COVIDPhase 2NCT04349371
Saved From COVID-19 - Chloroquine (CQ) Prophylaxis for Health Care Workers at Risk for COVID
A Phase 2 study testing Chloroquine in people with COVID and Coronavirus Infection, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Coronavirus Infection
- What is being tested?
- Chloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2020to 11 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years,
- Employment by New York Presbyterian Hospital
- 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
Who cannot join
- Individuals who are taking CQ for other indications
- New use of NSAIDs
- High risk background medications not limited to immunosuppressive regimens, steroids, anti-B cell therapies, anti-cytokine therapies, chemotherapies, Janus Kinase (JAK)-inhibitors
- Individuals with a history of retinopathy that would contraindicate the use of CQ
- Known allergy to CQ or chloroquine
- Known QT prolongation and torsades de point
- Individuals who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center/NYP
New York, New York, 10032
About this study
Official title: Chloroquine (CQ) Prophylaxis for Health Care Workers at Risk for COVID
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.
Read the 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
- Being tested
- Chloroquine, Placebo oral tablet
- Keywords
- SARS-CoV-2, Coronavirus
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroquineDrug
Also called CQ
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 oral tabletDrug
Also called Placebo pill
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Chloroquine |
| 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. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start21 Apr 2020
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
Why it stopped: Low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anca Askanase, Columbia University
- Investigators
- Anca Askanase, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349371
- Sponsor's protocol ID
- AAAS9992
- Status last verified
- Feb 2025
- First submitted
- 12 Apr 2020
- Last updated
- 27 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chloroquine (CQ) Prophylaxis for Health Care Workers at Risk for COVID
- ClinicalTrials.gov ID
- NCT04349371
- Acronym / sponsor ID
- AAAS9992
- Conditions
- COVID, Coronavirus Infection
- Keywords
- SARS-CoV-2, Coronavirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CQ group | Experimental | Drug: ChloroquineParticipants 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. |
| Placebo group | Placebo comparator | Drug: Placebo oral tabletParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years,
- Employment by New York Presbyterian Hospital
- 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
Key exclusion criteria (7 listed)
- Individuals who are taking CQ for other indications
- New use of NSAIDs
- High risk background medications not limited to immunosuppressive regimens, steroids, anti-B cell therapies, anti-cytokine therapies, chemotherapies, Janus Kinase (JAK)-inhibitors
- Individuals with a history of retinopathy that would contraindicate the use of CQ
- Known allergy to CQ or chloroquine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChloroquineAlso: CQSubjects 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. | Drug | CQ group |
| Placebo oral tabletAlso: Placebo pillSubjects 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). | Drug | Placebo group |
Primary outcome
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. This is to determine/measure the clinical efficacy of CQ in healthcare workers.
1 secondary outcome
Number of Workers and Patients With Infections
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anca Askanase, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chloroquine in people with COVID and Coronavirus Infection, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Healthcare Workers With Symptomatic COVID Infections (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.