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

Status

Unknown

Conditions

Intervention / Treatment

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

  • China
    • 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
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Huoshenshan Hospital of Wuhan
        • Contact:
          • Sibin Zhang
          • Phone Number: 13911992121
      • 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:

  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.

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.
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.

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

Peking University First Hospital

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.

General Publications

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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