Time frame: Baseline, 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydroxychloroquine | Change in Alanine Aminotransferase (ALT) Levels | 19.3 U/L | Standard Deviation 52.8 |
| Placebo | Change in Alanine Aminotransferase (ALT) Levels | 8.3 U/L | Standard Deviation 30.4 |
Secondary
Change in Aspartate Aminotransferase (AST) Levels
Biochemistry lab-work will be completed to obtain AST levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Time frame: Baseline, 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydroxychloroquine | Change in Aspartate Aminotransferase (AST) Levels | -1.52 U/L | Standard Deviation 66.2 |
| Placebo | Change in Aspartate Aminotransferase (AST) Levels | 3.66 U/L | Standard Deviation 35.3 |
Secondary
Change in C-Reactive Protein (CRP) Levels
Biochemistry lab-work will be completed to obtain CRP levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Time frame: Baseline, 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydroxychloroquine | Change in C-Reactive Protein (CRP) Levels | -21.8 mg/L | Standard Deviation 77.7 |
| Placebo | Change in C-Reactive Protein (CRP) Levels | -23.8 mg/L | Standard Deviation 113 |
Secondary
Change in Creatinine Levels
Biochemistry lab-work will be completed to obtain Creatinine levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Time frame: Baseline, 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydroxychloroquine | Change in Creatinine Levels | 0.0198 mg/dL | Standard Deviation 1.2 |
| Placebo | Change in Creatinine Levels | -0.169 mg/dL | Standard Deviation 1.19 |
Secondary
Change in Glucose Levels
Biochemistry lab-work will be completed to obtain Glucose levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Time frame: Baseline, 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydroxychloroquine | Change in Glucose Levels | 2.69 mg/dL | Standard Deviation 47.4 |
| Placebo | Change in Glucose Levels | -15.7 mg/dL | Standard Deviation 39.7 |
Secondary
Change in Hemoglobin Levels
Hematology lab-work will be completed to obtain hemoglobin levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Time frame: Baseline, 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydroxychloroquine | Change in Hemoglobin Levels | -0.5 gm/dL | Standard Deviation 1.07 |
| Placebo | Change in Hemoglobin Levels | -0.443 gm/dL | Standard Deviation 1.17 |
Secondary
Change in Interleukin 6 (IL-6) Levels
Biochemistry lab-work will be completed to obtain IL-6 levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Time frame: Baseline, 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydroxychloroquine | Change in Interleukin 6 (IL-6) Levels | 85.6 pg/ml | Standard Deviation 245 |
| Placebo | Change in Interleukin 6 (IL-6) Levels | 19.3 pg/ml | Standard Deviation 101 |
Secondary
Change in Lactate Dehydrogenase (LDH) Levels
Biochemistry lab-work will be completed to obtain LDH levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Time frame: Baseline, 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydroxychloroquine | Change in Lactate Dehydrogenase (LDH) Levels | -2.65 U/L | Standard Deviation 153 |
| Placebo | Change in Lactate Dehydrogenase (LDH) Levels | -45.1 U/L | Standard Deviation 162 |
Secondary
Change in Platelet Count
Hematology lab-work will be completed to obtain platelet count (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Time frame: Baseline, 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydroxychloroquine | Change in Platelet Count | 63.4 platelets per 10^6 L | Standard Deviation 110 |
| Placebo | Change in Platelet Count | 65.8 platelets per 10^6 L | Standard Deviation 100 |
Secondary
Change in Total Bilirubin Levels
Biochemistry lab-work will be completed to obtain bilirubin levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Time frame: Baseline, 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydroxychloroquine | Change in Total Bilirubin Levels | -0.183 mg/dL | Standard Deviation 0.819 |
| Placebo | Change in Total Bilirubin Levels | -0.0509 mg/dL | Standard Deviation 0.619 |
Secondary
Change in White Blood Cell (WBC) Count
Hematology lab-work will be completed to obtain WBC count (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Time frame: Baseline, 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydroxychloroquine | Change in White Blood Cell (WBC) Count | -0.0868 cells per 10^6 L | Standard Deviation 3.86 |
| Placebo | Change in White Blood Cell (WBC) Count | -0.0839 cells per 10^6 L | Standard Deviation 3.27 |
Secondary
Days of Fever
Defined as number of days with temperature \>100.4 degrees Fahrenheit.
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hydroxychloroquine | Days of Fever | 0 days |
| Placebo | Days of Fever | 0 days |
Secondary
Days of Non-invasive Ventilator Use
Defined as days the patient is placed on non-invasive ventilator support (CPAP or BiPAP), excluding routine CPAP use for sleep apnea.
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hydroxychloroquine | Days of Non-invasive Ventilator Use | 0 days |
| Placebo | Days of Non-invasive Ventilator Use | 0 days |
Secondary
Days of Non-rebreather Mask Oxygen Supplementation
Defined as the number of days the subject was on a non-rebreather mask.
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hydroxychloroquine | Days of Non-rebreather Mask Oxygen Supplementation | 0 days |
| Placebo | Days of Non-rebreather Mask Oxygen Supplementation | 0 days |
Secondary
Hospital Length of Stay
LOS is defined as the interval (in days) that the patient was admitted to a non-rehabilitation floor, categorized as short (\<7 days), moderate (7-10 days), or extended (\>10 days)
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydroxychloroquine | Hospital Length of Stay | 9.75 days | Standard Deviation 10.3 |
| Placebo | Hospital Length of Stay | 6.8 days | Standard Deviation 5.92 |
Secondary
Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale
Grade 1 (mild) = able to be managed with nonparenteral supportive care, Grade 2 (moderate) = at least one of the following present (hospitalization needed for management of CRS-related symptoms, parenteral nutrition or supportive care required, signs of moderate/severe organ dysfunction), Grade 3 (severe) = hospitalization needed for management of at least one of the following (hypotension, hypoxia, organ dysfunction, coagulopathy), Grade 4 (life-threatening) = at least one of the following present (hypotension requiring high-dose vasopressors, hypoxia requiring mechanical ventilation).
Time frame: Day 1
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hydroxychloroquine | Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale | Mild | 27 Participants |
| Hydroxychloroquine | Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale | Moderate | 25 Participants |
| Hydroxychloroquine | Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale | Severe | 15 Participants |
| Placebo | Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale | Mild | 21 Participants |
| Placebo | Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale | Moderate | 33 Participants |
| Placebo | Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale | Severe | 7 Participants |
Secondary
Percent of Participants Who Required Extracorporeal Membrane Oxygenation (ECMO)
Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100).
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydroxychloroquine | Percent of Participants Who Required Extracorporeal Membrane Oxygenation (ECMO) | 0 percentage of participants |
| Placebo | Percent of Participants Who Required Extracorporeal Membrane Oxygenation (ECMO) | 0 percentage of participants |
Secondary
Percent of Participants Who Required ICU Admission
Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100).
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydroxychloroquine | Percent of Participants Who Required ICU Admission | 17 percentage of participants |
| Placebo | Percent of Participants Who Required ICU Admission | 6 percentage of participants |
Secondary
Percent of Participants Who Required Invasive Mechanical Ventilation
Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100).
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydroxychloroquine | Percent of Participants Who Required Invasive Mechanical Ventilation | 9 percentage of participants |
| Placebo | Percent of Participants Who Required Invasive Mechanical Ventilation | 6 percentage of participants |
Secondary
Percent of Participants With Hypotension Requiring Vasopressor Support
Individual component of severe disease progression composite endpoint evaluated. For incidence, the measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100)
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydroxychloroquine | Percent of Participants With Hypotension Requiring Vasopressor Support | 3.77 percentage of participants |
| Placebo | Percent of Participants With Hypotension Requiring Vasopressor Support | 4 percentage of participants |
Secondary
Percent of Participants With SARS-CoV-2 Viral Eradication From Nasopharyngeal Specimens at EOT
Laboratory endpoint, measured by RT-PCR, reported as the percentage of negative results at day 6
Time frame: 6 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydroxychloroquine | Percent of Participants With SARS-CoV-2 Viral Eradication From Nasopharyngeal Specimens at EOT | 21.60 percentage of participants |
| Placebo | Percent of Participants With SARS-CoV-2 Viral Eradication From Nasopharyngeal Specimens at EOT | 33.30 percentage of participants |
Secondary
Percent of Patients Who Resulted in Mortality
Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100).
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydroxychloroquine | Percent of Patients Who Resulted in Mortality | 13.2 percentage of participants |
| Placebo | Percent of Patients Who Resulted in Mortality | 12 percentage of participants |
Secondary
Percent of Subjects With Q-T Interval, Corrected (qTC) Prolongation at End of Treatment (EOT)
(≥470 milliseconds in men; ≥480 milliseconds in women) on electrocardiogram at EOT (Day 6)
Time frame: 6 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydroxychloroquine | Percent of Subjects With Q-T Interval, Corrected (qTC) Prolongation at End of Treatment (EOT) | 24.4 percentage of participants |
| Placebo | Percent of Subjects With Q-T Interval, Corrected (qTC) Prolongation at End of Treatment (EOT) | 12.8 percentage of participants |