InfluenzaPhase 2NCT05095545
Dose Range Study to Evaluate the Efficacy and Safety of AV5080 in Patients With Influenza
A Phase 2 study testing AV5080 in people with Influenza, run by Viriom at 10 sites in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza
- What is being tested?
- AV5080
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 10 sitesRussia
- Study dates
- 13 Nov 2017to 30 Aug 2019
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent;
- Males and females between 18 and 65 years old (inclusive);
- 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;
- Positive enzyme-linked immunosorbent assay for influenza virus at screening;
- At least one episode of an increased body temperature up to 38°C and above within 48 hours before screening;
- The presence of at least one of the following symptoms of moderate severity on screening: Headache, weakness/malaise, myalgia/muscle ache, hot flash/chills;
Show all 11Show fewer
- Duration of the disease not exceeding 48 hours (according to the patient) on screening;
- 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.
Who cannot join
- 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;
- Individual intolerance of the AV5080 drug or its components;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- 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);
- The history of anti-influenza immunization within 12 months before the screening;
- Participation in other clinical studies within three months before screening;
Show all 12Show fewer
- Chronic respiratory system diseases (asthma, COPD);
- Administration of neuraminidase inhibitors (zanamivir, oseltamivir), immunomodulators, systemic glucocorticoids, and antibiotics within one month before screening;
- HIV infection, chronic hepatitis С or hepatitis B infection (according to the patient's history);
- 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;
- Chronic alcohol abuse, drug abuse or addiction to the other chemicals in history;
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Russia10 sites
City polyclinic №10
Kazan'
Infectious Clinical Hospital No. 1 of the Moscow City Health Department
Moscow
GBUZ NO Infections Clinical Hospital No.2
Nizhny Novgorod
Podolsk City Clinical Hospital №3
Podolsk
City Hospital No. 1 n.a. ON. Semashko
Rostov-on-Don
City Clinical Hospital of Infectious Diseases No. 17
Saint Petersburg
City hospital №40
Saint Petersburg
Federal Research Center Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences
Stavropol
Voronezh Regional Clinical Infectious Diseases Hospital
Voronezh
Medical Center for Diagnostics and Prevention Plus, LLC
Yaroslavl
About this study
Official title: 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.
Read the 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.
- Conditions
- Influenza
- Being tested
- AV5080, Placebo
- Keywords
- Influenza treatment in adults
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV5080Drug
Hard gelatin capsules with a white body
PlaceboOther
Hard gelatin capsules with a white body
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | AV5080 80 mg"/day (80 mg in the morning + placebo in the evening) Receives: Drug: AV5080 |
| Group 2 | Experimental | AV5080 160 mg"/day (80 mg in the morning + 80 mg in the evening) Receives: Drug: AV5080 |
| Group 3 | Placebo comparator | "Placebo" (placebo in the morning + placebo in the evening) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (4)
Time to symptoms resolution
The time before the resolution of influenza symptoms
Measured: 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
Measured: 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;
Measured: 15 Days
The incidence rate of influenza complications
Measured: 29 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start13 Nov 2017
- Primary completion7 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viriom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095545
- Sponsor's protocol ID
- FLU-AV5080-02
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Efficacy and Safety of the AV5080 Drug in Patients With Influenza
- ClinicalTrials.gov ID
- NCT05095545
- Acronym / sponsor ID
- FLU-AV5080-02
- Conditions
- Influenza
- Keywords
- Influenza treatment in adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- ViriomIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: AV5080AV5080 80 mg"/day (80 mg in the morning + placebo in the evening) |
| Group 2 | Experimental | Drug: AV5080AV5080 160 mg"/day (80 mg in the morning + 80 mg in the evening) |
| Group 3 | Placebo comparator | Other: Placebo"Placebo" (placebo in the morning + placebo in the evening) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent;
- Males and females between 18 and 65 years old (inclusive);
- 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;
- Positive enzyme-linked immunosorbent assay for influenza virus at screening;
- At least one episode of an increased body temperature up to 38°C and above within 48 hours before screening;
Key exclusion criteria (12 listed)
- 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;
- Individual intolerance of the AV5080 drug or its components;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- 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);
- The history of anti-influenza immunization within 12 months before the screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV5080Hard gelatin capsules with a white body | Drug | Group 1, Group 2 |
| PlaceboHard gelatin capsules with a white body | Other | Group 3 |
Primary outcome
Percentage of patients who reported resolution of influenza symptoms within 96 hours from the start of therapy
Time frame: 30 days
The absence of influenza symptoms or their reduction to mild severity for at least 24 hours indicates the resolution of influenza.
4 secondary outcomes
Time to symptoms resolution
Time frame: 30 days
Incidence rate of influenza virus elimination until Day 6
Time frame: 6 days
Change in titer of antibodies on Day 15 compared to baseline;
Time frame: 15 Days
The incidence rate of influenza complications
Time frame: 29 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Influenza
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
RecruitingPhase 1
A Trial to Evaluate the Effect of CD388/MK1406 on the Immunogenicity of Fluzone® HD Vaccine (CD388.SQ.1.08/MK-1406-007)
Healthy Participants
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Active, not recruiting
Conversational AI for Adult Flu Vaccination Decisions
Influenza, Human, Vaccine Hesitancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AV5080 in people with Influenza, run by Viriom at 10 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 11 inclusion and 12 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: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients who reported resolution of influenza symptoms within 96 hours from the start of therapy (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2021.