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Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections

Double-blind Placebo-controlled Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of XC8, Film-coated Tablets (Valenta Pharm JSC, Russia), in Children Aged 6-17 Years With Dry Non-productive Cough Against the Background of Acute Respiratory Viral Infection

NCT06379542•Valenta Pharm JSC

View on ClinicalTrials.gov

Summary

The study is planned to evaluate the therapeutic efficacy and safety of XC8, film-coated tablets, in the treatment of dry non-productive cough on the background of acute respiratory infections in children from 6 to 17 years compared with placebo.

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient signing the Informed Consent Form and parent/adoptive parent signing the Parent/Adoptive Informed Consent Form.
•2. Male and female children between the ages of 6 and 17 years 10 months inclusive at the time of screening.
•3. Clinical diagnosis of acute respiratory viral upper respiratory tract infection (J00-J06 according to ICD-10) or acute bronchitis (J20, J21 according to ICD-10).
•4. Onset of disease symptoms no more than 3 days prior to screening.
•5. Presence of dry non-productive cough in the patient.
•6. Frequency of cough attacks ≥10 in the last 24 h before the screening visit and randomization.
•7. Cough frequency rated by the patient (for patients 13-17 years of age) or parent/adoptive parent (for patients 6-12 years of age) as 3-4 points on the "daytime cough" section and 2-4 points on the "nighttime cough" Daytime and nighttime cough scales.
•8. Patient (for patients 13-17 years of age) or parent/adoptive parent (for patients 6-12 years of age) assessment of cough severity on the digital rating scale as ≥4 points.
•9. No indication for therapy due to BHSA infection at the time of inclusion in the study: negative rapid test for group A β-hemolytic streptococcus.
•10. For patients 14-17 years of age inclusive, consent to use reliable contraceptive methods throughout study participation and for 3 weeks after the end of the study.
+38 more criteria

Exclusion Criteria

•1. Identification of a confirmed case of COVID-19.
•2. Ineffectiveness of therapy - persistence or increase in cough attack frequency ≥1 by Visit 3 (Day 8-9) compared to Visit 1 (Day 1).
•3. Adverse events (AEs) requiring withdrawal of study drug/placebo.
•4. Occurrence of any disease or condition during the study that, in the opinion of the investigator, worsens the patient's prognosis and makes it impossible for the patient to continue participating in the clinical trial.

Locations (6)

City Pediatric Outpatient Clinic number 5

Perm, Russia

Professors' Clinic LLC.

Perm, Russia

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 44"

Saint Petersburg, Russia

ArsVite North-West, LLC

Saint Petersburg, Russia

PiterKlinika LLC

Saint Petersburg, Russia

St. Petersburg State Budgetary Healthcare Institution "City Pediatric Polyclinic No. 35"

Saint Petersburg, Russia

Key Dates

Start Date

December 4, 2023

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

April 23, 2024

Enrollment

252

ESTIMATED participants

Conditions

Acute Respiratory Infection

Interventions

XC8

DRUG

Placebo

DRUG

Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care

NCT07396428

Acute Respiratory InfectionInfluenza-like Illness

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RECRUITING

The Fever Clinic Acute Respiratory Cohort

NCT07278700

Acute Respiratory InfectionsFebrile Illnesses+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections

Inclusion Criteria

Exclusion Criteria

Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care

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