To verify that the efficacy of favipiravir exceeds that of the actual supportive care (symptomatic therapy) in SARS-CoV-2 infected patients (COVID-19 patients) with mild pneumonia, using the time required to improve clinical symptoms as the primary endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Name: AVIGAN Generic name: Favipiravir Content: T-705a tablets \[200\]
Department of Pulmonology Semmelweis University
Budapest, Hungary
National Korányi Institute for Pulmonology
Budapest, Hungary
Institute of Infectology, University of Debrecen
Debrecen, Hungary
1st Department of Medicine, University of Pécs
Pécs, Hungary
Time to improvement in body temperature
Time frame: 9 month
Time to improvement in SpO2
Time frame: 9 month
Time to improvement in chest imaging findings
Time frame: 9 month
Time to improvement in negative SARS-CoV-2
Time frame: 9 month
(1) Changes in patient status on a 5-point scale
Name of the scale is: Patient Status Score. 1:A condition in which the patient can be discharged; 5:A condition requiring ECMO or invasive oxygen therapy and ICU management
Time frame: 9 month
(2) Changes in the level of SARS-CoV-2 viral genome
Time frame: 9 month
(3) SARS-CoV-2 virus genome clearance rate
Time frame: 9 month
(4) Duration of pyrexia
Time frame: 9 month
(5) Changes in clinical symptoms
Changes in clinical symptoms, including: Patient's condition; Coughing, Sore throat, Headache, Muscle or joint pain, Nasal congestion or Nasal discharge, Chills or sweating, Malaise or fatigue, Chest pain, dehydration, cyanosis, pleural effusion, Thoracic rales, Conscious state.
Time frame: 9 month
(6) Changes in NEWS (National Early Warning Score)
Changes in NEWS (unabbreviated scale title: National Early Warning Score). Calculate the total value from the clinical symptoms and findings (consciousness) and vital signs (SpO2, body temperature, blood pressure, pulse rate, respiratory rate). 0 is normal
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First Department of Internal Medicine, University of Szeged
Szeged, Hungary
Time frame: 9 month
(7) Changes in chest imaging findings on Days 4,7,10,13,16,19,22,25,28.
Time frame: Changes in chest imaging findings will be collected and checked on Days 4,7,10,13,16,19,22,25,28, the data will be analyzied at 9. month.
(8) Percentage of patients requiring adjuvant oxygen therapy
Time frame: 9 month
(8) Adjuvant oxygen therapy average duration
Time frame: 9 month
(9) Percentage of patients requiring mechanical ventilation therapy
Time frame: 9 month
(9)Adjuvant oxygen therapy average durationduration
Time frame: 9 month