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

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 3

Conditions: 2019 Novel Coronavirus Infection

Treatments: Drug: thymosin alpha 1; Drug: recombinant human interferon Alpha-1b

Study type: Interventional

Funder types: Other

Identifiers

NCT04320238

Interferon_prophylaxis

Details and patient eligibility

About

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 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.

Enrollment: 2,944 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,944 participants in 2 patient groups

low-risk group

Experimental group

Description:

medical staff work in non-isolated general wards or laboratories, not directly contact with COVID-19 patients.

Treatment:

Drug: recombinant human interferon Alpha-1b

high-risk group

Experimental group

Description:

doctors and nurses work in isolated ward, directly contact with COVID-19 patients.

Treatment:

Drug: recombinant human interferon Alpha-1b

Drug: thymosin alpha 1