Efficacy and Safety of Ingavirin®, Capsules, 60 mg, in Children With Influenza and Other Acute Respiratory Viral Infections

NCT06315400 | Recruiting Phase 4

• 1 other identifier: ING-07-2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, capsules, 60 mg, in the treatment of influenza or other acute respiratory infections in children from 13 to 17 years compared with placebo.

Conditions

Influenza, Human; Acute Respiratory Infection; Common Cold

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with normalization of body temperature at Visit 3 (Day 3)

  Percentage of patients with body temperature \<37ºС with no rise above these values in the subsequent period until Visit 7

  Day 0 - Day 21±1

Secondary Outcomes (30)

• Timeframe for normalization of body temperature from the start of treatment, measured in hours

  Day 0 - Day 21±1

• Time of cough disappearance from the moment of treatment initiation

  Day 0 - Day 21±1

• Percentage of patients with absence of catarrhal syndrome

  Day 0 - Day 21±1

• Percentage of patients with absence of intoxication syndrome

  Day 0 - Day 21±1

• Average body temperature on days 1, 2, 3, 4 and 5 from the start of therapy

  Day 1 - Day 5

Study Arms (2)

Ingavirin®, capsules, 60 mg

EXPERIMENTAL

Ingavirin® will be administered once a day (60 mg/day) for 5 days on top of standard therapy.

Drug: Ingavirin®

Placebo

PLACEBO COMPARATOR

Placebo will be administered once a day for 5 days on top of standard therapy.

Drug: Placebo

Interventions

Ingavirin® DRUG

60 mg/day for 5 days

Ingavirin®, capsules, 60 mg

Placebo DRUG

1 capsule/day for 5 days

Placebo

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female patients aged 13 to 17 years inclusive.
• Clinically established diagnosis of influenza or acute respiratory viral infection based on the presence of body temperature \> 37.5 °C and at least 1 of the following symptoms of intoxication syndrome, and at least 1 manifestation of catarrhal syndrome: symptoms of intoxication syndrome (headache, chills, weakness, brokenness, eyeball pain, nausea); catarrhal syndrome (sore throat, rhinitis, pharyngitis, laryngitis, cough).
• Laboratory-confirmed diagnosis of influenza or acute respiratory viral infections using one or more of the following viral antigen detection methods.
• Uncomplicated course of influenza or ARVI.
• Availability of an informed consent form signed by one of the parents (or legal representatives) of the child for participation in the study.
• For patients 14 years and older, a signed informed consent form for participation in the study.

You may not qualify if:

• Hypersensitivity to any of the components included in the Ingavirin®.
• Complicated course of influenza and acute respiratory viral infections (clinically and laboratory determined bacterial infection).
• Taking antiviral drugs (antiviral agents, interferons, interferon inducers and drugs with immunomodulatory effect) or systemic antibacterial agents 7 days prior to the Screening Visit.
• Severe influenza with signs of cardiovascular failure and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions).
• Signs of viral pneumonia (presence of two or more of the following symptoms: dyspnea, chest pain when coughing, systemic cyanosis, dulling of the percussion sound with symmetric evaluation of the upper and lower lungs).
• "Frequently ill children" (frequency of acute respiratory illnesses during the last year 6 times or more).
• A history of bronchial asthma.
• A history of increased seizure activity.
• Severe, decompensated or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen the patient's prognosis, as well as make it impossible to conduct a clinical trial in the patient).
• History of oncologic diseases, HIV infection, tuberculosis.
• Diabetes mellitus, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, sucrose/isomaltase deficiency, fructose intolerance, hereditary disorders of glucose absorption, glucose-6-phosphate dehydrogenase deficiency.
• Participation in a clinical drug trial less than 3 months prior to the start of the study.
• Immunization of the patient 14 days prior to the Screening Visit.
• The need for concomitant therapy with any of the drugs listed under "Prohibited Concomitant Treatment".
• Any other concomitant somatic diseases or conditions that, in the opinion of the investigator, make it difficult to interpret the results of treatment or result in the inability to perform the procedures in this clinical trial or pose a risk to the patient in participating in the study.

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (3)

GBOU VPO "Rostov State Medical University" of Ministry of Health of Russian Federation

Rostov-on-Don, Russia

RECRUITING

GBOU VPO "Siberia State Medcial University" of Ministry of Health of Russian Federation

Tomsk, Russia

RECRUITING

GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation

Yaroslavl, 150000, Russia

RECRUITING

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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: December 19, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 1, 2024

Record last verified: 2024-02

Locations

RU (3)