COVID-19 PrEP HCW HCQ Study

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354870
• Other study ID #: s20-00390
• Status: Completed
• Phase: Phase 2
• Start date: April 3, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 1, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Hydroxychloroquine (HCQ)
Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

Raabe VN, Fleming A, Samanovic MI, Lai L, Belli HM, et al. (2022) Hydroxychloroquine Pre-Exposure Prophylaxis to Prevent SARS-CoV-2 Among Health Care Workers at High Risk For SARS-CoV-2 Exposure: A Nonrandomized Controlled Trial. Infect Dis Diag Treat 6:

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month	Antibody titers will be measured to determine seroconversion, a binomial endpoint defined by a four-fold increase in antibody titers compared to baseline.	Baseline to 1 month post-baseline
Primary	Number of Participants With Symptomatic vs. Asymptomatic Seroconversion	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).	4 Weeks Prior to Baseline
Secondary	Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time	To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population	Day 90

External Links

•   DOI: https://doi.org/10.29011/2577-1515.100201.