Phase 2 N=130 Treatment

COVID-19 PrEP HCW HCQ Study

COVID-19

Bottom Line

View on ClinicalTrials.gov: NCT04354870 ↗

Enrolled (actual)

130

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month — 4; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Hydroxychloroquine (HCQ) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Sep 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Number of Participants With Seroconversion to SARS-CoV-2 at 1 Month	4; 2	—
PRIMARY Number of Participants With Symptomatic vs. Asymptomatic Seroconversion	1; 2; 3; 0	—
SECONDARY Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time	8; 0; 0; 0	—

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.

Eligibility 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04354870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.