A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia

Phase 4

• Conditions: 2019-nCoV
• Interventions: Drug: Lopinavir/ritonavir; Drug: Abidol hydrochloride; Drug: Oseltamivir

• Registration Number: NCT04255017
• Lead Sponsor: Tongji Hospital

Brief Summary

At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of three antiviral drugs in the treatment of 2019-nCoV pneumonia by studying the efficacy of abidol hydrochloride, oseltamivir and lopinavir/ritonavir in the treatment of 2019-nCoV viral pneumonia, and to explore effective antiviral drugs for new coronavirus. To provide reliable evidence-based medicine basis for the treatment of viral pneumonia caused by new coronavirus infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-02-02
• Study First Submitted QC: 2020-02-02
• Study First Posted: 2020-02-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-14
• Last Update Posted: 2020-03-17
• Primary Completion: 2020-06-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. 2019-nCoV nucleic acid test was positive.
2. CT of the lung conformed to the manifestation of viral pneumonia.

Exclusion Criteria

1. Patients who meet any of the contraindications in the experimental drug labeling
2. Patients who do not want to participate in this clinical study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lopinavir/ritonavir was added on the basis of group I.	Lopinavir/ritonavir	Lopinavir/ritonavir 500mg once,twice a day,2 weeks
Abidol hydrochloride was added on the basis of group I.	Abidol hydrochloride	Abidol hydrochloride 0.2g once,3 times a day,2 weeks
Oseltamivir was added on the basis of group I.	Oseltamivir	Oseltamivir 75mg once,twice a day,2 weeks

Primary Outcome Measures

Name	Time	Method
Rate of disease remission	two weeks	A: For mild patients : fever, cough and other symptoms relieved with improved lung CT; B:For severe patients : fever, cough and other symptoms relieved with improved lung CT,SPO2\> 93% or PaO2/FiO2\>300mmHg (1mmHg=0.133Kpa);
Time for lung recovery	two weeks	Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.

Secondary Outcome Measures

Name	Time	Method
Rate of no fever	two weeks
Rate of respiratory symptom remission	two weeks
Rate of lung imaging recovery	two weeks
Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery	two weeks
Rate of undetectable viral RNA	two weeks

Trial Locations

Locations (1)

Department and Institute of Infectious Disease; 🇨🇳 Wuhan, Hubei, China