Trial Outcomes & Findings for Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP) (NCT NCT04328961)

NCT ID: NCT04328961

Last Updated: 2021-12-16

Results Overview

Polymerase chain reaction (PCR) confirmed severe acute respiratory syndrome coronavirus 2 of the genus Betacoronavirus (SARS-CoV-2) infection from self-collected samples collected daily for 14 days

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 943 participants
• Primary outcome timeframe: Day 1 through Day 14 after enrolment
• Results posted on: 2021-12-16

Participant Flow

949 participants were assessed for eligibility, 114 were excluded and 829 were randomized.

Participant milestones

Measure	Ascorbic Acid Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.	Hydroxychloroquine Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
Overall Study STARTED	422	407
Overall Study COMPLETED	336	353
Overall Study NOT COMPLETED	86	54

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)

Baseline characteristics by cohort

Measure	Ascorbic Acid n=336 Participants Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.	Hydroxychloroquine n=353 Participants Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy	Total n=689 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	307 Participants n=5 Participants	322 Participants n=7 Participants	629 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants
Age, Continuous	38 Years n=5 Participants	40 Years n=7 Participants	39 Years n=5 Participants
Sex: Female, Male Female	197 Participants n=5 Participants	215 Participants n=7 Participants	412 Participants n=5 Participants
Sex: Female, Male Male	139 Participants n=5 Participants	138 Participants n=7 Participants	277 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	86 Participants n=5 Participants	69 Participants n=7 Participants	155 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	250 Participants n=5 Participants	284 Participants n=7 Participants	534 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	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Asian	43 Participants n=5 Participants	30 Participants n=7 Participants	73 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	34 Participants n=5 Participants	20 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) White	160 Participants n=5 Participants	209 Participants n=7 Participants	369 Participants n=5 Participants
Race (NIH/OMB) More than one race	86 Participants n=5 Participants	69 Participants n=7 Participants	155 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	17 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	336 participants n=5 Participants	353 participants n=7 Participants	689 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 14 after enrolment

Population: The above participants qualified for the Modified Intention-to-Treat Cohort

Polymerase chain reaction (PCR) confirmed severe acute respiratory syndrome coronavirus 2 of the genus Betacoronavirus (SARS-CoV-2) infection from self-collected samples collected daily for 14 days

Outcome measures

Measure	Ascorbic Acid n=336 Participants Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.	Hydroxychloroquine n=353 Participants Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection	45 Participants	53 Participants

PRIMARY outcome

Timeframe: Day 28 after enrolment

Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit

Outcome measures

Measure	Ascorbic Acid n=336 Participants Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.	Hydroxychloroquine n=353 Participants Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
The Number of Participants Who Had Polymerase Chain Reaction (PCR) Confirmed SARS-CoV-2 Infection	48 Participants	58 Participants

SECONDARY outcome

Timeframe: 28 days from start of Hydroxychloroquine therapy

Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults

Outcome measures

Measure	Ascorbic Acid n=336 Participants Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.	Hydroxychloroquine n=353 Participants Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
Rate of Participant-reported Adverse Events	46 Participants	66 Participants

SECONDARY outcome

Timeframe: 28 days from enrolment

Participants who had a PCR-confirmed SARS-CoV-2 infection and met the Center for Disease Control (CDC) defined criteria for symptomatic COVID-19 disease.

Outcome measures

Measure	Ascorbic Acid n=336 Participants Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.	Hydroxychloroquine n=353 Participants Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
Number of Participants Who Had COVID-19 Disease	26 Participants	37 Participants

Adverse Events

Ascorbic Acid

Serious events: 2 serious events

Other events: 46 other events

Deaths: 0 deaths

Hydroxychloroquine

Serious events: 2 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ascorbic Acid n=422 participants at risk Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.	Hydroxychloroquine n=407 participants at risk Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
Infections and infestations Hospitalizations	0.24% 1/422 • Number of events 1 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.	0.25% 1/407 • Number of events 1 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.
Immune system disorders Allergic Reaction	0.24% 1/422 • Number of events 1 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.	0.25% 1/407 • Number of events 1 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.

Other adverse events

Measure	Ascorbic Acid n=422 participants at risk Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.	Hydroxychloroquine n=407 participants at risk Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
Gastrointestinal disorders Diarrhea, abdominal discomfort, or vomiting	1.7% 7/422 • Number of events 7 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.	6.1% 25/407 • Number of events 25 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.
Gastrointestinal disorders Nausea or upset stomach	2.4% 10/422 • Number of events 10 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.	3.4% 14/407 • Number of events 14 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.
Skin and subcutaneous tissue disorders Skin reaction/rash	1.9% 8/422 • Number of events 8 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.	2.7% 11/407 • Number of events 11 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.
General disorders Neurologic reaction: irritability, dizziness, or vertifgo	2.6% 11/422 • Number of events 11 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.	1.5% 6/407 • Number of events 6 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.
General disorders Headache	1.7% 7/422 • Number of events 7 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.	1.2% 5/407 • Number of events 5 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.
General disorders Hot flashes, night sweats, or palpitations	1.4% 6/422 • Number of events 6 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.	0.49% 2/407 • Number of events 2 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.
General disorders Taste change or dry mouth	1.4% 6/422 • Number of events 6 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.	0.25% 1/407 • Number of events 1 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.
General disorders Fatigue	0.47% 2/422 • Number of events 2 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.	0.98% 4/407 • Number of events 4 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.
Eye disorders Visual Changes	0.00% 0/422 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.	0.98% 4/407 • Number of events 4 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.
Immune system disorders Allergic reaction	0.00% 0/422 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.	0.49% 2/407 • Number of events 2 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.
Ear and labyrinth disorders Tinnitus	0.00% 0/422 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.	0.00% 0/407 • Adverse event data was collected during the period of follow up, which was 28 days. Adverse event collection was obtained through daily surveys completed by participants. If participants were experiencing symptoms they were contacted by study staff for more information.

Additional Information

Ruanne Barnabas

University of Washington

Phone: 206 520 3800

Email: rbarnaba@uw.edu

Results disclosure agreements

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