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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 2, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date March 17, 2020
Actual Study Start Date  ICMJE February 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE 2019-nCoV
Intervention  ICMJE
  • Drug: Abidol hydrochloride
    Abidol hydrochloride (0.2g once, 3 times a day,2 weeks)was added on the basis of group I.
  • Drug: Oseltamivir
    Oseltamivir(75mg once, twice a day,2 weeks) was added on the basis of group I.
  • Drug: Lopinavir/ritonavir
    Lopinavir/ritonavir (500mg once, twice a day,2 weeks)was added on the basis of group I.
Study Arms  ICMJE
  • 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
    Intervention: Drug: Abidol hydrochloride
  • Experimental: Oseltamivir was added on the basis of group I.
    Oseltamivir 75mg once,twice a day,2 weeks
    Intervention: Drug: Oseltamivir
  • Experimental: Lopinavir/ritonavir was added on the basis of group I.
    Lopinavir/ritonavir 500mg once,twice a day,2 weeks
    Intervention: Drug: Lopinavir/ritonavir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 2, 2020)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qing Ning, Professor +8613971521450 qning@vip.sina.com
Contact: Meifang Han, Professor +8613986093605 mfhan@foxmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04255017
Other Study ID Numbers  ICMJE TJ20200128
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Qin Ning, Tongji Hospital
Study Sponsor  ICMJE Tongji Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tongji Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP