v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT04940871 |
|
Full text link
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Nov. 17, 2022, 4 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Nov. 17, 2022, 4 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
2021-06-28 |
|
Recruitment status
Last imported at : Nov. 17, 2022, 4 a.m. Source : ClinicalTrials.gov |
Terminated |
|
Study design
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: male or female patients between the ages of 18 and 65 years. patients with pcr confirmed sars-cov-2 infection asymptomatic or have mild only symptoms and symptoms are onset less than 5 days signed informed consent form and patient information leaflet |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
pregnant or possibly pregnant patients or lactating females patients have moderate to severe or immediately life-threatening covid-19 major risk factor onset (obesity, diabetes, copd, hypertension) patients with spo2 less than 95% without oxygen therapy patients with severe hepatic impairment equivalent to grade c on child-pugh classification patients with renal impairment requiring dialysis patients with disturbed consciousness such as disturbed orientation female patients who are woman of childbearing potential and unable to consent to use of dual contraception from the start of favipiravir administration to 30 days after the end of favipiravir administration. dual contraception is a combination of two of the following: barrier method of contraception: condoms (male or female) with orwithout a spermicidal agent, diaphragm or cervical cap with spermicide; iud; hormone-based contraceptive; tubal ligation male patients whose are unable to consent to use of barrier method of contraception (condom) the start of favipiravir administration to 90 days after the end of favipiravir administration. male patients who are planning to donate sperm in 90 days after the start of favipiravir administration. patients with hereditary xanthinuria patient with severe uncontrolled hyperuricaemia patients receiving immunosuppressants patients who received interferon-alpha or drugs with reported antiviral activity against sars-cov- 2 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, ciclesonide, nafamostat mesylate, camostat mesylate, remdesivir, etc.) within 72 hours or patients who receive forbidden concomitant medication any medical condition that the examining physician deems unsuitable for the patient to participate in the study |
|
Number of arms
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
University of Pecs |
|
Inclusion age min
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
65 |
|
Countries
Last imported at : Nov. 17, 2022, 4 a.m. Source : ClinicalTrials.gov |
Hungary |
|
Type of patients
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
|
Severity scale
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
|
Total sample size
Last imported at : Nov. 17, 2022, 4 a.m. Source : ClinicalTrials.gov |
1 |
|
primary outcome
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
PRIM1_ the percentage of virus copy number |
|
Notes
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |