Study Evaluating the Efficacy and Safety of AV5080 in Patients With Uncomplicated Influenza

NCT05093998 | Unknown Phase 3 DMC

• 1 other identifier: FLU-AV5080-03
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 6

Brief Summary

To evaluate the efficacy of AV5080 versus Placebo based on time to symptom resolution in patients with uncomplicated influenza.

Conditions

Influenza

Keywords

Treatment for influenza in adults

Outcome Measures

Primary Outcomes (1)

• Time to symptom resolution

  The resolution of influenza symptoms is confirmed by the absence of symptoms or their reduction to mild severity (0-1 points) and a decrease in body temperature in the armpit to ≤ 37.2 °C for at least 24 hours. The time to resolve the flu symptoms is the start time of the 24-hour (or longer) interval.

  30 days

Secondary Outcomes (4)

• Profile of changes in influenza virus titer versus time (AUC) for 192 hours (in inpatients)

  192 hours

• Frequency of symptom resolution within 96 hours of initiation of study therapy

  96 hours

• Frequency of elimination of influenza virus before Day 6

  6 Days

• The incidence of complications from influenza

  30 days

Study Arms (2)

Group 1.

EXPERIMENTAL

AV5080 at a daily dose of 160 mg

Drug: AV5080

Group 2.

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

AV5080 DRUG

oral hard gelatin capsules

Also known as: AV5080 at a daily dose of 160 mg

Group 1.

Placebo OTHER

Hard gelatin capsules with a white body

Group 2.

Eligibility Criteria

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

You may qualify if:

• Signed informed consent.
• Men and women between the ages of 18 and 65 (inclusive).
• Outpatients (including those admitted at home) and inpatients hospitalized for epidemiological reasons, diagnosed with influenza (ICD 10: J10 Influenza caused by an identified influenza virus) of mild to moderate severity.
• Positive result of the rapid enzyme immunoassay test for influenza virus at screening.
• Increase in body temperature in the armpit up to ≥ 38.0 оС at screening (or within 24 hours before screening according to the patient's words).
• Presence of at least one of the following symptoms of moderate severity on screening:
• headache, weakness/malaise, muscle pain/aches, fever/chills.
• The duration of the disease is no more than 48 hours at the time of screening according to the patient.
• Consent of patients to use adequate methods of contraception throughout the study.
• Adequate methods of contraception include the use of:
• oral or transdermal contraceptives;
• a condom or diaphragm (barrier method) with spermicide or
• an intrauterine device.

You may not qualify if:

• Pregnant or lactating women or women planning pregnancy during a clinical study; women capable of childbearing (including menopausal women less than 2 years old) who do not use adequate methods of contraception.
• Individual intolerance to the drug AV5080 or its components. Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
• Presence of complications of influenza, signs of bacterial infection or severe flu at the time of screening.
• Infectious diseases transferred during the last week before screening
• The need for hospital treatment for influenza, with the exception of hospitalization for epidemiological indications.
• Reception of neuraminidase inhibitors (zanamivir and oseltamivir), immunotropic drugs, systemic glucocorticosteroids, antibacterial drugs of systemic action within 1 month before screening. Taking drugs that prolong the QT interval on an ECG (quinidine, amiodarone, procainamide, phenothiazine derivatives) for 5 half-lives or less before screening.
• A history of influenza vaccination within 3 months prior to screening.
• Chronic diseases of the respiratory system (bronchial asthma, COPD,) in history.
• Persons with metabolic disorders (diabetes mellitus, obesity of 2-3 degrees).
• Hypokalemia at screening (potassium level less than 3.5 mmol/L)
• Persons with chronic kidney disease, chronic liver disease, with certain neurological conditions (including neuromuscular, neurocognitive disorders, epilepsy), hemoglobinopathies or suppressed immune conditions, or due to primary immunosuppressive conditions such as HIV infection, or in connection with secondary immunodeficiency states due to the intake of immunosuppressive medications or malignant neoplasms.
• Significant cardiovascular diseases at present or during 12 months before screening, including: prolongation of the QT interval on ECG more than 450 ms, atrioventricular block, sinus bradycardia, chronic cerebrovascular insufficiency, chronic heart failure class III or IV (according to the classification of the New York Heart Association), severe arrhythmia, requiring treatment with class Ia, Ib, Ic, or III antiarrhythmic drugs, unstable angina pectoris, myocardial infarction, heart and coronary artery surgery, significant heart valve disease, transient ischemic attack or stroke, uncontrolled hypertension with systolic blood pressure\> 180 mm Hg ... and diastolic blood pressure\> 110 mm Hg, pulmonary embolism or deep vein thrombosis.
• A history of chronic alcoholism, drug addiction or dependence on other chemical compounds.
• Participation in other clinical trials within 3 months prior to screening.
• Inability to read or write; unwillingness to understand and follow research protocol procedures; non-compliance with the regimen of taking medications or performing procedures that, in the opinion of the Investigator, may affect the results of the study or the safety of the patient and prevent the patient from further participation in the study any other comorbid medical or serious mental condition that renders a patient ineligible for participation in a clinical research study, limits the ability to obtain informed consent, or may affect a patient's ability to participate in a study.

Sponsors & Collaborators

• Viriom: lead

Study Sites (6)

Specialized Clinical Infectious Diseases Hospital

Krasnodar, Russia

Location

Murmansk Regional Clinic named after P.A. Bayandin

Murmansk, Russia

Location

Federal Research Center Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences

Novosibirsk, Russia

Location

Center for the Prevention and Control of AIDS and Infectious Diseases

Saint Petersburg, Russia

Location

First Saint Petersburg State Medical University named after I.I. Academician Pavlov

Saint Petersburg, Russia

Location

Research Center Eco-safety

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Yulia Trakhtenberg, PhD

CONTACT

+7 (495) 276-11-43; jat@ipharma.ru

Xenia Kopylova

CONTACT

+7 (495) 276-11-43; kka@ipharma.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is double-blind. Clinical center staff and patients will not know what therapy and in what doses are prescribed for each individual patient. Blinding will be achieved by masking the AV5080/placebo drug (each patient will take a pill corresponding to 80 mg or placebo) and dispensing the drug using IWRS. Each patient will be given the study drug in banks. Banks will have a unique identification number, otherwise they will be identical in marking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: October 26, 2021
• Study Start: January 15, 2022
• Primary Completion: July 15, 2023
• Study Completion: July 31, 2023
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (6)