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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04320238

Enrollment

2944

Registered

2020-03-24

Start date

2020-01-21

Completion date

2020-06-30

Last updated

2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

2019 Novel Coronavirus Infection

Keywords

rhINF-α, 2019-nCOV, prophylaxis

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.

Interventions

DRUGrecombinant human interferon Alpha-1b

recombinant human interferon Alpha-1b nasal drops, 2-3 drops for each nostril per time, 4 times per day.

DRUGthymosin alpha 1

thymosin alpha 1 subcutaneous injection 1 time per week.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactZhongji Meng

zhongji.meng@163.com18971905757

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026