- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04333589
Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
April 22, 2020 updated by: Guiqiang Wang, Peking University First Hospital
The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
To investigate the mechanism, clinical outcome and therapeutic efficacy with favipiravir of Corona Virus Disease 2019 patients whose nucleic acids changed from negative to positive.
Study Overview
Detailed Description
In clinical institutions that enroll corona virus disease 2019 patients whose nucleic acids changed from negative to positive, two arms, multi-center, randomized and controlled methods are adopted.
Patients are divided into two groups, favipiravir group and regular treatment group.
210 patients are expected to be enrolled and the cases are allocated according to the ratio of 2( favipiravir group): 1(regular treatment group).
Study Type
Interventional
Enrollment (Anticipated)
210
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Anhui
-
Fuyang, Anhui, China, 230022
- Not yet recruiting
- The Second People's Hospital of Fuyang
-
Contact:
- Xianfeng Han
- Phone Number: 13955881280
-
-
Hubei
-
Ezhou, Hubei, China, 436000
- Not yet recruiting
- Ezhou Hospital of Traditional Chinese Medicine
-
Contact:
- Xinsheng Chen
- Phone Number: 13972975677
-
Wuhan, Hubei, China, 430000
- Recruiting
- Jinyintan Hospital of Wuhan
-
Wuhan, Hubei, China, 430000
- Not yet recruiting
- Ezhou Central Hospital
-
Contact:
- Junhua Yu
- Phone Number: 13908688619
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Wuhan, Hubei, China, 430000
- Not yet recruiting
- Huoshenshan Hospital of Wuhan
-
Contact:
- Sibin Zhang
- Phone Number: 13911992121
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Wuhan, Hubei, China, 430000
- Not yet recruiting
- Wuhan Pulmonary Hospital
-
Wuhan, Hubei, China, 430000
- Not yet recruiting
- Zhongnan Hospital of Wuhan University
-
Contact:
- Xinghuan Wang
- Phone Number: 18971387168
-
-
Zhejiang
-
Wenzhou, Zhejiang, China, 325000
- Not yet recruiting
- Wenzhou Medical University Affiliated First Hospital
-
Contact:
- Yongping Chen
- Phone Number: 13505777281
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- COVID-19 has been diagnosed, and the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs has been negative for two consecutive times after treatment (sampling time interval of at least 24 hours);
- The nucleic acid test of specimens such as sputum, throat swabs, blood, feces and other specimens was positive for COVID-19 during screening visits;
- Voluntarily participate in research and sign informed consent.
Exclusion Criteria:
- Those allergic to fapilavir;
- Pregnant or lactating women;
- Unstable liver, kidney, and heart diseases;
- History of mental disorders, substance abuse or dependence;
- Researchers consider it inappropriate to participate in research;
- Participating in other clinical research.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Favipiravir group
On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day.
Oral administration, the maximum number of days taken is not more than 14 days.
|
On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day.
Oral administration, the maximum number of days taken is not more than 14 days.
|
No Intervention: Regular treatment group
Treatments other than lopinavir and ritonavir, chloroquine phosphate, hydroxychloroquine sulfate, arbidol, and colomycin can be given.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Viral nucleic acid test negative conversion rate
Time Frame: 5 months
|
Proportion of subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times(sampling time at least 24 hours).
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical cure rate
Time Frame: 5 months
|
Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Anticipated)
June 1, 2020
Study Completion (Anticipated)
September 15, 2020
Study Registration Dates
First Submitted
April 1, 2020
First Submitted That Met QC Criteria
April 1, 2020
First Posted (Actual)
April 3, 2020
Study Record Updates
Last Update Posted (Actual)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 22, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020 research 112
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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