Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia
Latest Information Update: 07 Mar 2022
At a glance
- Drugs Chloroquine (Primary) ; Favipiravir (Primary)
- Indications COVID 2019 infections; Pneumonia
- Focus Therapeutic Use
- 26 Mar 2020 New trial record
Most Recent Events
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 | - |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT04319900 | C-reactive protein (CRP) | Outcome Measure |
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
show details
shuminwang7000@163.com |
Beijing Chaoyang hospital | China |
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| Beijing Chaoyang hospital | Beijing, Beijing | China |
| Beijing Chaoyang hospital | Beijing, Beijing | China |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 07 Mar 2022 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 07 Mar 2022 |
| 07 Mar 2022 | Other trial event | According to ClinicalTrials.gov, the recruitment status of this study is unknown because the information has not been verified recently (last verified Mar 2020) Updated 07 Mar 2022 |
| 26 Mar 2020 | New trial record | New trial record Updated 26 Mar 2020 |
| 24 Mar 2020 | Biomarker Update | Biomarkers information updated Updated 04 Nov 2021 |
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov
Adis International Ltd. Part of Springer Science+Business Media
© Springer Nature Switzerland AG