Last updated: July 29, 2022
Sponsor: Wits Health Consortium (Pty) Ltd
Overall Status: Terminated
Phase
2/3
Condition
Covid-19
Treatment
N/AClinical Study ID
NCT04581915
PHRU CoV01
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients ≥18 years of age, who have a clinical presentation suggestive of COVID-19, orwho have had a molecular laboratory assay that confirms SARS-CoV-2 infection that wascollected prior to the first dose of study treatment.
- Patients with mild to moderate COVID-19 who need admission and may require oxygen atadmission but not yet requiring escalation of oxygen therapy to CPAP, high flow nasaloxygen or intubation. We will not include patients with laboratory confirmation ofSARS-CoV-2 who report no symptoms at all.
- Able to provide own consent
- Willing to have HIV test - unless already has clinical documentation of HIV infection (as evidenced by a HIV rapid test result during the admission, or any one of thefollowing: a positive HIV ELISA assay; an ART prescription; a pill container for ARTwith the patient's name; a hard copy or an electronic viral load result that includesthe patient's name showing detectable HIV copies; clinical documentation of HIVsero-positivity included in the medical record)
- Randomisation must occur within 48 hours of first COVID-19 diagnosis during thecurrent illness.
Exclusion
Exclusion Criteria: 1. Women who are pregnant or breastfeeding at the time of enrolment 2. Weight <40kg. 3. Evidence of current liver disease (AST/ALT >3x ULN ; total bilirubin>3xULN or priorhistory of cirrhosis or other chronic liver disease) 4. Renal dysfunction as evidenced by an estimated glomerular filtration rate (eGFR) <60ml/min, or prior/current diagnosis of chronic kidney disease. 5. Prior receipt of any treatment with putative or proven anti-SARS-Cov-2 activity apartfrom the following: chloroquine, hydroxychloroquine, or ritonavir/lopinavir initiatedno more than 12 hours prior to first receipt of TZV/placebo for this trial.Antiretrovirals initiated prior to admission as treatment for HIV, supportive,steroidal and non-steroidal anti-inflammatory, or anti-pyretic treatments are allowed. 6. Indication for immediate initiation of antiretroviral therapy in HIV-infectedpatients, who are unable to delay ART initiation or re-initiation until the treatmentphase of this study is complete. 7. Permanently lives or works more than 120km from the hospital where recruited 8. Unable to provide own consent 9. In the opinion of either the attending doctor, or a study investigator that thepatient is not a candidate for a clinical trial 10. Receipt of anti-epileptic medication, warfarin or TB treatment at the time ofrecruitment or during the receipt of trial treatment. 11. Enrolled currently in a trial of novel preventive treatment or treatment ofSARS-CoV-2. 12. Potential participants who are investigational site staff members, or relatives of asite staff member, or those who are employees of PharmaCentrix involved in the conductof the trial.
Study Design
Total Participants: 74
Study Start date:
September 08, 2020
Estimated Completion Date:
April 20, 2021
Study Description
Connect with a study center
The Perinatal HIV Research Unit - Matlosana
Klerksdorp, North West Province
South AfricaSite Not Available
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