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
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 100 participants | 100 participants | 200 participants | |
Female |
49 49.0%
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54 54.0%
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103 51.5%
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Male |
51 51.0%
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46 46.0%
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97 48.5%
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | 0 participants | 0 participants | |
0 | ||||
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Russia | Number Analyzed | 100 participants | 100 participants | 200 participants |
100 | 100 | 200 |
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 |
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 |