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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04254874
Recruitment Status : Unknown
Verified March 2020 by Qin Ning, Tongji Hospital.
Recruitment status was:  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 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

Study Design
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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

Drug Information available for: Interferon

Arms and Interventions
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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


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): NCT04254874


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: 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

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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
COVID-19
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Pneumonia, Viral
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents