Saved From COVID-19 - Chloroquine (CQ) Prophylaxis for Health Care Workers at Risk for COVID

NCT04349371 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AAAS9992
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to determine the clinical efficacy of Chloroquine (CQ) in health care workers with moderate to high risk of exposure to COVID-19 in preventing symptomatic COVID-19 infections. Secondary endpoints will explore the efficacy of CQ in preventing any infection as defined by seroconversion to positive anti-COVID antibody status.

Conditions

COVID; Coronavirus Infection

Keywords

SARS-CoV-2; Coronavirus

Outcome Measures

Primary Outcomes (1)

• Number of Healthcare Workers With Symptomatic COVID Infections

  Diagnosis is based on symptoms of COVID-19 and confirmatory anti-COVID antibodies and when available, COVID-19 PCR. This is to determine/measure the clinical efficacy of CQ in healthcare workers.

  Up to 3 months

Secondary Outcomes (1)

• Number of Workers and Patients With Infections

  3 months

Study Arms (2)

CQ group

EXPERIMENTAL

Participants will receive CQ supply for 3 months. Patients will receive a supply of 36 -- 250 mg tabs or placebo that will last 3 months (enough for taking two tabs of 250mg for every day for one week and then two tabs of 250mg for 1 day a week thereafter for study duration of 3 months). Subjects with severe GI intolerance can take 1 tablet of 250mg daily for the first week and 1 tablet per week for the remainder of the 3 month study duration. Patients will attend 1 in person visits (month 0) and an additional visit during month 3 if possible with the physician where they will be evaluated for safety assessments including vital signs, physical exams, blood collection, and assessment of endpoints. During month 1, 2, and 3 participants will be followed up regarding concomitant medications and adverse events over the phone call.

Drug: Chloroquine

Placebo group

PLACEBO COMPARATOR

Participants will receive placebo supply for 3 months. Patients will attend 1 in person visits (month 0) and an additional visit during month 3 if possible with the physician where they will be evaluated for safety assessments including vital signs, physical exams, blood collection, and assessment of endpoints. During month 1, 2, and 3 participants will be followed up regarding concomitant medications and adverse events over the phone call.

Drug: Placebo oral tablet

Interventions

Chloroquine DRUG

Subjects will take two tabs of 250mg for every day for one week and then two tabs of 250mg for 1 day a week thereafter for study duration of 3 months). Subjects with severe GI intolerance can take 1 tablet of 250mg daily for the first week and 1 tablet per week for the remainder of the 3 month study duration.

Also known as: CQ

CQ group

Placebo oral tablet DRUG

Subjects will take two tabs of placebo for every day for one week and then two tabs of placebo for 1 day a week thereafter for study duration of 3 months).

Also known as: Placebo pill

Placebo group

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years,
• Employment by New York Presbyterian Hospital
• Clear assignment to areas of the hospital that involve patient contact and possible exposures for at least 2 days a week \>/= 8 hours a day

You may not qualify if:

• Individuals who are taking CQ for other indications
• New use of NSAIDs
• High risk background medications not limited to immunosuppressive regimens, steroids, anti-B cell therapies, anti-cytokine therapies, chemotherapies, Janus Kinase (JAK)-inhibitors
• Individuals with a history of retinopathy that would contraindicate the use of CQ
• Known allergy to CQ or chloroquine
• Known QT prolongation and torsades de point
• Individuals who are pregnant or nursing

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center/NYP

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Chloroquine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Study was stopped early due to poor enrollment. Data was not collected and therefore not analyzed.

Results Point of Contact

• Title: Anca Askanase, MD
• Organization: Columbia University

ada20@cumc.columbia.edu

212-305-0856

Study Officials

• Anca Askanase, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 16, 2020
• Study Start: April 21, 2020
• Primary Completion: February 11, 2021
• Study Completion: February 11, 2021
• Last Updated: February 27, 2025
• Results First Posted: August 13, 2024

Record last verified: 2025-02

Locations

US (1)