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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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2019-nCoV

Intervention / Treatment
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* Drug: Abidol hydrochloride
* Drug: Abidol Hydrochloride combined with Interferon atomization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1)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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abidol hydrochloride<br>Standard symptomatic support therapy (SMT) plus abidol hydrochloride(0.2g, 3 times a day). | Drug: Abidol hydrochloride<br>* 0.2g once, 3 times a day,two weeks<br>|
| Experimental: Abidol Hydrochloride combined with Interferon atomization<br>Interferon(PegIFN-α-2b) atomization was added(45ug, add to sterile water 2ml, twice a day) on the basis of group I. | Drug: Abidol Hydrochloride combined with Interferon atomization<br>* Abidol Hydrochloride:0.2g once, 3 times a day,two weeks; Interferon(PegIFN-α-2b) atomization:45ug, add to sterile water 2ml, twice a day,two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |