Viral Respiratory InfectionPhase 3NCT04244084
Clinical Trial of Efficacy and Safety of ММН-407 in Acute Respiratory Viral Infection
A Phase 3 study testing MMH-407 in people with Viral Respiratory Infection, run by Materia Medica Holding at 26 sites in Russia.
Trial summary
To evaluate the efficacy and safety of ММН-407 in treatment of acute respiratory viral infection (ARVI). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Viral Respiratory Infection
- 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
- 240 participants
- Where
- 26 sitesRussia
- Study dates
- 8 Oct 2019to 9 Apr 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either gender aged 18-70 years.
- Diagnosis of ARVI based on medical examination: axillary temperature ≥ 38.0°C at examination + total general symptoms score ≥4, nasal/throat/chest symptoms score ≥2.
- The first 24 hours after ARVI onset.
- Patients giving their consent to use reliable contraception during the study.
- Signed patient information sheet (informed consent form).
Who cannot join
- Clinical symptoms of severe influenza/ARVI requiring hospitalization.
- Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring administration of antibiotics from the first day of illness.
- Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic connective tissue diseases, and other pathology).
- Patients requiring antiviral medication prohibited within the study.
- Medical history of primary and secondary immunodeficiency.
- Medical history/suspicion of oncology of any localization (except for benign neoplasms).
Show all 16Show fewer
- Aggravation or decompensation of chronic diseases affecting a patient's ability to participate in the clinical trial.
- Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
- Allergy/ hypersensitivity to any component of the study drug.
- Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.
- Course administration of the drug products specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study.
- Patients who will not fulfill the requirements during the study or follow the order of administration of the studied drug products, from the Investigator's point of view.
- Medical history of mental diseases, alcoholism or drug abuse that according to the investigator's opinion will compromise compliance with the study procedures.
- Participation in other clinical trials for 3 months prior to enrollment in this study.
- Patients who are related to any of the on-site research personnel directly involved in 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. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Russia26 sites
Altai State Medical University, Department of Faculty Therapy with a course of immunology and allergology
Barnaul, 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
Kazan State Medical University, Professorial clinic
Kazan', 420012
Kuban State Medical University, Infectious Diseases and PhthisiopulmonologyDepartment
Krasnodar, 350063
Central Clinical Hospital of the Russian Academy of Sciences
Moscow, 117593
Moscow State Medical and Dental University named after A.I. Evdokimov, Pulmonology Laboratory
Moscow, 127473
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
Podolsk City Clinical Hospital # 3
Podolsk, 142105
City Emergency Hospital Rostov-on-Don
Rostov-on-Don, 344068
Ryazan State Medical University named after academician I.P. Pavlov, Department of Outpatient Therapy and Preventive Medicine
Ryazan, 390026
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
Road Clinical Hospital of JSC Russian Railways
Saint Petersburg, 195271
City Polyclinic #51
Saint Petersburg, 196211
City Polyclinic #34
Saint Petersburg, 197198
City Polyclinic #43
Saint Petersburg, 198207
Samara City Hospital #4
Samara, 443056
Scientific Medical Center for General Therapy and Pharmacology
Stavropol, 355000
Bashkir State Medical University, Internal Medicine Department
Ufa, 450008
Volgograd State Medical University
Volgograd, 400131
About this study
Official title: Multicenter Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of MMH-407 in the Treatment of Acute Respiratory Viral Infection
To evaluate the efficacy and safety of ММН-407 in treatment of acute respiratory viral infection (ARVI).
Read the detailed description
Design: multicenter, double blind, placebo-controlled, parallel group randomized clinical trial.
The study will enroll outpatients of either gender aged 18-70 years old with clinical manifestations of ARVI within the first day after the onset of the disease during seasonal ARVI morbidity.
After signing patient information sheet and informed consent form, medical history, thermometry, objective examination, laboratory tests and concomitant medication will be performed. Severity of ARVI symptoms is evaluated with 4-point scale.
The nasopharyngeal swabs for PCR diagnosis and verification of respiratory viruses will be performed prior to therapy to confirm the viral etiology of ARVI.
If a patient meets all inclusion criteria and does not have any exclusion criteria, at Visit 1 (Day 1) he/she will be randomized into one of two groups: the 1st group will take MMH-407 according to the dosage regimen for 5 days; the 2nd group will take Placebo according to MMH-407 dosage regimen for 5 days.
The study will use electronic patient diary for recording morning and evening axillary body temperature (measured using a mercury-free Geratherm Classic thermometer) and disease symptoms (Symptom Severity Score). Besides, antipyretic dosing (if applicable) and any aggravation in a patient's condition (if applicable, for safety evaluation/AE documentation) will also be recorded in a patient diary. The investigator will provide instructions on filling the diary; at Visit 1 the patient together with a doctor will record ARVI symptom severity and body temperature in the diary.
Patient will be observed for 14 days (screening, randomization - Day 1, treatment period - 5 days, follow-up - up to 2 days; deferred "phone visit" - Day 14).
During the treatment and follow-up period the patients or investigators will make 3 visits and the fourth "phone visit" will be scheduled additionally: 1) visits by physician/patient - on Days 1, 5 and 7 (Visits 1, 2 and 3) - in a study center or at home; 2) "phone visit" (Visit 4) - on Day 14.
At Visits 2 and 3, the investigator will perform an objective examination, document changes in the symptoms and concomitant medications to check patient diaries. At Visit 3 compliance will be evaluated and laboratory tests will be performed. "Phone visit" is carried out to interview the patient about his/her condition, presence/absence of secondary bacterial/viral complications and use of antibiotics.
During the study, symptomatic therapy and therapy for their co-morbidities are allowed with the exception of the drugs indicated in the section "Prohibited Concomitant Treatment".
- Conditions
- Viral Respiratory Infection
- Being tested
- MMH-407, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMH-407Drug
Also called Raphamin
Oral use.
PlaceboDrug
Oral use.
| Study group | Role | What they receive |
|---|---|---|
| MMH-407 | Experimental | Tablet for oral use. One tablet per intake. On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day. From day 2 through 5, one tablet is administered three times daily. The drug is administered not during meals (i.e. between the meals or 15-30 minutes before meal). The tablet should be held in mouth until complete dissolution. Receives: Drug: MMH-407 |
| Placebo | Placebo comparator | According to the scheme of receiving MMN-407 until the end of the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms
Outcome Measure is evaluated on the basis of the "ARVI severity scale" to calculate total symptom score (TSS) in patients with confirmed virus by Polymerase chain reaction (PCR).
ARVI's resolution criteria: temperature ≤37.3°С + TSS ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), and 6 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. The range of TSS was from "0" to "39".
Measured: 14 days of observation.
Secondary outcomes (11)
Severity of ARVI (Clinically Diagnosed and/or PCR-confirmed)
Outcome Measure is based on the area under the curve (AUC) for TSS. AUC was calculated between 6 points (by TSS for every 6 days of the treatment and observation). The minimum value for the AUC was "0" and the maximum value was "234" units (day*score). Higher TSS and AUC scores meant worse results.
Measured: On days 1- 6 of the observation.
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed)
ARVI's resolution criteria: temperature ≤37.3°С + total symptom score (TSS) ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness) and 6 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. The range of TSS was from "0" to "39".
Measured: On days 3, 4, 5 and 6 of observation.
Time to Resolution of Acute Respiratory Viral Infection Symptoms (Clinically Diagnosed and/or PCR-confirmed)
Acute Respiratory Viral Infection (ARVI) Symptoms resolution criteria: temperature ≤37.3°С + total symptom score (TSS) ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness) and 6 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. The range of TSS was from "0" to "39".
Measured: 14 days of observation.
Percentage of Patients With Resolution of Acute Respiratory Viral Infection (PCR-confirmed)
Outcome Measure is based on the Percentage of Patients With Resolution of Acute Respiratory Viral Infection, confirmed by Polymerase chain reaction (PCR), i.e virus detection.
Acute Respiratory Viral Infection resolution criteria: temperature ≤37.3°С + total symptom score (TSS) ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness) and 6 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. The range of TSS was from "0" to "39".
Measured: On days 3, 4, 5 and 6 of observation.
Dosing Frequency of Antipyretics.
Outcome Measure is based on the rates of antipyretic use per patient during days 1 to 3 of therapy.
Measured: On days 1, 2, 3 of therapy.
Percentage of Patients Reporting Worsening of Illness
Outcome Measure is based on the rates of Complications that require the use of antibiotics or hospitalization.
Measured: From day 4 to day 14 of the observation period.
Occurrence and Characteristics of Adverse Events (AEs)
Severity of AEs, its causal relationship to the study drug, and outcomes.
Measured: From day 1 to day 7 of the treatment period.
Changes in Vital Signs: Blood Pressure.
Outcome Measure is based on the medical records. Blood Pressure was measured by the physician in every visit (on days 1, 5, and 7).
Measured: On days 1, 5 and 7 of the treatment period.
Changes in Vital Signs: Pulse Rate (Heart Rate).
Outcome Measure is based on the medical records. Pulse Rate (Heart Rate) was measured by the physician in every visit (on days 1, 5, and 7).
Measured: On days 1, 5 and 7 of the treatment period.
Changes in Vital Signs: Respiration Rate (Breathing Rate).
Outcome Measure is based on the medical records. Respiration Rate (Breathing Rate) was measured by the physician in every visit (on days 1, 5, and 7).
Measured: On days 1, 5 and 7 of the treatment period.
Percentage of Patients With Clinically Relevant Laboratory Abnormalities
Outcome Measure is based on the Hematology, blood chemistry, and urinalysis parameters, which were beyond the reference values at the end of treatment.
Measured: From day 1 to day 7 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 posted28 Jan 2020
- Study start8 Oct 2019
- Primary completion9 Apr 2020
- Study completion9 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Viral Respiratory InfectionStudies 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244084
- Sponsor's protocol ID
- MMH-407-001
- Status last verified
- Oct 2021
- First submitted
- 13 Dec 2019
- Last updated
- 17 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of MMH-407 in the Treatment of Acute Respiratory Viral Infection
- ClinicalTrials.gov ID
- NCT04244084
- Acronym / sponsor ID
- MMH-407-001
- Conditions
- Viral Respiratory Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 9 Apr 2020 (actual)
- Study completion
- 9 Apr 2020 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Posted 6 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of ММН-407 in treatment of acute respiratory viral infection (ARVI).
Detailed description
Design: multicenter, double blind, placebo-controlled, parallel group randomized clinical trial.
The study will enroll outpatients of either gender aged 18-70 years old with clinical manifestations of ARVI within the first day after the onset of the disease during seasonal ARVI morbidity.
After signing patient information sheet and informed consent form, medical history, thermometry, objective examination, laboratory tests and concomitant medication will be performed. Severity of ARVI symptoms is evaluated with 4-point scale.
The nasopharyngeal swabs for PCR diagnosis and verification of respiratory viruses will be performed prior to therapy to confirm the viral etiology of ARVI.
If a patient meets all inclusion criteria and does not have any exclusion criteria, at Visit 1 (Day 1) he/she will be randomized into one of two groups: the 1st group will take MMH-407 according to the dosage regimen for 5 days; the 2nd group will take Placebo according to MMH-407 dosage regimen for 5 days.
The study will use electronic patient diary for recording morning and evening axillary body temperature (measured using a mercury-free Geratherm Classic thermometer) and disease symptoms (Symptom Severity Score). Besides, antipyretic dosing (if applicable) and any aggravation in a patient's condition (if applicable, for safety evaluation/AE documentation) will also be recorded in a patient diary. The investigator will provide instructions on filling the diary; at Visit 1 the patient together with a doctor will record ARVI symptom severity and body temperature in the diary.
Patient will be observed for 14 days (screening, randomization - Day 1, treatment period - 5 days, follow-up - up to 2 days; deferred "phone visit" - Day 14).
During the treatment and follow-up period the patients or investigators will make 3 visits and the fourth "phone visit" will be scheduled additionally: 1) visits by physician/patient - on Days 1, 5 and 7 (Visits 1, 2 and 3) - in a study center or at home; 2) "phone visit" (Visit 4) - on Day 14.
At Visits 2 and 3, the investigator will perform an objective examination, document changes in the symptoms and concomitant medications to check patient diaries. At Visit 3 compliance will be evaluated and laboratory tests will be performed. "Phone visit" is carried out to interview the patient about his/her condition, presence/absence of secondary bacterial/viral complications and use of antibiotics.
During the study, symptomatic therapy and therapy for their co-morbidities are allowed with the exception of the drugs indicated in the section "Prohibited Concomitant Treatment".
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-407Tablet for oral use. One tablet per intake. On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day. From day 2 through 5, one tablet is administered three times daily. The drug is administered not during meals (i.e. between the meals or 15-30 minutes before meal). The tablet should be held in mouth until complete dissolution. |
| Placebo | Placebo comparator | Drug: PlaceboAccording to the scheme of receiving MMN-407 until the end of the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of either gender aged 18-70 years.
- Diagnosis of ARVI based on medical examination: axillary temperature ≥ 38.0°C at examination + total general symptoms score ≥4, nasal/throat/chest symptoms score ≥2.
- The first 24 hours after ARVI onset.
- Patients giving their consent to use reliable contraception during the study.
- Signed patient information sheet (informed consent form).
Key exclusion criteria (16 listed)
- Clinical symptoms of severe influenza/ARVI requiring hospitalization.
- Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring administration of antibiotics from the first day of illness.
- Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic connective tissue diseases, and other pathology).
- Patients requiring antiviral medication prohibited within the study.
- Medical history of primary and secondary immunodeficiency.
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: RaphaminOral use. | Drug | MMH-407 |
| PlaceboOral use. | Drug | Placebo |
Primary outcome
Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms
Time frame: 14 days of observation.
Outcome Measure is evaluated on the basis of the "ARVI severity scale" to calculate total symptom score (TSS) in patients with confirmed virus by Polymerase chain reaction (PCR). ARVI's resolution criteria: temperature ≤37.3°С + TSS ≤2. Axillar temperature, 6 flu-like nonspecific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), and 6 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough) were registered for TSS according to the 4-point scale for each of them (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TSS absolute axillar temperature (in degrees Celsius) was converted to relative units (or points) using the following scale: ≤37.3 С=0 points; 37.4-38.0 С=1 point; 38.1-39.0 С=2 points; ≥39.1 С=3 points. The range of TSS was from "0" to "39".
11 secondary outcomes
Severity of ARVI (Clinically Diagnosed and/or PCR-confirmed)
Time frame: On days 1- 6 of the observation.
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed)
Time frame: On days 3, 4, 5 and 6 of observation.
Time to Resolution of Acute Respiratory Viral Infection Symptoms (Clinically Diagnosed and/or PCR-confirmed)
Time frame: 14 days of observation.
Percentage of Patients With Resolution of Acute Respiratory Viral Infection (PCR-confirmed)
Time frame: On days 3, 4, 5 and 6 of observation.
Dosing Frequency of Antipyretics.
Time frame: On days 1, 2, 3 of therapy.
Percentage of Patients Reporting Worsening of Illness
Time frame: From day 4 to day 14 of the observation period.
Occurrence and Characteristics of Adverse Events (AEs)
Time frame: From day 1 to day 7 of the treatment period.
Changes in Vital Signs: Blood Pressure.
Time frame: On days 1, 5 and 7 of the treatment period.
Changes in Vital Signs: Pulse Rate (Heart Rate).
Time frame: On days 1, 5 and 7 of the treatment period.
Changes in Vital Signs: Respiration Rate (Breathing Rate).
Time frame: On days 1, 5 and 7 of the treatment period.
Percentage of Patients With Clinically Relevant Laboratory Abnormalities
Time frame: From day 1 to day 7 of the treatment period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
26 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 Viral Respiratory Infection, run by Materia Medica Holding at 26 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 5 inclusion and 16 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 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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?
Yes. Results are posted in the registry (first posted 6 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms (time frame: 14 days 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 17 May 2022.