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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
Sponsor:
Information provided by (Responsible Party):
Promomed, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition COVID-19
Interventions Drug: Favipiravir
Drug: Standard of care
Enrollment 200
Recruitment Details  
Pre-assignment Details The study will randomize 200 patients. Given the possible non-inclusion of patients at the screening stage, the maximum number of patients to sign the Informed Consent Form in the Patient Information Leaflet and to participate in screening can be no more than 210 people.
Arm/Group Title Favipiravir (Areplivir) Standard of Care
Hide Arm/Group Description

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.

Favipiravir: 200 mg coated tablets

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.

Period Title: Overall Study
Started 100 100
Completed 96 100
Not Completed 4 0
Reason Not Completed
The need for prohibited therapy             2             0
Adverse Event             1             0
Protocol Violation             1             0
Arm/Group Title Favipiravir (Areplivir) Standard of Care Total
Hide Arm/Group Description

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.

Favipiravir: 200 mg coated tablets

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 200 participants
49.38  (13.18) 49.98  (13.06) 49.68  (13.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
49
  49.0%
54
  54.0%
103
  51.5%
Male
51
  51.0%
46
  46.0%
97
  48.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Russia Number Analyzed 100 participants 100 participants 200 participants
100 100 200
1.Primary Outcome
Title Rate of Clinical Status Improvement
Hide Description 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 Frame By Visit 3, approximately 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-tо-treat population
Arm/Group Title Favipiravir (Areplivir) Standard of Care
Hide Arm/Group Description:

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.

Favipiravir: 200 mg coated tablets

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.

Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
27
  27.0%
15
  15.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Favipiravir (Areplivir), Standard of Care
Comments A comparative analysis of the rate of clinical status improvement by 2 or more categories. The difference in percentages between the AREPLIVIR arm and the standard therapy arm (pa-pb)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0372
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter The difference in proportions
Estimated Value 0.1313
Confidence Interval (2-Sided) 95%
-0.0004 to 0.2367
Estimation Comments [Not Specified]
2.Primary Outcome
Title Time to Clinical Improvement
Hide Description Time (in days) to improvement in clinical status by WHO categorical ordinal scale of clinical status improvement.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients who received at least one dose of the drug in the study and for whom there is data for at least one visit after the baseline
Arm/Group Title Favipiravir (Areplivir) Standard of Care
Hide Arm/Group Description:

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.

Favipiravir: 200 mg coated tablets

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.

Overall Number of Participants Analyzed 100 100
Median (Inter-Quartile Range)
Unit of Measure: days
8
(6 to 10)
12
(7 to 12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Favipiravir (Areplivir), Standard of Care
Comments Comparative analysis of time to clinical status improvement by categorical ordinal clinical improvement scale between the AREPLIVIR arm and the standard therapy arm
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter The difference in days
Estimated Value 4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Rate of Viral Elimination by Day 10
Hide Description Percentage of patients with elimination (clearance) of COVID-19 according to PCR data by day 10 (negative PCR results).
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients who received at least one dose of the drug in the study and for whom there is data for at least one visit after the baseline
Arm/Group Title Favipiravir (Areplivir) Standard of Care
Hide Arm/Group Description:

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.

Favipiravir: 200 mg coated tablets

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.

Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
98
  98.0%
79
  79.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Favipiravir (Areplivir), Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00016
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter The difference in percentages
Estimated Value 22.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time Before the End of Fever
Hide Description Time (in days) before the end of fever (body temperature < 37.2 ° C for 3 consecutive days without antipyretic medication).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients who received at least one dose of the drug in the study and for whom there is data for at least one visit after the baseline
Arm/Group Title Favipiravir (Areplivir) Standard of Care
Hide Arm/Group Description:

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.

Favipiravir: 200 mg coated tablets

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.

Overall Number of Participants Analyzed 100 100
Median (Inter-Quartile Range)
Unit of Measure: days
4
(2 to 5)
5
(3 to 7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Favipiravir (Areplivir), Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.55
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in the Level of Lung Damage According to CT
Hide Description 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)
Time Frame Days 15, 21, 28
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Favipiravir (Areplivir) Standard of Care
Hide Arm/Group Description:

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.

Favipiravir: 200 mg coated tablets

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.

Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
60
  60.0%
40
  40.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Favipiravir (Areplivir), Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1953
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Rate of Transfer to the Intensive Care Unit
Hide Description Percentage of patients transferred to intensive care unit (% of patients).
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
the number of patients who required transfer to the intensive care unit
Arm/Group Title Favipiravir (Areplivir) Standard of Care
Hide Arm/Group Description:

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.

Favipiravir: 200 mg coated tablets

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.

Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Favipiravir (Areplivir), Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4975
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Rate of the Use of Non-invasive Lung Ventilation
Hide Description Percentage of cases with non-invasive lung ventilation (% of patients).
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
the number of patients who required non-invasive lung ventilation
Arm/Group Title Favipiravir (Areplivir) Standard of Care
Hide Arm/Group Description:

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.

Favipiravir: 200 mg coated tablets

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.

Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Rate of the Use of Mechanical Ventilation
Hide Description Percentage of cases with mechanical lung ventilation (% of patients)
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
the number of patients who required mechanical lung ventilation
Arm/Group Title Favipiravir (Areplivir) Standard of Care
Hide Arm/Group Description:

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.

Favipiravir: 200 mg coated tablets

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.

Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Mortality
Hide Description Incidence of fatal cases (% of patients)
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
the number of patients who died
Arm/Group Title Favipiravir (Areplivir) Standard of Care
Hide Arm/Group Description:

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.

Favipiravir: 200 mg coated tablets

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.

Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Post-Hoc Outcome
Title Amount of Patients Without Any Clinical Signs of Disease by the Completion of Therapy (Category 0 According to a WHO Categorical Ordinal Scale)
Hide Description [Not Specified]
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Favipiravir (Areplivir) Standard of Care
Hide Arm/Group Description:

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.

Favipiravir: 200 mg coated tablets

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.

Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
44
  44.0%
10
  10.0%
11.Post-Hoc Outcome
Title The Number of Patients Achieved a Category Lower Than or Equal to 2 on the WHO Clinical Improvement Scale (They Were Discharged From Hospital)
Hide Description [Not Specified]
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Favipiravir (Areplivir) Standard of Care
Hide Arm/Group Description:

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.

Favipiravir: 200 mg coated tablets

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.

Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
90
  90.0%
67
  67.0%
12.Post-Hoc Outcome
Title A Number of Patients With Fever Reduction Below 37.2 ° C by the 3rd Day of Therapy
Hide Description [Not Specified]
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Favipiravir (Areplivir) Standard of Care
Hide Arm/Group Description:

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.

Favipiravir: 200 mg coated tablets

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.

Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
60
  60.0%
37
  37.0%
Time Frame Safety assessment was carried out: up to 30 days for each patient and during the entire period of the study as a whole. Safety population: patients who have received at least one dose of the study drug and for whom there is an assessment of condition and/or AE for at least one time point after administration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Favipiravir (Areplivir) Standard of Care
Hide Arm/Group Description

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.

Favipiravir: 200 mg coated tablets

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.

All-Cause Mortality
Favipiravir (Areplivir) Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%) 
Hide Serious Adverse Events
Favipiravir (Areplivir) Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   3/100 (3.00%)   0/100 (0.00%) 
Cardiac disorders     
Aortic valve stenosis  1 [1]  1/100 (1.00%)  0/100 (0.00%) 
General disorders     
Multiple organ failure syndrome  1 [2]  1/100 (1.00%)  0/100 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1 [2]  1/100 (1.00%)  0/100 (0.00%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
[1]
According to investigators, the causal relationship with the study drug was estimated as "doubtful", SAE was associated with the presence of concomitant diseases, i.e. type 2 diabetes mellitus, obesity, and hyperthyroidism.
[2]
According to investigators, the causal relationship with the study drug was estimated as "unrelated", SAE was associated with the presence of concomitant diseases, i.e. type 2 diabetes mellitus, obesity, and hyperthyroidism.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Favipiravir (Areplivir) Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   25/100 (25.00%)   28/100 (28.00%) 
Hepatobiliary disorders     
Increased alanine aminotransferase activity  1 [1]  18/100 (18.00%)  19/100 (19.00%) 
Increased aspartate aminotransferase activity  1 [2]  13/100 (13.00%)  13/100 (13.00%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
[1]
According to investigators, the causal relationship with the study drug was estimated as "unrelated" in 22.2%
[2]
According to investigators, the causal relationship with the study drug / standard therapy was estimated as "unrelated" in 69.2% /61.5%
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Academician Dmitry Pushkar
Organization: A.I. Yevdokimov Moscow State University of Medicine and Dentistry of the Ministry of Healthcare of the Russian Federation
Phone: +7495-609-67-00
EMail: dmitry.pushkar@gmail.com
Layout table for additonal information
Responsible Party: Promomed, LLC
ClinicalTrials.gov Identifier: NCT04542694    
Other Study ID Numbers: FAV052020
First Submitted: September 4, 2020
First Posted: September 9, 2020
Results First Submitted: October 11, 2020
Results First Posted: November 5, 2020
Last Update Posted: November 5, 2020