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

Primary Purpose

2019 Novel Coronavirus Infection

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
recombinant human interferon Alpha-1b
thymosin alpha 1
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for 2019 Novel Coronavirus Infection focused on measuring rhINF-α, 2019-nCOV, prophylaxis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Taihe HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

low-risk group

high-risk group

Arm Description

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

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

Outcomes

Primary Outcome Measures

new-onset COVID-19
new-onset coronavirus disease-2019

Secondary Outcome Measures

Number of Participants with coronavirus related symptoms
new-onset fever or respiratory symptoms but with negative pulmonary images evidence.
Number of Participants with adverse effect
adverse effect of interferon α

Full Information

First Posted
March 21, 2020
Last Updated
March 30, 2020
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04320238
Brief Title
Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff
Official Title
An Clinic Trial of Recombinant Human Interferon Alpha Nasal Drops to Prevent Coronavirus Disease 2019 in Medical Staff in Epidemic Area
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
2019 Novel Coronavirus Infection
Keywords
rhINF-α, 2019-nCOV, prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2944 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low-risk group
Arm Type
Experimental
Arm Description
medical staff work in non-isolated general wards or laboratories, not directly contact with COVID-19 patients.
Arm Title
high-risk group
Arm Type
Experimental
Arm Description
doctors and nurses work in isolated ward, directly contact with COVID-19 patients.
Intervention Type
Drug
Intervention Name(s)
recombinant human interferon Alpha-1b
Other Intervention Name(s)
interferon α
Intervention Description
recombinant human interferon Alpha-1b nasal drops, 2-3 drops for each nostril per time, 4 times per day.
Intervention Type
Drug
Intervention Name(s)
thymosin alpha 1
Other Intervention Name(s)
thymosin α
Intervention Description
thymosin alpha 1 subcutaneous injection 1 time per week.
Primary Outcome Measure Information:
Title
new-onset COVID-19
Description
new-onset coronavirus disease-2019
Time Frame
From date of randomization until the diagnosis of COVID-19, assessed up to 6 weeks.
Secondary Outcome Measure Information:
Title
Number of Participants with coronavirus related symptoms
Description
new-onset fever or respiratory symptoms but with negative pulmonary images evidence.
Time Frame
during 28-day intervention.
Title
Number of Participants with adverse effect
Description
adverse effect of interferon α
Time Frame
during 28-day intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongji Meng
Phone
18971905757
Email
zhongji.meng@163.com
Facility Information:
Facility Name
Taihe Hospital
City
Shiyan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongji Meng
Phone
+86-18971905757
Email
zhongji.meng@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31995857
Citation
Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
Results Reference
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PubMed Identifier
32064853
Citation
Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
Results Reference
background
PubMed Identifier
34676127
Citation
Tang X, Wu C, Li X, Song Y, Yao X, Wu X, Duan Y, Zhang H, Wang Y, Qian Z, Cui J, Lu J. On the origin and continuing evolution of SARS-CoV-2. Natl Sci Rev. 2020 Jun;7(6):1012-1023. doi: 10.1093/nsr/nwaa036. Epub 2020 Mar 3.
Results Reference
background
PubMed Identifier
32113704
Citation
Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.
Results Reference
background
PubMed Identifier
32043978
Citation
Thompson R. Pandemic potential of 2019-nCoV. Lancet Infect Dis. 2020 Mar;20(3):280. doi: 10.1016/S1473-3099(20)30068-2. Epub 2020 Feb 7. No abstract available.
Results Reference
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Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff

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