Randomized Multicenter Study on the Efficacy and Safety of Favipiravir for Parenteral Administration Compared to Standard of Care in Hospitalized Patients With COVID-19

NCT05185284 | Completed Phase 3

• 1 other identifier: FAV-052021
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 6

Brief Summary

This is open-labe randomized multicenter comparative Phase III study conducted in 7 medical facilities. The objective of the study is to assess the efficacy and safety of Favipiravir for parenteral administration compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19 pneumonia.

Conditions

COVID-19

Keywords

SARS-CoV-2; Areplivir; 2019-nCoV; Favipiravir; Pneumonia; Coronavirus Infections

Outcome Measures

Primary Outcomes (2)

• Rate of Clinical Status Improvement

  Rate of clinical status improvement by WHO 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 (9)

• Rate of Clinical Status Improvement

  14 days

• Rate of Clinical Status Improvement

  14 Days

• End of Fever on Days of study

  14 Days

• Change in the Level of Lung Damage According to CT

  14 Days

• Rate of Viral Elimination

  14 days

Study Arms (2)

Favipiravir (Areplivir)

EXPERIMENTAL

Arm 1 (n=106) receives the study drug Areplivir for parenteral administration as follows: Day 1 1600 mg 2 times a day, Day 2-10 800 mg 2 times a day. Administration will be done intravenously by drip infusion for 2 hours. The course of treatment is 10 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=108) 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 by decision of the investigator and taking into account the availability of drugs at the study site. Might include Favipiravir tab, Remdesivir 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: Favipiravir; Drug: Remdesivir

Interventions

Favipiravir DRUG

400 mg, lyophilizate for preparation of concentrate for solution for infusion

Also known as: Areplivir

Favipiravir (Areplivir)

Remdesivir DRUG

100 mg, lyophilizate for preparation of concentrate for solution for infusion

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:

• Availability of the Informed Consent Form of the Patient Information Leaflet (PIL) signed and dated by patient.
• Men and women aged 18 to 80 years inclusive at the time of signing the Informed Consent Form in PIL.
• Confirmed case of COVID-19 at the time of screening based on SARS-CoV-2 RNA test using nucleic acid amplification (NAA) method. It is acceptable to include a patient with a presumptive COVID-19 diagnosis prior to receiving the results of SARS-CoV-2 RNA test made at the screening stage.
• Hospital admission due to COVID-19.
• Moderate severity infection with SARS-CoV-2:
• Clinical signs:
• Mandatory: CT pattern typical of a viral lesion (lesion volume is minimal or moderate; CT 1-2).
• Additional (at least 1 of the following criteria):
• body temperature \> 38 °C;
• RR \> 22/min;
• shortness of breath on exertion;
• SpO2 \< 95%;
• Serum CRP \> 10 mg/L.
• 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. Reliable means of contraception are: sexual abstinence, use of condom in combination with spermicide.
• For men (optional): Consent to avoid sexual contact with pregnant women for the duration of the study and for 3 months after its completion.

You may not qualify if:

• Hypersensitivity to favipiravir, remdesivir and/or other components of the study drug.
• Impossibility of CT procedure (for example, gypsum dressing or metal structures in the field of imaging).
• History of vaccination against COVID-19.
• History of presumptive or confirmed COVID-19 case of moderate, severe and extremely severe course of the disease.
• Use of favipiravir or remdesivir within 10 days prior to screening.
• The need to use drugs from the list of prohibited therapy.
• Meeting the criteria for severe and extremely severe course of the disease.
• 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.
• Renal impairment (GFR \< 60 ml/min) at the time of screening.
• History of gout.
• 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 (see Appendix 2).
• Malignancies in the past medical history.
• Alcohol, pharmacological and/or drug addiction in the past medical history and/or at the time of screening.

Sponsors & Collaborators

• Promomed, LLC: lead
• Solyur Pharmaceuticals Group: collaborator

Study Sites (6)

Regional budgetary health care institution "Ivanovo Clinical Hospital named after Kuvaevs"

Ivanovo, 153025, Russia

Location

State Budgetary Institution of Healthcare of the City of Moscow "City Clinical Hospital No. 24 of the Department of Healthcare of the City of Moscow"

Moscow, 127015, Russia

Location

State Clinical Hospital №50

Moscow, Russia

Location

Regional Clinic Hospital of Ryazan

Ryazan, Russia

Location

Medical institute Ogarev Mordovia State university

Saransk, Russia

Location

Smolensk clinical hospital №1

Smolensk, Russia

Location

MeSH Terms

Conditions

COVID-19; Pneumonia; Coronavirus Infections

Interventions

favipiravir; remdesivir

Condition Hierarchy (Ancestors)

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

Study Officials

• Dmitriy Pushkar, MD, Academic

  Moscow State Clinical Hospital №50

  PRINCIPAL INVESTIGATOR

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: January 7, 2022
• First Posted: January 11, 2022
• Study Start: August 11, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: January 2022

Locations

RU (6)