Trial Outcomes & Findings for COVID-19 PrEP HCW HCQ Study (NCT NCT04354870)
NCT ID: NCT04354870
Last Updated: 2022-12-14
Results Overview
Antibody titers will be measured to determine seroconversion, a binomial endpoint defined by a four-fold increase in antibody titers compared to baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
Baseline to 1 month post-baseline
Results posted on
2022-12-14
Participant Flow
Participant milestones
| Measure |
HCQ Group
Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ
Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
|
Control Group
approximately 50 HCW who choose not to be provided HCQ
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
47
|
|
Overall Study
COMPLETED
|
35
|
14
|
|
Overall Study
NOT COMPLETED
|
48
|
33
|
Reasons for withdrawal
| Measure |
HCQ Group
Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ
Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
|
Control Group
approximately 50 HCW who choose not to be provided HCQ
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
32
|
12
|
|
Overall Study
Withdrawal by Subject
|
10
|
16
|
|
Overall Study
Did not complete all study visits
|
6
|
5
|
Baseline Characteristics
COVID-19 PrEP HCW HCQ Study
Baseline characteristics by cohort
| Measure |
HCQ Group
n=35 Participants
Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ
Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
|
Control Group
n=14 Participants
approximately 50 HCW who choose not to be provided HCQ
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.6 years
n=5 Participants
|
43.7 years
n=7 Participants
|
43.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
47 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1 month post-baselineAntibody titers will be measured to determine seroconversion, a binomial endpoint defined by a four-fold increase in antibody titers compared to baseline.
Outcome measures
| Measure |
HCQ Group
n=56 Participants
Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ
Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
|
Control Group
n=24 Participants
approximately 50 HCW who choose not to be provided HCQ
|
|---|---|---|
|
Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 4 Weeks Prior to BaselineTo characterize whether high-risk HCW who seroconvert to SARS-CoV-2 have asymptomatic infection or report symptoms of COVID-19 in the 4 weeks preceding seroconversion (assessed by symptom questionnaire).
Outcome measures
| Measure |
HCQ Group
n=56 Participants
Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ
Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
|
Control Group
n=24 Participants
approximately 50 HCW who choose not to be provided HCQ
|
|---|---|---|
|
Number of Participants With Symptomatic vs. Asymptomatic Seroconversion
Symptomatic Seroconversion
|
1 Participants
|
2 Participants
|
|
Number of Participants With Symptomatic vs. Asymptomatic Seroconversion
Asymptomatic Seroconversion
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 90To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population
Outcome measures
| Measure |
HCQ Group
n=83 Participants
Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ
Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
|
Control Group
n=47 Participants
approximately 50 HCW who choose not to be provided HCQ
|
|---|---|---|
|
Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time
with AEs Related to HCQ
|
8 Participants
|
0 Participants
|
|
Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time
with SAEs Related to HCQs
|
0 Participants
|
0 Participants
|
Adverse Events
HCQ Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Control 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
| Measure |
HCQ Group
n=83 participants at risk
Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ
Hydroxychloroquine (HCQ): Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
|
Control Group
n=47 participants at risk
approximately 50 HCW who choose not to be provided HCQ
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
1.2%
1/83 • 90 days
|
0.00%
0/47 • 90 days
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
2/83 • 90 days
|
0.00%
0/47 • 90 days
|
|
Skin and subcutaneous tissue disorders
Itching
|
1.2%
1/83 • 90 days
|
0.00%
0/47 • 90 days
|
|
General disorders
Hair Loss
|
1.2%
1/83 • 90 days
|
0.00%
0/47 • 90 days
|
|
General disorders
Appetite Loss
|
1.2%
1/83 • 90 days
|
0.00%
0/47 • 90 days
|
|
Gastrointestinal disorders
Gastrointestinal Discomfort
|
1.2%
1/83 • 90 days
|
0.00%
0/47 • 90 days
|
|
Gastrointestinal disorders
Gastroesophageal Reflux
|
1.2%
1/83 • 90 days
|
0.00%
0/47 • 90 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/83 • 90 days
|
0.00%
0/47 • 90 days
|
Additional Information
H. Michael Belmont, MD
NYU Langone Health - Bellevue Hospital
Phone: 646-501-7400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place