InfluenzaPhase 3NCT05544916
A Study to Evaluate the Safety and Efficacy of XC221 in Patients With Uncomplicated Influenza or Other Acute Viral Upper Respiratory Infections
A Phase 3 study testing XC221 in people with Influenza and Respiratory Viral Infection, run by Valenta Pharm JSC at 13 sites in Russia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza, Respiratory Viral Infection
- What is being tested?
- XC221
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 13 sitesRussia
- Study dates
- 5 Aug 2022to 4 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between the ages of 18 and 65 years inclusive;
- Presence of written consent to participate in the study in accordance with applicable law;
- Clinical signs of mild to moderate influenza or other acute respiratory infections (ARIs): an increase in body temperature, measured at the axilla, with a value between 38.0 °C and 39.5 °C, inclusive, during the current illness and without taking antipyretics within the last 8 h at the time of screening; at least one respiratory manifestation of influenza or other ARI (cough, runny nose/ stuffy nose, sore throat) of at least 2 points on a 4-point scale; at least one systemic manifestation of influenza or other ARI (headache, muscle pain, chills/sweating, fatigue) of at least 2 points on a 4-point scale.
- No indication for hospitalization at the time of enrollment in the study;
- Duration of illness from manifestation of symptoms to the first dose of study drug/placebo not more than 48 hours;
- Negative pregnancy test for women of preserved reproductive potential;
- Consent to use adequate contraceptive methods throughout the study and for 30 days after study completion;
- Ability to understand the requirements for study participants, to give written consent to participate in the study (including the use and communication of patient health information relevant to the study) and to comply with the procedures of the study protocol.
Who cannot join
- Pregnant and breastfeeding women;
- Known hypersensitivity to the study drug, including the active and/or excipients.
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption, galactose intolerance;
- Diagnosis of COVID-19 established or probable at present (based on examination and analysis of epidemiological history);
- Positive result of rapid test for SARS-CoV-2;
- Blood oxygen saturation (SpO2) ≤ 95%, respiratory rate ≥ 22/min.
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- Complicated course of influenza or other acute respiratory infections;
- Participation in any other clinical trial within 90 days prior to the screening period;
- Known (based on medical history) or suspected alcohol abuse, psychotropic drugs, drug dependence, drug addiction;
- Presence of mental illness, including a history of mental illness;
- Clinical suspicion of pneumonia or other bacterial infections (including sinusitis, otitis media, urinary tract infection, meningitis, sepsis, etc.) requiring prescription of antibacterial drugs;
- Taking antibiotics, antivirals, or immunomodulatory drugs for < 48 h before the study and/or plans to use these groups of drugs (other than the study drug) during the study;
- Use of systemic, inhaled, or nasal glucocorticosteroids within 30 days prior to the study and/or plans to use glucocorticosteroids (except topical cutaneous agents) during the study;
- Failure to withdraw for the duration of the study other medications that may affect the outcome of this study, such as antiviral medications, or medications that are incompatible with the study therapy;
- Any cardiovascular, renal, hepatic, gastrointestinal, endocrine or nervous system diseases, severe decompensated chronic (including chronic kidney disease and chronic liver disease) or acute diseases or any other condition/disease that, in the opinion of the investigator, would make it unsafe for the patient to participate in the study;
- Any vaccination of the patient within 90 days prior to inclusion in the study;
- Diabetes mellitus in decompensation;
- Obesity of 2-3 degrees (body mass index of 35 kg/m2 or more).
- Patients who have undergone surgery within 30 days prior to the Screening Visit and patients who are scheduled to undergo surgery, including diagnostic procedures, or a hospital stay during the study;
- The presence of cancer, including a history of cancer (with the exception of a cured tumor with sustained remission for more than 5 years);
- The presence of HIV infection, tuberculosis, including in the anamnesis;
- Meningeal syndrome;
- Disturbance of consciousness (in the form of stunting, soporus, delirium, delirium, etc.).
- Symptoms of pneumonia and possible acute respiratory distress syndrome (ARDS): cough with foaming sputum with blood, shortening of the pulmonary sound on percussion, a large number of different-caliber wet rales and abundant crepitation on auscultation, a sharp drop in blood pressure, deafness of heart tones and arrhythmia;
- Patient's refusal to use approved contraception or to completely abstain from sexual intercourse for the duration of study participation, beginning at Visit 1, and for 30 days after completion of study participation;
- Other reasons that, in the opinion of the investigator, prevent the patient from participating in the study or create an unreasonable risk.
- Withdrawal Criteria:
- Patient's desire to stop participating in the study (withdrawal of informed consent). Each patient has the right to stop participating in the study at any time without giving a reason. Withdrawal from the study will not affect the medical care provided to the patient in the future.
- The decision by the research physician that the patient should be excluded is in the patient's own interest;
- The need to prescribe etiotropic or any other treatment prohibited in the study, as determined by the investigating physician.
- Patient refuses to cooperate with the investigator or is undisciplined;
- Causes/occurrence during the study of situations that threaten patient safety (e.g., hypersensitivity reactions, serious adverse events, etc.);
- Inclusion of a patient in the study with inclusion/inclusion criteria not met (prior to randomization);
- Significant treatment failure; Significant failure is defined as a) skipping study drug/placebo for 2 consecutive days or more or b) taking, in total, < 80% or > 120% of the full course (full course = 10 pills).
- Positive pregnancy test;
- A confirmed diagnosis of COVID-19;
- Occurrence in the course of the study of other reasons that prevent the study according to the protocol.
- Death of a patient.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Russia13 sites
State autonomous health care institution "Engels City Clinical Hospital No. 1"
Engel's, 413116
Medical Diagnostic Center "Medexpert", LLC
Engel's
Unimed-C Jsc
Moscow, 119571
Professors' Clinic LLC.
Perm, 614070
Limited Liability Company "Health Energy"
Saint Petersburg, 194156
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
Saint Petersburg, 194358
Saint Petersburg State Budgetary Healthcare Institution "City polyclinic No. 112"
Saint Petersburg, 195427
Limited Liability Company "Research Center Eco-Security"
Saint Petersburg, 196143
Saint Petersburg State Budgetary Institution of Healthcare "City Pokrovskaya Hospital"
Saint Petersburg, 199106
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 4"
Saint Petersburg, 199178
Limited Liability Company "Meili"
Saint Petersburg, 199406
"Medical Clinic" Ltd.
Saint Petersburg
State budgetary institution of health care of the Yaroslavl region "Clinical Hospital No. 2"
Yaroslavl, 150030
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Comparative, Multicenter Phase III Clinical Trial to Study the Clinical Efficacy and Safety of XC221, Tablets, 100 mg in Patients With Uncomplicated Influenza or Other Acute Respiratory Viral Infections
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.
- Conditions
- Influenza, Respiratory Viral Infection
- Being tested
- XC221, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC221Drug
200 mg/day, for 5 days
PlaceboDrug
2 tablets/day, for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: XC221 |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- nasal congestion/runny nose;
- sore throat;
- cough;
- muscle aches;
- headaches;
- fatigue;
- chills/sweats. Patients will assess and record the severity of all symptoms 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.
Measured: Day 1 - Day 10
Secondary outcomes (66)
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
Measured: Day 1 - Day 10
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 - Day 10
Time till elimination viruses based on qualitative polymerase chain reaction (PCR) test
Time to the first negative PCR test)
Measured: Day 1 - Day 10
The need for paracetamol or ibuprofen: daily dose on days 1-10
Dose of paracetamol or ibuprofen taken
Measured: Day 1 - Day 10
Safety and Tolerability: adverse event (AE) rate
Number and frequency of adverse events (AEs) or serious AEs (SAEs)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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, %
Measured: 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
Measured: 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
Measured: 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
Measured: 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, %
Measured: 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, %
Measured: 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, %
Measured: 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, %
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start5 Aug 2022
- Primary completion1 Feb 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Valenta Pharm JSCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544916
- Sponsor's protocol ID
- XC221-03-04-2022
- Status last verified
- Oct 2023
- First submitted
- 14 Sep 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Comparative, Multicenter Phase III Clinical Trial to Study the Clinical Efficacy and Safety of XC221, Tablets, 100 mg in Patients With Uncomplicated Influenza or Other Acute Respiratory Viral Infections
- ClinicalTrials.gov ID
- NCT05544916
- Acronym / sponsor ID
- XC221-03-04-2022
- Conditions
- Influenza, Respiratory Viral Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XC221 | Experimental | Drug: XC221Patients 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 | Drug: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women between the ages of 18 and 65 years inclusive;
- Presence of written consent to participate in the study in accordance with applicable law;
- Clinical signs of mild to moderate influenza or other acute respiratory infections (ARIs): an increase in body temperature, measured at the axilla, with a value between 38.0 °C and 39.5 °C, inclusive, during the current illness and without taking antipyretics within the last 8 h at the time of screening; at least one respiratory manifestation of influenza or other ARI (cough, runny nose/ stuffy nose, sore throat) of at least 2 points on a 4-point scale; at least one systemic manifestation of influenza or other ARI (headache, muscle pain, chills/sweating, fatigue) of at least 2 points on a 4-point scale.
- No indication for hospitalization at the time of enrollment in the study;
- Duration of illness from manifestation of symptoms to the first dose of study drug/placebo not more than 48 hours;
Key exclusion criteria (38 listed)
- Pregnant and breastfeeding women;
- Known hypersensitivity to the study drug, including the active and/or excipients.
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption, galactose intolerance;
- Diagnosis of COVID-19 established or probable at present (based on examination and analysis of epidemiological history);
- Positive result of rapid test for SARS-CoV-2;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XC221200 mg/day, for 5 days | Drug | XC221 |
| Placebo2 tablets/day, for 5 days | Drug | Placebo |
Primary outcome
Time (in hours) from the first dose of the drug to the resolution of all of the ARI symptoms/events
Time frame: Day 1 - Day 10
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: * nasal congestion/runny nose; * sore throat; * cough; * muscle aches; * headaches; * fatigue; * chills/sweats. Patients will assess and record the severity of all symptoms 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.
66 secondary outcomes
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)
Time frame: Day 1 - Day 10
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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Day 1 - Day 6
Frequency complications of influenza or other viral upper respiratory tract infections (URIs)
Time frame: Day 1 - Day 10
Time till elimination viruses based on qualitative polymerase chain reaction (PCR) test
Time frame: Day 1 - Day 10
The need for paracetamol or ibuprofen: daily dose on days 1-10
Time frame: Day 1 - Day 10
Safety and Tolerability: adverse event (AE) rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing XC221 in people with Influenza and Respiratory Viral Infection, run by Valenta Pharm JSC at 13 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (in hours) from the first dose of the drug to the resolution of all of the ARI symptoms/events (time frame: Day 1 - Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.