An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Two Therapeutic Schemes(Abidol Hydrochloride,Abidol Hydrochloride Combined With Interferon Atomization)in the Treatment of 2019-nCoV Pneumonia.
Overview
- Phase
- Phase 4
- Intervention
- Abidol hydrochloride
- Conditions
- 2019-nCoV
- Sponsor
- Tongji Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Time for lung recovery
- Last Updated
- 6 years ago
Overview
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 two therapeutic schemes(abidol hydrochloride,abidol hydrochloride combined with interferon atomization)in the treatment of 2019-nCoV viral pneumonia, so as to provide reliable evidence-based medicine for the treatment of viral pneumonia caused by 2019-nCoV.
Investigators
Qin Ning
Professor
Tongji Hospital
Eligibility Criteria
Inclusion Criteria
- •2019-nCoV nucleic acid test was positive. 2)CT of the lung conformed to the manifestation of viral pneumonia.
Exclusion Criteria
- •Patients who meet any of the contraindications in the experimental drug labeling
- •Patients who do not want to participate in this clinical study
Arms & Interventions
Abidol hydrochloride
Standard symptomatic support therapy (SMT) plus abidol hydrochloride(0.2g, 3 times a day).
Intervention: Abidol hydrochloride
Abidol Hydrochloride combined with Interferon atomization
Interferon(PegIFN-α-2b) atomization was added(45ug, add to sterile water 2ml, twice a day) on the basis of group I.
Intervention: Abidol Hydrochloride combined with Interferon atomization
Outcomes
Primary Outcomes
Time for lung recovery
Time Frame: two weeks
Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.
Rate of disease remission
Time Frame: 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);
Secondary Outcomes
- Rate of undetectable viral RNA(two weeks)
- Rate of respiratory symptom remission(two weeks)
- Rate of CRP,ES,Biochemical criterion (CK,ALT,Mb)recovery(two weeks)
- Rate of no fever(two weeks)
- Rate of lung imaging recovery(two weeks)