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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 26 Mar 2020

At a glance

  • Drugs Chloroquine (Primary) ; Favipiravir (Primary)
  • Indications COVID 2019 infections; Pneumonia
  • Focus Therapeutic Use
  • Most Recent Events

    • 26 Mar 2020 New trial record

Trial Overview

Purpose

This study is a multi-centered, three-armed, randomized, double-blinded, controlled study to evaluate the efficacy and safety of favipiravir tablets combined with chloroquine phosphatetablets tablets in the treatment of novel coronavirus pneumonia.

Primary Endpoints

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

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

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

Other Endpoints

Duration of fever

description: Duration of fever after recruitment
time_frame: 10 days during the intervention period

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

Time of improvement of pulmonary imaging

description: Time of improvement of pulmonary imaging
time_frame: 10 days during the intervention period

Peripheral blood c-reactive protein concentration

description: Peripheral blood c-reactive protein concentration
time_frame: day-1,3,7,14 after the intervention period

Absolute value of peripheral blood lymphocytes

description: Absolute value of peripheral blood lymphocytes
time_frame: day-1,3,7,14 after the intervention period

percentage of peripheral blood lymphocytes

description: percentage of peripheral blood lymphocytes
time_frame: day-1,3,7,14 after the intervention period [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Pneumonia treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 150

  • Sex male & female
  • Age Group 18-75 years; adult; elderly

Patient 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

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04319900 ClinicalTrials.gov: US National Institutes of Health
2020K24-2 -

Trial Dates

  • Initiation Dates

    Actual : 05 Mar 2020

  • Primary Completion Dates

    Planned : 30 Apr 2020

  • End Dates

    Planned : 25 Jun 2020

Other Details

  • Design multicentre; parallel; prospective; randomised; single-blind
  • Phase of Trial Phase II/III
  • Location China
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
ChloroquinePrimary Drug Oral Tablet
FavipiravirPrimary Drug Oral Tablet

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.)

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 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.)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Shumin Wang, Phd.
+86 13488760399
shuminwang7000@163.com
show details
Beijing Chaoyang hospital China

Centres

Centre Name Location Trial Centre Country
Beijing Chaoyang hospital Beijing, Beijing China

Trial History

Event Date Event Type Comment
26 Mar 2020 New trial record New trial record Updated 26 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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