Treating COVID-19 With Hydroxychloroquine (TEACH)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Hydroxychloroquine (HCQ); Placebo: Calcium citrate
Intervention description: HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5); Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Intervention MeSH terms: Hydroxychloroquine; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo-controlled, Randomized
Masking: Double (Participant, Care Provider)
Masking description: Double-blind
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 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.
    

Eligibility criteria:

        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.