InfluenzaPhase 3NCT04250311
Clinical Trial of Efficacy and Safety of ММН-407 in the Treatment of Influenza in Outpatient Adults
A Phase 3 study testing MMH-407 in people with Influenza, run by Materia Medica Holding at 20 sites in Russia.
Trial summary
The main purpose of this study is: to evaluate the efficacy and safety of MMH-407 in the treatment of influenza in outpatient adults. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Influenza
- What is being tested?
- MMH-407
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- 20 sitesRussia
- Study dates
- 12 Dec 2019to Dec 2024
- Phase
- Phase 3
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of male and female gender aged 18 to 64 years.
- Uncomplicated, moderate influenza supported by all the symptoms:
- axillary temperature ≥38.1°С on physician examination;
- at least one moderate general symptom of influenza infection (headache, fever/chill, aches in the muscles/joints, weakness/drowsiness);
- at least one moderate respiratory symptom of influenza infection (cough, sore throat, or nasal congestion).
- Positive influenza rapid test (detection of virus antigens in the nasal epithelium).
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- First 24 hours of the onset of illness.
- Patients who agree to use a reliable method of birth control during the study.
- Patients who have provided signed Participant Information Sheet and Informed Consent form to participate in a clinical trial.
Who cannot join
- Severe influenza infection that requires hospitalization.
- Suspected pneumonia or bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) that requires the use of antibiotics, starting from the first day of illness.
- Suspected early manifestations of a condition that, on its first onset, produces symptoms similar to those of influenza (other infectious diseases and/or influenza-like syndrome associated with the first onset of a systemic connective tissue disorder or another condition).
- Patients who require the use of antivirals that are not permitted during the study.
- Current season influenza vaccination.
- Prior history or diagnosis of primary or secondary immunodeficiency
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- Patients with any known or suspected malignant neoplasm.
- An exacerbated or decompensated chronic disease interfering with the subject's participation in the clinical trial.
- Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency), and/or galactosemia.
- Current allergy to or intolerance of the active substances or any of the excipients in the medications used in the treatment.
- Pregnancy, breast-feeding, childbirth within less than 3 months prior to the inclusion in the trial, or unwillingness to use contraceptive methods during the study
- Prior history of non-adherence to medication; mental disorder; or alcohol or substance abuse, which, in the investigator's opinion, will compromise compliance with study procedures.
- Use of any of the "Prohibited Concomitant Medications" within 2 weeks prior to study entry.
- Patients who, as judged by the investigator, will fail or be unwilling to comply with the observation requirements or adhere to the dosing regimen during the study.
- Participation in other clinical studies within 3 months prior to the inclusion in this study.
- Patients who are related to any of the on-site research personnel directly involved in the conduct of the study or are an immediate relative of the investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
- Patients who work for OOO "NPF "Materia Medica Holding" (i.e. company employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Russia20 sites
Altai State Medical University, Department of Faculty Therapy with a course of immunology and allergology
Barnaul, Moscow, 656038
City Hospital # 5
Barnaul, 656045
Belgorod State National Research University, Hospital Therapy Department
Belgorod, 308015
Road Clinical Hospital at Chelyabinsk station of JSC Russian Railways
Chelyabinsk, 454000
City Clinical Hospital # 9 of the Ministry of Health of the Udmurt Republic
Izhevsk, 426063
Kazan State Medical University, Internal Medicine Department
Kazan', 420012
Kuban State Medical University, Infectious Diseases and Phthisiopulmonology Department
Krasnodar, 350063
Central Clinical Hospital of the Russian Academy of Sciences
Moscow, 117593
City Clinical Hospital # 10 of the Kanavinsky District of Nizhny Novgorod
Nizhny Novgorod, 603011
Road Clinical Hospital at the station Nizhny Novgorod of JSC Russian Railways
Nizhny Novgorod, 603140
Vvedensky City Clinical Hospital
Saint Petersburg, 191180
City Polyclinic # 25 of the Nevsky District
Saint Petersburg, 193312
Medical Center "Reavita Med SPb"
Saint Petersburg, 194354
Llc "Medical Clinic"
Saint Petersburg, 194356
City Polyclinic # 43
Saint Petersburg, 198207
Samara City Hospital # 4
Samara, 443056
Scientific Medical Center for General Therapy and Pharmacology
Stavropol, 355000
Tver State Medical University, Department of Hospital Therapy
Tver', 170100
Bashkir State Medical University, Internal Medicine Department
Ufa, 450008
Volgograd State Medical University
Volgograd, 400131
About this study
Official title: A Multicenter, Placebo-controlled, Double-blind, Randomized Clinical Trial in Parallel Groups to Evaluate the Efficacy and Safety of ММН-407 in the Treatment of Influenza in Outpatient Adults
The main purpose of this study is:
- to evaluate the efficacy and safety of MMH-407 in the treatment of influenza in outpatient adults.
Read the detailed description
Design: a multicenter, placebo-controlled, double-blind, randomized clinical trial in parallel groups.
The study will include both male and female patients aged 18-64 years with clinical signs of influenza within the first 24 hours of the onset of illness.
The influenza diagnosis must be supported by a positive rapid test (detection of influenza virus antigens in nasal epithelial cells). After the patients provide signed Participant Information Sheet and Informed Consent form, their medical history and body temperature will be recorded and physical examination and rapid diagnostic test performed. Patients who test positive will be assessed for 7 influenza-associated symptoms: cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, fatigue.
4-point Flu Symptom Severity scale will be used: 0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom.
Nasopharyngeal swabs will be obtained from these patients for subsequent real-time reverse transcription polymerase chain reaction (RT-PCR) influenza A/B testing and laboratory tests performed.
If a patient meets all inclusion criteria and does not meet any of the exclusion criteria at Visit 1 (Day 1), he/she will be randomized into one of the treatment groups: Group 1: ММН-407 for 5 days, or Group 2: Placebo on the ММН-407 regimen for 5 days.
The patients will use electronic patient diaries to daily record their morning and evening axillary temperature (taken using a Geratherm mercury-free thermometer) and severity of 7 influenza-associated symptoms (using the Flu Symptom Severity scale). In addition to this, the patients will record doses of antipyretic drugs taken (when applicable) and any worsening of their health status (when applicable, to assess treatment safety and collect adverse events data).
In total, patients will be observed for 14 days (screening and randomization - up to 24 hours, treatment - 5 days, subsequent observation - up to 2 days; and a follow-up 'telephone' visit - Day 14).
During the study, 3 visits from patient to the physician's office and a follow-up telephone visit will be accomplished: 1) patient visits - Days 1, 3 and 7 (Visits 1, 2, and 3) at the medical centre; 2) telephone visit from the physician (Visit 4) - Day 14.
During Visits 2 and 3, the physician will perform a physical examination, record the changes in patients' symptoms and the use of concomitant medications and check the completion of patient diaries. At Visit 2, nasopharyngeal swabs for RT-PCR will be collected. Visit 3 will involve an assessment of treatment compliance and laboratory tests. The telephone visit is intended to provide information on a patient's health status, presence/absence of secondary bacterial complications and the use of antibiotics.
During the study, subjects will be allowed to use symptomatic therapy and medications for their co-morbidities, except for the medicines listed in the "Prohibited Concomitant Medications" section.
- Conditions
- Influenza
- Being tested
- MMH-407, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMH-407Drug
Also called Raphamin
MMH-407: For oral use.
PlaceboDrug
Placebo: For oral use.
| Study group | Role | What they receive |
|---|---|---|
| MMH-407 | Experimental | Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day. Days 2 to 5: 1 tablet 3 times daily. Receives: Drug: MMH-407 |
| Placebo | Placebo comparator | Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day. Days 2 to 5: 1 tablet 3 times daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to improvement of influenza symptoms.
Based on patient diaries. In the morning and in the evening, the patients rate the severity of their symptoms on a 4-point scale (7 symptoms of influenza): headache, fever/chill, aches in the muscles/joints, weakness/drowsiness, cough, sore throat, and nasal congestion, where the absence of symptoms is 0, mild symptoms - 1, moderate symptoms - 2, and severe symptoms is 4. "Improvement of influenza symptoms" means no or mild symptoms.
Measured: On days 1-14 of observation.
Secondary outcomes (8)
Proportion of patients reporting improvement of influenza symptoms.
Based on patient diaries.
Measured: On days 1-14 of observation period.
Severity of illness.
Total symptom score AUC (to be estimated from each of the seven symptom subscores).
Measured: On days 1- 6 of the observation period.
Proportion of patients with negative virus shedding.
Negative influenza RT-PCR on nasopharyngeal swabs.
Measured: On day 3 of the observation period.
Dosing frequency of antipyretics according to indications.
A decrease dosing frequency of antipyretics while taking MMN-407 is one of the criteria for effectiveness. Based on patient diaries.
Measured: On days 1-3 of the treatment period.
Proportion of subjects reporting worsening of illness.
Worsening of illness is bacterial complication of influenza that require the use of antibiotics or hospitalization.
Measured: On days 4 -14 of the observation period.
Occurrence and nature of adverse events (AE).
AE severity, causal relationship to the study drug and outcome.
Measured: On days 1-5 of the treatment period.
Number of patients with treatment-related changes in vital signs: body temperature, pulse rate (heart rate), respiration rate (breathing rate), and blood pressure.
Based on medical records. Vital signs will be measured in a medical setting.
Measured: On days 1- 5 of the treatment period.
Proportion of subjects with clinically significant abnormal laboratory data.
Вased on medical records.
Measured: On days 1- 5 of the treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start12 Dec 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Due to the end of the ARVI and influenza season, it was suspended until approximately October 01, 2023
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250311
- Sponsor's protocol ID
- MMH-407-002
- Status last verified
- Aug 2023
- First submitted
- 29 Jan 2020
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Placebo-controlled, Double-blind, Randomized Clinical Trial in Parallel Groups to Evaluate the Efficacy and Safety of ММН-407 in the Treatment of Influenza in Outpatient Adults
- ClinicalTrials.gov ID
- NCT04250311
- Acronym / sponsor ID
- MMH-407-002
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to the end of the ARVI and influenza season, it was suspended until approximately October 01, 2023
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Jan 2020 (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.
The main purpose of this study is:
- to evaluate the efficacy and safety of MMH-407 in the treatment of influenza in outpatient adults.
Detailed description
Design: a multicenter, placebo-controlled, double-blind, randomized clinical trial in parallel groups.
The study will include both male and female patients aged 18-64 years with clinical signs of influenza within the first 24 hours of the onset of illness.
The influenza diagnosis must be supported by a positive rapid test (detection of influenza virus antigens in nasal epithelial cells). After the patients provide signed Participant Information Sheet and Informed Consent form, their medical history and body temperature will be recorded and physical examination and rapid diagnostic test performed. Patients who test positive will be assessed for 7 influenza-associated symptoms: cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, fatigue.
4-point Flu Symptom Severity scale will be used: 0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom.
Nasopharyngeal swabs will be obtained from these patients for subsequent real-time reverse transcription polymerase chain reaction (RT-PCR) influenza A/B testing and laboratory tests performed.
If a patient meets all inclusion criteria and does not meet any of the exclusion criteria at Visit 1 (Day 1), he/she will be randomized into one of the treatment groups: Group 1: ММН-407 for 5 days, or Group 2: Placebo on the ММН-407 regimen for 5 days.
The patients will use electronic patient diaries to daily record their morning and evening axillary temperature (taken using a Geratherm mercury-free thermometer) and severity of 7 influenza-associated symptoms (using the Flu Symptom Severity scale). In addition to this, the patients will record doses of antipyretic drugs taken (when applicable) and any worsening of their health status (when applicable, to assess treatment safety and collect adverse events data).
In total, patients will be observed for 14 days (screening and randomization - up to 24 hours, treatment - 5 days, subsequent observation - up to 2 days; and a follow-up 'telephone' visit - Day 14).
During the study, 3 visits from patient to the physician's office and a follow-up telephone visit will be accomplished: 1) patient visits - Days 1, 3 and 7 (Visits 1, 2, and 3) at the medical centre; 2) telephone visit from the physician (Visit 4) - Day 14.
During Visits 2 and 3, the physician will perform a physical examination, record the changes in patients' symptoms and the use of concomitant medications and check the completion of patient diaries. At Visit 2, nasopharyngeal swabs for RT-PCR will be collected. Visit 3 will involve an assessment of treatment compliance and laboratory tests. The telephone visit is intended to provide information on a patient's health status, presence/absence of secondary bacterial complications and the use of antibiotics.
During the study, subjects will be allowed to use symptomatic therapy and medications for their co-morbidities, except for the medicines listed in the "Prohibited Concomitant Medications" section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMH-407 | Experimental | Drug: MMH-407Oral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day. Days 2 to 5: 1 tablet 3 times daily. |
| Placebo | Placebo comparator | Drug: PlaceboOral administration. Single dose: 1 tablet. First 24 hours of therapy: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals during the rest of the day. Days 2 to 5: 1 tablet 3 times daily. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients of male and female gender aged 18 to 64 years.
- Uncomplicated, moderate influenza supported by all the symptoms:
- Positive influenza rapid test (detection of virus antigens in the nasal epithelium).
- First 24 hours of the onset of illness.
- Patients who agree to use a reliable method of birth control during the study.
Key exclusion criteria (17 listed)
- Severe influenza infection that requires hospitalization.
- Suspected pneumonia or bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) that requires the use of antibiotics, starting from the first day of illness.
- Suspected early manifestations of a condition that, on its first onset, produces symptoms similar to those of influenza (other infectious diseases and/or influenza-like syndrome associated with the first onset of a systemic connective tissue disorder or another condition).
- Patients who require the use of antivirals that are not permitted during the study.
- Current season influenza vaccination.
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 |
|---|---|---|
| MMH-407Also: RaphaminMMH-407: For oral use. | Drug | MMH-407 |
| PlaceboPlacebo: For oral use. | Drug | Placebo |
Primary outcome
Time to improvement of influenza symptoms.
Time frame: On days 1-14 of observation.
Based on patient diaries. In the morning and in the evening, the patients rate the severity of their symptoms on a 4-point scale (7 symptoms of influenza): headache, fever/chill, aches in the muscles/joints, weakness/drowsiness, cough, sore throat, and nasal congestion, where the absence of symptoms is 0, mild symptoms - 1, moderate symptoms - 2, and severe symptoms is 4. "Improvement of influenza symptoms" means no or mild symptoms.
8 secondary outcomes
Proportion of patients reporting improvement of influenza symptoms.
Time frame: On days 1-14 of observation period.
Severity of illness.
Time frame: On days 1- 6 of the observation period.
Proportion of patients with negative virus shedding.
Time frame: On day 3 of the observation period.
Dosing frequency of antipyretics according to indications.
Time frame: On days 1-3 of the treatment period.
Proportion of subjects reporting worsening of illness.
Time frame: On days 4 -14 of the observation period.
Occurrence and nature of adverse events (AE).
Time frame: On days 1-5 of the treatment period.
Number of patients with treatment-related changes in vital signs: body temperature, pulse rate (heart rate), respiration rate (breathing rate), and blood pressure.
Time frame: On days 1- 5 of the treatment period.
Proportion of subjects with clinically significant abnormal laboratory data.
Time frame: On days 1- 5 of the treatment period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MMH-407 in people with Influenza, run by Materia Medica Holding at 20 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 9 inclusion and 17 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: paused, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Time to improvement of influenza symptoms. (time frame: On days 1-14 of observation.). 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 18 Aug 2023.