A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19
Condition: SARS-CoV Infection; Covid19
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Intervention: Nitazoxanide; Placebo Nitazoxanide; Ribavirin; Placebo Ribavirin; Hydroxychloroquine; Placebo Hydroxychloroquine
Intervention description: Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days); Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days); Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days); Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days); Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days); Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
Intervention MeSH terms: Ribavirin; Hydroxychloroquine; Nitazoxanide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Study medication will be tablets/capsules containing either active drug or placebo
Enrollment: 7.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      New outpatient treatments for COVID-19 are urgently needed. There is some evidence that a
      combination of three medications currently used to treat other viral infections could be
      effective in fighting this new virus. The purpose of this trial is to evaluate the efficacy
      of Nitazoxanide (NTZ), Ribavirin (RBV) and Hydroxychloroquine (HCQ) versus placebo in
      participants with proven SARS-CoV-2 infection

      The study will enroll 70 participants within the 7 days after having been diagnosed with
      coronavirus infection. The purpose is to determine if those randomized to 5-day dosing with
      the three medication combination have decreased viral load and severity of illness in the 10
      days following treatment as compared to those taking placebo. Participants will be actively
      followed for 28 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented SARS-CoV-2 infection by qPCR assay performed within the past 7 days

        Exclusion Criteria:

          -  COVID-19 symptoms requiring hospitalization

          -  PO2 < 92%

          -  Short of breath at time of enrollment

          -  Retinal eye disease

          -  Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency

          -  Known chronic kidney disease, stage - 5 or receiving dialysis

          -  Current use of:

               -  Class 3 AAD (amiodarone, dronaderone, dofetilide, sotalol)

               -  Class 1A AAD (procainamide, quinidine, disopyramide)

               -  Flecainide

               -  SSRI: citalopram (Celexa), Escitalopram (Lexapro)

               -  chlorpromazine

               -  Cilostazol (Pletal)

               -  Donepezil (Aricept)

               -  Droperidol

               -  Fluoconazole

               -  Methadone

               -  Ondansetron (Zofran)

               -  Thioridazine

               -  Macrolides (clarithromycin, erythromycin)

               -  Fluroquinolones (ciprofloxacin, levofloxacin, moxifloxacin)

               -  Tamoxifen

          -  Pregnancy or women who are breast feeding

          -  Inability to tolerate oral medications

          -  Allergy or prior adverse reaction to either hydroxychloroquine sulfate, ribavirin, or
             nitazoxanide

          -  Allergy to adhesives

          -  QTc interval > 450 mSEC for men and women

          -  History of Torsade de Pointes VT or prior cardiac arrest or congenital long QT
             interval

          -  Non-English-speaking