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

March 30, 2020 updated by: Zhongji Meng, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

2944

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Shiyan, Hubei, China
        • Recruiting
        • Taihe Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
new-onset COVID-19
Time Frame: From date of randomization until the diagnosis of COVID-19, assessed up to 6 weeks.
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
Time Frame: during 28-day intervention.
new-onset fever or respiratory symptoms but with negative pulmonary images evidence.
during 28-day intervention.
Number of Participants with adverse effect
Time Frame: during 28-day intervention.
adverse effect of interferon α
during 28-day intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2020

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

March 21, 2020

First Submitted That Met QC Criteria

March 21, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Interferon_prophylaxis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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