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A randomized, open-label, controlled clinical trial for azvudine in the treatment of novel coronavirus pneumonia (COVID-19)

A randomized, open-label, controlled clinical trial for azvudine in the treatment of novel coronavirus pneumonia (COVID-19)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029853
Enrollment
Unknown
Registered
2020-02-15
Start date
2020-02-16
Completion date
Unknown
Last updated
2020-02-17

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:Oral administration of 5 tablets of 1mg Azvudine tablets daily
Control group:According to the "Pneumonia Diagnosis and Treatment Plan for New Coronavirus Infection (Trial Version 5)" issued by National Health Commission of People's Republic of China, the subjects

Sponsors

People's Hospital of Guangshan County
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) aged >=18 years old; (2) real-time fluorescence rt-pcr of respiratory or blood samples presents the positive nucleic acid of COVID-19, or the viral gene sequencing of respiratory or blood samples was highly homologous with the known COVID-19. (3) patients diagnosed with novel coronavirus meet the diagnostic criteria of the latest clinical guidelines for novel coronavirus issued by the world health organization (WHO) on January 28, 2020 and the diagnostic criteria of the pneumonia diagnosis and treatment program for novel coronavirus infection (trial version 5) issued by National Health commission of the People's Republic of China.

Exclusion criteria

Exclusion criteria: (1) known or suspected allergy to the components of Azivudine tablets; (2) patients with malabsorption syndrome or any other condition that affects gastrointestinal absorption and requires intravenous nutrition or unable to take oral medication; (3) patients who is currently receiving anti-hiv treatment; (4) patients with one of the following conditions: respiratory failure and mechanical ventilation;Shock;Combined with other organ failure, intensive care unit(ICU) was needed. (5) women who are pregnant or breast-feeding or have a family planning plan during the trial period and within 6 months after the end of the trial; (6) participating in another clinical trials or using experimental drugs within 12 weeks prior to administration; (7) there are other conditions that are not suitable for participating in this experiment evaluated by the investigator.

Design outcomes

Primary

MeasureTime frame
time and rate of temperature return to normal;;time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.);time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms;time and rate of pulmonary imaging improvement;time and rate of change to negative COVID-19 nucleic acid test;time and rate of improvement of oxygenation measurement;improvement time and rate of CD4 count;rate of mild/modorate type to severe type, rate of severe type to critical type;length of hospitalization;mortality;

Countries

China

Contacts

Public ContactPei Guangzhong

People's Hospital of Guangshan County

503818505@qq.com+86 13839708181

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026