Coronavirus Infection, COVID
Conditions
Keywords
SARS-CoV-2, Coronavirus
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.
Interventions
DRUGChloroquine
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.
DRUGPlacebo 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).
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Healthcare Workers With Symptomatic COVID Infections | Up to 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Workers and Patients With Infections | 3 months | This is to measure the efficacy of CQ in preventing any infection as defined by seroconversion to positive anti-COVID antibody status. The number of severe illnesses in at risk healthcare workers and patients with adverse events grade 3 or higher and GI intolerance will be tallied. |
Countries
United States
Participant flow
Pre-assignment details
The study was terminated before participants could be assigned to any Arm. There were 5 participants who signed informed consent form: 3 participants withdrew, and 2 participants did not proceed due to study termination.
Participants by arm
| Arm | Count |
|---|---|
| CQ and Placebo Group Participants will receive CQ or placebo supply for 3 months. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
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.
Time frame: Up to 3 months
Population: The study was terminated before participants could be assigned to any Arm. Data was therefore not collected or analyzed.
Secondary
Number of Workers and Patients With Infections
This is to measure the efficacy of CQ in preventing any infection as defined by seroconversion to positive anti-COVID antibody status. The number of severe illnesses in at risk healthcare workers and patients with adverse events grade 3 or higher and GI intolerance will be tallied.
Time frame: 3 months
Population: The study was terminated before participants could be assigned to any Arm. Data was therefore not collected or analyzed.