Trial Outcomes & Findings for Hydroxychloroquine as Chemoprevention for COVID-19 for High Risk Healthcare Workers (NCT NCT04345653)

Last Updated: 2021-05-12

Results Overview

To evaluate the feasibility of this protocol including participants' recruitment within the estimated time frame, i.e. understand the ability of the team to identify eligible participants, enroll them, retain them and follow them up until study completion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

Study period, up to two months from the day the first participant was screened

Results posted on

2021-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	Study Arm - Hydroxychloroquine Sulfate (HCQ) HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth Hydroxychloroquine Sulfate (HCQ): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.
Overall Study STARTED	48
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Arm - Hydroxychloroquine Sulfate (HCQ) HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth Hydroxychloroquine Sulfate (HCQ): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Hydroxychloroquine as Chemoprevention for COVID-19 for High Risk Healthcare Workers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Arm - Hydroxychloroquine Sulfate (HCQ) n=46 Participants HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth Hydroxychloroquine Sulfate (HCQ): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.5 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 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	23 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

Timeframe: Study period, up to two months from the day the first participant was screened

Population: High risk healthcare providers

Outcome measures

Outcome measures
Measure	Study Arm n=46 Participants HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth Hydroxychloroquine Sulfate (HCQ): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.
Recruitment Feasibility	46 Participants

PRIMARY outcome

Timeframe: Study period, up to two months from the day the first participant was screened

To evaluate the utilization of tests and drug for this study in consideration with the limited availability of both for research purposes as reflected on the number of participants that got tested and received at least one dose of the drug.

Outcome measures

Outcome measures
Measure	Study Arm n=46 Participants HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth Hydroxychloroquine Sulfate (HCQ): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.
Resource Utilization	46 Participants

PRIMARY outcome

Timeframe: 28 day post enrollment

Population: High risk healthcare providers

To Determine the Safety profile for a previously well studied drug in this select group of HCP. Incidence of well described side effects would be studied over the course of the study and will be compared with the side effects and their prevalence as described in the Pharmacy manual for HCQ.

Outcome measures

Outcome measures
Measure	Study Arm n=46 Participants HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth Hydroxychloroquine Sulfate (HCQ): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.
Safety as Reflected on the Number and Severity of Adverse Events and Serious Adverse Events Serious Adverse events	0 Adverse Events
Safety as Reflected on the Number and Severity of Adverse Events and Serious Adverse Events Adverse events	24 Adverse Events

PRIMARY outcome

Timeframe: 28 day post enrollment

To evaluate the early efficacy of HCQ in high-risk, healthy volunteers in the prevention of acquiring COVID-19 while continuing to follow standard precautions that meet or exceed Centers of Disease Control (CDC) guidelines.

Outcome measures

Outcome measures
Measure	Study Arm n=46 Participants HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth Hydroxychloroquine Sulfate (HCQ): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.
Early Feasibility as Reflected on the Number of Participants Contracting COVID-19 (10% or Less) in Comparison to the Expected 30% as Per CDC.	0 participants

Adverse Events

Study Arm - Hydroxychloroquine Sulfate (HCQ)

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Study Arm - Hydroxychloroquine Sulfate (HCQ) n=46 participants at risk HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth Hydroxychloroquine Sulfate (HCQ): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.
Gastrointestinal disorders Abdominal pain	4.3% 2/46 • Number of events 2 • Overall follow up period: 6 month
Gastrointestinal disorders Diarrhea	10.9% 5/46 • Number of events 5 • Overall follow up period: 6 month
Gastrointestinal disorders Nausea	6.5% 3/46 • Number of events 3 • Overall follow up period: 6 month
General disorders Fatigue	8.7% 4/46 • Number of events 4 • Overall follow up period: 6 month
Skin and subcutaneous tissue disorders Rash	4.3% 2/46 • Number of events 2 • Overall follow up period: 6 month
Nervous system disorders Headaches	6.5% 3/46 • Number of events 3 • Overall follow up period: 6 month
Cardiac disorders Shortness of breath and chest pain	8.7% 4/46 • Number of events 4 • Overall follow up period: 6 month
Skin and subcutaneous tissue disorders Alopecia	2.2% 1/46 • Number of events 1 • Overall follow up period: 6 month
Psychiatric disorders Mood Disorder	4.3% 2/46 • Number of events 2 • Overall follow up period: 6 month

Additional Information

Dr. Jawad Kirmani

JFK University Medical Center - Hackensack Meridian Health

Phone: 7327745805

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place