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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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17 February 2020 |
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Main ID: |
ChiCTR2000029600 |
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Date of registration:
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2020-02-06 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical study for safety and efficacy of Favipiravir in the treatment of novel coronavirus pneumonia (COVID-19)
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Scientific title:
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Clinical study on safety and efficacy of Favipiravir in the treatment of novel coronavirus pneumonia (COVID-19) |
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Date of first enrolment:
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2020-01-30 |
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Target sample size:
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Group A:30;Group B:30;Group C:30; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=49042 |
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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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0
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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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Liao Xuejiao
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Address:
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29 Bulan Road, Longgang District, Shenzhen, Guangdong, China
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Telephone:
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+86 755 612223333-1214 |
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Email:
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392402597@qq.com |
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Affiliation:
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The Third People's Hospital of Shenzhen |
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Name:
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Liu Yingxia
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Address:
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29 Bulan Road, Longgang District, Shenzhen, Guangdong, China
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Telephone:
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+86 755 61238922 |
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Email:
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yingxialiu@hotmail.com |
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Affiliation:
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The Third People's Hospital of Shenzhen |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. 16 to 75 years of age, male or female;
2. Respiratory or blood samples tested positive for novel coronavirus;
3. Within 7 days of onset: Onset is defined as body temperature exceeding 38 degree C (armpit temperature) or at least one 2019-nCoV pneumonia related systemic or respiratory symptom;
4. Willing to take contraception during the study and within 7 days after treatment;
5. No difficulty in swallowing the Pills;
6. Willing to sign informed consent form.
Exclusion criteria: 1. Any situation which the protocol cannot be carried out safely;
2. Patient refuses to receive invasive tracheal support (if needed);
3. Pregnant or lactating women:childbearing age women with positive pregnancy test, breastfeeding, miscarriage or within 2 weeks after delivery.Postmenopausal and hysterectomy women do not need a pregnancy test;
4. Patients with chronic liver and kidney disease and reaching end-stage;
5. Previous history of allergic reactions to Fapiravir or Lopinavir and Ritonavir;
6. Currently or in the past 28 days, participated in another clinical trial against novel coronavirus treatment;
7. After the investigator's judgment, the subjects could not participate the study protocol, follow-up or self-evaluation after enrollment.
Age minimum:
16
Age maximum:
75
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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Group A:alpha-Interferon atomization;Group B:Lopinavir and Ritonavir + alpha-Interferon atomization;Group C:Favipiravir + alpha-Interferon atomization;
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Primary Outcome(s)
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Declining speed of Novel Coronavirus by PCR;Negative Time of Novel Coronavirus by PCR;Incidentce rate of chest imaging;Incidence rate of liver enzymes;Incidence rate of kidney damage;
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Source(s) of Monetary Support
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Self-financing
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Ethics review
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Status: Approved
Approval date: 30/01/2020
Contact:
Huang Fang
+86 755 61222333-6665
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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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