Randomized Multicenter Study on the Efficacy and Safety of Favipiravir for Parenteral Administration Compared to Standard of Care in Hospitalized Patients With COVID-19
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|ClinicalTrials.gov Identifier: NCT05185284|
Recruitment Status : Completed
First Posted : January 11, 2022
Last Update Posted : January 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Favipiravir Drug: Remdesivir||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||217 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Randomized Multicenter Comparative Study on the Efficacy and Safety of AREPLIVIR® (Favipiravir) for Parenteral Administration (PROMOMED RUS LLC, Russia) in Hospitalized Patients With COVID-19|
|Actual Study Start Date :||August 11, 2021|
|Actual Primary Completion Date :||December 30, 2021|
|Actual Study Completion Date :||December 30, 2021|
Experimental: Favipiravir (Areplivir)
Arm 1 (n=106) receives the study drug Areplivir for parenteral administration as follows: Day 1 1600 mg 2 times a day, Day 2-10 800 mg 2 times a day. Administration will be done intravenously by drip infusion for 2 hours. The course of treatment is 10 days. The test drug is administered in hospital setting under supervision of a clinical investigator. The test drug is not handed over to the patient.
400 mg, lyophilizate for preparation of concentrate for solution for infusion
Other Name: Areplivir
Active Comparator: Standard of care
Arm 2 (n=108) patients receive standard therapy prescribed in accordance with the recommended treatment regimens included in the Interim Guidelines for the prevention, diagnosis and treatment of new coronavirus infection (COVID-19) approved by the Russian Ministry of Health by decision of the investigator and taking into account the availability of drugs at the study site. Might include Favipiravir tab, Remdesivir or other recommended schemes.
Standard therapy is administered in hospital setting. Discharge of patients from a hospital is carried out in accordance with the local practice of the study site in compliance with the current sanitary and epidemiological regime.
200 mg coated tablets
100 mg, lyophilizate for preparation of concentrate for solution for infusion
- Rate of Clinical Status Improvement [ Time Frame: By Visit 3, approximately 10 days ]Rate of clinical status improvement by WHO categorical ordinal scale of clinical status improvement by 2 or more categories by Day 10. WHO Ordinal Scale for Clinical Improvement (WHO-OSCI), 0 - uninfected (There are no clinical and virological signs of infection), 8 - dead, higher scores mean a worse outcome
- Time to Clinical Improvement [ Time Frame: 28 days ]Time (in days) to improvement in clinical status by WHO categorical ordinal scale of clinical status improvement
- Rate of Clinical Status Improvement [ Time Frame: 14 days ]Rate of clinical status improvement by WHO categorical ordinal scale of clinical status improvement by 2 or more categories at Visits 2 (Day 5) and 4 (Day 14)
- Rate of Clinical Status Improvement [ Time Frame: 14 Days ]Percentage of patients with clinical status of 0 and 1 point according to the WHO categorical ordinal scale of clinical improvement on Days 5, 10 and 14.
- End of Fever on Days of study [ Time Frame: 14 Days ]Percentage of patients with fever disappearance (body temperature < 37,2 °C in 3 consecutive measurements without antipyretic medication) an Days 5, 10 and 14.
- Change in the Level of Lung Damage According to CT [ Time Frame: 14 Days ]Assessment of lung injury (degree of damage by "empirical" visual scale and % of patients) according to CT data comparing to baseline. The number of patients in whom by the end of therapy there was an improvement in the condition of the lungs (a decrease in the volume of the lesion according to CT)
- Rate of Viral Elimination [ Time Frame: 14 days ]Percentage of patients with SARS-CoV-2 elimination (negative test for SARS-CoV-2 by NAA method) on Days 5, 10, and 14.
- Rate of Transfer to the Intensive Care Unit [ Time Frame: 28 days ]Percentage of patients transferred to intensive care unit
- Rate of the Use of Non-invasive Lung Ventilation [ Time Frame: 28 Days ]Percentage of cases with non-invasive lung ventilation
- Rate of the Use of Mechanical Ventilation [ Time Frame: 28 Days ]Percentage of cases with mechanical lung ventilation (% of patients)
- Mortality [ Time Frame: 28 Days ]Incidence of fatal cases (% of patients)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05185284
|Regional budgetary health care institution "Ivanovo Clinical Hospital named after Kuvaevs"|
|Ivanovo, Russian Federation, 153025|
|State Budgetary Institution of Healthcare of the City of Moscow "City Clinical Hospital No. 24 of the Department of Healthcare of the City of Moscow"|
|Moscow, Russian Federation, 127015|
|State Clinical Hospital №50|
|Moscow, Russian Federation|
|Regional Clinic Hospital of Ryazan|
|Ryazan', Russian Federation|
|Medical institute Ogarev Mordovia State university|
|Saransk, Russian Federation|
|Smolensk clinical hospital №1|
|Smolensk, Russian Federation|
|Principal Investigator:||Dmitriy Pushkar, MD, Academic||Moscow State Clinical Hospital №50|