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ClinicalTrials.gov Identifier: NCT04349371
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Anca Askanase, Columbia University

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.

Condition or disease Intervention/treatment Phase
COVID Drug: Chloroquine Drug: Placebo oral tablet Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Chloroquine (CQ) Prophylaxis for Health Care Workers at Risk for COVID
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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

Placebo Comparator: 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.
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).




Primary Outcome Measures :
  1. Number of symptomatic illness in at risk healthcare workers [ Time Frame: Up to 3 months ]
    Symptomatic illness is defined as COVID infection guidelines and confirmed with anti-COVID antibodies that will be done on serum collect at the final visit. Symptoms include fever, chills, muscle pain, cough, shortness of breath, and diarrhea.

  2. Number of healthcare workers with symptomatic COVID infections [ Time Frame: Up to 3 months ]
    Diagnosis is based on symptoms of COVID-19 and confirmatory anti-COVID antibodies and when available, COVID-19 PCR.

  3. Number of severe illness in at risk healthcare workers [ Time Frame: Up to 3 months ]
    Severe illness includes worsening of symptoms.


Secondary Outcome Measures :
  1. Number of sero-conversions in at risk healthcare workers [ Time Frame: Up to 3 months ]
    Confirmation with polymerase chain reaction (PCR) when available.

  2. Percentage of patients with adverse events Grade 3 or higher [ Time Frame: Up to 3 months ]
    Adverse events that are NCI-CTCAE Grade 3 or higher will be counted.

  3. Percentage of patients with GI intolerance [ Time Frame: Up to 3 months ]
    GI intolerance to chloroquine will be documented and recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349371


Contacts
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Contact: Anca D. Askanase, MD, MPH 212-305-0856 ada20@cumc.columbia.edu
Contact: Tommy Chen 212-342-9051 tkc2120@cumc.columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center/NYP Recruiting
New York, New York, United States, 10032
Contact: Anca D. Askanase, MD, MPH    212-305-0856    ada20@cumc.columbia.edu   
Contact: Tommy Chen    2123429051    tkc2120@cumc.columbia.edu   
Principal Investigator: Anca D. Askanase, MD, MPH         
Sub-Investigator: Deborah A Theodore, MD         
Sub-Investigator: Yevgeniya Gartshyten, MD         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Anca Askanase, MD, MPH Columbia University
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Responsible Party: Anca Askanase, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT04349371    
Other Study ID Numbers: AAAS9992
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Anca Askanase, Columbia University:
SARS-CoV-2
Coronavirus
Additional relevant MeSH terms:
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Chloroquine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents