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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Qin Ning, Tongji Hospital

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.

Condition or disease Intervention/treatment Phase
2019-nCoV Drug: Abidol hydrochloride Drug: Oseltamivir Drug: Lopinavir/ritonavir Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
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
Drug: Oseltamivir
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
Drug: Lopinavir/ritonavir
Lopinavir/ritonavir (500mg once, twice a day,2 weeks)was added on the basis of group I.

Primary Outcome Measures :
  1. 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);

  2. Time for lung recovery [ Time Frame: two weeks ]
    Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.

Secondary Outcome Measures :
  1. Rate of no fever [ Time Frame: two weeks ]
  2. Rate of respiratory symptom remission [ Time Frame: two weeks ]
  3. Rate of lung imaging recovery [ Time Frame: two weeks ]
  4. Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery [ Time Frame: two weeks ]
  5. Rate of undetectable viral RNA [ Time Frame: two weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 2019-nCoV nucleic acid test was positive.
  2. CT of the lung conformed to the manifestation of viral pneumonia.

Exclusion Criteria:

  1. Patients who meet any of the contraindications in the experimental drug labeling
  2. Patients who do not want to participate in this clinical study

Information from the National Library of Medicine

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 identifier (NCT number): NCT04255017

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Contact: Qing Ning, Professor +8613971521450
Contact: Meifang Han, Professor +8613986093605

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China, Hubei
Department and Institute of Infectious Disease Recruiting
Wuhan, Hubei, China, 430030
Contact: Qin Ning, professor   
Contact: Meifang Han, professor   
Sponsors and Collaborators
Tongji Hospital
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Responsible Party: Qin Ning, Professor, Tongji Hospital Identifier: NCT04255017    
Other Study ID Numbers: TJ20200128
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors