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

NCT ID: NCT04320238

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

2944 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-21

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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2019 Novel Coronavirus Infection

Keywords

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rhINF-α 2019-nCOV prophylaxis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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low-risk group

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

Group Type EXPERIMENTAL

recombinant human interferon Alpha-1b

Intervention Type DRUG

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

high-risk group

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

Group Type EXPERIMENTAL

recombinant human interferon Alpha-1b

Intervention Type DRUG

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

thymosin alpha 1

Intervention Type DRUG

thymosin alpha 1 subcutaneous injection 1 time per week.

Interventions

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recombinant human interferon Alpha-1b

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

Intervention Type DRUG

thymosin alpha 1

thymosin alpha 1 subcutaneous injection 1 time per week.

Intervention Type DRUG

Other Intervention Names

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interferon α thymosin α

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Zhongji Meng

Chief of Infectious disease department, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taihe Hospital

Shiyan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhongji Meng

Role: CONTACT

Phone: 18971905757

Email: [email protected]

Facility Contacts

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Zhongji Meng

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 31995857 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32064853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34676127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32113704 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32043978 (View on PubMed)

Other Identifiers

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Interferon_prophylaxis

Identifier Type: -

Identifier Source: org_study_id