A Phase 3 interventional study of Raphamin and Placebo in Acute Respiratory Viral Infection, sponsored by Materia Medica Holding. Recruiting at 35 sites in Russia. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by Materia Medica Holding · Phase 3, Interventional, and Treatment
Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.
Design: a multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial.
The trial will enroll outpatients of either gender aged 3 to 12 years with clinical manifestations of acute respiratory viral infection (ARVI) within the first 24 hours after the disease onset. Patient enrollment will be conducted in 2 stages during the seasonal incidence of ARVI. First, children aged 6-12 years will be enrolled in the trial. Once the required number of patients is reached, an "unblinded" interim analysis with the primary efficacy endpoint assessment and safety analysis will be performed. Based on the data from the unblinded interim analysis, a decision will be made whether the age range of enrollment can be expanded from 3 to 12 years. Patient enrollment will not be stopped until the results of the "unblinded" interim analysis are available.
After the parent/adopter signs the information sheet and informed consent form for the patient's parents/adopters to participate in the clinical trial, the medical history will be collected, thermometry, objective examination, laboratory tests will be performed, and concomitant therapy will be recorded. The severity of ARVI symptoms will be assessed using a 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), they will be randomized into one of two groups: Group 1 patients will receive Raphamin according to the dosage regimen for 5 days; Group 2 patients will receive Placebo using the Raphamin dosage regimen for 5 days.
The trial will utilize an electronic patient diary (EPD) where the patient will make daily records of morning and evening axillary body temperature (measured with a classic mercury-free thermometer) and symptoms of the disease (ARVI Symptom Severity Score). In addition, antipyretic dosing (if applicable) as well as any possible worsening of the patient's condition (if applicable, to assess safety / to record adverse events) will also be recorded in the patient diary. The investigator will instruct the parent/adopter on how to complete the diary. At Visit 1, the parent/adopter together with the physician will record the severity of ARVI symptoms and body temperature in the diary.
The patient will be observed for 14 days (screening, randomization - up to 1 day, treatment - 5 days, follow-up - up to 2 days; deferred "phone visit" - day 14).
During the treatment and follow-up period, patients/physicians will pay 3 visits, and the fourth "phone visit" will be scheduled additionally: 1) physician/patient visits - on days 1, 5 and 7 (Visits 1, 2 and 3) - at the health center or at home; 2) a phone "visit" by the physician (Visit 4) - on day 14.
During Visits 2 and 3, the physician will perform objective examination, record changes in the disease symptoms, concomitant therapy, and monitor the completion of the diary. During Visit 3, compliance will be assessed and laboratory tests will be performed.
A phone "visit" will be performed to interview the parent/adopter about the patient's condition, presence/absence of secondary bacterial/viral complications, and use of antibiotics.
Symptomatic therapy and therapy for concomitant diseases will be permitted during the trial except for the drugs listed under "Prohibited Concomitant Treatment".
Exclusion Criteria:
Per os without food. The tablet should be kept in mouth until completely dissolved. On day 1 of treatment, 8 tablets should be taken using the following regimen: 1 tablet every 30 minutes for the first 2 hours (5 tablets in total for 2 hours), then 1 more tablet 3 times at equal intervals during the same day. On day 2 and onwards, 1 tablet should be taken 3 times a day. The duration of treatment is 5 days.
Drug: Raphamin
Placebo using the Raphamin dosage regimen.
Drug: Placebo
Tablet for oral use.
Also known as: MMH-407
Tablet for oral use.
Time to resolution of ARVI symptoms (PCR-confirmed)
Time from recording the disease symptoms at Visit 1 until resolution of the disease symptoms. Resolution of ARVI symptoms will be defined if axillary temperature is ≤37.3°C for 24 hours (without further increase during observation period) + lack/presence of ARVI general symptoms ≤2 points. Based on the patient's diary.
Time frame: 14 days
ARVI severity (clinically diagnosed, including PCR-confirmed)
Вased on the area under curve (AUC) results for the total severity score. The total disease severity score will be calculated based on the severity of each of the ARVI symptoms (body temperature, general symptoms, and nasal/throat and chest symptoms in points). To calculate the total score, absolute values of body temperature measured in degrees Celsius will be converted into relative units (or points) based on the following classification: ≤37.3°C=0 points; 37.4-38.0°C=1 point; 38.1-39.0°C=2 points; ≥39.1°C =3 points.
Time frame: From day 1 to day 6
Percentage of patients with resolution of ARVI symptoms
Clinically diagnosed, including PCR-confirmed. Based on medical records.
Time frame: 14 days
Time to resolution of ARVI symptoms
Clinically diagnosed, including PCR-confirmed. Based on medical records.
Time frame: 14 days
Percentage of patients with resolution of ARVI symptoms (PCR-confirmed)
Based on medical records.
Time frame: 14 days
Dosing frequency of antipyretics
Based on the patient's diary.
Time frame: From day 1 to day 3
Percentage of patients with worsening of the disease
Development of complications requiring antibiotics or hospitalization.
Time frame: From day 4 to day 14
Number of Participants With Adverse Events (AEs)
Presence and nature of adverse events during therapy. Based on medical records.
Time frame: From day 1 to day 6
Severity of AEs
The intensity (severity) of adverse events. Based on medical records.
Time frame: From day 1 to day 6
Causal Relationship of AEs to the Sudy Drug
The causal relationship to the study drug of adverse events. Based on medical records.
Time frame: From day 1 to day 6
Outcome of AEs
The outcome of adverse events. Based on medical records.
Time frame: From day 1 to day 6
Changes in Vital Signs (Blood Pressure) measured in mm Hg
Blood Pressure measured in mm Hg. Based on medical records.
Time frame: On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7)
Changes in Vital Signs (Heart Rate)
Pulse Rate measured in beats per minute. Based on medical records.
Time frame: On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7)
Changes in Vital Signs (Breathing Rate)
Respiratory Rate measured in breaths per minute. Based on medical records.
Time frame: On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7)
Changes in Vital Signs (Axillary temperature)
Temperature is measured in the armpit using a classic mercury-free thermometer. Based on medical records.
Time frame: On Visit 1 (day 1), Visit 2 (day 5) and Visit 3 (day 7)
Percentage of Patients With Clinically Significant Abnormal Laboratory Tests
Measure is based on the Hematology, blood chemistry, and urinalysis parameters, which are beyond the reference values.
Time frame: On Visit 1 (day 1) and Visit 2 (day 5)
Plan to share: No
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Materia Medica Holding