Trial Outcomes & Findings for Efficacy of Hydroxychloroquine Prophylaxis for Health Care Workers at High Risk for COVID-19 (NCT NCT04435808)

NCT ID: NCT04435808

Last Updated: 2022-02-14

Results Overview

Number of health care workers who become infected with SARS-CoV-2 as detected by PCR

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2022-02-14

Participant Flow

Participant milestones

Measure	Hydroxychloroquine Arm Group A: 0 health care workers who chose to take hydroxychloroquine Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria. Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily	No Intervention Arm Group B: 1 health care worker who chose not to take hydroxychloroquine
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Hydroxychloroquine Arm Group A: 0 health care workers who chose to take hydroxychloroquine Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria. Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily	No Intervention Arm Group B: 1 health care worker who chose not to take hydroxychloroquine
Overall Study Study stopped by DSMB	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Hydroxychloroquine Arm Group A: 0 health care workers who choose to take hydroxychloroquine Hydroxychloroquine: Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria. Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily	No Intervention Arm n=1 Participants Group B: 1 health care workers who chose not to take hydroxychloroquine	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	0 Participants	1 Participants n=1 Participants	1 Participants n=1 Participants
Age, Categorical >=65 years	0 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Sex: Female, Male Female	0 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Sex: Female, Male Male	0 Participants	1 Participants n=1 Participants	1 Participants n=1 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	—	1 participants n=1 Participants	1 participants n=1 Participants

PRIMARY outcome

Timeframe: 3 months

Population: DSMB stopped trial early prior to any data collection.

Number of health care workers who become infected with SARS-CoV-2 as detected by PCR

Outcome measures

Outcome data not reported

Adverse Events

Hydroxychloroquine Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Intervention Arm

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

Walter Dehority

The University of New Mexico School of Medicine

Phone: 5052725535

Email: wdehority@salud.unm.edu

Results disclosure agreements

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