Acute Respiratory Infection, Common Cold, Influenza, Human
Conditions
Keywords
Respiratory Tract Infections, Acute Respiratory Viral Infection
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.
Detailed description
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).
Interventions
DRUGIngavirin
DRUGPlacebo
Sponsors
Valenta Pharm JSC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to resolution of fever | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to resolution / alleviation of intoxication symptoms | 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 to resolution / alleviation of catarrhal symptoms | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 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. |
Countries
Russia
Outcome results
None listed