Ingavirin
DrugOther names: Imidazolyl ethanamide pentandioic acid
NCT Number: NCT03154515
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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Notify Me18 year–60 year
All sexes
Interventional
Phase 4
State educational institution of higher professional education "Chelyabinsk State Medical Academy of Federal Agency of Health Care and Social Development", Chelyabinsk, Russia
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Imidazolyl ethanamide pentandioic acid
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).
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.
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.
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.
Valenta Pharm JSC
Industry
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.
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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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