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

NCT04542694 | Completed Phase 3 Results DMC

• 1 other identifier: FAV052020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

COVID-19

Keywords

Favipiravir; Areplivir; COVID-19; SARS-CoV-2; 2019-nCoV

Outcome Measures

Primary Outcomes (2)

• Rate of Clinical Status Improvement

  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

  By Visit 3, approximately 10 days

• Time to Clinical Improvement

  Time (in days) to improvement in clinical status by WHO categorical ordinal scale of clinical status improvement.

  28 days

Secondary Outcomes (7)

• Rate of Viral Elimination by Day 10

  10 days

• Time Before the End of Fever

  28 days

• Change in the Level of Lung Damage According to CT

  Days 15, 21, 28

• Rate of Transfer to the Intensive Care Unit

  28 Days

• Rate of the Use of Non-invasive Lung Ventilation

  28 Days

Study Arms (2)

Favipiravir (Areplivir)

EXPERIMENTAL

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.

Drug: Favipiravir

Standard of care

ACTIVE COMPARATOR

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.

Drug: Standard of care

Interventions

Favipiravir DRUG

200 mg coated tablets

Also known as: AREPLIVIR

Favipiravir (Areplivir)

Standard of care DRUG

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.

Standard of care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing and dating of the Informed Consent Form of the Patient Information Leaflet (PIL) by patients.
• Men and women aged 18 to 80 years inclusive at the time of signing the Informed Consent Form in PIL.
• No difficulty with oral medication (e.g. swallowing disorder).
• 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.
• Patient should be hospitalized no more than 48 hours before the start of the study therapy.
• Positive PCR result for presence of SARS-CoV-2 RNA at screening phase (results obtained within 7 days prior to screening are appropriate).
• 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.

You may not qualify if:

• Hypersensitivity to favipiravir and/or other components of the study drug.
• Impossibility of CT procedure (for example, gypsum dressing or metal structures in the field of imaging).
• The need to use drugs from the list of prohibited therapy.
• Need for treatment in the intensive care unit.
• Impaired liver function (AST and/or ALT ≥ 2 UNL and/or total bilirubin ≥ 1.5 UNL) at the time of screening.
• Impaired kidney function (creatinine clearance according to Cockcroft-Gault formula less than 45 ml/min) at the time of screening.
• Positive testing for HIV, syphilis, hepatitis B and/or C.
• Chronic heart failure FC III-IV according to New York Heart Association (NYHA) functional classification.
• Malabsorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
• Malignancies in the past medical history.
• Alcohol, pharmacological and/or drug addiction in the past medical history and/or at the time of screening.
• Schizophrenia, schizoaffective disorder, bipolar disorder, or other history of mental pathology or suspicion of their presence at the time of screening.
• 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).
• 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.
• Patient's unwillingness or inability to comply with procedures of the Study Protocol (in the opinion of physician investigator).

Sponsors & Collaborators

• Promomed, LLC: lead

Study Sites (5)

State Clinical Hospital №50

Moscow, Russia

Location

Regional Clinic Hospital of Ryazan

Ryazan, Russia

Location

City Hospital N40 of Kurortny District

Saint Petersburg, Russia

Location

Medical institute Ogarev Mordovia State university

Saransk, Russia

Location

Smolensk clinical hospital №1

Smolensk, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

favipiravir; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Academician Dmitry Pushkar
• Organization: A.I. Yevdokimov Moscow State University of Medicine and Dentistry of the Ministry of Healthcare of the Russian Federation

dmitry.pushkar@gmail.com

+7495-609-67-00

Study Officials

• Dmitriy Pushkar

  Moscow State Clinical Hospital №50

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 9, 2020
• Study Start: May 21, 2020
• Primary Completion: August 10, 2020
• Study Completion: August 20, 2020
• Last Updated: November 5, 2020
• Results First Posted: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (5)