COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

A Prospective/Retrospective,Randomized Controlled Clinical Study of Interferon Atomization 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. Identifier: NCT04254874
Recruitment Status : 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 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.

Condition or disease Intervention/treatment Phase
2019-nCoV Drug: Abidol hydrochloride Drug: Abidol Hydrochloride combined with Interferon atomization Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 Two Therapeutic Schemes(Abidol Hydrochloride,Abidol Hydrochloride Combined With Interferon Atomization)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
Drug Information available for: Interferon

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

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.

Layout table for eligibility information
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): NCT04254874

Layout table for location contacts
Contact: Qing Ning, Professor +8613971521450
Contact: Meifang Han, Professor +8613986093605

Layout table for location information
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

Layout table for additonal information
Responsible Party: Qin Ning, Professor, Tongji Hospital Identifier: NCT04254874    
Other Study ID Numbers: TJ20200131
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents