Clincosm LogoSign in Get a demo

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

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Unknown status
CT.gov ID
NCT04320238
Collaborator
(none)
2,944
Enrollment
1
Location
2
Arms
4.3
Anticipated Duration (Months)
678.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: recombinant human interferon Alpha-1b
  • Drug: thymosin alpha 1
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
2944 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
An Clinic Trial of Recombinant Human Interferon Alpha Nasal Drops to Prevent Coronavirus Disease 2019 in Medical Staff in Epidemic Area
Actual Study Start Date :
Jan 21, 2020
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Number of Participants with coronavirus related symptoms [during 28-day intervention.]

      new-onset fever or respiratory symptoms but with negative pulmonary images evidence.

    2. Number of Participants with adverse effect [during 28-day intervention.]

      adverse effect of interferon α

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taihe Hospital Shiyan Hubei China

    Sponsors and Collaborators

    • Shanghai Jiao Tong University School of Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Zhongji Meng, Chief of Infectious disease department, Principal Investigator, Clinical Professor, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT04320238
    Other Study ID Numbers:
    • Interferon_prophylaxis
    First Posted:
    Mar 24, 2020
    Last Update Posted:
    Mar 31, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zhongji Meng, Chief of Infectious disease department, Principal Investigator, Clinical Professor, Shanghai Jiao Tong University School of Medicine
    rhINF-α
    2019-nCOV
    prophylaxis
    Additional relevant MeSH terms:
    Coronavirus Infections
    COVID-19
    Interferons
    Interferon-alpha
    Interferon-alfa-1b
    Thymalfasin

    Study Results

    No Results Posted as of Mar 31, 2020