NCT04320238

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,944

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

March 21, 2020

Last Update Submit

March 30, 2020

Conditions

2019 Novel Coronavirus Infection

Keywords

rhINF-α2019-nCOVprophylaxis

Outcome Measures

Primary Outcomes (1)

  • new-onset COVID-19

    new-onset coronavirus disease-2019

    From date of randomization until the diagnosis of COVID-19, assessed up to 6 weeks.

Secondary Outcomes (2)

  • Number of Participants with coronavirus related symptoms

    during 28-day intervention.

  • Number of Participants with adverse effect

    during 28-day intervention.

Study Arms (2)

low-risk group

EXPERIMENTAL

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

Drug: recombinant human interferon Alpha-1b

high-risk group

EXPERIMENTAL

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

Drug: recombinant human interferon Alpha-1bDrug: thymosin alpha 1

Interventions

recombinant human interferon Alpha-1bDRUG

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

Also known as: interferon α
high-risk grouplow-risk group
thymosin alpha 1DRUG

thymosin alpha 1 subcutaneous injection 1 time per week.

Also known as: thymosin α
high-risk group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Formally serving medical staff in Taihe Hospital;

You may not qualify if:

  • pregnant women;
  • severe chronic diseases who are unable to participate in daily routine work;
  • fever (temperature≥37.3 ° ) and / or respiratory symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taihe Hospital

Shiyan, Hubei, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 31995857BACKGROUND

  • 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.

    PMID: 32064853BACKGROUND

  • 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.

    PMID: 34676127BACKGROUND

  • 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.

    PMID: 32113704BACKGROUND

  • 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.

    PMID: 32043978BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Thymalfasin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThymosinThymus HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesPeptidesAmino Acids, Peptides, and ProteinsProteins

Central Study Contacts

Zhongji Meng

CONTACT

18971905757zhongji.meng@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Infectious disease department, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

March 21, 2020

First Posted

March 24, 2020

Study Start

January 21, 2020

Primary Completion

May 1, 2020

Study Completion

June 1, 2020

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

CN(1)