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 antiviral effect. However, HCQ's effect on COVID-19 in human infection remains unknown. To fill this knowledge gap, we will enroll 626 adult patients hospitalized with laboratory-confirmed COVID-19 and randomize them 1:1 to a five-day course of HCQ or placebo. Notable exclusion criteria include ICU admission or ventilation on enrollment, prior therapy with HCQ, and baseline prolonged qTC. Our primary endpoint is a severe disease progression composite outcome (death, ICU admission, mechanical ventilation, ECMO, , and/or vasopressor requirement) at the 14-day post-treatment evaluation. Notable secondary clinical outcomes include 30-day mortality, hospital length of stay, noninvasive ventilator support, and cytokine release syndrome (CRS) grading scale. Secondary exploratory objectives will examine SARS-CoV-2 viral eradication at the EOT, changes in COVID-19 putative prognostic markers and cytokine levels, and titers of anti-SARS-CoV-2 antibodies. This randomized trial will determine if HCQ is effective as treatment in hospitalized non-ICU patients with COVID-19.
Drug: Hydroxychloroquine (HCQ)
HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)
Drug: Placebo: Calcium citrate
Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the
following criteria:
1. 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
2. Informed consent signed by patient
3. 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:
1. Presence of the primary endpoint (ICU admission, mechanical ventilation, ECMO, and/or
vasopressor requirement) at time of randomization.
2. Treatment with CQ or HCQ within the 30 days prior to the start of the study drug
treatment.
3. 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.
4. Unable to take oral medications.
5. History of allergic reaction or intolerance to CQ or HCQ.
6. Baseline corrected qT interval >470 milliseconds (male) or >480 milliseconds (female),
history of congenital qT prolongation, and/or history of cardiac arrest.
7. Concomitant therapy with flecainide, amiodarone, digoxin, procainamide, propafenone,
thioridazine, or pimozide
8. History of retinal disease including a documented history of diabetic retinopathy.
9. Known history of G6PD deficiency.
State University of New York (SUNY) Downstate Medical Center
Brooklyn, New York, United States
NYU Langone Health
New York, New York, United States
Mark Mulligan, MD, FIDSA, Principal Investigator
NYU Langone Health