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

Primary Purpose

2019-nCoV

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Abidol hydrochloride
Oseltamivir
Lopinavir/ritonavir
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for 2019-nCoV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department and Institute of Infectious DiseaseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Symptomatic supportive treatment

Abidol hydrochloride was added on the basis of group I.

Oseltamivir was added on the basis of group I.

Lopinavir/ritonavir was added on the basis of group I.

Arm Description

Symptomatic supportive treatment

Abidol hydrochloride 0.2g once,3 times a day,2 weeks

Oseltamivir 75mg once,twice a day,2 weeks

Lopinavir/ritonavir 500mg once,twice a day,2 weeks

Outcomes

Primary Outcome Measures

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);
Time for lung recovery
Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.

Secondary Outcome Measures

Rate of no fever
Rate of respiratory symptom remission
Rate of lung imaging recovery
Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery
Rate of undetectable viral RNA

Full Information

First Posted
February 2, 2020
Last Updated
March 14, 2020
Sponsor
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04255017
Brief Title
A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
2019-nCoV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Symptomatic supportive treatment
Arm Type
No Intervention
Arm Description
Symptomatic supportive treatment
Arm Title
Abidol hydrochloride was added on the basis of group I.
Arm Type
Experimental
Arm Description
Abidol hydrochloride 0.2g once,3 times a day,2 weeks
Arm Title
Oseltamivir was added on the basis of group I.
Arm Type
Experimental
Arm Description
Oseltamivir 75mg once,twice a day,2 weeks
Arm Title
Lopinavir/ritonavir was added on the basis of group I.
Arm Type
Experimental
Arm Description
Lopinavir/ritonavir 500mg once,twice a day,2 weeks
Intervention Type
Drug
Intervention Name(s)
Abidol hydrochloride
Intervention Description
Abidol hydrochloride (0.2g once, 3 times a day,2 weeks)was added on the basis of group I.
Intervention Type
Drug
Intervention Name(s)
Oseltamivir
Intervention Description
Oseltamivir(75mg once, twice a day,2 weeks) was added on the basis of group I.
Intervention Type
Drug
Intervention Name(s)
Lopinavir/ritonavir
Intervention Description
Lopinavir/ritonavir (500mg once, twice a day,2 weeks)was added on the basis of group I.
Primary Outcome Measure Information:
Title
Rate of disease remission
Description
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 Frame
two weeks
Title
Time for lung recovery
Description
Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Rate of no fever
Time Frame
two weeks
Title
Rate of respiratory symptom remission
Time Frame
two weeks
Title
Rate of lung imaging recovery
Time Frame
two weeks
Title
Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery
Time Frame
two weeks
Title
Rate of undetectable viral RNA
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Ning, Professor
Phone
+8613971521450
Email
qning@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meifang Han, Professor
Phone
+8613986093605
Email
mfhan@foxmail.com
Facility Information:
Facility Name
Department and Institute of Infectious Disease
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Ning, professor
Email
qning@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Meifang Han, professor
Email
mfhan@foxmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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