COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04581915

Not reported

Not reported

2020-10-09

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: patients ≥18 years of age, who have a clinical presentation suggestive of covid-19, or who have had a molecular laboratory assay that confirms sars-cov-2 infection that was collected prior to the first dose of study treatment. patients with mild to moderate covid-19 who need admission and may require oxygen at admission but not yet requiring escalation of oxygen therapy to cpap, high flow nasal oxygen or intubation. we will not include patients with laboratory confirmation of sars-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 the following: a positive hiv elisa assay; an art prescription; a pill container for art with the patient's name; a hard copy or an electronic viral load result that includes the patient's name showing detectable hiv copies; clinical documentation of hiv sero-positivity included in the medical record) randomisation must occur within 48 hours of first covid-19 diagnosis during the current illness.

women who are pregnant or breastfeeding at the time of enrolment weight <40kg. evidence of current liver disease (ast/alt >3x uln ; total bilirubin>3xuln or prior history of cirrhosis or other chronic liver disease) renal dysfunction as evidenced by an estimated glomerular filtration rate (egfr) <60ml/min, or prior/current diagnosis of chronic kidney disease. prior receipt of any treatment with putative or proven anti-sars-cov-2 activity apart from the following: chloroquine, hydroxychloroquine, or ritonavir/lopinavir initiated no 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. indication for immediate initiation of antiretroviral therapy in hiv-infected patients, who are unable to delay art initiation or re-initiation until the treatment phase of this study is complete. permanently lives or works more than 120km from the hospital where recruited unable to provide own consent in the opinion of either the attending doctor, or a study investigator that the patient is not a candidate for a clinical trial receipt of anti-epileptic medication, warfarin or tb treatment at the time of recruitment or during the receipt of trial treatment. enrolled currently in a trial of novel preventive treatment or treatment of sars-cov-2. potential participants who are investigational site staff members, or relatives of a site staff member, or those who are employees of pharmacentrix involved in the conduct of the trial. -

2

Wits Health Consortium (Pty) Ltd

18

100

South Africa

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

74

To compare the slope of cycle threshold(Ct) values of nasopharyngeal swabs in people receiving Triazavirin versus placebo;To assess the proportion of patients who progress to severe COVID-19 and the proportion who need ICU or die.;To determine the proportion of patients who stop taking either placebo/Triazavirin;To determine the proportion of patients who develop grade 3 or grade 4 adverse events on treatment

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 1315, "treatment_name": "Triazavirin", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]