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COVID-19Phase 2/3NCT04434248

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

A Phase 2/3 study testing Favipiravir in people with COVID-19, run by Chromis LLC at 22 sites in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Favipiravir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
22 sitesRussia
Study dates
23 Apr 2020to Jul 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Patient Information Sheet and Informed Consent form to participate in the study.
  • Men and women aged 18 years and older.
  • Patients hospitalized with a diagnosis of COVID-19.
  • 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.
  • Moderate severity of COVID-19 with pneumonia with at least 1 of the following symptoms:
  • Fever above 38 °C;
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  • Cough;
  • Shortness of breath during physical exertion;
  • C reactive protein (CRP) of blood serum > 10 mg/l;
  • SpO2 < 95%
  • The capability of oral drug administration.
  • The patients' consent to use adequate contraception methods during the study (condom with spermicide) and for 3 months following completion.

Who cannot join

  • 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;
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  • Septic shock.
  • Patients treated with lopinavir/ritonavir, ribavirin, arbidol, chloroquine, hydroxychloroquine, mefloquine, favipiravir within 7 days prior to screening.
  • 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.
  • Severe chronic renal impairment (GFR < 30 ml / min) or continuous renal replacement therapy, hemodialysis or peritoneal dialysis.
  • A history of cirrhosis or an increase in alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) > 5 times × upper limit of normal (ULN).
  • 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.
  • 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
  • Malignancies that require chemotherapy within 6 months prior to screening.
  • Known HIV infection
  • Hypersensitivity to any component of the study drug.
  • Participation in other clinical studies or taking other study drugs within 28 days prior to screening.
  • 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.
  • 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Russia22 sites

  • Republican Clinical Hospital

    Makhachkala

  • "K+31" Clinic

    Moscow

  • "Khaven" Llc

    Moscow

  • Central Clinical Hospital with Polyclinic

    Moscow

  • Central Research Institute of Epidemiology

    Moscow

  • City Clinical Hospital n.a. O.M. Filatov

    Moscow

  • City Clinical Hospital named after S.S. Yudin

    Moscow

  • City Clinical Hospital No. 24

    Moscow

  • City Clinical Hospital No. 51

    Moscow

  • First Moscow State Medical University n.a. I.M. Sechenov

    Moscow

  • Moscow State University n.a. M. V. Lomonosov

    Moscow

  • National Medical and Surgical Center named after N.I. Pirogov

    Moscow

  • City Hospital № 33 of the Leninsky region of Nizhny Novgorod

    Nizhny Novgorod

  • Infectious clinical hospital No.2 of Nizhny Novgorod

    Nizhny Novgorod

  • Ryazan State Medical University named after I.P. Pavlov

    Ryazan

  • Military Medical Academy named after S.M. Kirova

    Saint Petersburg

  • Saratov State Medical University named after V.I. Razumovsky

    Saratov

  • Clinical hospital No.1

    Smolensk

  • Regional Clinic Hospital

    Tver'

  • Bashkir State Medical University

    Ufa

  • Yakutsk City Clinical Hospital

    Yakutsk

  • Yaroslavl Regional Clinical Hospital for War Veterans

    Yaroslavl

Other trials in Russia

About this study

Official title: An Adaptive, Multicenter, Randomized, Open-label, Comparative Clinical Study to Assess Efficacy and Safety of Favipiravir in Hospitalized Patients With COVID-19

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.

Read the 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.

Conditions
COVID-19
Being tested
Favipiravir, Standard of Care
Keywords
SARS-CoV-2, 2019-nCoV
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FavipiravirDrug

    Also called Avifavir

    200 mg coated tablets

  • Standard of CareDrug

    Also called Hydroxychloroquine, chloroquine, lopinavir/ritonavir, etc.

    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.

Study groups in NCT04434248
Study groupRoleWhat they receive
Favipiravir, lower dose (pilot stage)Experimental1600mg BID on the 1st day followed by 600mg BID for 13 days
Receives: Drug: Favipiravir
Favipiravir, higher dose (pilot stage)Experimental1800mg BID on the 1st day followed by 800mg BID for 13 days
Receives: Drug: Favipiravir
Standard of care (pilot stage)Active comparatorBased 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.
Receives: Drug: Standard of Care
Favipiravir, selected dose (pivotal stage)ExperimentalThe dose will be selected based on pilot study results.
Receives: Drug: Favipiravir
Standard of care (pivotal stage)Active comparatorBased 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.
Receives: Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of viral elimination by Day 10 [pilot stage, dose selection]

    Percent of patients with undetectable SARS-CoV-2 RNA level on Day 10

    Measured: 10 Days

  2. Time to viral elimination [pivotal stage]

    Median time to reach undetectable SARS-CoV-2 RNA level

    Measured: 28 Days

  3. Time to clinical improvement [pivotal stage]

    Median time reach clinical improvement (2 points of the Ordinal Scale for Clinical Improvement) or discharge from the hospital

    Measured: 28 Days

Secondary outcomes (12)

  1. Rate of viral elimination

    Percent of patients with undetectable SARS-CoV-2 RNA level

    Measured: Days 3, 5, 7, 9, and 11

  2. Time to normalization of clinical symptoms

    Median time [days] to reach normal levels of clinical indicators (body temperature, SpO2, breathing rate)

    Measured: 28 Days

  3. Duration of oxygen therapy

    Mean duration of oxygen therapy [days]

    Measured: 28 Days

  4. Change in the level of lung damage according to CT

    Change of lung damage level according to CT comparing to baseline [% of patients]

    Measured: Days 15, 22, and 29

  5. Rate of transfer to the intensive care unit

    Percent of patients transferred to the intensive care unit [% of patients]

    Measured: 28 days

  6. Rate of the use of non-invasive lung ventilation

    Percent of patients undergoing non-invasive lung ventilation [% of patients]

    Measured: 28 days

  7. Rate of the use of mechanical ventilation

    Percent of patients undergoing mechanical ventilation [% of patients]

    Measured: 28 days

  8. Mortality

    Percent of patients died within 28-days period [% of patients]

    Measured: 28 days

  9. Peak plasma concentration (Cmax)

    Determination of Cmax [ng/ml]

    Measured: Day 1

  10. Time to peak plasma concentration (Tmax)

    Determination of Tmax [h]

    Measured: Day 1

  11. Area under the plasma concentration versus time curve (AUC0-t)

    Determination of AUC0-t [ng*h/ml]

    Measured: 10 days

  12. Trough plasma concentration (Ctrough)

    Determination of Ctrough [ng/ml]

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start23 Apr 2020
  3. Primary completionJul 2020 (estimated)
  4. Study completionJul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
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)
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04434248
Sponsor's protocol ID
COVID-FPR-01
Status last verified
Jun 2020
First submitted
13 Jun 2020
Last updated
16 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ivashchenko AA, Dmitriev KA, Vostokova NV, Azarova VN, Blinow AA, Egorova AN, Gordeev IG, Ilin AP, Karapetian RN, Kravchenko DV, Lomakin NV, Merkulova EA, Papazova NA, Pavlikova EP, Savchuk NP, Simakina EN, Sitdekov TA, Smolyarchuk EA, Tikhomolova EG, Yakubova EV, Ivachtchenko AV. AVIFAVIR for Treatment of Patients With Moderate Coronavirus Disease 2019 (COVID-19): Interim Results of a Phase II/III Multicenter Randomized Clinical Trial. Clin Infect Dis. 2021 Aug 2;73(3):531-534. doi: 10.1093/cid/ciaa1176.

    PubMed 32770240

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Favipiravir in people with COVID-19, run by Chromis LLC at 22 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of viral elimination by Day 10 [pilot stage, dose selection] (time frame: 10 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04434248, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.

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