COVID-19 PrEP HCW HCQ Study
Study Details
Study Description
Brief Summary
Off label study to evaluate the efficacy of HCQ for pre-exposure prophylaxis (PrEP) to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. 350 participants will be assigned to the group that takes HCQ or the group that opts to not take the study medication. Participants will be NYULH HCW at high risk for occupational exposure to SARS-CoV-2. Study timepoints will include screening/enrollment, 30 day, 60 day, and 90 day visits. Questionnaires, and DBS will be collected in all timepoints.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
Hydroxychloroquine (HCQ) is licensed for the chemoprophylaxis and treatment of malaria and as a disease modifying antirheumatic drug. It has a long history of being safe and well tolerated at typical doses. HCQ has antiviral activity in vitro against coronaviruses, and specifically Covid-19. This study is designed to evaluate the efficacy of hydroxychloroquine (HCQ) for pre exposure prophylaxis (PrEP) to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among health care workers at high risk of occupational exposure to SARS-CoV-2 compared to the eligible cohort that declines treatment.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: HCQ Group Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ |
Drug: Hydroxychloroquine (HCQ)
Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
|
No Intervention: Control Group approximately 50 HCW who choose not to be provided HCQ |
Outcome Measures
Primary Outcome Measures
- Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month [Baseline to 1 month post-baseline]
Antibody titers will be measured to determine seroconversion, a binomial endpoint defined by a four-fold increase in antibody titers compared to baseline.
- Number of Participants With Symptomatic vs. Asymptomatic Seroconversion [4 Weeks Prior to Baseline]
To 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).
Secondary Outcome Measures
- Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time [Day 90]
To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population
Eligibility Criteria
Criteria
Inclusion Criteria for Group A and B
- Men or women ages ≥18 years NYULH health care worker who meets one of the following criteria
-
Involved in an aerosol generating procedure (nasopharyngeal specimen collection, tracheal intubation, nebulizer treatment, open airway suctioning, collection of sputum, tracheostomy, bronchoscopy, CPR) on a confirmed COVID-19 patient while wearing PPE
-
Direct bedside care of confirmed COVID-19 patient while wearing PPE for 3 or more shifts in a 7 day period
-
Direct care of PUIs in the ED or other inpatient unit while wearing PPE for 3 or more shifts in a 7 day period
- Willing and able to provide informed consent
Exclusion Criteria for Group A only :
-
Known hypersensitivity to hydroxychloroquine or chloroquine
-
Known diagnosis of COVID-19
-
Concomitant use of
-
amiodarone
-
digoxin
-
flecainide
-
procainamide
-
propafenone
-
History of Torsades de pontes
-
History of retinal disease
-
Known chronic kidney disease ≥ stage 4
-
Congenital prolonged QTc interval syndrome (Jervell and Lange-Nielsen syndrome, Romano-Ward syndrome)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | NYU Langone Health | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: H. Michael Belmont, MD, NYU Langone Health
Study Documents (Full-Text)
More Information
Publications
None provided.- s20-00390
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | HCQ Group | Control Group |
---|---|---|
Arm/Group Description | 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 | approximately 50 HCW who choose not to be provided HCQ |
Period Title: Overall Study | ||
STARTED | 83 | 47 |
COMPLETED | 35 | 14 |
NOT COMPLETED | 48 | 33 |
Baseline Characteristics
Arm/Group Title | HCQ Group | Control Group | Total |
---|---|---|---|
Arm/Group Description | 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 | approximately 50 HCW who choose not to be provided HCQ | Total of all reporting groups |
Overall Participants | 35 | 14 | 49 |
Age (years) [Mean (Full Range) ] | |||
Mean (Full Range) [years] |
43.6
|
43.7
|
43.7
|
Sex: Female, Male (Count of Participants) | |||
Female |
19
54.3%
|
9
64.3%
|
28
57.1%
|
Male |
16
45.7%
|
5
35.7%
|
21
42.9%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
2
5.7%
|
0
0%
|
2
4.1%
|
Not Hispanic or Latino |
33
94.3%
|
14
100%
|
47
95.9%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
5
14.3%
|
5
35.7%
|
10
20.4%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
White |
27
77.1%
|
9
64.3%
|
36
73.5%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
3
8.6%
|
0
0%
|
3
6.1%
|
Outcome Measures
Title | Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month |
---|---|
Description | Antibody titers will be measured to determine seroconversion, a binomial endpoint defined by a four-fold increase in antibody titers compared to baseline. |
Time Frame | Baseline to 1 month post-baseline |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | HCQ Group | Control Group |
---|---|---|
Arm/Group Description | 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 | approximately 50 HCW who choose not to be provided HCQ |
Measure Participants | 56 | 24 |
Count of Participants [Participants] |
4
11.4%
|
2
14.3%
|
Title | Number of Participants With Symptomatic vs. Asymptomatic Seroconversion |
---|---|
Description | To 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). |
Time Frame | 4 Weeks Prior to Baseline |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | HCQ Group | Control Group |
---|---|---|
Arm/Group Description | 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 | approximately 50 HCW who choose not to be provided HCQ |
Measure Participants | 56 | 24 |
Symptomatic Seroconversion |
1
2.9%
|
2
14.3%
|
Asymptomatic Seroconversion |
3
8.6%
|
0
0%
|
Title | Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time |
---|---|
Description | To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population |
Time Frame | Day 90 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | HCQ Group | Control Group |
---|---|---|
Arm/Group Description | 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 | approximately 50 HCW who choose not to be provided HCQ |
Measure Participants | 83 | 47 |
with AEs Related to HCQ |
8
22.9%
|
0
0%
|
with SAEs Related to HCQs |
0
0%
|
0
0%
|
Adverse Events
Time Frame | 90 days | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | HCQ Group | Control Group | ||
Arm/Group Description | 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 | approximately 50 HCW who choose not to be provided HCQ | ||
All Cause Mortality |
||||
HCQ Group | Control Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/83 (0%) | 0/47 (0%) | ||
Serious Adverse Events |
||||
HCQ Group | Control Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/83 (0%) | 0/47 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
HCQ Group | Control Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 8/83 (9.6%) | 0/47 (0%) | ||
Ear and labyrinth disorders | ||||
Tinnitus | 1/83 (1.2%) | 0/47 (0%) | ||
Gastrointestinal disorders | ||||
Diarrhea | 2/83 (2.4%) | 0/47 (0%) | ||
Gastrointestinal Discomfort | 1/83 (1.2%) | 0/47 (0%) | ||
Gastroesophageal Reflux | 1/83 (1.2%) | 0/47 (0%) | ||
General disorders | ||||
Hair Loss | 1/83 (1.2%) | 0/47 (0%) | ||
Appetite Loss | 1/83 (1.2%) | 0/47 (0%) | ||
Skin and subcutaneous tissue disorders | ||||
Itching | 1/83 (1.2%) | 0/47 (0%) | ||
Rash | 1/83 (1.2%) | 0/47 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | H. Michael Belmont, MD |
---|---|
Organization | NYU Langone Health - Bellevue Hospital |
Phone | 646-501-7400 |
Michael.Belmont@nyulangone.org |
- s20-00390