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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04320238
Recruitment Status : Unknown
Verified March 2020 by Zhongji Meng, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : March 24, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Zhongji Meng, Shanghai Jiao Tong University School of Medicine

Study Description
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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
2019 Novel Coronavirus Infection 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 21, 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arms and Interventions
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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 Name: 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 Name: interferon α

Drug: thymosin alpha 1
thymosin alpha 1 subcutaneous injection 1 time per week.
Other Name: thymosin α


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Number of Participants with adverse effect [ Time Frame: during 28-day intervention. ]
    adverse effect of interferon α


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320238


Contacts
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Contact: Zhongji Meng 18971905757 zhongji.meng@163.com

Locations
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China, Hubei
Taihe Hospital Recruiting
Shiyan, Hubei, China
Contact: Zhongji Meng    +86-18971905757    zhongji.meng@163.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
More Information
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Publications:

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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: March 24, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhongji Meng, Shanghai Jiao Tong University School of Medicine:
rhINF-α
2019-nCOV
prophylaxis
Additional relevant MeSH terms:
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Coronavirus Infections
COVID-19
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Lung Diseases
 Respiratory Tract Diseases
Interferons
Interferon-alpha
Interferon-alfa-1b
Thymalfasin
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic