DRUG
recombinant human interferon Alpha-1b
recombinant human interferon Alpha-1b nasal drops, 2-3 drops for each nostril per time, 4 times per day.
Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff
Status
Unknown
Phase
Phase 3
Enrollment
2,944
Locations
1
Results
Not posted
Publications
5
Study summary
What the protocol is testing.
The investigators plan to carry out an experimental study on the preventive effect of recombinant human interferon alpha nasal drops on the infection of 2019 new coronavirus in medical staff.
Full detailed description
The investigators plan to carry out an experimental study enrolling more than 2000 medical staff and divide participants into low-risk group and high-risk group according to whether they can directly exposed to 2019-nCOV infected patients. In the low-risk group, participants will be given recombinant human interferon alpha-1b nasal drops (2-3 drops/nostril/ time, 4 times/ day), and in the high-risk group will be given preventive intervention with interferon nasal drops and thymosin-α (thymosin was injected subcutaneously once / week), and the intervention time is 28 days.
Interventions
Treatment arms and agents.
DRUG
thymosin alpha 1
thymosin alpha 1 subcutaneous injection 1 time per week.
Timeline
From registration to results.
First posted
Mar 24, 2020
Study start
Jan 21, 2020
Primary completion
May 2020
Study completion
Jun 2020
Results posted
Not reported
Registry updated
Mar 31, 2020
Outcomes
What the study measures.
Primary outcomes
new-onset COVID-19
Time frame · From date of randomization until the diagnosis of COVID-19, assessed up to 6 weeks.
new-onset coronavirus disease-2019
Secondary outcomes
Number of Participants with coronavirus related symptoms
Time frame · during 28-day intervention.
new-onset fever or respiratory symptoms but with negative pulmonary images evidence.
Number of Participants with adverse effect
Time frame · during 28-day intervention.
adverse effect of interferon α
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: * Formally serving medical staff in Taihe Hospital; Exclusion Criteria: * pregnant women; * severe chronic diseases who are unable to participate in daily routine work; * fever (temperature≥37.3 ° ) and / or respiratory symptoms.
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Taihe Hospital
Shiyan, Hubei, China
Publications
Results and literature.
PMID 31995857 ↗Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.PMID 32064853 ↗Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.PMID 34676127 ↗Tang X, Wu C, Li X, Song Y, Yao X, Wu X, Duan Y, Zhang H, Wang Y, Qian Z, Cui J, Lu J. On the origin and continuing evolution of SARS-CoV-2. Natl Sci Rev. 2020 Jun;7(6):1012-1023. doi: 10.1093/nsr/nwaa036. Epub 2020 Mar 3.PMID 32113704 ↗Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.PMID 32043978 ↗Thompson R. Pandemic potential of 2019-nCoV. Lancet Infect Dis. 2020 Mar;20(3):280. doi: 10.1016/S1473-3099(20)30068-2. Epub 2020 Feb 7. No abstract available.
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