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Completed

NCT Number: NCT03154515

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Ingavirin in the Treatment of Influenza and Other Acute Viral Respiratory Infection. Study treatment was 5 days followed by 2 ± 1 days of follow up period. Thus, study participation was 7 ± 1 days (8 days max).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Ingavirin

Drug

Other names: Imidazolyl ethanamide pentandioic acid

Placebo

Drug

Primary outcomes

  1. Time to resolution of fever

    Time frame: 7 ± 1 days

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

Secondary outcomes

  1. Time to resolution / alleviation of intoxication symptoms

    Time frame: 7 ± 1 days

    Following symptoms were recorded and rated each visit, to evaluate symptoms progress:

    Dizziness, headache, chills, fever, sweating, fatigue, myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances, decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs.

  2. Time to resolution / alleviation of catarrhal symptoms

    Time frame: 7 ± 1 days

    Following symptoms were recorded and rated each visit, to evaluate symptoms progress:

    Sore throat, rhinorrhea and nasal congestion, difficulty swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough, expectoration.

Other outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: Through study completion, an average of 8 days

    All adverse events recorded and analysed, to compare incidence rate with one of placebo.

    Complete blood count test performed at the beginning and at the end of the study.

    Vital signs taken and recorded at each visit throughout the study, usually every day for 7 ± 1 days.

Sponsors and collaborators

Lead sponsor

Valenta Pharm JSC

Industry

Registry information

Official study title

Randomised Double Blind Placebo Controlled Multicenter Study for Evaluation of Clinical Efficacy and Safety of Ingavirin 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults.

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 16, 2017
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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