Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04260594
Other study ID # Abdrcspc202001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 8, 2020
Est. completion date December 30, 2020

Study information

Verified date September 2021
Source Ruijin Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In the absence of 2019-ncov specific therapeutic drugs, arbidol is effective against a variety of coronaviruses in vitro pharmacodynamics. In order to observe the efficacy and safety of arbidol in the treatment of 2019-ncov infected pneumonia, this study is planned.


Description:

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.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Arbidol
Arbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days
Other:
basic treatment
basic treatment

Locations

Country Name City State
China Ruijin Hospital, Medical School of Shanghai Jiaotong University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Jieming QU

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Virus negative conversion rate in the first week first week
Secondary Virus negative conversion rate virus negative conversion rate in second week, overall virus negative conversion rate 14-20 days
Secondary Antipyretic rate defined as: the rate of Axillary temperature =37.5 ? for at least 48h 14-20 days
Secondary Symptom relief time time to relieve symptoms of fever, cough, dyspnea, myalgia, etc 14-20 days
Secondary Finger oxygen improvement rate no adjuvant oxygen therapy, resting oxygen saturation>95%, oxygenation index>350 14-20 days
Secondary Disease progression rate Mild, common type progression to severe or critical illness rate 14-20 days
Secondary Mortality rate 14-20 days
Secondary Incidence of severe adverse reactions 14-20 days
Secondary Change curve of peripheral blood lymphocyte count 14-20 days
See also
  Status Clinical Trial Phase
Suspended NCT04334967 - Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care Phase 4
Not yet recruiting NCT04264858 - Treatment of Acute Severe 2019-nCoV Pneumonia With Immunoglobulin From Cured Patients N/A
Withdrawn NCT04272710 - Prognositc Factors in COVID-19 Patients Complicated With Hypertension
Active, not recruiting NCT04273763 - Evaluating the Efficacy and Safety of Bromhexine Hydrochloride Tablets Combined With Standard Treatment/ Standard Treatment in Patients With Suspected and Mild Novel Coronavirus Pneumonia (COVID-19) N/A
Not yet recruiting NCT04270383 - Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children
Terminated NCT04261907 - Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Novel Coronavirus Infection N/A
Not yet recruiting NCT04261426 - The Efficacy of Intravenous Immunoglobulin Therapy for Severe 2019-nCoV Infected Pneumonia Phase 2/Phase 3
Recruiting NCT04255017 - A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia Phase 4
Recruiting NCT04254874 - A Prospective/Retrospective,Randomized Controlled Clinical Study of Interferon Atomization in the 2019-nCoV Pneumonia Phase 4
Not yet recruiting NCT04356508 - COVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1 Phase 2
Terminated NCT04321928 - Personalized Health Education Against the Health Damage of Novel Coronavirus (COVID-19) Outbreak in Hungary N/A