Status:
TERMINATED
The Nitazoxanide Plus Atazanavir for COVID-19 Study
Lead Sponsor:
Obafemi Awolowo University
Collaborating Sponsors:
University of Liverpool
African Centre of Excellence for Genomics of Infectious Diseases
Conditions:
Covid-19
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Since the outbreak of the novel coronavirus disease in 2019 (COVID-19), an unprecedented global search for potential therapeutics and vaccines is ongoing. In this study, a combination of two drugs tha...
Detailed Description
COVID-19 caused by a novel severe acute respiratory syndrome coronavirus (SARS-CoV-2) is an unprecedented global public health challenge which as at July 1, 2020 has spread to over 210 countries with ...
Eligibility Criteria
Inclusion
- Willingness and ability to provide written informed consent
- At least 18 and not more than 75 years of age at study entry
- SARS-CoV-2 infection confirmed by PCR test within 4 days before randomization
- Currently symptomatic (fever or chills, cough, myalgia, sore throat, shortness of breath, or new onset of anosmia or ageusia) and at COVID-19 isolation and treatment centre
Exclusion
- Inability to take orally administered medication or food
- Known hypersensitivity to study medication
- Pregnant or lactating (unless practicing exclusive replacement feeding for the entire study duration)
- Participation in any other interventional trial for COVID-19 (observational study co-enrollment allowed)
- Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 less than 24 hours prior to study drug dosing
- Concurrent use of agents with known or uncertain interaction with study drugs, including ritonavir
- Requiring mechanical ventilation at screening
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) above 5 times upper limit of normal (ULN)
- Creatinine clearance below 50 mL/min using the Cockcroft-Gault formula for participants above 18 years of age
Key Trial Info
Start Date :
October 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2021
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04459286
Start Date
October 9 2020
End Date
May 2 2021
Last Update
March 2 2022
Active Locations (2)
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1
Olabisi Onabanjo University Teaching Hospital
Sagamu, Ogun State, Nigeria
2
Infectious Disease Hospital, Olodo
Ibadan, Oyo State, Nigeria