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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 : Recruiting
First Posted : February 5, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Qin Ning, Tongji Hospital

Study Description
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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

Study Design
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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

Arms and Interventions
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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.


Outcome Measures
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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 ]

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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04255017


Contacts
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Contact: Qing Ning, Professor +8613971521450 qning@vip.sina.com
Contact: Meifang Han, Professor +8613986093605 mfhan@foxmail.com

Locations
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China, Hubei
Department and Institute of Infectious Disease Recruiting
Wuhan, Hubei, China, 430030
Contact: Qin Ning, professor       qning@vip.sina.com   
Contact: Meifang Han, professor       mfhan@foxmail.com   
Sponsors and Collaborators
Tongji Hospital
More Information
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Responsible Party: Qin Ning, Professor, Tongji Hospital
ClinicalTrials.gov 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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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ritonavir
Lopinavir
Oseltamivir
Antiviral Agents
HIV Protease Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors