Status:
TERMINATED
Treating COVID-19 With Hydroxychloroquine (TEACH)
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
State University of New York - Downstate Medical Center
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Treatments for COVID-19 are urgently needed. Hydroxychloroquine (HCQ) is an antimalarial and immunomodulatory agent being repurposed for COVID-19 therapy based off in vitro data suggesting a possible ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Hospitalized adult (≥18 years old) with symptoms consistent with COVID-19 including but not limited to any of the following: fever (documented or subjective), cough, dyspnea, diarrhea, nausea, diffuse myalgias, and/or anosmia
- Informed consent signed by patient
- Positive SARS-CoV-2 RT-PCR testing (nasopharyngeal, oropharyngeal, sputum and/or bronchoalveolar lavage) o The testing may:
- Occur up to ≤72h prior to informed consent of participation in the study
- Be undertaken either on-site or in an external laboratory certified by New York State to run testing for SARS-CoV-2
- Exclusion Criteria
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Presence of the primary endpoint (ICU admission, mechanical ventilation, ECMO, and/or vasopressor requirement) at time of randomization.
- Treatment with CQ or HCQ within the 30 days prior to the start of the study drug treatment.
- Participation in a clinical trial to investigate a non-FDA approved drug with the intent to treat SARS-CoV-2 within the 30 days prior to the start of the study drug treatment.
- Unable to take oral medications.
- History of allergic reaction or intolerance to CQ or HCQ.
- Baseline corrected qT interval \>470 milliseconds (male) or \>480 milliseconds (female), history of congenital qT prolongation, and/or history of cardiac arrest.
- Concomitant therapy with flecainide, amiodarone, digoxin, procainamide, propafenone, thioridazine, or pimozide
- History of retinal disease including a documented history of diabetic retinopathy.
- Known history of G6PD deficiency.
Exclusion
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04369742
Start Date
April 15 2020
End Date
April 1 2021
Last Update
April 22 2022
Active Locations (2)
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1
State University of New York (SUNY) Downstate Medical Center
Brooklyn, New York, United States, 11203
2
NYU Langone Health
New York, New York, United States, 10016