A Randomized Multicenter Controlled Clinical Trial of Arbidol in Patients With 2019 Novel Coronavirus (2019-nCoV)

2019 Novel Coronavirus Clinical Trial

Official title:

A Randomized Multicenter Controlled Clinical Trial of Arbidol in Patients With 2019 Novel Coronavirus (2019-nCoV)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04246242
• Other study ID #: 81770083
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 25, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: January 2020
• Source: Xiangya Hospital of Central South University
• Contact: Pinhua Pan, Medical PhD
• Phone: +86 13574810968
• Email: pinhuapan668[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective To determine the efficacy and safety of arbidol in patients with 2019 Novel Coronavirus (2019-nCoV).Methods Patients with 2019-nCoV were divided into three groups according to randomized double-blinded controlled clinical trial principle.Patients in three groups were administrated with arbidol,200mg,tid or arbidol,400 mg,tid or not for 5 days respectively. Other antiviral and comprehensive treatments of the three groups of patients are consistent. Then investigators will compare the first outcome: 28-day mortality, and secondary outcome: ICU hospitalization time, mechanical ventilation time, Hospitalization costs, antibiotic use costs, SOFA scores, CURB-65 scores, APACHE scores, and other clinical indicators.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: May 30, 2021
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients diagnosed with RT-PCR for 2019 Novel Coronavirus (2019-nCoV)

Exclusion Criteria:

Patients infected with other viruses

Related Conditions & MeSH terms

• 2019 Novel Coronavirus
• Coronavirus Infections

Intervention

Drug:
• Conventional treatment group
Methods Patients with 2019-nCoV were divided into three groups according to randomized double-blinded controlled clinical trial principle.Patients in three groups were administrated with arbidol,200mg,tid or arbidol,400 mg,tid or not for 5 days respectively.
• arbidol,200mg,tid
Methods Patients with 2019-nCoV were divided into three groups according to randomized double-blinded controlled clinical trial principle.Patients in three groups were administrated with arbidol,200mg,tid or arbidol,400 mg,tid or not for 5 days respectively.
• arbidol,400mg,tid
Methods Patients with 2019-nCoV were divided into three groups according to randomized double-blinded controlled clinical trial principle.Patients in three groups were administrated with arbidol,200mg,tid or arbidol,400 mg,tid or not for 5 days respectively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	Using the Kaplan-Meier method to analyze the differences in mortality between the two groups within 28 days	28 day
Secondary	mechanical ventilation time	According to the secondary result, comprehensively evaluate the two detection methods for the treatment of patients with severe pneumonia	30 days