Trial Outcomes & Findings for Treating COVID-19 With Hydroxychloroquine (TEACH) (NCT NCT04369742)

NCT ID: NCT04369742

Last Updated: 2022-04-22

Results Overview

The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100)

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 128 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2022-04-22

Participant Flow

Participant milestones

Measure	Hydroxychloroquine Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Overall Study STARTED	67	61
Overall Study COMPLETED	53	50
Overall Study NOT COMPLETED	14	11

Reasons for withdrawal

Measure	Hydroxychloroquine Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Overall Study Lost to Follow-Up (Day 14)	7	4
Overall Study Lost to Follow-Up (Day 30)	7	7

Baseline Characteristics

Treating COVID-19 With Hydroxychloroquine (TEACH)

Baseline characteristics by cohort

Measure	Hydroxychloroquine n=67 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=61 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5	Total n=128 Participants Total of all reporting groups
Age, Continuous	66.5 years STANDARD_DEVIATION 16.4 • n=5 Participants	65.8 years STANDARD_DEVIATION 16 • n=7 Participants	66.2 years STANDARD_DEVIATION 16.2 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	30 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	31 Participants n=7 Participants	76 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	36 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	18 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100)

Outcome measures

Measure	Hydroxychloroquine n=67 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=61 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Percent of Participants With SAE Through Day 30	14.90 percentage of participants	16.40 percentage of participants

PRIMARY outcome

Timeframe: 30 days

The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100)

Outcome measures

Measure	Hydroxychloroquine n=67 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=61 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Percent of Participants With Grade 3 or 4 AEs Through Day 30	13.40 percentage of participants	13.10 percentage of participants

PRIMARY outcome

Timeframe: 30 days

The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100)

Outcome measures

Measure	Hydroxychloroquine n=67 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=61 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Percent of Participants With Discontinuation of Therapy (for Any Reason)	23.90 percentage of participants	24.6 percentage of participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=60 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=57 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Percent of Participants Showing a Severe Disease Progression Composite Outcome	18.30 percentage of participants	10.50 percentage of participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Hydroxychloroquine n=67 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=61 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Hospital Length of Stay	9.75 days Standard Deviation 10.3	6.8 days Standard Deviation 5.92

SECONDARY outcome

Timeframe: 14 days

Defined as number of days with temperature >100.4 degrees Fahrenheit.

Outcome measures

Measure	Hydroxychloroquine n=67 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=59 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Days of Fever	0 days Interval 0.0 to 5.0	0 days Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 14 days

Defined as days the patient is placed on non-invasive ventilator support (CPAP or BiPAP), excluding routine CPAP use for sleep apnea.

Outcome measures

Measure	Hydroxychloroquine n=67 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=61 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Days of Non-invasive Ventilator Use	0 days Interval 0.0 to 4.0	0 days Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 14 days

Defined as the number of days the subject was on a non-rebreather mask.

Outcome measures

Measure	Hydroxychloroquine n=67 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=61 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Days of Non-rebreather Mask Oxygen Supplementation	0 days Interval 0.0 to 6.0	0 days Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=67 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=61 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale Mild	27 Participants	21 Participants
Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale Moderate	25 Participants	33 Participants
Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale Severe	15 Participants	7 Participants

SECONDARY outcome

Timeframe: 6 Days

(≥470 milliseconds in men; ≥480 milliseconds in women) on electrocardiogram at EOT (Day 6)

Outcome measures

Measure	Hydroxychloroquine n=41 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=39 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Percent of Subjects With Q-T Interval, Corrected (qTC) Prolongation at End of Treatment (EOT)	24.4 percentage of participants	12.8 percentage of participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=53 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=50 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Percent of Patients Who Resulted in Mortality	13.2 percentage of participants	12 percentage of participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=53 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=50 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Percent of Participants Who Required ICU Admission	17 percentage of participants	6 percentage of participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=53 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=50 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Percent of Participants Who Required Invasive Mechanical Ventilation	9 percentage of participants	6 percentage of participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=53 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=50 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Percent of Participants Who Required Extracorporeal Membrane Oxygenation (ECMO)	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Hydroxychloroquine n=53 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=50 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Percent of Participants With Hypotension Requiring Vasopressor Support	3.77 percentage of participants	4 percentage of participants

SECONDARY outcome

Timeframe: 6 days

Laboratory endpoint, measured by RT-PCR, reported as the percentage of negative results at day 6

Outcome measures

Measure	Hydroxychloroquine n=37 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=30 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Percent of Participants With SARS-CoV-2 Viral Eradication From Nasopharyngeal Specimens at EOT	21.60 percentage of participants	33.30 percentage of participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=58 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=44 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Change in Alanine Aminotransferase (ALT) Levels	19.3 U/L Standard Deviation 52.8	8.3 U/L Standard Deviation 30.4

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=58 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=44 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Change in Aspartate Aminotransferase (AST) Levels	-1.52 U/L Standard Deviation 66.2	3.66 U/L Standard Deviation 35.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=64 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=57 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Change in Creatinine Levels	0.0198 mg/dL Standard Deviation 1.2	-0.169 mg/dL Standard Deviation 1.19

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=64 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=56 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Change in Glucose Levels	2.69 mg/dL Standard Deviation 47.4	-15.7 mg/dL Standard Deviation 39.7

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=63 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=56 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Change in White Blood Cell (WBC) Count	-0.0868 cells per 10^6 L Standard Deviation 3.86	-0.0839 cells per 10^6 L Standard Deviation 3.27

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=63 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=56 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Change in Hemoglobin Levels	-0.5 gm/dL Standard Deviation 1.07	-0.443 gm/dL Standard Deviation 1.17

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=63 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=56 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Change in Platelet Count	63.4 platelets per 10^6 L Standard Deviation 110	65.8 platelets per 10^6 L Standard Deviation 100

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=52 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=43 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Change in Total Bilirubin Levels	-0.183 mg/dL Standard Deviation 0.819	-0.0509 mg/dL Standard Deviation 0.619

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=53 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=52 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Change in Lactate Dehydrogenase (LDH) Levels	-2.65 U/L Standard Deviation 153	-45.1 U/L Standard Deviation 162

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=55 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=50 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Change in C-Reactive Protein (CRP) Levels	-21.8 mg/L Standard Deviation 77.7	-23.8 mg/L Standard Deviation 113

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Hydroxychloroquine n=25 Participants Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=19 Participants Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Change in Interleukin 6 (IL-6) Levels	85.6 pg/ml Standard Deviation 245	19.3 pg/ml Standard Deviation 101

Adverse Events

Hydroxychloroquine

Serious events: 10 serious events

Other events: 32 other events

Deaths: 7 deaths

Placebo

Serious events: 10 serious events

Other events: 30 other events

Deaths: 6 deaths

Serious adverse events

Measure	Hydroxychloroquine n=67 participants at risk Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=61 participants at risk Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Renal and urinary disorders Acute renal failure	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Alcohol withdrawal syndrome	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Nervous system disorders Cerebral hemorrhage	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Cardiac disorders Congestive heart failure	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Death	10.4% 7/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	9.8% 6/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Infections and infestations Diverticulitis	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Cardiac disorders Electrocardiogram QTc interval prolonged	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Hospice care	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Infections and infestations Hospital acquired hyponatremia	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Hospitalization	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Hyperkalemia	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Infections and infestations Intra-abdominal abscess	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Blood and lymphatic system disorders Pulmonary embolus	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Nervous system disorders stroke	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Nervous system disorders Subdural hematoma	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Nervous system disorders Subdural hemorrhage	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Syncope	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)

Other adverse events

Measure	Hydroxychloroquine n=67 participants at risk Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)	Placebo n=61 participants at risk Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Gastrointestinal disorders Abdominal pain	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Renal and urinary disorders Acute kidney injury	3.0% 2/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	3.3% 2/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Reproductive system and breast disorders Bleeding vaginal	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Cardiac disorders Bradycardia	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	3.3% 2/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Chest pain	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Gastrointestinal disorders Constipation	9.0% 6/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	6.6% 4/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Deliria (incl confusion)	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Psychiatric disorders Depression	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Endocrine disorders Diabetes mellitus (incl subtypes)	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Gastrointestinal disorders Diarrhea	6.0% 4/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	6.6% 4/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Skin and subcutaneous tissue disorders Dry mouth	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Blood and lymphatic system disorders DVT	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Cardiac disorders Electrocardiogram QTc interval prolonged	3.0% 2/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Electrolytes NOS abnormal	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Hepatobiliary disorders Elevated liver enzyme levels	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Epistaxis	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Fall	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Gastrointestinal disorders Gastrointestinal hemorrhage	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Nervous system disorders Headache	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	3.3% 2/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Hematoma	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Immune system disorders Hives	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Hyperkalemia	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	4.9% 3/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Hypokalemia	3.0% 2/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	3.3% 2/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Hypomagnesemia	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Hyponatremia	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Hypotension	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Respiratory, thoracic and mediastinal disorders Hypoxia	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Respiratory, thoracic and mediastinal disorders Increased shortness of breath	4.5% 3/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Skin and subcutaneous tissue disorders Injection site pain	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Musculoskeletal and connective tissue disorders Muscle pain	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Gastrointestinal disorders Nausea and/or vomiting	10.4% 7/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	3.3% 2/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Cardiac disorders Non-sustained ventricular tachycardia	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Skin and subcutaneous tissue disorders Rash	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	6.6% 4/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Infections and infestations Staphylococcal pneumonia	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Cardiac disorders Supraventricular tachycardia	0.00% 0/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	1.6% 1/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
General disorders Syncope	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
Infections and infestations Vaginal yeast infection	1.5% 1/67 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)	0.00% 0/61 • 30 days Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)

Additional Information

Mark Mulligan, MD

NYU Langone Health

Phone: (212) 263-5182

Email: Mark.mulligan@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place