A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy 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 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.

Official Title
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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.

Conditions
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2019-nCoV

Intervention / Treatment
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* Drug: Abidol hydrochloride
* Drug: Oseltamivir
* Drug: Lopinavir/ritonavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 2019-nCoV nucleic acid test was positive. 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 |
| --- | --- |
| No Intervention: Symptomatic supportive treatment<br>Symptomatic supportive treatment | |
| Experimental: Abidol hydrochloride was added on the basis of group I.<br>Abidol hydrochloride 0.2g once,3 times a day,2 weeks | Drug: Abidol hydrochloride<br>* Abidol hydrochloride (0.2g once, 3 times a day,2 weeks)was added on the basis of group I.<br>|
| Experimental: Oseltamivir was added on the basis of group I.<br>Oseltamivir 75mg once,twice a day,2 weeks | Drug: Oseltamivir<br>* Oseltamivir(75mg once, twice a day,2 weeks) was added on the basis of group I.<br>|
| Experimental: Lopinavir/ritonavir was added on the basis of group I.<br>Lopinavir/ritonavir 500mg once,twice a day,2 weeks | Drug: Lopinavir/ritonavir<br>* Lopinavir/ritonavir (500mg once, twice a day,2 weeks)was added on the basis of group I.<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 |