COVID-19 PrEP HCW HCQ Study

NCT04354870 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: s20-00390
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Number of Participants With of AEs or SAEs Possibly, Probably, or Definitely Related to HCQ Upon Study Termination Time

  Day 90

Study Arms (2)

HCQ Group

EXPERIMENTAL

Approximately 300 Health Care Workers (HCW) who choose to be provided HCQ

Drug: Hydroxychloroquine (HCQ)

Control Group

NO INTERVENTION

approximately 50 HCW who choose not to be provided HCQ

Interventions

Hydroxychloroquine (HCQ) DRUG

Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days

HCQ Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related 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: 201.

  RESULT

Related Links

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

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: H. Michael Belmont, MD
• Organization: NYU Langone Health - Bellevue Hospital

Michael.Belmont@nyulangone.org

646-501-7400

Study Officials

• H. Michael Belmont, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 21, 2020
• Study Start: April 3, 2020
• Primary Completion: September 15, 2020
• Study Completion: October 1, 2020
• Last Updated: December 14, 2022
• Results First Posted: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)