Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoV-2 Virus Infection (COVID-19)

• Status: Recruiting
• Trial end date: 2020-12-26
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of the efficacy and safety of NTX in adult patients (≥18 years and <60 years), with SARS-CoV-2 infection with mild symptoms of COVID-19, compared to a placebo control arm. 135 patients will be randomized to either Nitazoxanide (n=90) or placebo (n=45) (2:1). Simple blind design. Primary endpoint: eradication of virus from patients' respiratory tract secretions by the 7th day of treatment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Roemmers S.A.I.C.F.
• Treatments: Nitazoxanide

Criteria

Inclusion Criteria:

• Adult male and female patients (≥ 18 years and <60 years).

• Signature of informed consent.

• Patients with a positive test for SARS-CoV-2 and mild symptoms of COVID-19 (without severity criteria as detailed by the Ministry of Health of Argentina - MSN)

Exclusion Criteria:

• Patients under 18 years of age and over 60 years of age.

• Breastfeeding or pregnant women (with positive pregnancy blood test in women of childbearing age).

• Patients with mild pneumonia in the presence of risk factors or moderate or severe pneumonia (based on the severity criteria set by the Ministry of Health of Argentina), or patients who require mechanical ventilation at screening.

• Patients in whom NTX and/or lactose is contraindicated.

• Any other contraindication based on the judgment of the treating physician.