A Phase 4 interventional study of Ingavirin® and Placebo in Influenza, Human, Acute Respiratory Infection and Common Cold, sponsored by Valenta Pharm JSC. Recruiting at 3 sites in Russian Federation. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by Valenta Pharm JSC · Phase 4, Interventional, and Treatment
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.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's planned enrollment of 80 is below the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Valenta Pharm JSC is the lead sponsor of 40 studies on the registry; 18 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ingavirin® will be administered once a day (60 mg/day) for 5 days on top of standard therapy.
Drug: Ingavirin®
Placebo will be administered once a day for 5 days on top of standard therapy.
Drug: Placebo
60 mg/day for 5 days
1 capsule/day for 5 days
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
Time frame: Day 0 - Day 21±1
Timeframe for normalization of body temperature from the start of treatment, measured in hours
Time (hours) to reach body temperature \<37ºС with no rise above these values in the subsequent period until Visit 7 (Day 21±1)
Time frame: Day 0 - Day 21±1
Time of cough disappearance from the moment of treatment initiation
Disappearance of cough; no recurrence of cough in the following days of observation
Time frame: Day 0 - Day 21±1
Percentage of patients with absence of catarrhal syndrome
Percentage of patients with disappearance of all manifestations; no recurrence on subsequent days of follow-up) at Visit 3 (Day 3)
Time frame: Day 0 - Day 21±1
Percentage of patients with absence of intoxication syndrome
Percentage of patients with disappearance of all manifestations; no recurrence on subsequent days of follow-up) at Visit 3 (Day 3)
Time frame: Day 0 - Day 21±1
Average body temperature on days 1, 2, 3, 4 and 5 from the start of therapy
Average body temperature (two measurements per a day)
Time frame: Day 1 - Day 5
Percentage of patients with complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration
Percentage of patients with at least one complication of disease
Time frame: Day 0 - Day 21±1
Percentage of patients with severe complications of influenza/acute respiratory infection that developed between days 1-6 and days 1-21 from the start of study drug administration
Percentage of patients with at least one severe complication of disease
Time frame: Day 0 - Day 21±1
Assessment of vital signs: blood pressure
Blood pressure, mmHg
Time frame: Day 1, Day 3, Day 6
Assessment of vital signs: heart rate
Heart rate, bpm
Time frame: Day 1, Day 3, Day 6
Assessment of vital signs: respiratory rate
Respiratory rate, bpm
Time frame: Day 1, Day 3, Day 6
Assessment of vital signs: body temperature
Temperature, ºС
Time frame: Day 1 - Day 6
Evaluation of concomitant therapy
Number and types of concomitant therapy
Time frame: Day 0 - Day 21±1
Laboratory evaluation: leukocyte formula
Precentage of white blood cells of different types
Time frame: Day 1, Day 6
Laboratory evaluation: hemoglobin
Hemoglobin, g/L
Time frame: Day 1, Day 6
Laboratory evaluation: leukocyte count
Cell/mL
Time frame: Day 1, Day 6
Laboratory evaluation: platelet count
Cell/mL
Time frame: Day 1, Day 6
Laboratory evaluation: red blood cell count
Cell/mL
Time frame: Day 1, Day 6
Laboratory evaluation: hematocrit
Hematocrit, %
Time frame: Day 1, Day 6
Laboratory evaluation: erythrocyte sedimentation rate
mm/h
Time frame: Day 1, Day 6
Laboratory evaluation: blood glucose
mmol/L
Time frame: Day 1, Day 6
Laboratory evaluation: total protein
g/L
Time frame: Day 1, Day 6
Laboratory evaluation: total bilirubin
mcmol/L
Time frame: Day 1, Day 6
Laboratory evaluation: AST
U/L
Time frame: Day 1, Day 6
Laboratory evaluation: ALT
U/L
Time frame: Day 1, Day 6
Laboratory evaluation: creatinine
mcmol/L
Time frame: Day 1, Day 6
Laboratory evaluation: urea
mmol/L
Time frame: Day 1, Day 6
Laboratory evaluation: triglycerides
mmol/L
Time frame: Day 1, Day 6
Laboratory evaluation: urinalysis
Urune color, transparency, specific gravity, pH, presence of protein, glucose, bilirubin, microscopy of urine sediment (epithelium, erythrocytes, leukocytes, cylinders, bacteria, salts)
Time frame: Day 1, Day 6
Frequency of adverse events (AEs) and serious adverse events (SAEs)
Total number and frequency of AEs and SAEs stratified by severity and frequency
Time frame: Day 0 - Day 21±1
Percentage of patients who discontinued study due to AE/SAE
Percentage of patients who discontinued study participation early due to the occurrence of AE/SAE and time to dropout due to AE/SAE
Time frame: Day 0 - Day 21±1
Plan to share: Undecided
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