Clinical Study of Arbidol Hydrochloride Tablets in the Treatment of Pneumonia Caused by Novel Coronavirus
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|ClinicalTrials.gov Identifier: NCT04260594|
Recruitment Status : Completed
First Posted : February 7, 2020
Last Update Posted : September 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|2019-nCoV||Drug: Arbidol Other: basic treatment||Phase 4|
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. The number of cases of infection with 2019-nCoV identified in Wuhan increased markedly over the later part of January 2020, with cases identified in multiple other Provinces of China and internationally. Mathematical models of the expansion phase of the epidemic suggested that sustained person-to-person transmission is occurring, and the R-zero is substantially above 1, the level required for a self-sustaining epidemic in human populations.
There is currently no specific treatment for 2019-ncov-infected pneumonia. Arbidol tablet is a non-nucleoside broad-spectrum antiviral drug with immune-enhancing effect. Abidor is pharmacodynamic in vitro against a variety of coronaviruses.This is a randomized, open, multicenter clinical study of pneumonic subjects diagnosed with 2019-ncov infection. The main objective was to compare the viral negative conversion rate in the first week after the subjects were randomized to arbidol plus basic treatment.
In this study, 380 eligible patients with pneumonia diagnosed with 2019-ncov infection were randomly assigned to one of two treatment groups at a 1:1 ratio.
patients will receive one of two treatment regimens: A .Abidor tablets + basic treatment B. basic treatment Arbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days Basic treatment :The basic treatment used by the investigator was based on the condition of the patient.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||236 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Open, Multicenter Study on the Efficacy and Safety of Arbidol Hydrochloride Tablets in Treating Pneumonia in Patients Infected With Novel Coronavirus (2019-ncov).|
|Actual Study Start Date :||February 8, 2020|
|Actual Primary Completion Date :||March 12, 2020|
|Actual Study Completion Date :||December 30, 2020|
|Experimental: Arbidol tablets + basic treatment||
Arbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days
Other Name: The basic treatment used by the investigator was based on the condition of the patient
Other: basic treatment
|Sham Comparator: basic treatment||
Other: basic treatment
- Virus negative conversion rate in the first week [ Time Frame: first week ]
- Virus negative conversion rate [ Time Frame: 14-20 days ]virus negative conversion rate in second week, overall virus negative conversion rate
- Antipyretic rate [ Time Frame: 14-20 days ]defined as: the rate of Axillary temperature ≤37.5 ℃ for at least 48h
- Symptom relief time [ Time Frame: 14-20 days ]time to relieve symptoms of fever, cough, dyspnea, myalgia, etc
- Finger oxygen improvement rate [ Time Frame: 14-20 days ]no adjuvant oxygen therapy, resting oxygen saturation>95%, oxygenation index>350
- Disease progression rate [ Time Frame: 14-20 days ]Mild, common type progression to severe or critical illness rate
- Mortality rate [ Time Frame: 14-20 days ]
- Incidence of severe adverse reactions [ Time Frame: 14-20 days ]
- Change curve of peripheral blood lymphocyte count [ Time Frame: 14-20 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260594
|Ruijin Hospital, Medical School of Shanghai Jiaotong University|
|Shanghai, Shanghai, China, 200025|