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

NCT ID: NCT04349371

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-21
• Study Completion Date: 2021-02-11

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.

Detailed Description

Chloroquine (CQ) phosphate is an immunomodulatory drug that has been approved by the FDA for prophylaxis of and treatment of malaria, treatment of lupus erythematosus, and treatment of rheumatoid arthritis. Anecdotal data and in-vitro studies suggests potential benefit of chloroquine in treating COVID-19 patients. The use of CQ to treat COVID-19 patients have been demonstrated to be effective in inhibiting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The use of CQ in health care workers with moderate to high risk of exposure to COVID-19 in could prevent symptomatic COVID 19 infections. 350 participants will be randomized (like a flip of a coin) to a 3 month chloroquine versus an identical course of placebo. A placebo is a sugar pill which has no active ingredient. will attend one in person visit during month 0 for screening and randomization, and if possible during the last visit at month 3. During month 1 and 2 the in person visits are optional and the PI can follow up with subjects through telemedicine or phone call. Informed consent, inclusion/exclusion criteria, demographic, medical/ disease history/ comorbidity/ medical records review, prior/ concomitant meds and procedures, and adverse events will be collected from patient during screening visit 1 (month 0). Limited physical assessment, vitals, blood serum, investigational product compliance review, assessment of adverse events, serious adverse events, adverse events of special interest, and endpoint assessments are also collected during visit 1. Prior/concomitant medications and procedures, adverse events, study drug compliance review, adverse events of special interest, adverse events of special interest and endpoint assessments will be reviewed at every visit. Blood serum will be collected during visits 1 (month 0) and at visit 4 (month 3) if subject can come to the visit physically. By the end of the study, the investigators hope that there is decrease of symptomatic illness in at risk healthcare workers and a decrease in symptomatic COVID infection.

Conditions

COVID; Coronavirus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

CQ group

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.

Group Type: EXPERIMENTAL

Chloroquine

Intervention Type: 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.

Placebo group

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.

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: 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).

Interventions

Chloroquine

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.

Intervention Type: DRUG

Placebo oral tablet

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).

Intervention Type: DRUG

Other Intervention Names

CQ; Placebo pill

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years,

2. Employment by New York Presbyterian Hospital

3. 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

Exclusion Criteria

1. Individuals who are taking CQ for other indications

2. New use of NSAIDs

3. High risk background medications not limited to immunosuppressive regimens, steroids, anti-B cell therapies, anti-cytokine therapies, chemotherapies, Janus Kinase (JAK)-inhibitors

4. Individuals with a history of retinopathy that would contraindicate the use of CQ

5. Known allergy to CQ or chloroquine

6. Known QT prolongation and torsades de point

7. Individuals who are pregnant or nursing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Anca Askanase

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anca Askanase, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center/NYP

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAS9992

Identifier Type: -

Identifier Source: org_study_id