A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19

Rutgers The State University of New Jersey

Status and phase: Terminated; Phase 2

Conditions: SARS-CoV Infection; Covid19

Treatments: Drug: Placebo Nitazoxanide; Drug: Ribavirin; Drug: Placebo Hydroxychloroquine; Drug: Hydroxychloroquine; Drug: Placebo Ribavirin; Drug: Nitazoxanide

Study type: Interventional

Funder types: Other

Identifiers

NCT04605588

Pro2020001862

Details and patient eligibility

About

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.

Full description

Participants will be randomized into one of two treatment plans

• Triple combination:

  • 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)
  • Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)

• No active Medication:

  • Placebo administered according to the above schedule

Viral load (qPCR via nasal swab) will be assessed at baseline (day 0) as well as at days 3, 6, and 10 to monitor response to antiviral treatment. Immune status will be determined by antibody testing of blood collected at baseline and day 28. Symptom questionnaires will be completed daily for 10 days and day 28.

Enrollment: 7 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7 participants in 2 patient groups, including a placebo group

Active Study Drug

Active Comparator group

Description:

5 day dosing of Nitazoxanide, Ribavirin \& Hydroxychloroquine sulfate

Treatment:

Drug: Ribavirin

Drug: Hydroxychloroquine

Drug: Nitazoxanide

Placebo

Placebo Comparator group

Description:

5 day dosing of placebo

Treatment:

Drug: Placebo Nitazoxanide

Drug: Placebo Hydroxychloroquine

Drug: Placebo Ribavirin