Clinical trial NCT04320238: Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff
Official title: An Clinic Trial of Recombinant Human Interferon Alpha Nasal Drops to Prevent Coronavirus Disease 2019 in Medical Staff in Epidemic Area
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: 2019 Novel Coronavirus Infection
Keywords: rhINF-α
2019-nCOV
prophylaxis
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 2944
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: new-onset COVID-19
timeFrame: From date of randomization until the diagnosis of COVID-19, assessed up to 6 weeks.
Secondary outcomes:
measure: Number of Participants with coronavirus related symptoms
timeFrame: during 28-day intervention.
measure: Number of Participants with adverse effect
timeFrame: during 28-day intervention.
Other outcomes:
Locations:
city: Shiyan
country: China
facility: Taihe Hospital
state: Hubei
Study officials:
References:
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citation: 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.
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. No abstract available.