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PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19

NCT04581915 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2022-08-02

No results posted yet for this study

Summary

A) Phase II: Early viral responses to triazavirin In hospitalised patients with mild-moderate COVID-19, in addition to standard of care therapy, treatment with triazavirin 250mg three times daily for five days, the slope of increase of the Ct values of serial nasopharyngeal swabs to 12 days after initiation of treatment will be ≥24% higher than in hospitalised patients receiving standard of care treatment only.

B) Phase III: Efficacy of triazavirin to improve clinical outcomes In hospitalised patients with mild-moderate laboratory proven COVID-19, in addition to standard of care therapy, treatment with triazavirin 250mg three times daily for five days will reduce a composite outcome - death; ICU admission or mechanical ventilation; or prolonged duration of admission- by ≥29% when compared to the composite outcome in hospitalised patients receiving standard of care therapy only.

Conditions

  • Covid19

Interventions

DRUG

Triazavirin (Riamilovir)

Capsule - 250mg 8 hourly po

OTHER

Placebo

Placebo capsule

Sponsors & Collaborators

  • PharmaCentrix (Pty) Ltd

    collaborator UNKNOWN

  • Perinatal HIV Research Unit of the University of the Witswatersrand

    collaborator OTHER

  • Wits Health Consortium (Pty) Ltd

    lead OTHER

Principal Investigators

  • Neil A Martinson, MBChB · Perinatl HIV Research Unit CEO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2021-04-20
Completion
2021-04-20

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04581915 on ClinicalTrials.gov