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

March 14, 2020 updated by: Qin Ning, Tongji Hospital

An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Two Therapeutic Schemes(Abidol Hydrochloride,Abidol Hydrochloride Combined With Interferon Atomization)in the Treatment of 2019-nCoV Pneumonia.

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 two therapeutic schemes(abidol hydrochloride,abidol hydrochloride combined with interferon atomization)in the treatment of 2019-nCoV viral pneumonia, so as to provide reliable evidence-based medicine for the treatment of viral pneumonia caused by 2019-nCoV.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Department and Institute of Infectious Disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abidol hydrochloride
Standard symptomatic support therapy (SMT) plus abidol hydrochloride(0.2g, 3 times a day).
Drug: Abidol hydrochloride
0.2g once, 3 times a day,two weeks
Experimental: Abidol Hydrochloride combined with Interferon atomization
Interferon(PegIFN-α-2b) atomization was added(45ug, add to sterile water 2ml, twice a day) on the basis of group I.
Drug: Abidol Hydrochloride combined with Interferon atomization
Abidol Hydrochloride:0.2g once, 3 times a day,two weeks; Interferon(PegIFN-α-2b) atomization:45ug, add to sterile water 2ml, twice a day,two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for lung recovery
Time Frame: two weeks
Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.
two weeks
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);
two weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of no fever
Time Frame: two weeks
two weeks
Rate of respiratory symptom remission
Time Frame: two weeks
two weeks
Rate of lung imaging recovery
Time Frame: two weeks
two weeks
Rate of undetectable viral RNA
Time Frame: two weeks
two weeks
Rate of CRP,ES,Biochemical criterion (CK,ALT,Mb)recovery
Time Frame: two weeks
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

February 2, 2020

First Submitted That Met QC Criteria

February 2, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 14, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ20200131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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