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The Efficacy and Safety of Triazavirin for COVID-19: A Trial Protocol
Xiaoke Wu1,2,3, Kaijiang Yu4, Yongchen Wang5
1Department of Pharmacology & State-Province Key Laboratories of Biomedicine-Pharmaceutics of China & Key Laboratory of Cardiovascular Medicine Research, Ministry of Education, College of Pharmacology, Harbin Medical University, Harbin 150001, China.
Insights
This clinical trial evaluates Triazavirin (TZV) for treating coronavirus disease 2019 (COVID-19). Researchers are assessing TZV
Area of Science:
- Infectious Diseases
- Virology
- Clinical Pharmacology
Background:
- Coronavirus disease 2019 (COVID-19) rapidly became a global pandemic.
- Effective antiviral treatments for COVID-19 remain limited.
- Novel therapeutic strategies are crucial for managing the pandemic.
Purpose of the Study:
- To investigate the efficacy and safety of Triazavirin (TZV) in treating COVID-19 patients.
- To compare TZV with a placebo in a randomized controlled trial setting.
- To provide evidence-based recommendations for COVID-19 treatment.
Main Methods:
- A multicenter, blind, randomized controlled trial (RCT) involving 240 COVID-19 participants.
- Participants received standard therapy plus either TZV or a placebo for 7 days, with a 21-day follow-up.
- Primary outcome: time to clinical improvement; Secondary outcomes: clinical improvement rate, fever alleviation, lung inflammation absorption, viral clearance, mortality, and disease severity progression.
Main Results:
- This section is to be populated once the trial is concluded and results are available.
- Ongoing data collection on clinical improvement, viral load, and patient outcomes.
- Monitoring of adverse events, liver and kidney function, and concurrent treatments.
Conclusions:
- This ongoing RCT aims to determine the clinical utility of Triazavirin for COVID-19.
- Results will inform clinical practice and guide treatment decisions for COVID-19.
- The study will contribute valuable data on TZV's safety and effectiveness against SARS-CoV-2.
Abstract:
The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019. COVID-19 is highly contagious and has rapidly developed from a regional epidemic into a global pandemic. As yet, no effective drugs have been found to treat this virus. This study, an ongoing multicenter and blind randomized controlled trial (RCT), is being conducted at ten study sites in Heilongjiang Province, China, to investigate the efficacy and safety of Triazavirin (TZV) versus its placebo in COVID-19 patients. A total of 240 participants with COVID-19 are scheduled to be enrolled in this trial. Participants with positive tests of throat swab virus nucleic acid are randomized (1:1) into two groups: standard therapy plus TZV or standard therapy plus placebo for a 7-day treatment with a 21-day follow-up. The primary outcome is the time to clinical improvement of the subjects. Secondary outcomes include clinical improvement rate, time to alleviation of fever, mean time and proportion of obvious inflammatory absorption in the lung, conversion rate of repeated negative virus nucleic acid tests, mortality rate, and conversion rate to severe and critically severe patients. Adverse events, serious adverse events, liver function, kidney function, and concurrent treatments will be monitored and recorded throughout the trial. The results of this trial should provide evidence-based recommendations to clinicians for the treatment of COVID-19.
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