Trial Outcomes & Findings for Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19) (NCT NCT04318444)

Last Updated: 2024-09-25

Results Overview

This is defined as either 1. COVID-19 infection confirmed within 14 days of enrollment, following self-report of COVID-19 symptoms to the research study; OR, 2. COVID-19 infection confirmed within 14 days of enrollment, with self-report of COVID-19 symptoms to a treating physician.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

10 participants

Primary outcome timeframe

Date of enrollment to 14 days post-enrollment date

Results posted on

2024-09-25

Participant Flow

Only 8 completers out of 10 enrolled/consented. 2 participants withdrew consent prior to initiating study intervention.

Participant milestones

Participant milestones
Measure	Hydroxychloroquine Group Participants will take 2 tablets (400mg) of hydroxychloroquine orally twice daily on day 1; for days 2-5, they will be instructed to take 1 tablet (200mg) twice daily.	Placebo Group Participants will take 2 tablets (400mg) of placebo orally twice daily on day 1; for days 2-5, they will be instructed to take 1 tablet (200mg) twice daily.
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydroxychloroquine/Placebo Group n=8 Participants Participants will take 2 tablets (400mg) of either hydroxychloroquine or placebo orally twice daily on day 1. For days 2-5, they will be instructed to take 1 tablet (200mg) of either hydroxychloroquine or placebo orally twice daily.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Date of enrollment to 14 days post-enrollment date

Outcome measures

Outcome measures
Measure	Hydroxychloroquine Group n=4 Participants Participants will take 2 tablets (400mg) of hydroxychloroquine orally twice daily on day 1; for days 2-5, they will be instructed to take 1 tablet (200mg) twice daily.	Placebo Group n=4 Participants Participants will take 2 tablets (400mg) of placebo orally twice daily on day 1; for days 2-5, they will be instructed to take 1 tablet (200mg) twice daily.
Number of Participants With Symptomatic, Lab-confirmed COVID-19.	0 Participants	0 Participants

Adverse Events

Hydroxychloroquine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jon T. Giles, MD

Columbia University

Phone: 212-305-6327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place