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

NCT04319900 | Unknown Phase 2

• 1 other identifier: 2020-K-24-2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Novel Coronavirus Pnuemonia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Duration of fever

  10 days during the intervention period

• Frequencies of progression to severe illness

  10 days during the intervention period

• Time of improvement of pulmonary imaging

  10 days during the intervention period

• Peripheral blood c-reactive protein concentration

  day-1,3,7,14 after the intervention period

• Absolute value of peripheral blood lymphocytes

  day-1,3,7,14 after the intervention period

Study Arms (3)

favipiravir tablets+chloroquine phosphatetablets tablets group

EXPERIMENTAL

favipiravir tablets+chloroquine phosphatetablets tablets

Drug: favipiravir tablets+chloroquine phosphatetablets tablets

favipiravir tablets group

EXPERIMENTAL

favipiravir tablets

Drug: Favipiravir tablets

placebo treatment group

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

favipiravir tablets+chloroquine phosphatetablets tablets DRUG

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.

favipiravir tablets+chloroquine phosphatetablets tablets group

Favipiravir tablets DRUG

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.

favipiravir tablets group

Placebo DRUG

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.

placebo treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chaoyang hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Interventions

favipiravir

Central Study Contacts

Shumin Wang, Phd.

CONTACT

+86 13488760399; shuminwang7000@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: March 5, 2020
• Primary Completion: April 30, 2020
• Study Completion: June 25, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

CN (1)