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

Sponsor

Tongji Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04254874

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

20.2

Patients Per Site Per Month

Study Details

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 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

Study Type:

Interventional

Anticipated 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 :

Feb 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

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

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

Primary Outcome Measures

Rate of disease remission [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 [two weeks]
Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

Patients who meet any of the contraindications in the experimental drug labeling
Patients who do not want to participate in this clinical study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department and Institute of Infectious Disease	Wuhan	Hubei	China	430030

Sponsors and Collaborators

Tongji Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qin Ning, Professor, Tongji Hospital

ClinicalTrials.gov Identifier:

NCT04254874

Other Study ID Numbers:

TJ20200131

First Posted:

Feb 5, 2020

Last Update Posted:

Mar 17, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pneumonia

Interferons

Study Results

No Results Posted as of Mar 17, 2020