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Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333589
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Guiqiang Wang, Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Favipiravir Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine


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.
Drug: Favipiravir
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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);
  2. The nucleic acid test of specimens such as sputum, throat swabs, blood, feces and other specimens was positive for COVID-19 during screening visits;
  3. Voluntarily participate in research and sign informed consent.

Exclusion Criteria:

  1. Those allergic to fapilavir;
  2. Pregnant or lactating women;
  3. Unstable liver, kidney, and heart diseases;
  4. History of mental disorders, substance abuse or dependence;
  5. Researchers consider it inappropriate to participate in research;
  6. Participating in other clinical research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333589


Contacts
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Contact: Guiqiang Wang 13911405123 john131212@sina.com
Contact: Hong Zhao 13810765943 zhaohong_pufh@bjmu.edu.cn

Locations
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China, Anhui
The Second People's Hospital of Fuyang Not yet recruiting
Fuyang, Anhui, China, 230022
Contact: Xianfeng Han    13955881280      
China, Hubei
Ezhou Hospital of Traditional Chinese Medicine Not yet recruiting
Ezhou, Hubei, China, 436000
Contact: Xinsheng Chen    13972975677      
Ezhou Central Hospital Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Junhua Yu    13908688619      
Huoshenshan Hospital of Wuhan Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Sibin Zhang    13911992121      
Jinyintan Hospital of Wuhan Recruiting
Wuhan, Hubei, China, 430000
Contact: Dingyu Zhang    13507117929      
Wuhan Pulmonary Hospital Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Xianxiang Chen    18971570937      
Zhongnan Hospital of Wuhan University Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Xinghuan Wang    18971387168      
China, Zhejiang
Wenzhou Medical University Affiliated First Hospital Not yet recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Yongping Chen    13505777281      
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Guiqiang Wang Peking University First Hospital
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Responsible Party: Guiqiang Wang, Principal Investigator, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT04333589    
Other Study ID Numbers: 2020 research 112
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guiqiang Wang, Peking University First Hospital:
Favipiravir
Additional relevant MeSH terms:
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Coronavirus Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections