Trial Outcomes & Findings for Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection (NCT NCT04372017)
NCT ID: NCT04372017
Last Updated: 2021-12-10
Results Overview
Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in healthcare workers who have been exposed to a known case of COVID-19.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1 participants
Primary outcome timeframe
At enrollment completion outcome 1 will be analyzed.
Results posted on
2021-12-10
Participant Flow
Participant milestones
| Measure |
Cohort A: Healthcare Worker (Hydroxychloroquine)
Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
|
Cohort A: Healthcare Worker (Placebo)
Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
|
Cohort B: High-Risk Participant (Hydroxychloroqine)
Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
|
Cohort B: High-Risk Participant (Placebo)
Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hydroxychloroquine as Post-Exposure Prophylaxis Against COVID-19 Infection
Baseline characteristics by cohort
| Measure |
Cohort A: Healthcare Worker (Hydroxychloroquine)
n=1 Participants
Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
|
Cohort A: Healthcare Worker (Placebo)
Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
|
Cohort B: High-Risk Participant (Hydroxychloroqine)
Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
|
Cohort B: High-Risk Participant (Placebo)
Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
1 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
—
|
—
|
1 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At enrollment completion outcome 1 will be analyzed.Population: No subject data was analyzed. Study was closed early.
Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in healthcare workers who have been exposed to a known case of COVID-19.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At enrollment completion outcome 2 will be analyzed.Population: No subject data was analyzed. Study was closed early.
Determine whether post-exposure prophylaxis with hydroxychloroquine can prevent COVID-19 in high-risk individuals who have been exposed to a known case of COVID-19.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A: Healthcare Worker (Hydroxychloroquine)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort A: Healthcare Worker (Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B: High-Risk Participant (Hydroxychloroqine)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B: High-Risk Participant (Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A: Healthcare Worker (Hydroxychloroquine)
n=1 participants at risk
Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
|
Cohort A: Healthcare Worker (Placebo)
Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
|
Cohort B: High-Risk Participant (Hydroxychloroqine)
Hydroxychloroquine: Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
|
Cohort B: High-Risk Participant (Placebo)
Vitamin D: Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 12 months after day 1.
No enrollments to Cohort B. No enrollments to Cohort A (Healthcare Worker-Placebo). CT CAE criteria was used for the 1 participant on Cohort A (Healthcare Worker-Hydroxychloroquine)
|
—
0/0 • Adverse events were collected from Day 1 of treatment through 12 months after day 1.
No enrollments to Cohort B. No enrollments to Cohort A (Healthcare Worker-Placebo). CT CAE criteria was used for the 1 participant on Cohort A (Healthcare Worker-Hydroxychloroquine)
|
—
0/0 • Adverse events were collected from Day 1 of treatment through 12 months after day 1.
No enrollments to Cohort B. No enrollments to Cohort A (Healthcare Worker-Placebo). CT CAE criteria was used for the 1 participant on Cohort A (Healthcare Worker-Hydroxychloroquine)
|
—
0/0 • Adverse events were collected from Day 1 of treatment through 12 months after day 1.
No enrollments to Cohort B. No enrollments to Cohort A (Healthcare Worker-Placebo). CT CAE criteria was used for the 1 participant on Cohort A (Healthcare Worker-Hydroxychloroquine)
|
|
Gastrointestinal disorders
Stomach pain
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 12 months after day 1.
No enrollments to Cohort B. No enrollments to Cohort A (Healthcare Worker-Placebo). CT CAE criteria was used for the 1 participant on Cohort A (Healthcare Worker-Hydroxychloroquine)
|
—
0/0 • Adverse events were collected from Day 1 of treatment through 12 months after day 1.
No enrollments to Cohort B. No enrollments to Cohort A (Healthcare Worker-Placebo). CT CAE criteria was used for the 1 participant on Cohort A (Healthcare Worker-Hydroxychloroquine)
|
—
0/0 • Adverse events were collected from Day 1 of treatment through 12 months after day 1.
No enrollments to Cohort B. No enrollments to Cohort A (Healthcare Worker-Placebo). CT CAE criteria was used for the 1 participant on Cohort A (Healthcare Worker-Hydroxychloroquine)
|
—
0/0 • Adverse events were collected from Day 1 of treatment through 12 months after day 1.
No enrollments to Cohort B. No enrollments to Cohort A (Healthcare Worker-Placebo). CT CAE criteria was used for the 1 participant on Cohort A (Healthcare Worker-Hydroxychloroquine)
|
|
Infections and infestations
infections and infestations - Other, specify
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from Day 1 of treatment through 12 months after day 1.
No enrollments to Cohort B. No enrollments to Cohort A (Healthcare Worker-Placebo). CT CAE criteria was used for the 1 participant on Cohort A (Healthcare Worker-Hydroxychloroquine)
|
—
0/0 • Adverse events were collected from Day 1 of treatment through 12 months after day 1.
No enrollments to Cohort B. No enrollments to Cohort A (Healthcare Worker-Placebo). CT CAE criteria was used for the 1 participant on Cohort A (Healthcare Worker-Hydroxychloroquine)
|
—
0/0 • Adverse events were collected from Day 1 of treatment through 12 months after day 1.
No enrollments to Cohort B. No enrollments to Cohort A (Healthcare Worker-Placebo). CT CAE criteria was used for the 1 participant on Cohort A (Healthcare Worker-Hydroxychloroquine)
|
—
0/0 • Adverse events were collected from Day 1 of treatment through 12 months after day 1.
No enrollments to Cohort B. No enrollments to Cohort A (Healthcare Worker-Placebo). CT CAE criteria was used for the 1 participant on Cohort A (Healthcare Worker-Hydroxychloroquine)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place