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The efficacy and safety of Triazavirin for 2019 novel coronary pneumonia (COVID-19): a multicenter, randomized, double blinded, placebo-controlled trial

The efficacy and safety of Triazavirin for 2019 novel coronary pneumonia (COVID-19): a multicenter, randomized, double blinded, placebo-controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030001
Enrollment
Unknown
Registered
2020-02-19
Start date
2020-02-15
Completion date
Unknown
Last updated
2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Experimental group:Basic treatment combined Triazavirin
Control group:Basic treatment combined Triazavirin placebo

Sponsors

Health commission of Heilongjiang province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Adult aged >=18 years and agrees to sign the informed consent; (2) Laboratory-confirmed 2019-nCoV infection by real-time RT-PCR; (3) Chest imaging (CT) confirmed lung damage: multiple small plaques and stromal changes in the lungs, which were obvious in the outer lung, or multiple ground-glass shadows and infiltration shadows in both lungs, the changes may not be present in mild patients; (4) Hospitalized patients with fever (axillary temperature >=37.0 degree C) or respiratory symptoms; (5) The interval between symptom onset and randomization was within 12 days; (6) Did not participate in other clinical researches within 3 months; (7) Do not participate other antiviral studies within 28 days of follow-up.

Exclusion criteria

Exclusion criteria: (1) The PI considers that the patient is not suitable to participate the study or the patient may be unsafe if he participate the study; (2) Patients with serious liver disease, grade C according to child-pugh; (3) Patients with severe renal impairment (glomerular filtration rate <=30mL/min/1.73m2) or who have received continuous renal replacement therapy, hemodialysis or peritoneal dialysis; (4) Patients with severe anemia, Hgb < 60g/L. (5) Pregnant women or women with pregnancy test positive or breastfeeding women; (6) Patients with allergy history of Triazavirin or its components; (7) Confused to sign the informed consent; (8) Patients may be transferred to another hospital within 72h; (9) Received any experimental treatment for novel coronavirus infection within 30 days prior to screening.

Design outcomes

Primary

MeasureTime frame
Time to Clinical recovery;

Secondary

MeasureTime frame
Antifebrile time;Inflammatory absorption of chest CT;Intervals from positive to negative of Nucleic acid test;Mortality rate;conversion rate of severe patients;

Countries

China

Contacts

Public ContactBaofeng Yang

Heilongjiang Province hospital

yangbf@ems.hrbmu.edu.cn+86 133 0451 2381

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026