A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia
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|ClinicalTrials.gov Identifier: NCT04255017|
Recruitment Status : Unknown
Verified March 2020 by Qin Ning, Tongji Hospital.
Recruitment status was: Recruiting
First Posted : February 5, 2020
Last Update Posted : March 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|2019-nCoV||Drug: Abidol hydrochloride Drug: Oseltamivir Drug: Lopinavir/ritonavir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Actual Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||July 1, 2020|
No Intervention: Symptomatic supportive treatment
Symptomatic supportive treatment
Experimental: Abidol hydrochloride was added on the basis of group I.
Abidol hydrochloride 0.2g once,3 times a day,2 weeks
Drug: Abidol hydrochloride
Abidol hydrochloride (0.2g once, 3 times a day,2 weeks)was added on the basis of group I.
Experimental: Oseltamivir was added on the basis of group I.
Oseltamivir 75mg once,twice a day,2 weeks
Oseltamivir(75mg once, twice a day,2 weeks) was added on the basis of group I.
Experimental: Lopinavir/ritonavir was added on the basis of group I.
Lopinavir/ritonavir 500mg once,twice a day,2 weeks
Lopinavir/ritonavir (500mg once, twice a day,2 weeks)was added on the basis of group I.
- 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);
- 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 no fever [ Time Frame: two weeks ]
- Rate of respiratory symptom remission [ Time Frame: two weeks ]
- Rate of lung imaging recovery [ Time Frame: two weeks ]
- Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery [ Time Frame: two weeks ]
- Rate of undetectable viral RNA [ Time Frame: two weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04255017
|Contact: Qing Ning, Professorfirstname.lastname@example.org|
|Contact: Meifang Han, Professoremail@example.com|