Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19
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|ClinicalTrials.gov Identifier: NCT04542694|
Recruitment Status : Completed
First Posted : September 9, 2020
Results First Posted : November 5, 2020
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Favipiravir Drug: Standard of care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Randomized Multicenter Comparative Study on the Efficacy and Safety of Areplivir Film-coated Tablets (PROMOMED RUS LLC, Russia) in Patients Hospitalized With COVID-19|
|Actual Study Start Date :||May 21, 2020|
|Actual Primary Completion Date :||August 10, 2020|
|Actual Study Completion Date :||August 20, 2020|
Experimental: Favipiravir (Areplivir)
Arm 1 (n=100) receives the study drug Areplivir film-coated tablets:
on day 1 of therapy - 1600 mg (8 tablets) 2 times a day; on days 2-14 of treatment - 600 mg (3 tablets) 2 times a day. The drug is taken orally every 12 hours, swallowing whole tablet without chewing and washing down with a glass of water. The course of treatment is 14 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.
200 mg coated tablets
Other Name: AREPLIVIR
Active Comparator: Standard of care
Arm 2 (n=100) 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 (but not Favipiravir) by decision of the investigator and taking into account the availability of drugs at the study site. Might include hydroxychloroquine (with or without azithromycin), chloroquine, lopinavir/ritonavir 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.
Drug: Standard of care
Drug: Standard of Care Standard of Care will be prescribed in accordance with the recommended treatment regimens presented in the Russian guidelines for the prevention, diagnosis and treatment of COVID-19 according to the decision of the Investigator.
Other Name: Hydroxychloroquine, chloroquine, lopinavir/ritonavir, etc.
- Rate of Clinical Status Improvement [ Time Frame: By Visit 3, approximately 10 days ]Rate of clinical status improvement by 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 Viral Elimination by Day 10 [ Time Frame: 10 days ]Percentage of patients with elimination (clearance) of COVID-19 according to PCR data by day 10 (negative PCR results).
- Time Before the End of Fever [ Time Frame: 28 days ]Time (in days) before the end of fever (body temperature < 37.2 ° C for 3 consecutive days without antipyretic medication).
- Change in the Level of Lung Damage According to CT [ Time Frame: Days 15, 21, 28 ]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 Transfer to the Intensive Care Unit [ Time Frame: 28 Days ]Percentage of patients transferred to intensive care unit (% of patients).
- Rate of the Use of Non-invasive Lung Ventilation [ Time Frame: 28 Days ]Percentage of cases with non-invasive lung ventilation (% of patients).
- 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): NCT04542694
|State Clinical Hospital №50|
|Moscow, Russian Federation|
|Regional Clinic Hospital of Ryazan|
|Ryazan', Russian Federation|
|City Hospital N40 of Kurortny District|
|Saint Petersburg, Russian Federation|
|Medical institute Ogarev Mordovia State university|
|Saransk, Russian Federation|
|Smolensk clinical hospital №1|
|Smolensk, Russian Federation|
|Principal Investigator:||Dmitriy Pushkar||Moscow State Clinical Hospital №50|