Dose Range Study to Evaluate the Efficacy and Safety of AV5080 in Patients With Influenza

Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Efficacy and Safety of the AV5080 Drug in Patients With Influenza

Assessment of the effect reached with the different doses of AV5080 on the duration and severity of influenza symptoms based on the incidence of their resolution within 96 hours from study treatment initiation compared to Placebo.

The absence of influenza symptoms or their reduction to mild severity for at least 24 hours indicates the resolution of influenza.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Other: Placebo; Drug: AV5080

Detailed Description

The study was a multi-center, double-blind, randomized, parallel- group clinical study to assess the efficacy and safety of different AV5080 doses as compared to placebo in patients with influenza during the 5-day treatment period.

The study included only patients with influenza of mild and moderate severity, without complications, both outpatients and those hospitalized for epidemiological reasons. The study included three periods for each patient: Screening, randomization, and study treatment, follow up period.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Kazan, Russian Federation
    • City polyclinic №10
  • Moscow, Russian Federation
    • Infectious Clinical Hospital No. 1 of the Moscow City Health Department
  • Nizhny Novgorod, Russian Federation
    • GBUZ NO Infections Clinical Hospital No.2
  • Podolsk, Russian Federation
    • Podolsk City Clinical Hospital №3
  • Rostov-on-Don, Russian Federation
    • City Hospital No. 1 n.a. ON. Semashko
  • Saint Petersburg, Russian Federation
    • City Clinical Hospital of Infectious Diseases No. 17
  • Saint Petersburg, Russian Federation
    • City Hospital №40
  • Stavropol', Russian Federation
    • Federal Research Center Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences
  • Voronezh, Russian Federation
    • Voronezh Regional Clinical Infectious Diseases Hospital
  • Yaroslavl, Russian Federation
    • Medical Center for Diagnostics and Prevention Plus, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed informed consent;
2. Males and females between 18 and 65 years old (inclusive);
3. Outpatients and those hospitalized for epidemiological reasons with mild and moderate severity diagnosed influenza (ICD 10: J10 Influenza caused by an identified influenza virus) without complications; The severity of influenza is defined under the Influenza in the Influenza in Adults Clinical Guidelines of the National Scientific Society of the Infectious Diseases Specialists;
4. Positive enzyme-linked immunosorbent assay for influenza virus at screening;
5. At least one episode of an increased body temperature up to 38°C and above within 48 hours before screening;
6. The presence of at least one of the following symptoms of moderate severity on screening: Headache, weakness/malaise, myalgia/muscle ache, hot flash/chills;
7. Duration of the disease not exceeding 48 hours (according to the patient) on screening;

8. Consent of patients to use adequate contraception methods throughout the study. Adequate contraception methods include:

   • Oral contraceptives or contraceptive patches;
   • Condoms or diaphragms (barrier method) with spermicide; or
   • An intrauterine device.

Exclusion Criteria:

1. Pregnant or breastfeeding women or women planning to become pregnant during the clinical study; women of child-bearing potential (including women in their post-menopausal period for less than two years) who do not use adequate contraception measures;
2. Individual intolerance of the AV5080 drug or its components;
3. Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
4. Influenza complications, signs of a bacterial infection or severe disease course at the screening (based on the criteria specified in the Influenza in Adults Clinical Guidelines of the National Scientific Society of Infectious Diseases Specialists, 2014);
5. The history of anti-influenza immunization within 12 months before the screening;
6. Participation in other clinical studies within three months before screening;
7. Chronic respiratory system diseases (asthma, COPD);
8. Administration of neuraminidase inhibitors (zanamivir, oseltamivir), immunomodulators, systemic glucocorticoids, and antibiotics within one month before screening;
9. HIV infection, chronic hepatitis С or hepatitis B infection (according to the patient's history);
10. Significant cardiovascular diseases at present or within 12 months prior to screening including: class III or IV chronic heart failure (as defined by NYHA), severe arrhythmia requiring administration of class Ia, Ib, Ic or III anti-arrhythmic drugs, non-stable angina, myocardial infarction, previous surgery on the heart and coronary vessels, significant heart valves diseases, transient ischemic attack or stroke, uncontrollable hypertension with systolic BP > 180 mmHg and diastolic BP > 110 mmHg, pulmonary embolism or deep vein thrombosis;
11. Chronic alcohol abuse, drug abuse or addiction to the other chemicals in history;
12. Inability to read or write; unwillingness to understand and comply with the Protocol procedures; non-compliance with the drug dosing regimen or procedures which, in the Investigator's opinion, may affect the study results or the patient's safety and prevent the patient to participate in the study; any other concomitant diseases or severe mental disorders, which make the patient ineligible to participate in the study, limit the legal basis for Informed Consent procedure, or may affect the patient's ability to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1; AV5080 80 mg"/day (80 mg in the morning + placebo in the evening)	Drug: AV5080; Hard gelatin capsules with a white body
EXPERIMENTAL: Group 2; AV5080 160 mg"/day (80 mg in the morning + 80 mg in the evening)	Drug: AV5080; Hard gelatin capsules with a white body
PLACEBO_COMPARATOR: Group 3; "Placebo" (placebo in the morning + placebo in the evening)	Other: Placebo; Hard gelatin capsules with a white body

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients who reported resolution of influenza symptoms within 96 hours from the start of therapy	The absence of influenza symptoms or their reduction to mild severity for at least 24 hours indicates the resolution of influenza.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to symptoms resolution	The time before the resolution of influenza symptoms	30 days
Incidence rate of influenza virus elimination until Day 6	The incidence rate of influenza virus elimination from mucous membranes of the nasopharynx and oropharynx until Day 6	6 days
Change in titer of antibodies on Day 15 compared to baseline;	Change in titer of IgG and IgM antibodies to influenza A and B virus on Day 15 compared to baseline;	15 Days
The incidence rate of influenza complications		29 Days

Collaborators and Investigators

• Sponsor: Viriom

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 13, 2017
• Primary Completion (ACTUAL): August 7, 2019
• Study Completion (ACTUAL): August 30, 2019

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (ACTUAL): October 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Influenza treatment in adults
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: FLU-AV5080-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No