Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults

NCT03154515 | Completed Phase 4

• 1 other identifier: 5P/08
• Study Type: interventional
• Target: 445
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to determine whether Ingavirin® 90 mg once daily is effective and safe for the treatment of influenza and other laboratory confirmed acute respiratory viral infections in the course of standard therapy in patients 18-60 years old.

Conditions

Common Cold; Influenza, Human; Acute Respiratory Infection

Keywords

Respiratory Tract Infections; Acute Respiratory Viral Infection

Outcome Measures

Primary Outcomes (1)

• Time to resolution of fever

  Time from the start of study treatment to resolution of fever ( t ≤ 36,9 ºС, till the end of the follow up).

  7 ± 1 days

Secondary Outcomes (2)

• Time to resolution / alleviation of intoxication symptoms

  7 ± 1 days

• Time to resolution / alleviation of catarrhal symptoms

  7 ± 1 days

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Through study completion, an average of 8 days

Study Arms (2)

Ingavirin

EXPERIMENTAL

Imidazolyl ethanamide pentandioic acid 90 mg once daily for 5 days

Drug: Ingavirin

Placebo

PLACEBO COMPARATOR

Placebo capsule identical in appearance to Ingavirin capsule

Drug: Placebo

Interventions

Ingavirin DRUG

Also known as: Imidazolyl ethanamide pentandioic acid

Ingavirin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with clinically diagnosed influenza, body temperature ≥ 38 ºС or other acute respiratory viral infection, body temperature ≥ 37 ºС, with no less than 2 symptoms of catarrhal and intoxication each:
• Intoxication symptoms: Dizziness, headache, chills, fever, sweating, fatigue, myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances, decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs.
• Catarrhal symptoms: Sore throat, rhinorrhea and nasal congestion, difficulty swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough, expectoration.
• Laboratory confirmation of viral origin of the disease
• Uncomplicated influenza and other acute respiratory viral infections
• Interval between onset of symptoms and enrollment to the study not more than 48 hours
• Have read, understood and signed an informed consent form

You may not qualify if:

• Complicated course of influenza and other acute respiratory viral infections (secondary bacterial infection)
• Pregnancy and Breastfeeding
• Severe decompensated or unstable medical or psychiatric conditions (any diseases or conditions that threaten the life of the patient or worsen the patient's prognosis)
• Cancer, HIV infection, tuberculosis, including those in history
• History of alcohol and drug abuse

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (9)

State educational institution of higher professional education "Chelyabinsk State Medical Academy of Federal Agency of Health Care and Social Development"

Chelyabinsk, 454092, Russia

Location

N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology

Moscow, 123098, Russia

Location

State budgetary health care institution novosibirsk region "city clinical infectious diseases hospital no. 1"

Novosibirsk, Russia

Location

North-western State Medical University named after I.I.Mechnikov

Saint Petersburg, 195067, Russia

Location

Saratov State Medical University named after V. I. Razumovsky

Saratov, 410012, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Pacific State Medical University" of the Ministry of Healthcare of the Russian Federation

Vladivostok, 690002, Russia

Location

Volgograd State Medical University

Volgograd, 400131, Russia

Location

Yaroslavl State Medical University

Yaroslavl, 150000, Russia

Location

Federal State Budgetary Institution of Higher Professional Education "Urals State Medical University" of the Ministry of Healthcare of the Russian Federation

Yekaterinburg, 620028, Russia

Location

MeSH Terms

Conditions

Common Cold; Influenza, Human; Respiratory Tract Infections

Interventions

pentanedioic acid imidazolyl ethanamide

Condition Hierarchy (Ancestors)

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

Study Officials

• Ekaterina Zakharova, MD, PhD

  Valenta Pharm JSC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 16, 2017
• Study Start: January 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (9)