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

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.

Study Overview

• Status: Unknown
• Conditions: Novel Coronavirus Pnuemonia
• Intervention / Treatment: Drug: favipiravir tablets+chloroquine phosphatetablets tablets; Drug: Favipiravir tablets; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Beijing Chaoyang Hospital
      • Contact: Shumin Wang, Phd.; Phone Number: +86 13488760399; Email: shuminwang7000@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Improvement or recovery of respiratory symptoms	Time of improvement or recovery of respiratory symptoms	10 days during the intervention period
Number of days virus nucleic acid shedding	Number of days from positive to negative for test of swab or sputum virus nucleic acid	10 days during the intervention period
Frequency of Improvement or recovery of respiratory symptoms	Frequency of improvement or recovery of respiratory symptoms	10 days during the intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of fever	Duration of fever after recruitment	10 days during the intervention period
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)	10 days during the intervention period
Time of improvement of pulmonary imaging	Time of improvement of pulmonary imaging	10 days during the intervention period
Peripheral blood c-reactive protein concentration	Peripheral blood c-reactive protein concentration	day-1,3,7,14 after the intervention period
Absolute value of peripheral blood lymphocytes	Absolute value of peripheral blood lymphocytes	day-1,3,7,14 after the intervention period
percentage of peripheral blood lymphocytes	percentage of peripheral blood lymphocytes	day-1,3,7,14 after the intervention period

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): June 25, 2020

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 22, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 22, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Coronavirus Infections; Pneumonia; Anti-Infective Agents; Antiviral Agents; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Amebicides; Favipiravir; Chloroquine
• Other Study ID Numbers: 2020-K-24-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No