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

2019-nCoV Clinical Trial

Official title:

An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Three Antiviral Drugs(Abidol Hydrochloride, Oseltamivir and Lopinavir/Ritonavir) in the Treatment of 2019-nCoV Pneumonia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04255017
• Other study ID #: TJ20200128
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: March 2020
• Source: Tongji Hospital
• Contact: Qing Ning, Professor
• Phone: +8613971521450
• Email: qning[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 2019-nCoV
• Pneumonia

Intervention

Drug:
• Abidol hydrochloride
Abidol hydrochloride (0.2g once, 3 times a day,2 weeks)was added on the basis of group I.
• Oseltamivir
Oseltamivir(75mg once, twice a day,2 weeks) was added on the basis of group I.
• Lopinavir/ritonavir
Lopinavir/ritonavir (500mg once, twice a day,2 weeks)was added on the basis of group I.

Locations

Country	Name	City	State
China	Department and Institute of Infectious Disease	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of disease remission	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);	two weeks
Primary	Time for lung recovery	Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.	two weeks
Secondary	Rate of no fever		two weeks
Secondary	Rate of respiratory symptom remission		two weeks
Secondary	Rate of lung imaging recovery		two weeks
Secondary	Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery		two weeks
Secondary	Rate of undetectable viral RNA		two weeks