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

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ClinicalTrials.gov Identifier: NCT04319900
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Lihong Liu, Beijing Chao Yang Hospital

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.


Condition or disease Intervention/treatment Phase
Novel Coronavirus Pnuemonia Drug: favipiravir tablets+chloroquine phosphatetablets tablets Drug: Favipiravir tablets Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 25, 2020


Arm Intervention/treatment
Experimental: favipiravir tablets+chloroquine phosphatetablets tablets group
favipiravir tablets+chloroquine phosphatetablets tablets
Drug: favipiravir tablets+chloroquine phosphatetablets tablets

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.


Experimental: favipiravir tablets group
favipiravir tablets
Drug: Favipiravir tablets
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.

Placebo Comparator: placebo treatment group
placebo
Drug: Placebo
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 Measures :
  1. Time of Improvement or recovery of respiratory symptoms [ Time Frame: 10 days during the intervention period ]
    Time of improvement or recovery of respiratory symptoms

  2. Number of days virus nucleic acid shedding [ Time Frame: 10 days during the intervention period ]
    Number of days from positive to negative for test of swab or sputum virus nucleic acid

  3. Frequency of Improvement or recovery of respiratory symptoms [ Time Frame: 10 days during the intervention period ]
    Frequency of improvement or recovery of respiratory symptoms


Secondary Outcome Measures :
  1. Duration of fever [ Time Frame: 10 days during the intervention period ]
    Duration of fever after recruitment

  2. Frequencies of progression to severe illness [ Time Frame: 10 days during the intervention period ]
    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)

  3. Time of improvement of pulmonary imaging [ Time Frame: 10 days during the intervention period ]
    Time of improvement of pulmonary imaging

  4. Peripheral blood c-reactive protein concentration [ Time Frame: day-1,3,7,14 after the intervention period ]
    Peripheral blood c-reactive protein concentration

  5. Absolute value of peripheral blood lymphocytes [ Time Frame: day-1,3,7,14 after the intervention period ]
    Absolute value of peripheral blood lymphocytes

  6. percentage of peripheral blood lymphocytes [ Time Frame: day-1,3,7,14 after the intervention period ]
    percentage of peripheral blood lymphocytes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04319900


Contacts
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Contact: Shumin Wang, Phd. +86 13488760399 shuminwang7000@163.com

Locations
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China, Beijing
Beijing Chaoyang hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Shumin Wang, Phd.    +86 13488760399    shuminwang7000@163.com   
Sponsors and Collaborators
Beijing Chao Yang Hospital
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Responsible Party: Lihong Liu, Prof., Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT04319900    
Other Study ID Numbers: 2020-K-24-2
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Chloroquine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents