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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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2 March 2020 |
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Main ID: |
ChiCTR2000030013 |
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Date of registration:
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2020-02-19 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A prospective clinical study for recombinant human interferon alpha 1b spray in the prevention of novel coronavirus (COVID-19) infection in highly exposed medical staffs.
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Scientific title:
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A study on the efficacy and safety of recombinant human interferon alpha 1b spray in preventing novel coronavirus (COVID-19) infection in highly exposed medical staffs. |
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Date of first enrolment:
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2020-02-20 |
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Target sample size:
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Experimental group:300;Control group:150; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=49796 |
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Study type:
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Interventional study |
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Study design:
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Non randomized control
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Phase:
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4
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Countries of recruitment
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China
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Contacts
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Name:
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Yabin Wang
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Address:
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28 Fuxing Road, Haidian District, Beijing, China
100853
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Telephone:
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+86 15711482012 |
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Email:
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wyb8202@163.com |
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Affiliation:
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Chinese PLA General Hospital |
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Name:
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Feng Cao
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Address:
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28 Fuxing Road, Haidian District, Beijing, China
100853
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Telephone:
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+86 13911798280 |
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Email:
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fengcao8828@163.com |
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Affiliation:
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Chinese PLA General Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 18 to 70 years old;
2. Non-suspected and non-confirmed cases;
3. Front-line medical staffs in designated hospitals during the outbreak of pneumonia caused by COVID-19;
4. Participate voluntarily and sign the informed consent.
Exclusion criteria: 1. Suspected cases and confirmed cases;
2. Patients with severe heart, brain, liver, kidney and other visceral diseases or other serious metabolic disorders and tumors;
3. People who could not complete the study for other reasons;
4. Pregnant or lactating women.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Novel Coronavirus Pneumonia (COVID-19)
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Intervention(s)
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Experimental group:recombinant human interferon a1b spray;Control group:Blank;
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Primary Outcome(s)
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Blood routine examination;Chest CT;Arterial Blood Oxygen Saturation;
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Secondary Outcome(s)
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Incidence of fever;Incidence of cough;Incidence of pneumonia in imaging;
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Source(s) of Monetary Support
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Emergency project funds of Chinese PLA general hospital
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Ethics review
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Status: Approved
Approval date: 26/02/2020
Contact:
Nan Bai
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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