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Low enrollment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anca Askanase, MD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center/NYP | New York | New York | 10032 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | CQ Group | The study was terminated before participants could be assigned to any Arm. Per protocol, participants will receive CQ supply for 3 months. |
| FG001 | Placebo Group | The study was terminated before participants could be assigned to any Arm. Per protocol, participants will receive placebo supply for 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The study was terminated before participants could be assigned to any Arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | CQ and Placebo Group | Participants will receive CQ or placebo supply for 3 months. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The study was terminated before participants could be assigned to any Arm. Data was therefore not collected or analyzed. | Posted | Up to 3 months |
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Up to 3 months
The study was terminated before participants could be assigned to any Arm, therefore Adverse Events cannot be reported per Arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CQ and Placebo Group | Participants will receive CQ or placebo supply for 3 months. The study was terminated before participants could be assigned to any Arm. |
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Study was stopped early due to poor enrollment. Data was not collected and therefore not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anca Askanase, MD | Columbia University | 212-305-0856 | ada20@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2020 | Feb 11, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D002738 | Chloroquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 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). |
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| Sex: Female, Male |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | participants |
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| Participants |
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| 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. | The study was terminated before participants could be assigned to any Arm. Data was therefore not collected or analyzed. | Posted | 3 months |
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| 5 |
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| 5 |
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| D007239 |
| Infections |
| D006571 | Heterocyclic Compounds |