Favipiravir +/- Nitazoxanide: Early Antivirals Combination Therapy in COVID-19

Summary

The 2020 pandemic of SARS-CoV-2 causing COVID-19 disease is an unprecedented global emergency. COVID-19 appears to be a disease with an early phase where the virus replicates, coinciding with first presentation of symptoms, followed by a later 'inflammatory' phase which results in severe disease in some individuals. It is known from other rapidly progressive infections such as sepsis and influenza that early treatment with antimicrobials is associated with better outcome. The hypothesis is that this holds for COVID-19 and that early antiviral treatment may prevent progression to the later phase of the disease.

The plan is to conduct a proof-of-principle placebo-controlled clinical trial of favipiravir plus or minus nitazoxanide in health workers, their household members and IMSS beneficiaries. Participants with or without symptomatic COVID-19 or tested positive will be assigned to receive favipiravir plus nitazoxanide or favipiravir plus nitazoxanide placebo. The primary outcome will be the difference in the amount of virus ('viral load') in the upper respiratory tract after 5 days of therapy. Secondary outcomes will include hospitalization, major morbidity and mortality, pharmacokinetics, and impact of antiviral therapy on viral genetic mutation rate.

If favipiravir with nitazoxanide demonstrates important antiviral effects without significant toxicity, there will be a strong case for a larger trial in people at high risk of hospitalization or intensive care admission, for example older patients and/or those with comorbidities and with early disease.

Conditions

• Covid19

Interventions

DRUG

Favipiravir

Oral Favipiravir 1800 mg twice daily on Day 1, followed by 400 mg four (4) times daily from Day 2 to Day 7

DRUG

Nitazoxanide

Nitazoxanide at 1000 mg twice daily on Day 1 followed by 500 mg four (4) times daily from Day 2 to Day 7

OTHER

Nitazoxanide Placebo

Nitazoxanide matched placebo at 1000 mg twice daily on Day 1 followed by 500 mg four (4) times daily from Day 2 to Day 7.

Sponsors & Collaborators

• University College, London

  collaborator OTHER

• Centro de Investigacion y Estudios Avanzados del Instituto Politecnico Nacional (CINVESTAV)

  collaborator UNKNOWN

• Universidad Autonoma de Guadalajara

  collaborator UNKNOWN

• Siegfried Rhein S.A. de C.V.

  collaborator UNKNOWN

• Strides Pharma Science Limited

  collaborator UNKNOWN

• Hakken Enterprise

  collaborator UNKNOWN

• Coordinación de Investigación en Salud, Mexico

  lead OTHER_GOV

Principal Investigators

• Jorge Escobedo, Dr. · Instituto Mexicano del Seguro Social

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-12

Primary Completion

2023-03-21

Completion

2023-03-21

Countries

• Mexico

Study Locations