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

Phase 3

• Conditions: 2019 Novel Coronavirus Infection
• Interventions: Drug: recombinant human interferon Alpha-1b; Drug: thymosin alpha 1

• Registration Number: NCT04320238
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2020-01-21
• Status Verified: 2020-03
• Study First Submitted: 2020-03-21
• Study First Submitted QC: 2020-03-21
• Study First Posted: 2020-03-24
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31
• Primary Completion: 2020-05
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2944

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high-risk group	thymosin alpha 1	doctors and nurses work in isolated ward, directly contact with COVID-19 patients.
low-risk group	recombinant human interferon Alpha-1b	medical staff work in non-isolated general wards or laboratories, not directly contact with COVID-19 patients.
high-risk group	recombinant human interferon Alpha-1b	doctors and nurses work in isolated ward, directly contact with COVID-19 patients.

Primary Outcome Measures

Name	Time	Method
new-onset COVID-19	From date of randomization until the diagnosis of COVID-19, assessed up to 6 weeks.	new-onset coronavirus disease-2019

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taihe Hospital; 🇨🇳 Shiyan, Hubei, China