Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff

2019 Novel Coronavirus Infection Clinical Trial

Official title:

An Clinic Trial of Recombinant Human Interferon Alpha Nasal Drops to Prevent Coronavirus Disease 2019 in Medical Staff in Epidemic Area

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04320238
• Other study ID #: Interferon_prophylaxis
• Status: Recruiting
• Phase: Phase 3
• Start date: January 21, 2020
• Est. completion date: June 2020

Study information

• Verified date: March 2020
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Zhongji Meng
• Phone: 18971905757
• Email: zhongji.meng[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2944
• Est. completion date: June 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• 2019 Novel Coronavirus Infection
• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Intervention

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.
• thymosin alpha 1
thymosin alpha 1 subcutaneous injection 1 time per week.

Locations

Country	Name	City	State
China	Taihe Hospital	Shiyan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (5)

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, Li 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 JTK, 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 Jan 29. doi: 10.1056/NEJMoa2001316. [Epub ahead of print] — View Citation

Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 17;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. [Epub ahead of print] Chinese. — View Citation

Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 Feb 26:102433. doi: 10.1016/j.jaut.2020.102433. [Epub ahead of print] Review. — View Citation

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. — View Citation

Xiaolu T, Changcheng W, Xiang L, et al. On the origin and continuing evolution of SARS-CoV-2. National Science Review. nwaa036.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	new-onset COVID-19	new-onset coronavirus disease-2019	From date of randomization until the diagnosis of COVID-19, assessed up to 6 weeks.
Secondary	Number of Participants with coronavirus related symptoms	new-onset fever or respiratory symptoms but with negative pulmonary images evidence.	during 28-day intervention.
Secondary	Number of Participants with adverse effect	adverse effect of interferon a	during 28-day intervention.