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The main purpose of the study was to evaluate the effectiveness of XC221, tablets, at a dose of 200 mg/day compared to placebo in patients with uncomplicated influenza or other acute respiratory viral infections (ARIs).
An additional purpose of the study was to evaluate the safety of XC221, tablets, at a dose of 200 mg/day compared to placebo in patients with uncomplicated influenza or other ARIs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XC221 | Experimental | Patients will take 1 tablet of XC221, tablets, 100 mg twice daily, in the morning (between 7:00 and 11:00 a.m.) and in the evening (between 7:00 and 11:00 p.m.), for 5 days. |
|
| Placebo | Placebo Comparator | Patients will take 1 placebo pill orally twice a day, in the morning (between 7:00 and 11:00 a.m.) and in the evening (between 7:00 and 11:00 p.m.), for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XC221 | Drug | 200 mg/day, for 5 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time (in hours) from the first dose of the drug to the resolution of all of the ARI symptoms/events | Time (in hours) from the first dose of the drug to the resolution of all of the following symptoms/events. • fever (the day of fever resolution is the first day on which stable normal body temperature is achieved (<37.0°C without the use of antipyretics)); All achieved symptoms/events scores maintained for at least 24 h at 0-1 point:
| Day 1 - Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to decrease in 24-hour body temperature to ≤ 37.0°C without using antipyretics (number of hours from the first dose of the study treatment to a decrease in 24-hour body temperature to ≤ 37.0°C) | Patients will assess and record body temperature in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents | Day 1 - Day 10 |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State autonomous health care institution "Engels City Clinical Hospital No. 1" | Engel's | 413116 | Russia | |||
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| Drug |
2 tablets/day, for 5 days |
|
| Time to nasal congestion/runny nose resolution (number of hours from the first dose of the drug to runny nose/congestion resolution, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point) | Patients will assess and record the severity of symptom on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom | Day 1 - Day 10 |
| Patient rate with reported nasal congestion/runny nose resolution by day 4 and day 6 from treatment initiation (i.e. patient rate who assessed the 24-hour severity of this symptom at 0-1 point). | Patients will assess and record the severity of symptom on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom. | Day 1 - Day 10 |
| Time to sore throat resolution (number of hours from the first dose of the drug to sore throat resolution, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point). | Patients will assess and record the severity of symptom on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom. | Day 1 - Day 10 |
| Patient rate with reported sore throat resolution by day 4 and day 6 from treatment initiation (i.e. patient rate who assessed the 24-hour severity of this symptom at 0-1 point). | Patients will assess and record the severity of symptom on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom. | Day 1 - Day 6 |
| Time to cough resolution (number of hours from the first dose of the drug to cough resolution, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point. | Patients will assess and record the severity of symptom on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom. | Day 1 - Day 10 |
| Patient rate with reported cough resolution by day 4 and day 6 from treatment initiation (i.e. patient rate who assessed the 24-hour severity of this symptom at 0-1 point). | Patients will assess and record the severity of symptom on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom. | Day 1 - Day 6 |
| Time to muscle ache resolution (number of hours from the first dose of the drug to the resolution of muscle aches, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point | Patients will assess and record the severity of symptom on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom. | Day 1 - Day 10 |
| Patient rate with reported muscle ache resolution by day 4 and day 6 from treatment initiation (i.e. patient rate who assessed the 24-hour severity of this symptom at 0-1 point). | Patients will assess and record the severity of symptom on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom. | Day 1 - Day 6 |
| Time to headache resolution (number of hours from the first dose of the drug to headache resolution, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point). | Patients will assess and record the severity of symptom on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom. | Day 1 - Day 10 |
| Patient rate with reported headache resolution by day 4 and day 6 from treatment initiation (i.e. patient rate who assessed the 24-hour severity of this symptom at 0-1 point). | Patients will assess and record the severity of symptom on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom. | Day 1 - Day 6 |
| Time to fatigue resolution (number of hours from the first dose of the drug to fatigue resolution, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point). | Patients will assess and record the severity of symptom on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom. | Day 1 - Day 10 |
| Patient rate with reported fatigue resolution by day 4 and day 6 from treatment initiation (i.e. patient rate who assessed the 24-hour severity of this symptom at 0-1 point). | Patients will assess and record the severity of symptom on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom. | Day 1 - Day 6 |
| Time to chills/sweats resolution (number of hours from the first dose of the drug to the resolution of chills/sweats, i.e. the time when the subject rates the 24-hour severity of this symptom at 0-1 point). | Patients will assess and record the severity of symptom on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom. | Day 1 - Day 10 |
| Patient rate with reported chills/sweats resolution by day 4 and day 6 from treatment initiation (i.e. patient rate who assessed the 24-hour severity of this symptom at 0-1 point). | Patients will assess and record the severity of symptom on a 4-point scale in the Patient's Diary for 10 days 2 times a day with a 12 ± 2 h interval before the next use of symptomatic agents, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom. | Day 1 - Day 6 |
| Frequency complications of influenza or other viral upper respiratory tract infections (URIs) | Frequency complications of influenza or other viral URIs: sinusitis, otitis, bronchitis, pneumonia. | Day 1 - Day 10 |
| Time till elimination viruses based on qualitative polymerase chain reaction (PCR) test | Time to the first negative PCR test) | Day 1 - Day 10 |
| The need for paracetamol or ibuprofen: daily dose on days 1-10 | Dose of paracetamol or ibuprofen taken | Day 1 - Day 10 |
| Safety and Tolerability: adverse event (AE) rate | Number and frequency of adverse events (AEs) or serious AEs (SAEs) | From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 20 for each participant |
| Safety and Tolerability: AEs associated with the study drug | Number and frequency of AEs or SAEs) associated with the study drug | From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 20 for each participant |
| Safety and Tolerability: treatment discontinuation | Percentage of patients who discontinued treatment due to the occurrence of AEs/SAEs | From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 20 for each participant |
| Safety and Tolerability: hospitalization rate | Frequency of need for hospitalization due to AEs/SAEs | From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 20 for each participant |
| Safety and Tolerability: vital signs - systolic blood pressure (SBP) | SBP, mmHg | Screening, day 4, day 6, day 10, and day 20 of the study or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: vital signs - diastolic blood pressure (DBP) | DBP, mmHg | Screening, day 4, day 6, day 10, and day 20 of the study or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: vital signs - respiratory rate (RR) | RR, breaths per minute | Screening, day 4, day 6, day 10, and day 20 of the study or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: vital signs - heart rate (HR) | HR, beats per minute | Screening, day 4, day 6, day 10, and day 20 of the study or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: vital signs - body temperature | Body temperature, centigrade scale | Screening, day 4, day 6, day 10, and day 20 of the study or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: physical examination results | Physical examination will follow the general rules of internal medicine: general examination, examination of mucous membranes and skin, including palpation of lymph nodes, evaluation of the musculoskeletal system, palpation, percussion, and auscultation of the main organ systems (cardiovascular, respiratory, digestive, and urinary systems) will be performed sequentially. | Screening, day 4, day 6, day 10, and day 20 of the study or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate | 12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute) | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval | 12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms) | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex | 12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms) | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc) | 12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms) | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: complete blood count - hemoglobin | Hemoglobin, g/dL | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: complete blood count - red blood cells | Red blood cells, 10^6/uL | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: complete blood count - hematocrit | Hematocrit, % | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: complete blood count - platelets | Platelets, 10^3/uL | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: complete blood count - white blood cells | White blood cells, 10^3/uL | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: complete blood count - erythrocyte sedimentation rate | Erythrocyte sedimentation rate, mm per hour | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: complete blood count - lymphocytes | Lymphocytes, % | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: complete blood count - eosinophils | Eosinophils, % | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: complete blood count - monocytes | Monocytes, % | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: complete blood count - basophils | Basophils, % | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: complete blood count - neutrophils | Neutrophils, % (segmented and stab) | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: blood test results - glucose | Glucose in blood serum, mmol/L | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: blood test results - total cholesterol | Total cholesterol in blood serum, mmol/L | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: blood test results - triglycerides | Triglycerides in blood serum, mmol/L | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: blood test results - total bilirubin | Total bilirubin in blood serum, umol/L | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: blood test results - total protein | Total protein in blood serum, g/L | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: blood test results - creatinine | Creatinine in blood serum, umol/L | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: blood test results - urea | Urea in blood serum, mmol/L | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: blood test results - aspartate transaminase (AST) | AST in blood serum, U/L | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: blood test results - alanine transaminase (ALT) | ALT in blood serum, U/L | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: blood test results - alkaline phosphatase (ALP) | ALP in blood serum, U/L | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: blood test results - creatine kinase (CK) | CK in blood serum, U/L | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: urinalysis - specific gravity | Specific gravity of the urine | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: urinalysis - color | Color of the urine | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: urinalysis - transparency | Transparency of the urine | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: urinalysis - pH | pH of the urine | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: urinalysis - protein | Protein in the urine (g/L) | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: urinalysis - glucose | Glucose in the urine (mmol/L) | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: urinalysis (microscopy) - red blood cells | Red blood cells in the urine (number in sight) | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: urinalysis (microscopy) - white blood cells | White blood cells in the urine (number in sight) | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: urinalysis (microscopy) - epithelial cells | Epithelial cells in the urine (number in sight) | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: urinalysis (microscopy) - cylinders | Cylinders in the urine (number in sight) | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: urinalysis (microscopy) - bacteria | Bacteria in the urine (number in sight) | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Safety and Tolerability: urinalysis (microscopy) - mucus | Presence of mucus in the urine | Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation |
| Medical Diagnostic Center "Medexpert", LLC |
| Engel's |
| Russia |
| Unimed-C Jsc | Moscow | 119571 | Russia |
| Professors' Clinic LLC. | Perm | 614070 | Russia |
| Limited Liability Company "Health Energy" | Saint Petersburg | 194156 | Russia |
| St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117" | Saint Petersburg | 194358 | Russia |
| Saint Petersburg State Budgetary Healthcare Institution "City polyclinic No. 112" | Saint Petersburg | 195427 | Russia |
| Limited Liability Company "Research Center Eco-Security" | Saint Petersburg | 196143 | Russia |
| Saint Petersburg State Budgetary Institution of Healthcare "City Pokrovskaya Hospital" | Saint Petersburg | 199106 | Russia |
| St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 4" | Saint Petersburg | 199178 | Russia |
| Limited Liability Company "Meili" | Saint Petersburg | 199406 | Russia |
| "Medical Clinic" Ltd. | Saint Petersburg | Russia |
| State budgetary institution of health care of the Yaroslavl region "Clinical Hospital No. 2" | Yaroslavl | 150030 | Russia |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000718222 | XC221 |
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