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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Favipiravir
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Favipiravir

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second People's Hospital of Fuyang
  • Ezhou Hospital of Traditional Chinese Medicine
  • Ezhou Central Hospital
  • Huoshenshan Hospital of Wuhan
  • Jinyintan Hospital of WuhanRecruiting
  • Wuhan Pulmonary Hospital
  • Zhongnan Hospital of Wuhan University
  • Wenzhou Medical University Affiliated First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Favipiravir group

Regular treatment group

Arm Description

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.

Treatments other than lopinavir and ritonavir, chloroquine phosphate, hydroxychloroquine sulfate, arbidol, and colomycin can be given.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Clinical cure rate
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.

Full Information

First Posted
April 1, 2020
Last Updated
April 22, 2020
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04333589
Brief Title
Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
Official Title
The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
September 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Favipiravir

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Favipiravir group
Arm Type
Experimental
Arm Description
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.
Arm Title
Regular treatment group
Arm Type
No Intervention
Arm Description
Treatments other than lopinavir and ritonavir, chloroquine phosphate, hydroxychloroquine sulfate, arbidol, and colomycin can be given.
Intervention Type
Drug
Intervention Name(s)
Favipiravir
Intervention Description
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.
Primary Outcome Measure Information:
Title
Viral nucleic acid test negative conversion rate
Description
Proportion of subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times(sampling time at least 24 hours).
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Clinical cure rate
Description
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.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guiqiang Wang
Phone
13911405123
Email
john131212@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Zhao
Phone
13810765943
Email
zhaohong_pufh@bjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guiqiang Wang
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second People's Hospital of Fuyang
City
Fuyang
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianfeng Han
Phone
13955881280
Facility Name
Ezhou Hospital of Traditional Chinese Medicine
City
Ezhou
State/Province
Hubei
ZIP/Postal Code
436000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinsheng Chen
Phone
13972975677
Facility Name
Ezhou Central Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junhua Yu
Phone
13908688619
Facility Name
Huoshenshan Hospital of Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sibin Zhang
Phone
13911992121
Facility Name
Jinyintan Hospital of Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingyu Zhang
Phone
13507117929
Facility Name
Wuhan Pulmonary Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianxiang Chen
Phone
18971570937
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinghuan Wang
Phone
18971387168
Facility Name
Wenzhou Medical University Affiliated First Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongping Chen
Phone
13505777281

12. IPD Sharing Statement

Citations:
PubMed Identifier
32503657
Citation
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.
Results Reference
derived

Learn more about this trial

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

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