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An Adaptive Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19

  • Clinicaltrials.gov identifier

    NCT04434248

  • Recruitment Status

    Active, not recruiting

  • First Posted

    June 16, 2020

  • Last update posted

    June 16, 2020

Study Description

Brief summary:

The study is Phase II/III and consists of pilot and pivotal stages. The objective of the pilot stage is to conduct a preliminary assessment of the efficacy and safety of Favipiravir, and to select the optimal dosing regimen to study during the pivotal stage. The objective of the pivotal stage is to assess the efficacy and safety of Favipiravir compared with the Standard of care (SOC) in hospitalized patients with moderate to severe COVID-19 pneumonia.

  • Condition or Disease:COVID-19
  • Intervention/Treatment: Drug: Favipiravir
    Drug: Standard of Care
  • Phase: Phase 2/Phase 3

Detailed Description

At the pilot stage: upon signing the informed consent form and screening, 60 eligible patients with polymerase chain reaction (PCR) confirmed COVID-19 pneumonia are randomized at a 1:1:1 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 Favipiravir 1800 mg BID on Day 1 followed by 800 mg BID on Days 2-14 (1800/800 mg), or SOC. At the pivotal stage: additional 270 eligible patients are randomized at a 1:1 ratio to receive either Favipiravir (the dose regimen depends of the subject's weight) or SOC.

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 330 participants
  • Allocation: Randomized
  • Intervention Model: Sequential Assignment
  • Intervention Model Description: This is an adaptive, multicenter, open-label, randomized clinical study of Favipiravir versus standard of care (SOC) in hospitalized patients with moderate to severe COVID-19 pneumonia.
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: An Adaptive, Multicenter, Randomized, Open-label, Comparative Clinical Study to Assess Efficacy and Safety of Favipiravir in Hospitalized Patients With COVID-19
  • Actual Study Start Date: April 2020
  • Estimated Primary Completion Date: July 2020
  • Estimated Study Completion Date: July 2020

Arms and interventions

Arm Intervention/treatment
Experimental: Favipiravir, higher dose (pilot stage)
1800mg BID on the 1st day followed by 800mg BID for 13 days
Drug: Favipiravir
200 mg coated tablets
Experimental: Favipiravir, lower dose (pilot stage)
1600mg BID on the 1st day followed by 600mg BID for 13 days
Drug: Favipiravir
200 mg coated tablets
Experimental: Favipiravir, selected dose (pivotal stage)
The dose will be selected based on pilot study results.
Drug: Favipiravir
200 mg coated tablets
Active Comparator: Standard of care (pilot stage)
Based on approved clinical recommendations for treatment of COVID-19 in the Russian Federation (but not Favipiravir). Might include hydroxychloroquine, chloroquine, lopinavir/ritonavir or other recommended schemes.
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.
Active Comparator: Standard of care (pivotal stage)
Based on approved clinical recommendations for treatment of COVID-19 in the Russian Federation (but not Favipiravir). Might include hydroxychloroquine, chloroquine, lopinavir/ritonavir or other recommended schemes.
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.

Outcome Measures

  • Primary Outcome Measures: 1. Rate of viral elimination by Day 10 [pilot stage, dose selection] [ Time Frame: 10 Days ]
    Percent of patients with undetectable SARS-CoV-2 RNA level on Day 10
  • 2. Time to viral elimination [pivotal stage] [ Time Frame: 28 Days ]
    Median time to reach undetectable SARS-CoV-2 RNA level
  • 3. Time to clinical improvement [pivotal stage] [ Time Frame: 28 Days ]
    Median time reach clinical improvement (2 points of the Ordinal Scale for Clinical Improvement) or discharge from the hospital
  • Secondary Outcome Measures: 1. Rate of viral elimination [ Time Frame: Days 3, 5, 7, 9, and 11 ]
    Percent of patients with undetectable SARS-CoV-2 RNA level
  • 2. Time to normalization of clinical symptoms [ Time Frame: 28 Days ]
    Median time [days] to reach normal levels of clinical indicators (body temperature, SpO2, breathing rate)
  • 3. Duration of oxygen therapy [ Time Frame: 28 Days ]
    Mean duration of oxygen therapy [days]
  • 4. Change in the level of lung damage according to CT [ Time Frame: Days 15, 22, and 29 ]
    Change of lung damage level according to CT comparing to baseline [% of patients]
  • 5. Rate of transfer to the intensive care unit [ Time Frame: 28 days ]
    Percent of patients transferred to the intensive care unit [% of patients]
  • 6. Rate of the use of non-invasive lung ventilation [ Time Frame: 28 days ]
    Percent of patients undergoing non-invasive lung ventilation [% of patients]
  • 7. Rate of the use of mechanical ventilation [ Time Frame: 28 days ]
    Percent of patients undergoing mechanical ventilation [% of patients]
  • 8. Mortality [ Time Frame: 28 days ]
    Percent of patients died within 28-days period [% of patients]
  • 9. Peak plasma concentration (Cmax) [ Time Frame: Day 1 ]
    Determination of Cmax [ng/ml]
  • 10. Time to peak plasma concentration (Tmax) [ Time Frame: Day 1 ]
    Determination of Tmax [h]
  • 11. Area under the plasma concentration versus time curve (AUC0-t) [ Time Frame: 10 days ]
    Determination of AUC0-t [ng*h/ml]
  • 12. Trough plasma concentration (Ctrough) [ Time Frame: 10 days ]
    Determination of Ctrough [ng/ml]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: 1. Signed Patient Information Sheet and Informed Consent form to participate in the study. 2. Men and women aged 18 years and older. 3. Patients hospitalized with a diagnosis of COVID-19. 4. The diagnosis of COVID-19 was confirmed by positive reverse transcription polymerase chain reaction (RT-PCR) test for SARS-CoV-2, performed no earlier than 7 days before hospitalization or at screening. 5. Moderate severity of COVID-19 with pneumonia with at least 1 of the following symptoms: - Fever above 38 °C; - Cough; - Shortness of breath during physical exertion; - C reactive protein (CRP) of blood serum > 10 mg/l; - SpO2 < 95% 6. The capability of oral drug administration. 7. The patients' consent to use adequate contraception methods during the study (condom with spermicide) and for 3 months following completion. Exclusion Criteria: 1. Severe type of disease, with at least one of the following criteria: - Frequency of breath > 35 per minute, which does not decrease after the body temperature drops to normal or subfebrile values; - Blood oxygen saturation (SpO2) < 90% at rest; - Partial pressure of oxygen in arterial blood (PaO2) < 60 mm Hg; - Oxygenation index (RaO2/FiO2) ≤ 200 mm Hg; - Partial pressure of CO2 in arterial blood (PaCO2) < 60 mm Hg; - Septic shock. 2. Patients treated with lopinavir/ritonavir, ribavirin, arbidol, chloroquine, hydroxychloroquine, mefloquine, favipiravir within 7 days prior to screening. 3. Severe cardiovascular diseases currently or 6 months prior to randomization, including: New York Heart Association (NYHA) Class III or IV chronic heart failure, clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction, heart and coronary vessel surgery, significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure > 180 mm Hg and diastolic blood pressure > 110 mm Hg, pulmonary embolism or deep vein thrombosis. 4. Severe chronic renal impairment (GFR < 30 ml / min) or continuous renal replacement therapy, hemodialysis or peritoneal dialysis. 5. A history of cirrhosis or an increase in alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) > 5 times × upper limit of normal (ULN). 6. Severe diseases of the central nervous system, including seizures in history or conditions that may lead to their development; stroke or transient ischemic attack within 12 months prior to screening; head injuries or loss of consciousness within 12 months prior to screening; a brain tumor. 7. Significant uncontrolled concomitant disease, e.g. neurological, renal, hepatic, endocrinological or gastrointestinal disorder which according to the Investigator, could prevent the patient from participating in the study 8. Malignancies that require chemotherapy within 6 months prior to screening. 9. Known HIV infection 10. Hypersensitivity to any component of the study drug. 11. Participation in other clinical studies or taking other study drugs within 28 days prior to screening. 12. Pregnant or lactating women or women planning to get pregnant during the clinical study; women of child-bearing potential (including non-sterilized by surgical means and during the post-menopause period less than 2 years) who do not use adequate contraception methods. 13. Inability to read or write, unwillingness to understand and follow procedures of study protocol, as well as any other concomitant medical or serious mental conditions that make the patient unfit to participate in the study, limit the legality of obtaining informed consent or can affect patient's ability to participate in the study.

Contacts and Locations

Contacts

Locations

Russian Federation
Republican Clinical Hospital
Makhachkala

Russian Federation
"K+31" Clinic
Moscow

Russian Federation
"Khaven" Llc
Moscow

Russian Federation
Central Clinical Hospital with Polyclinic
Moscow

Russian Federation
Central Research Institute of Epidemiology
Moscow

Russian Federation
City Clinical Hospital n.a. O.M. Filatov
Moscow

Russian Federation
City Clinical Hospital named after S.S. Yudin
Moscow

Russian Federation
City Clinical Hospital No. 24
Moscow

Russian Federation
City Clinical Hospital No. 51
Moscow

Russian Federation
First Moscow State Medical University n.a. I.M. Sechenov
Moscow

Russian Federation
Moscow State University n.a. M. V. Lomonosov
Moscow

Russian Federation
National Medical and Surgical Center named after N.I. Pirogov
Moscow

Russian Federation
City Hospital № 33 of the Leninsky region of Nizhny Novgorod
Nizhny Novgorod

Russian Federation
Infectious clinical hospital No.2 of Nizhny Novgorod
Nizhny Novgorod

Russian Federation
Ryazan State Medical University named after I.P. Pavlov
Ryazan

Russian Federation
Military Medical Academy named after S.M. Kirova
Saint Petersburg

Russian Federation
Saratov State Medical University named after V.I. Razumovsky
Saratov

Russian Federation
Clinical hospital No.1
Smolensk

Russian Federation
Regional Clinic Hospital
Tver

Russian Federation
Bashkir State Medical University
Ufa

Russian Federation
Yakutsk City Clinical Hospital
Yakutsk

Russian Federation
Yaroslavl Regional Clinical Hospital for War Veterans
Yaroslavl

Sponsors and Collaborators

Chromis LLC

Chemical Diversity Research Institute

Investigators

Principal Investigator: Elena Pavlikova, MD,PhD,Prof Moscow State University n.a. M.V. Lomonosov

Principal Investigator: Nikita Lomakin, MD,PhD Central Clinical Hospital with Polyclinic

More Information

  • Responsible Party: Chromis LLC
  • ClinicalTrials.gov Identifier: NCT04434248 History of Changes
  • Other Study ID Numbers: COVID-FPR-01
  • First Posted: June 16, 2020 Key Record Dates
  • Last Update Posted: June 16, 2020
  • Last Verified: June 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Chromis LLC: 2019-nCoV SARS-CoV-2
  • Additional relevant MeSH terms: COVID-19