Status:
COMPLETED
Favipiravir +/- Nitazoxanide: Early Antivirals Combination Therapy in COVID-19
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Collaborating Sponsors:
University College, London
Centro de Investigacion y Estudios Avanzados del Instituto Politecnico Nacional (CINVESTAV)
Conditions:
Covid19
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 pr...
Detailed Description
FANTAZE is a Phase IIA randomised, double-blind, placebo-controlled, interventional trial.Participants will be adults who have developed the early symptoms of COVID-19 within the first 5 days, or test...
Eligibility Criteria
Inclusion
- Health workers, their household members and, IMSS beneficiaries with the following:
- Symptoms compatible with COVID-19 disease (Fever \>37.8oC on at least one occasion AND either cough and/ or anosmia) within the first 5 days of symptom onset (date/time of enrolment must be within the first 5 days of symptom onset)
- OR ANY symptoms compatible with COVID-19 disease (may include, but are not limited to fever, cough, shortness of breath, malaise, myalgia, headache, coryza) and tested positive for SARS-CoV-2 within the first 7 days of symptom onset (date/time of enrolment must be within the first 7 days of symptom onset)
- OR no symptoms but tested positive for SARS-CoV-2 within the last 48 hours (date/time of test must be within 48 hours of enrolment)
- Male or female aged 18 years to 70 years old inclusive at screening
- Willing and able to take daily saliva samples
- Able to provide full informed consent and willing to comply with trial-related procedures
Exclusion
- Known hypersensitivity to any of the active ingredients or excipients in favipiravir, and in nitazoxanide and matched placebo
- Chronic liver disease at screening (known cirrhosis of any aetiology, chronic hepatitis (e.g. autoimmune, viral, steatohepatitis), cholangitis or any known elevation of liver aminotransferases with AST or ALT \> 3 X ULN)\*
- Chronic kidney disease (stage 3 or beyond) at screening: eGFR \< 60 ml/min/1.73m2\*
- HIV infection, if untreated, detectable viral load or on protease inhibitor therapy
- Any clinical condition which the investigator considers would make the participant unsuitable for the trial
- Concomitant medications known to interact with favipiravir, and with nitazoxanide and matched placebo, and carry risk of toxicity for the participant (See Appendix 4)
- Current severe illness requiring hospitalisation
- Pregnancy and/ or breastfeeding
- Eligible female participants of childbearing potential and male participants with a partner of childbearing potential not willing to use highly effective contraceptive measures during the trial and within the time point specified following last trial treatment dose.
- Participants enrolled in any other interventional drug or vaccine trial (co-enrolment in observational studies is acceptable).
- Considering the importance of early treatment of COVID-19 to impact viral load, the absence of chronic liver/ kidney disease will be confirmed verbally by the participant during pre- screening and Screening/Baseline visit. Safety blood samples will be collected at Screening/Baseline visit (Day 1) and test results will be examined as soon as they become available within 24 hours.
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04918927
Start Date
October 12 2021
End Date
March 21 2023
Last Update
March 24 2023
Active Locations (1)
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1
Hospital de Infectología "Daniel Méndez Hernández" del Centro Médico Nacional La Raza
Mexico City, Azcapotzalco, Mexico, 02290