A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia
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.
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2020
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 2, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedMarch 17, 2020
March 1, 2020
4 months
February 2, 2020
March 14, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
Time for lung recovery
Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.
two weeks
Secondary Outcomes (5)
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
Study Arms (4)
Symptomatic supportive treatment
NO INTERVENTIONSymptomatic supportive treatment
Abidol hydrochloride was added on the basis of group I.
EXPERIMENTALAbidol hydrochloride 0.2g once,3 times a day,2 weeks
Oseltamivir was added on the basis of group I.
EXPERIMENTALOseltamivir 75mg once,twice a day,2 weeks
Lopinavir/ritonavir was added on the basis of group I.
EXPERIMENTALLopinavir/ritonavir 500mg once,twice a day,2 weeks
Interventions
Abidol hydrochloride (0.2g once, 3 times a day,2 weeks)was added on the basis of group I.
Oseltamivir(75mg once, twice a day,2 weeks) was added on the basis of group I.
Lopinavir/ritonavir (500mg once, twice a day,2 weeks)was added on the basis of group I.
Eligibility Criteria
You may qualify if:
- nCoV nucleic acid test was positive.
- CT of the lung conformed to the manifestation of viral pneumonia.
You may not qualify if:
- Patients who meet any of the contraindications in the experimental drug labeling
- Patients who do not want to participate in this clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Study Sites (1)
Department and Institute of Infectious Disease
Wuhan, Hubei, 430030, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 2, 2020
First Posted
February 5, 2020
Study Start
February 1, 2020
Primary Completion
June 1, 2020
Study Completion
July 1, 2020
Last Updated
March 17, 2020
Record last verified: 2020-03