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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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2019 Novel Coronavirus Infection

Intervention / Treatment
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* Drug: recombinant human interferon Alpha-1b
* Drug: thymosin alpha 1


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low-risk group<br>medical staff work in non-isolated general wards or laboratories, not directly contact with COVID-19 patients. | Drug: recombinant human interferon Alpha-1b<br>* recombinant human interferon Alpha-1b nasal drops, 2-3 drops for each nostril per time, 4 times per day.<br>* Other names: interferon α;|
| Experimental: high-risk group<br>doctors and nurses work in isolated ward, directly contact with COVID-19 patients. | Drug: recombinant human interferon Alpha-1b<br>* recombinant human interferon Alpha-1b nasal drops, 2-3 drops for each nostril per time, 4 times per day.<br>* Other names: interferon α;Drug: thymosin alpha 1<br>* thymosin alpha 1 subcutaneous injection 1 time per week.<br>* Other names: thymosin α;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with coronavirus related symptoms | new-onset fever or respiratory symptoms but with negative pulmonary images evidence. | during 28-day intervention. | 
| Number of Participants with adverse effect | adverse effect of interferon α | during 28-day intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhINF-α, 2019-nCOV, prophylaxis