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Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia

Primary Purpose

Novel Coronavirus Pnuemonia

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
favipiravir tablets+chloroquine phosphatetablets tablets
Favipiravir tablets
Placebo
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Novel Coronavirus Pnuemonia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female, 18-75 years old
  • Patients previously diagnosed with novel coronavirus pneumonia: the course of illness is no more than 14 days; if the course of the disease was more than 14 days, patient meets one of the following conditions can also be included in the group: (1) No apparent absorption or progression of chest radiograph was observed within 7 days; (2) respiratory symptoms (chest tightness, or cough, or breathing difficulties); (3) Test for viral nucleic acid positive within 3 days.
  • informed consent should be signed by the participate or an authorized agent
  • Agree to clinical samples collection
  • Female or male subjects of childbearing age agree to take effective contraceptive measures within 3 months of the last oral medication to ensure that female or male partners of childbearing age do not become pregnant

Exclusion Criteria:

  • Severe vomiting or difficulty ingesting medication
  • Woman who are pregnant or during lactation
  • Patients received lopinavir/ridonavir, ribavirin, interferon and monoclonal antibody specific antiviral drugs three days before enrollment
  • Cases of respiratory failure requiring mechanical ventilation
  • Shock
  • Combined with other organ failure and requires ICU care
  • Clinical prognostic non-survival, palliative care, or in deep coma and no have response to supportive treatment within three hours of admission

Sites / Locations

  • Beijing Chaoyang hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

favipiravir tablets+chloroquine phosphatetablets tablets group

favipiravir tablets group

placebo treatment group

Arm Description

favipiravir tablets+chloroquine phosphatetablets tablets

favipiravir tablets

placebo

Outcomes

Primary Outcome Measures

Time of Improvement or recovery of respiratory symptoms
Time of improvement or recovery of respiratory symptoms
Number of days virus nucleic acid shedding
Number of days from positive to negative for test of swab or sputum virus nucleic acid
Frequency of Improvement or recovery of respiratory symptoms
Frequency of improvement or recovery of respiratory symptoms

Secondary Outcome Measures

Duration of fever
Duration of fever after recruitment
Frequencies of progression to severe illness
Disease is defined as severe if it meets any of the following criteria: 1.Respiratory rate ≥30/min; 2. Oxygen saturation ≤93%; 3. Arterial partial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) ≤300 mmHg (1 mmHg=0.133 kPa)
Time of improvement of pulmonary imaging
Time of improvement of pulmonary imaging
Peripheral blood c-reactive protein concentration
Peripheral blood c-reactive protein concentration
Absolute value of peripheral blood lymphocytes
Absolute value of peripheral blood lymphocytes
percentage of peripheral blood lymphocytes
percentage of peripheral blood lymphocytes

Full Information

First Posted
March 20, 2020
Last Updated
March 22, 2020
Sponsor
Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04319900
Brief Title
Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia
Official Title
Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
June 25, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital

4. Oversight

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

5. Study Description

Brief Summary
This study is a multi-centered, three-armed, randomized, double-blinded, controlled study, namely, the oral trial drug favipiravir tablets plus chloroquine phosphatetablets tablets group (combined group), the oral trial drug favipiravir tablets group (pirovir group), and the oral placebo treatment group (control group). The total number of enrolled cases in this study was set at 150. During the treatment, the clinical data of the subjects were collected, the changes of viral load and biochemical indicators were detected, and the outcome of the subjects was monitored. The main indicators of efficacy include improvement or recovery of respiratory symptoms and viral nucleic acid shedding. The rate of progression to severe disease, duration of fever, peripheral blood index and improvement time of pulmonary imaging were the secondary indicators to evaluate the efficacy. Statistical analysis was performed at the middle and final stages of the study to evaluate the efficacy and safety of favipiravir tablets combined with chloroquine phosphatetablets tablets in the treatment of novel coronavirus pneumonia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Novel Coronavirus Pnuemonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
favipiravir tablets+chloroquine phosphatetablets tablets group
Arm Type
Experimental
Arm Description
favipiravir tablets+chloroquine phosphatetablets tablets
Arm Title
favipiravir tablets group
Arm Type
Experimental
Arm Description
favipiravir tablets
Arm Title
placebo treatment group
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
favipiravir tablets+chloroquine phosphatetablets tablets
Intervention Description
Favipiravir tablets+ chloroquine phosphate tablets group: 50 patients (anticipated). Favipiravir tablets: On the first day, once for 1600 mg, twice a day; From the 2nd day to the 10th day, once for 600 mg, twice a day; maximum of 10 days for oral administration of the drug. Chloroquine phosphate tablets: a total of 1000mg split into two times on day one; from day two to day three, 500mg, once a day; from day four to day ten, 250mg, once a day. Maximum of 10 days for oral administration of the drug.
Intervention Type
Drug
Intervention Name(s)
Favipiravir tablets
Intervention Description
Favipiravir tablets group: 50 patients (anticipated). Favipiravir tablets: On the first day, once for 1600 mg, twice a day; From the 2nd day to the 10th day, once for 600 mg, twice a day; maximum of 10 days for oral administration of the drug.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for favipiravir tablets is produced by Zhejiang Haizheng pharmaceutical co, LTD, batch no. 21812252, Placebo for chloroquine phosphate tablets is produced by the Chinese people's liberation army academy of military science military medical research institute production, batch no. 20200215. All placebos were complied with the quality inspection standard.
Primary Outcome Measure Information:
Title
Time of Improvement or recovery of respiratory symptoms
Description
Time of improvement or recovery of respiratory symptoms
Time Frame
10 days during the intervention period
Title
Number of days virus nucleic acid shedding
Description
Number of days from positive to negative for test of swab or sputum virus nucleic acid
Time Frame
10 days during the intervention period
Title
Frequency of Improvement or recovery of respiratory symptoms
Description
Frequency of improvement or recovery of respiratory symptoms
Time Frame
10 days during the intervention period
Secondary Outcome Measure Information:
Title
Duration of fever
Description
Duration of fever after recruitment
Time Frame
10 days during the intervention period
Title
Frequencies of progression to severe illness
Description
Disease is defined as severe if it meets any of the following criteria: 1.Respiratory rate ≥30/min; 2. Oxygen saturation ≤93%; 3. Arterial partial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) ≤300 mmHg (1 mmHg=0.133 kPa)
Time Frame
10 days during the intervention period
Title
Time of improvement of pulmonary imaging
Description
Time of improvement of pulmonary imaging
Time Frame
10 days during the intervention period
Title
Peripheral blood c-reactive protein concentration
Description
Peripheral blood c-reactive protein concentration
Time Frame
day-1,3,7,14 after the intervention period
Title
Absolute value of peripheral blood lymphocytes
Description
Absolute value of peripheral blood lymphocytes
Time Frame
day-1,3,7,14 after the intervention period
Title
percentage of peripheral blood lymphocytes
Description
percentage of peripheral blood lymphocytes
Time Frame
day-1,3,7,14 after the intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female, 18-75 years old Patients previously diagnosed with novel coronavirus pneumonia: the course of illness is no more than 14 days; if the course of the disease was more than 14 days, patient meets one of the following conditions can also be included in the group: (1) No apparent absorption or progression of chest radiograph was observed within 7 days; (2) respiratory symptoms (chest tightness, or cough, or breathing difficulties); (3) Test for viral nucleic acid positive within 3 days. informed consent should be signed by the participate or an authorized agent Agree to clinical samples collection Female or male subjects of childbearing age agree to take effective contraceptive measures within 3 months of the last oral medication to ensure that female or male partners of childbearing age do not become pregnant Exclusion Criteria: Severe vomiting or difficulty ingesting medication Woman who are pregnant or during lactation Patients received lopinavir/ridonavir, ribavirin, interferon and monoclonal antibody specific antiviral drugs three days before enrollment Cases of respiratory failure requiring mechanical ventilation Shock Combined with other organ failure and requires ICU care Clinical prognostic non-survival, palliative care, or in deep coma and no have response to supportive treatment within three hours of admission
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shumin Wang, Phd.
Phone
+86 13488760399
Email
shuminwang7000@163.com
Facility Information:
Facility Name
Beijing Chaoyang hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shumin Wang, Phd.
Phone
+86 13488760399
Email
shuminwang7000@163.com

12. IPD Sharing Statement

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Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia

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