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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 240
- Locations
- 26
- Primary Endpoint
- Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 ≥
- •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).
Exclusion Criteria
- •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).
- •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).
Arms & Interventions
MMH-407
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.
Intervention: MMH-407 (Drug)
Placebo
According to the scheme of receiving MMN-407 until the end of the study.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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".
Secondary Outcomes
- Time to Resolution of Acute Respiratory Viral Infection Symptoms (Clinically Diagnosed and/or PCR-confirmed)(14 days of observation.)
- Dosing Frequency of Antipyretics.(On days 1, 2, 3 of therapy.)
- Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed)(On days 3, 4, 5 and 6 of observation.)
- Occurrence and Characteristics of Adverse Events (AEs)(From day 1 to day 7 of the treatment period.)
- Changes in Vital Signs: Respiration Rate (Breathing Rate).(On days 1, 5 and 7 of the treatment period.)
- Percentage of Patients With Resolution of Acute Respiratory Viral Infection (PCR-confirmed)(On days 3, 4, 5 and 6 of observation.)
- Severity of ARVI (Clinically Diagnosed and/or PCR-confirmed)(On days 1- 6 of the observation.)
- Percentage of Patients Reporting Worsening of Illness(From day 4 to day 14 of the observation period.)
- Changes in Vital Signs: Pulse Rate (Heart Rate).(On days 1, 5 and 7 of the treatment period.)
- Changes in Vital Signs: Blood Pressure.(On days 1, 5 and 7 of the treatment period.)
- Percentage of Patients With Clinically Relevant Laboratory Abnormalities(From day 1 to day 7 of the treatment period.)