Publication Ren Z, Adv Sci, 2020 (published paper)
Dates: 18/02/2020 to 29/02/2020
Funding: Mixed (Henan Genuine Biotech Co. Ltd.; Henan province novel coronavirus control and prevention emergency science and technology tackling key project; National S&T Major Project of China)
Conflict of interest: No
Single center / China |
Follow-up duration (days): 18
|Inclusion criteria||1) age 18 and over, regardless of gender;
2) respiratory or blood samples that were tested positive for SARS-CoV-2 nucleic acid by RT-PCR, or respiratory or blood samples that were tested highly homologous with the known SARS-CoV-2 by viral gene sequencing;
3) the confimation of COVID-19 according to the diagnostic criteria of "the latest Clinical guidelines for novel coronavirus" issued by the World Health Organization (WHO) on 2020 January 28, and the diagnostic criteria from the "Diagnosis and treatment program trial version 5 (or 6) guidelines" issued by the National Health Commission of the People's Republic of China. All enrolled patients signed informed consent forms.
|Exclusion criteria||1) known or suspected allergy to the composition of azvudine tablets; |
2) patients with malabsorption syndrome or any other condition that affects gastrointestinal absorption, the need for intravenous nutrition or an inability to take oral medication;
3) patients on anti-HIV treatment;
4) patients with one of the following conditions: respiratory failure and the need for mechanical ventilation; shock; intensive care unit (ICU) monitoring and treatment for other organ failures;
5) pregnant women or those who were lactating or may have a birth plan during the trial period and within 6 months after the end of the trial;
6) patients participating in other clinical trials or using experimental drugs within 12 weeks before administration; and
7) patients with other conditions that were not suitable for participating in this experiment according to the judgment of the researcher.
Azvudine (5mg)Co-Intervention: Standard care
Definition of Standard care: Patients in the control group were treated with standard antiviral treatment and symptomatic treatment. When patients developed clinical symptoms and signs, such as fever and cough, patients were treated with febrifuge or cough mixture, which was called symptomatic treatment. If not, patients were only treated with antiviral therapy. Standard antiviral treatment and symptomatic treatment were used according to the routine treatment of "Diagnosis and treatment program trial version 5 (or 6) guidelines" issued by the National Health Commission of the People's Republic of China. The standard antiviral drugs used in this trial were interferon alpha, kaletra, and ribavirin according to the Diagnosis and treatment program trial version 5 guidelines, and were interferon alpha, kaletra and ribavirin, chloroquine phosphate, and hydroxychloroquine sulfate according to the trial version 6 guidelines.On 2020 February 19, which overlapped with the study period, the "Diagnosis and treatment program trial version 5 guidelines" was updated to the sixth edition, and subsequent participants were given routine treatment according to the sixth edition treatment program. The drug was administered daily until the patient was discharged from the hospital or transferred to the corresponding department for the treatment of other diseases or death. During the treatment, no anti-HIV drugs other than azvudine were used, and if there were patients with liver damage (the normal phenomenon of antiviral therapy), liver protection was provided in time.
20 participants (n1=10 / n2= 10)
|Characteristics of participants|
Mean age : 49
Severity : Mild: n=3 / Moderate: n=17/ Severe: n=0 Critical: n=0
|In the register|
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
|In the report|
Rate of nucleic acid negativity conversion of SARS-CoV-2 and the negativity conversion time.
Yes. In language other than English
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
In addition to the published article, the study registry was used in data extraction and risk of bias assessment. This is a report on a pilot trial. The target sample size specified in the registry was achieved. There is no change from the trial registration in the intervention and control treatments. All secondary outcomes in the report are presented as primary outcomes in the trial registry. Some primary outcomes in the registry are not reported (e.g., rate of mild/moderate type to severe type, rate of severe type to critical type, improvement time and rate of CD4 count). Primary outcome in the registry and report is not the same.
On September 18th 2020, we received additional information from authors on this study.