Favipiravir +/- Nitazoxanide: Early Antivirals Combination Therapy in COVID-19
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Collaborators:
Centro de Investigacion y Estudios Avanzados del Instituto Politecnico Nacional (CINVESTAV) Hakken Enterprise Siegfried Rhein S.A. de C.V. Strides Pharma Science Limited Universidad Autonoma de Guadalajara University College, London