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.
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.
Drug: 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.
Other Name: CQ
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).
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
Columbia University Irving Medical Center/NYP
New York, New York, United States
Anca Askanase, MD, MPH, Principal Investigator
Columbia University