The Nitazoxanide Plus Atazanavir for COVID-19 Study
- Conditions
- COVID-19Respiratory
- Registration Number
- PACTR202008855701534
- Lead Sponsor
- Obafemi Awolowo University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 98
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
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
Recent history of or currently having a noncommunicable disease (e.g. cardiovascular disease, cancer, chronic respiratory diseases and diabetes)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to clinical improvement - Proportion of patients with clinical improvement, as defined by live discharge from the hospital, a decrease of at least 2 points from baseline on a 7-point ordinal scale, or both.<br><br>;Time to SARS-CoV-2 negativity - Proportion of participants with SARS-CoV-2 polymerase chain reaction (PCR) negative result;Difference in SARS-CoV-2 AUC - Temporal patterns of SARS-CoV-2 viral load quantified by RT-PCR from nasal swabs or sputum of patients receiving SOC alone versus SOC plus study drug
- Secondary Outcome Measures
Name Time Method Time to symptoms resolution - Time to symptoms resolution as monitored by the Performance of the inFLUenza Patient-Reported Outcome (FLU-PRO) questionnaire with some modifications for COVID-19;Clinical status as assessed with the seven-category ordinal scale;Duration of hospitalization in survivors;Day 28 mortality;Time from treatment initiation to death;Proportion with viral RNA detection over time