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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

Tracking Information
First Submitted Date  ICMJE September 4, 2020
First Posted Date  ICMJE September 9, 2020
Results First Submitted Date  ICMJE October 11, 2020
Results First Posted Date  ICMJE November 5, 2020
Last Update Posted Date November 5, 2020
Actual Study Start Date  ICMJE May 21, 2020
Actual Primary Completion Date August 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2020)
  • Time to clinical improvement [ Time Frame: 10 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: 10 days ]
    Rate of clinical status improvement by categorical ordinal scale of clinical status improvement by 2 or more categories by Day 10
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2020)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2020)
  • Rate of viral elimination by Day 10 [ Time Frame: 10 days ]
    Percentage of patients with elimination* of COVID-19 according to PCR data by day 10
  • 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 (% of patients) according to CT data comparing to baseline
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19
Official Title  ICMJE 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
Brief Summary This is open-labe randomized multicenter comparative Phase III study conducted in 5 medical facilities. The objective of the study is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19 pneumonia.
Detailed Description Upon signing the informed consent form and screening, 200 eligible patients with polymerase chain reaction (PCR) confirmed COVID-19 are randomized at a 1:1 ratio to receive either Favipiravir 1600 mg twice a day (BID) on Day 1 followed by 600 mg BID on Days 2-14 (1600/600 mg), or SOC. The course of treatment by Favipiravir is 14 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Favipiravir
    200 mg coated tablets
    Other Name: AREPLIVIR
  • 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.

Study Arms  ICMJE
  • 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.

    Intervention: Drug: Favipiravir
  • 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.

    Intervention: Drug: Standard of care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2020)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 20, 2020
Actual Primary Completion Date August 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signing and dating of the Informed Consent Form of the Patient Information Leaflet (PIL) by patients.
  2. Men and women aged 18 to 80 years inclusive at the time of signing the Informed Consent Form in PIL.
  3. No difficulty with oral medication (e.g. swallowing disorder).
  4. Patient diagnosed with "Coronavirus infection caused by SARS-CoV-2 (confirmed)1, moderate severity form*" established in accordance with the Interim Guidelines of the Russian Ministry of Health for the prevention, diagnosis and treatment of a new coronavirus infection (COVID-19), (revision 6 of 28.04.2020).

    *Moderate severity form: fever above 38 °C, BR above 22/min, dyspnea during exercise, pneumonia (confirmed by lung CT), SpO2 < 95%, C reactive protein (CRP) serum level above 10 mg/l.

  5. Patient should be hospitalized no more than 48 hours before the start of the study therapy.
  6. Positive PCR result for presence of SARS-CoV-2 RNA at screening phase (results obtained within 7 days prior to screening are appropriate).
  7. Patient's consent to use reliable contraceptive methods throughout the study and within 1 month for women and 3 months for men after its completion. Persons eligible for participation in the study: - Women who have a negative pregnancy test and use the following contraceptives: barrier method (condom or occlusive cap (diaphragm or cervical/vaulted cap)) or double barrier method of contraception (condom or occlusive cap (diaphragm or cervical/vaulted cap) plus spermicide (foam/gel/film/cream/suppository)). Women incapable of childbearing may also participate in the study (with past history of: hysterectomy, tubal ligation, infertility, menopause more than 1 year) or men with preserved reproductive function who use barrier contraceptives, as well as men with infertility or vasectomy in the past medical history.

Exclusion Criteria:

  1. Hypersensitivity to favipiravir and/or other components of the study drug.
  2. Impossibility of CT procedure (for example, gypsum dressing or metal structures in the field of imaging).
  3. The need to use drugs from the list of prohibited therapy.
  4. Need for treatment in the intensive care unit.
  5. Impaired liver function (AST and/or ALT ≥ 2 UNL and/or total bilirubin ≥ 1.5 UNL) at the time of screening.
  6. Impaired kidney function (creatinine clearance according to Cockcroft-Gault formula less than 45 ml/min) at the time of screening.
  7. Positive testing for HIV, syphilis, hepatitis B and/or C.
  8. Chronic heart failure FC III-IV according to New York Heart Association (NYHA) functional classification.
  9. Malabsorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
  10. Malignancies in the past medical history.
  11. Alcohol, pharmacological and/or drug addiction in the past medical history and/or at the time of screening.
  12. Schizophrenia, schizoaffective disorder, bipolar disorder, or other history of mental pathology or suspicion of their presence at the time of screening.
  13. Severe, decompensated or unstable somatic diseases (any disease or condition that threaten the patient's life or impair the patient's prognosis, and also make it impossible for him/her to participate in the clinical study).
  14. Any history data that the investigating physician believes could lead to complication in the interpretation of the study results or create an additional risk to the patient as a result of his/her participation in the study.
  15. Patient's unwillingness or inability to comply with procedures of the Study Protocol (in the opinion of physician investigator).
  16. Pregnant or nursing women or women planning pregnancy.
  17. Participation in another clinical study for 3 months prior to inclusion in the study.
  18. Other conditions that, according to the physician investigator, prevent the patient from being included in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04542694
Other Study ID Numbers  ICMJE FAV052020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Promomed, LLC
Study Sponsor  ICMJE Promomed, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dmitriy Pushkar Moscow State Clinical Hospital №50
PRS Account Promomed, LLC
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP