Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
1 other identifier
interventional
210
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable covid19
Started Apr 2020
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedFirst Posted
Study publicly available on registry
April 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2020
CompletedApril 24, 2020
April 1, 2020
2 months
April 1, 2020
April 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Viral nucleic acid test negative conversion rate
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 Outcomes (1)
Clinical cure rate
5 months
Study Arms (2)
Favipiravir group
EXPERIMENTALOn 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.
Regular treatment group
NO INTERVENTIONTreatments other than lopinavir and ritonavir, chloroquine phosphate, hydroxychloroquine sulfate, arbidol, and colomycin can be given.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
The Second People's Hospital of Fuyang
Fuyang, Anhui, 230022, China
Ezhou Hospital of Traditional Chinese Medicine
Ezhou, Hubei, 436000, China
Ezhou Central Hospital
Wuhan, Hubei, 430000, China
Huoshenshan Hospital of Wuhan
Wuhan, Hubei, 430000, China
Jinyintan Hospital of Wuhan
Wuhan, Hubei, 430000, China
Wuhan Pulmonary Hospital
Wuhan, Hubei, 430000, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000, China
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, 325000, China
Related Publications (1)
Li J, Zhang C, Wu Z, Wang G, Zhao H. The Mechanism and Clinical Outcome of patients with Corona Virus Disease 2019 Whose Nucleic Acid Test has changed from negative to positive, and the therapeutic efficacy of Favipiravir: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 5;21(1):488. doi: 10.1186/s13063-020-04430-y.
PMID: 32503657DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guiqiang Wang
Peking University First Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 1, 2020
First Posted
April 3, 2020
Study Start
April 1, 2020
Primary Completion
June 1, 2020
Study Completion
September 15, 2020
Last Updated
April 24, 2020
Record last verified: 2020-04