SARS-CoV-2
Conditions
Interventions
Nitazoxanide
Standard of care
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female = 18 years old with laboratory confirmed SARS-CoV-2 infection (PCR). 2. All participants must agree to use effective methods of contraception throughout the study (if conception is possible). 3. Mild-moderate COVID-19 disease only: ambulant, with peripheral capillary oxygen saturation (SpO2) =94% on room air (NB the Master Protocol also includes hospitalised patients, which this study will not). 5. Has signs or symptoms of COVID-19 that began within 5 days of the first dose of study drug. 6. Is in generally good health (except for current respiratory infection). 7. Is willing and able to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5 times the upper limit of normal (ULN) 2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration rate <30 mL/min/1.73 m2) 3. Pregnant or breast feeding 4. Allergy to any study medication 5. Patients taking other prohibited drugs (as outlined in CST protocol, section 6.prohibited medications) within 30 days or 5 times the half-life (whichever is longer) of enrolment 7. Patients participating in another CTIMP trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Objective: To determine the safety, tolerability and optimum dosing schedule of nitazoxanide in participants with COVID-19. Efficacy Objective (virological): To assess the difference in viral clearance (time to negative PCR) between Nitazoxanide and control. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) Objective: To define the PK of Nitazoxanide and its metabolites (tizoxanide and tizoxanide glucuronide) in plasma following multiple doses administered to participants with COVID-19. Samples will be taken whilst a participant is in clinic (for up to 8 hours) following initial dosing and on day 5 (steady state) and pre-dose day 8. Additional trough PK samples will be obtained throughout the dosing period. Efficacy objective (Clinical): 1. To determine the ability of nitazoxanide to reduce serious complications of COVID-19 including hospitalization, reduction in Sao2 <92%, or death. 2. To determine the ability of nitazoxanide to reduce the signs and symptoms of COVID-19 in patients based on a patient reported outcome tool. | — |
Countries
South Africa
Contacts
Public ContactMonica Vogt
Regulatory Officer
Outcome results
None listed