Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections

NCT05269290 | Completed Phase 3

• 1 other identifier: ING-03-04-2020
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 8

Brief Summary

The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, syrup, 30 mg/5 ml, in the treatment of influenza or other acute respiratory infections in children from 6 months to 2 years compared with placebo.

Conditions

Influenza, Human; Acute Respiratory Infection; Common Cold

Outcome Measures

Primary Outcomes (1)

• Time of symptoms/events resolution

  Time, in hours, from the first administration of the drug until all of the following symptoms/events have resolved (if each symptom/event has been achieved for at least 24 hours): Fever; Cough and/or runny nose/nasal congestion; Child's return to normal daytime activity and normal nighttime sleep (as assessed by the parent/adopter).

  From Day 1 up to Day 13-14 (visit 4)

Secondary Outcomes (14)

• Time to fever relief

  From Day 1 up to Day 13-14 (visit 4)

• Time to cough relief

  From Day 1 up to Day 13-14 (visit 4)

• Time to cough/nasal congestion relief

  From Day 1 up to Day 13-14 (visit 4)

• Frequency of complications of acute viral infection and influenza

  From Day 1 up to Day 13-14 (visit 4)

• Frequency of patients with PCR-confirmed viral infection

  Day 1, Day 3-4 (visit 2), Day 6-7 (visit 3)

Study Arms (2)

Ingavirin®, syrup, 30 mg/5 ml

EXPERIMENTAL

Ingavirin®, syrup, 30 mg/5 ml will be administered on top of standard therapy

Drug: Ingavirin®, syrup, 30 mg/5 ml

Placebo

PLACEBO COMPARATOR

Placebo will be administered on top of standard therapy

Drug: Placebo

Interventions

Ingavirin®, syrup, 30 mg/5 ml DRUG

A dose will be based on the body weight; Ingavirin® will be administered once a day on top of standard therapy.

Ingavirin®, syrup, 30 mg/5 ml

Placebo DRUG

Placebo will be administered once a day on top of standard therapy.

Placebo

Eligibility Criteria

• Age: 6 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient's parent/adoptive parent's informed consent form voluntarily signed by the patient's parent/adoptive parent;
• Boys and girls aged 6 months - 2 years 11 months 14 days, inclusive, with the following clinical signs of acute respiratory infections/flu: body temperature above 38.0 °C but not higher than 39.0 °C (without taking antipyretics within the last 8 h) at the time of screening/randomization; at least one of the respiratory manifestations of acute respiratory infection/influenza (cough, runny nose/ stuffy nose) of at least 2 points on a 4-point scale; decrease in the child's daytime activity and change in nighttime sleep, as compared with the state before the illness;

You may not qualify if:

• Presence of at least one of the epidemic signs: return from an overseas trip 14 days prior to the onset of symptoms; having close contact in the last 14 days with a person under observation for COVID-19 who has subsequently become ill; having close contact within the past 14 days with a person who has a laboratory-confirmed diagnosis of COVID-19;
• Positive result of laboratory testing for SARS-CoV-2 RNA using nucleic acid amplification techniques or antigen SARS-CoV-2 antigen using an immunochromatographic assay at the time of screening;
• Severe general intoxication syndrome (severe agitation with seizure syndrome and loss of consciousness against a background of hyperthermia);
• Hemorrhagic syndrome (nasal bleeding, blood in sputum, vomit and stool, hemorrhagic rash), disseminated intravascular coagulation syndrome (DIC) or Hasser syndrome with the formation of acute renal failure;
• Diffuse cyanosis or pallor;
• Symptoms of pneumonia and possible acute respiratory distress syndrome (ARDS): cough with frothy sputum with blood, shortened pulmonary sound on percussion, a large number of different-caliber moist rales and abundant crepitation on auscultation, a sharp drop in blood pressure (BP), deafness of heart tones and arrhythmia;
• Phenomena of respiratory distress combined with any of the following symptoms: grunting breathing, blowing of the wings of the nose when breathing, nodding movements (head movements synchronized with breathing); BPM in a child aged 6-11 months \> 50 per minute, child over 1 year old \> 40 per minute; lower chest retraction when breathing; blood oxygen saturation (SpO2) \< 92% when breathing room air;
• Moderate acute respiratory infections (fever ≥ 38.5 °C) with exacerbation of comorbidities;
• Presence of any of the following symptoms: inability to drink/breastfeed; drowsiness or unconsciousness; respiratory rate less than 30 per minute or apnea; heart failure phenomena; severe dehydration;
• Febrile seizures, including a history of seizures; known intolerance to the active ingredient or excipient of the study drug or placebo components, paracetamol;
• Withdrawal Criteria:
• Identification of a probable or confirmed case COVID-19;
• Signs of complications of viral infection, including signs of secondary bacterial infection;
• The investigating physician decides that the patient must be excluded for the patient's own benefit;
• Withdrawal of informed consent by the parent or adoptive parent;

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (8)

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

Odintsovo, Moscow Oblast, 1430010, Russia

Location

City Pediatric Outpatient Clinic number 5

Perm, 614066, Russia

Location

Professors' Clinic LLC.

Perm, 614070, Russia

Location

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

Saint Petersburg, 191144, Russia

Location

City Polyclinic No. 45 of Nevsky District

Saint Petersburg, 193312, Russia

Location

PiterKlinika LLC

Saint Petersburg, 196158, Russia

Location

Uromed LLC

Smolensk, 214031, Russia

Location

Bashkir State Medical University

Ufa, 450008, Russia

Location

MeSH Terms

Conditions

Influenza, Human; Common Cold

Interventions

pentanedioic acid imidazolyl ethanamide

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Picornaviridae Infections

Study Design

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

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 7, 2022
• Study Start: September 23, 2021
• Primary Completion: April 29, 2022
• Study Completion: July 15, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

RU (8)