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

NCT ID: NCT04918771

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 435 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-29
• Study Completion Date: 2023-07-21

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.

Detailed Description

Design: a multicenter, double-blind, placebo-controlled, parallel-group randomized clinical trial.

The study will enroll outpatient subjects of either gender aged 12-18 old years with clinical manifestations of acute respiratory viral infection (ARVI) within the first days after the onset of the disease. The patients will be recruited during seasonal ARVI morbidity. Collection of history, thermometry, objective examination, laboratory tests, recording concomitant therapy will be made after parent/adoptive parent signing information sheet and informed consent form for the child participation in the clinical study, for children ≥14 years old after signing patient information sheet and informed consent form for children ≥14 years old to participate in the clinical study. The severity of ARVI symptoms will be evaluated with 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. To rule out the infection caused by the new coronavirus COVID-19 (Coronavirus disease 2019), a rapid test for SARS-CoV-2 antigen will be made. In case of a positive SARS-CoV-2 test, the physician will act in accordance with the current version of the RF MoH Temporary methodological recommendations "Prevention, diagnosis, and therapy of new coronavirus infection (COVID-19)".

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: patients of group 1 will take Raphamin according to the dosage regimen for 5 days; patients of group 2 will take Placebo using Raphamin 5-day regimen.

The study will use an electronic patient diary (EPD) for recording morning and evening axillary body temperature (using a classic mercury-free thermometer) and disease symptoms (Symptom Severity Score). Besides, antipyretic dosing (if applicable) and any deterioration 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 parent/adoptive parent together with an investigator will record ARVI symptom severity and body temperature in the diary.

Patients will be observed for 14 days (screening, randomization - up to 1 day, treatment period - 5 days, follow-up - up to 2 days; deferred "phone visit" - day 14).

During the treatment and follow-up period the patients/physicians 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, and check patient diaries. At Visit 3 laboratory tests will be performed and compliance will be checked.

"Phone visit" will be performed to interview parents/adoptive parents about the patient's 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

Acute Respiratory Viral Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Raphamin

Tablet for oral use.

Group Type: EXPERIMENTAL

Raphamin

Intervention Type: 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.

Placebo

Tablet for oral use.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Raphamin

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients of either gender aged 12 to 18 years.

2. 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.

3. The first 24 hours after ARVI onset.

4. Contraceptive measures by sexually active adolescents of both genders during the study.

5. 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.

Exclusion Criteria

1. Clinical symptoms of severe influenza/ARVI requiring hospitalization.

2. Positive SARS-CoV-2 (COVID-19/Coronavirusdisease2019) antigen test.

3. Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring administration of antibiotics from the first day of illness.

4. 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).

5. Patients requiring antiviral medication prohibited within the study.

6. Medical history of primary and secondary immunodeficiency.

7. Medical history/suspicion of oncology of any localization (except for benign neoplasms).

8. 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.

9. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.

10. Allergy/ hypersensitivity to any component of the study drugs used in the treatment.

11. Pregnancy. Breast-feeding.

12. Use of medications specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study.

13. 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.

14. Medical history of mental diseases of the patient or their parent(s)/adoptive parents.

15. Participation in other clinical trials for 3 months prior to enrollment in this study.

16. 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).

17. The patient's parent/adopter 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).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Materia Medica Holding

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kazan State Medical University

Kazan', , Russia

Llc "Medlight"

Kazan', , Russia

Specialized Clinical Hospital for Infectious Diseases

Krasnodar, , Russia

Llc "Olla-Med"

Moscow, , Russia

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

Moscow, , Russia

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

Moscow, , Russia

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

Moscow, , Russia

Llc "Diagnostics and Vaccines"

Moscow, , Russia

Novosibirsk State Medical University

Novosibirsk, , Russia

City Children's Clinical Polyclinic # 5

Perm, , Russia

LLC "Professorial Clinic"

Perm, , Russia

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

Rostov-on-Don, , Russia

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

Rostov-on-Don, , Russia

Rostov State Medical University

Rostov-on-Don, , Russia

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

Ryazan, , Russia

Children's city polyclinic # 44

Saint Petersburg, , Russia

LLC "Energy of health"

Saint Petersburg, , Russia

Children's city polyclinic # 35

Saint Petersburg, , Russia

Research Institute of Influenza named after A.A. Smorodintsev

Saint Petersburg, , Russia

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

Samara, , Russia

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

Saransk, , Russia

LLC "DNA Research Center"

Saratov, , Russia

Smolensk State Medical University

Smolensk, , Russia

Bashkir State Medical University/Department of Outpatient and Emergency Pediatrics

Ufa, , Russia

Volgograd State Medical University/Department of Pediatrics and Neonatology

Volgograd, , Russia

Yaroslavl State Medical University/Department of Pediatrics IPGE

Yaroslavl, , Russia

Yaroslavl State Medical University/Department of Pediatrics № 2

Yaroslavl, , Russia

Clinical Hospital # 2

Yaroslavl, , Russia

LLC "European Medical Center "UMMC-Health"

Yekaterinburg, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MMH-407-003

Identifier Type: -

Identifier Source: org_study_id