A Prospective/Retrospective,Randomized Controlled Clinical Study of Interferon Atomization in the 2019-nCoV Pneumonia
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ClinicalTrials.gov Identifier: NCT04254874 |
Recruitment Status :
Recruiting
First Posted : February 5, 2020
Last Update Posted : March 17, 2020
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Condition or disease | Intervention/treatment | Phase |
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2019-nCoV | Drug: Abidol hydrochloride Drug: Abidol Hydrochloride combined with Interferon atomization | Phase 4 |
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 |

Arm | Intervention/treatment |
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Experimental: Abidol hydrochloride
Standard symptomatic support therapy (SMT) plus abidol hydrochloride(0.2g, 3 times a day).
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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.
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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 |
- 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);
- Time for lung recovery [ Time Frame: two weeks ]Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.
- Rate of no fever [ Time Frame: two weeks ]
- Rate of respiratory symptom remission [ Time Frame: two weeks ]
- Rate of lung imaging recovery [ Time Frame: two weeks ]
- Rate of CRP,ES,Biochemical criterion (CK,ALT,Mb)recovery [ Time Frame: two weeks ]
- Rate of undetectable viral RNA [ Time Frame: two weeks ]

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

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
Contact: Qing Ning, Professor | +8613971521450 | qning@vip.sina.com | |
Contact: Meifang Han, Professor | +8613986093605 | mfhan@foxmail.com |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Interferons Antineoplastic Agents Antiviral Agents Anti-Infective Agents |