Clinical Study of Efficacy and Safety of Raphamin in the Treatment of ARVI in Children 12-18 Years Old

NCT04918771 | Completed Phase 3 Results

• 1 other identifier: MMH-407-003
• Study Type: interventional
• Target: 435
• Locations: 1 country
• Sites: 29

Brief Summary

The multicenter double-blind placebo-controlled randomized in parallel-group. The objective of this study is to evaluate efficacy and safety of Raphamin in the treatment of acute respiratory viral infection (ARVI) in children aged 12-18 years old.

Conditions

Acute Respiratory Viral Infection

Outcome Measures

Primary Outcomes (1)

• Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms (ARVI, Confirmed by Polymerase Chain Reaction (PCR)).

  Outcome Measure is evaluated on the basis of ARVI, confirmed by Polymerase chain reaction (PCR), i.e virus detection. 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 7 nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, hoarseness, sore throat, cough, pain/heaviness in chest) 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. So the range of TSS was from "0" to "42". The TSS higher score is the worse outcome.

  14 days of observation

Secondary Outcomes (11)

• Severity of ARVI (Clinically Diagnosed and/or PCR-confirmed).

  Day1 through Day6 of the treatment and observation

• Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).

  14 days of observation

• Time to Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).

  14 days of observation

• Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed).

  14 days of observation

• Dosing Frequency of Antipyretics.

  3 days of therapy

Study Arms (2)

Raphamin

EXPERIMENTAL

Tablet for oral use.

Drug: Raphamin

Placebo

PLACEBO COMPARATOR

Tablet for oral use.

Drug: Placebo

Interventions

Raphamin DRUG

Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved. On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days.

Raphamin

Placebo DRUG

Oral administration - not with food. Placebo using Raphamin scheme.

Placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients of either gender aged 12 to 18 years.
• Diagnosis of ARVI based on medical examination: axillary temperature ≥ 37.8°C at examination + non-specific flu-like symptoms score ≥4, nasal/throat/chest symptom score ≥2.
• The first 24 hours after ARVI onset.
• Contraceptive measures by sexually active adolescents of both genders during the study.
• Patient information sheet (informed consent form) signed by one parent/adoptive parent of the patient and there is also a signed patient information sheet (informed consent form) for children aged 14 and over.

You may not qualify if:

• Clinical symptoms of severe influenza/ARVI requiring hospitalization.
• Positive SARS-CoV-2 (COVID-19/Coronavirusdisease2019) antigen test.
• 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 (diabetes mellitus, infantile cerebral paralysis, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, respiratory and ENT congenital defects, etc.) 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 drugs used in the treatment.
• Pregnancy. Breast-feeding.
• Patients whose parents/adopters, from the investigator's point of view, will not comply with the observation requirements during the study or follow the procedure for taking the study drugs.
• Medical history of mental diseases of the patient or their parent(s)/adoptive parents.
• Participation in other clinical trials for 3 months prior to enrollment in this study.
• Patient's parents/adopters 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).

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (29)

Kazan State Medical University

Kazan', 420012, Russia

Location

Llc "Medlight"

Kazan', 420097, Russia

Location

Specialized Clinical Hospital for Infectious Diseases

Krasnodar, 350015, Russia

Location

Llc "Olla-Med"

Moscow, 105554, Russia

Location

Russian National Research Medical University named after N.I. Pirogov

Moscow, 117997, Russia

Location

Morozovskaya Children's City Clinical Hospital of the Moscow Department of Health

Moscow, 119049, Russia

Location

Federal Scientific and Clinical Center for Physical and Chemical Medicine of the Federal Medical and Biological Agency

Moscow, 119435, Russia

Location

Llc "Diagnostics and Vaccines"

Moscow, 129515, Russia

Location

Novosibirsk State Medical University

Novosibirsk, 630091, Russia

Location

City Children's Clinical Polyclinic # 5

Perm, 614066, Russia

Location

LLC "Professorial Clinic"

Perm, 614070, Russia

Location

Clinical and diagnostic center "Health" of the city of Rostov-on-Don

Rostov-on-Don, 344011, Russia

Location

Children's City Hospital #1 of Rostov-on-Don city

Rostov-on-Don, 344019, Russia

Location

Rostov State Medical University

Rostov-on-Don, 344022, Russia

Location

Ryazan State Medical University named after academician I.P. Pavlov

Ryazan, 390026, Russia

Location

Children's city polyclinic # 44

Saint Petersburg, 191144, Russia

Location

LLC "Energy of health"

Saint Petersburg, 194156, Russia

Location

Children's city polyclinic # 35

Saint Petersburg, 196191, Russia

Location

Research Institute of Influenza named after A.A. Smorodintsev

Saint Petersburg, 197376, Russia

Location

Samara Regional Children's Clinical Hospital named after N.N. Ivanova

Samara, 443079, Russia

Location

National Research Mordovian State University named after N.P. Ogarev

Saransk, 430005, Russia

Location

LLC "DNA Research Center"

Saratov, 410005, Russia

Location

Smolensk State Medical University

Smolensk, 214019, Russia

Location

Bashkir State Medical University/Department of Outpatient and Emergency Pediatrics

Ufa, 450008, Russia

Location

Volgograd State Medical University/Department of Pediatrics and Neonatology

Volgograd, 400131, Russia

Location

Yaroslavl State Medical University/Department of Pediatrics IPGE

Yaroslavl, 150000, Russia

Location

Yaroslavl State Medical University/Department of Pediatrics № 2

Yaroslavl, 150000, Russia

Location

Clinical Hospital # 2

Yaroslavl, 150030, Russia

Location

LLC "European Medical Center "UMMC-Health"

Yekaterinburg, 620144, Russia

Location

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: MATERIA MEDICA HOLDING

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 9, 2021
• Study Start: April 29, 2021
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2023-08

Locations

RU (29)