COVID-19 PrEP HCW HCQ Study

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT04354870
Collaborator
(none)
130
1
2
5.9
21.9

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
  • Drug: Hydroxychloroquine (HCQ)
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

Study Type:
Interventional
Actual Enrollment :
130 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Total number of participant: 350 (Group A and B) Group A: projected 300 (HCW choose to be provided HCQ) Group B: projected 50 (HCW choose not to be provided HCQ)Total number of participant: 350 (Group A and B) Group A: projected 300 (HCW choose to be provided HCQ) Group B: projected 50 (HCW choose not to be provided HCQ)
Masking:
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Treatment
Official Title:
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 Among Health Care Workers (HCWs) Who Are at High Risk of Occupational Exposure to SARS-CoV-2
Actual Study Start Date :
Apr 3, 2020
Actual Primary Completion Date :
Sep 15, 2020
Actual Study Completion Date :
Oct 1, 2020

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

  1. 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.

  2. 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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria for Group A and B

  • Men or women ages ≥18 years NYULH health care worker who meets one of the following criteria
  1. 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

  2. Direct bedside care of confirmed COVID-19 patient while wearing PPE for 3 or more shifts in a 7 day period

  3. 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

  1. amiodarone

  2. digoxin

  3. flecainide

  4. procainamide

  5. 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.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04354870
Other Study ID Numbers:
  • s20-00390
First Posted:
Apr 21, 2020
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

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

1. Primary Outcome
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%
2. Primary Outcome
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%
3. Secondary Outcome
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

[Not Specified]

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
Email Michael.Belmont@nyulangone.org
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04354870
Other Study ID Numbers:
  • s20-00390
First Posted:
Apr 21, 2020
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021