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Completed

NCT Number: NCT05544916

A Study to Evaluate the Safety and Efficacy of XC221 in Patients With Uncomplicated Influenza or Other Acute Viral Upper Respiratory 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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Respiratory Viral Infection Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Diagnostic Center "Medexpert", LLC, Engel's, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

XC221

Drug

200 mg/day, for 5 days

Placebo

Drug

2 tablets/day, for 5 days

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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

  2. 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

    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

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  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

    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.

  7. 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

    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.

  8. 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

    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.

  9. 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

    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.

  10. 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

    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.

  11. 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

    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.

  12. 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

    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.

  13. 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

    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.

  14. 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

    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.

  15. 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

    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.

  16. Frequency complications of influenza or other viral upper respiratory tract infections (URIs)

    Time frame: Day 1 - Day 10

    Frequency complications of influenza or other viral URIs: sinusitis, otitis, bronchitis, pneumonia.

  17. Time till elimination viruses based on qualitative polymerase chain reaction (PCR) test

    Time frame: Day 1 - Day 10

    Time to the first negative PCR test)

  18. The need for paracetamol or ibuprofen: daily dose on days 1-10

    Time frame: Day 1 - Day 10

    Dose of paracetamol or ibuprofen taken

  19. 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

    Number and frequency of adverse events (AEs) or serious AEs (SAEs)

  20. 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

    Number and frequency of AEs or SAEs) associated with the study drug

  21. 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

    Percentage of patients who discontinued treatment due to the occurrence of AEs/SAEs

  22. 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

    Frequency of need for hospitalization due to AEs/SAEs

  23. 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

    SBP, mmHg

  24. 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

    DBP, mmHg

  25. 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

    RR, breaths per minute

  26. 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

    HR, beats per minute

  27. 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

    Body temperature, centigrade scale

  28. 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

    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.

  29. 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

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute)

  30. 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

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms)

  31. 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

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms)

  32. 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

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms)

  33. 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

    Hemoglobin, g/dL

  34. 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

    Red blood cells, 10^6/uL

  35. 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

    Hematocrit, %

  36. 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

    Platelets, 10^3/uL

  37. 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

    White blood cells, 10^3/uL

  38. 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

    Erythrocyte sedimentation rate, mm per hour

  39. 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

    Lymphocytes, %

  40. 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

    Eosinophils, %

  41. Safety and Tolerability: complete blood count - monocytes

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Monocytes, %

  42. Safety and Tolerability: complete blood count - basophils

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Basophils, %

  43. Safety and Tolerability: complete blood count - neutrophils

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Neutrophils, % (segmented and stab)

  44. Safety and Tolerability: blood test results - glucose

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Glucose in blood serum, mmol/L

  45. Safety and Tolerability: blood test results - total cholesterol

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Total cholesterol in blood serum, mmol/L

  46. Safety and Tolerability: blood test results - triglycerides

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Triglycerides in blood serum, mmol/L

  47. Safety and Tolerability: blood test results - total bilirubin

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Total bilirubin in blood serum, umol/L

  48. Safety and Tolerability: blood test results - total protein

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Total protein in blood serum, g/L

  49. Safety and Tolerability: blood test results - creatinine

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Creatinine in blood serum, umol/L

  50. Safety and Tolerability: blood test results - urea

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Urea in blood serum, mmol/L

  51. Safety and Tolerability: blood test results - aspartate transaminase (AST)

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    AST in blood serum, U/L

  52. Safety and Tolerability: blood test results - alanine transaminase (ALT)

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    ALT in blood serum, U/L

  53. Safety and Tolerability: blood test results - alkaline phosphatase (ALP)

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    ALP in blood serum, U/L

  54. Safety and Tolerability: blood test results - creatine kinase (CK)

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    CK in blood serum, U/L

  55. Safety and Tolerability: urinalysis - specific gravity

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Specific gravity of the urine

  56. Safety and Tolerability: urinalysis - color

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Color of the urine

  57. Safety and Tolerability: urinalysis - transparency

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Transparency of the urine

  58. Safety and Tolerability: urinalysis - pH

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    pH of the urine

  59. Safety and Tolerability: urinalysis - protein

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Protein in the urine (g/L)

  60. Safety and Tolerability: urinalysis - glucose

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Glucose in the urine (mmol/L)

  61. Safety and Tolerability: urinalysis (microscopy) - red blood cells

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Red blood cells in the urine (number in sight)

  62. Safety and Tolerability: urinalysis (microscopy) - white blood cells

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    White blood cells in the urine (number in sight)

  63. Safety and Tolerability: urinalysis (microscopy) - epithelial cells

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Epithelial cells in the urine (number in sight)

  64. Safety and Tolerability: urinalysis (microscopy) - cylinders

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Cylinders in the urine (number in sight)

  65. Safety and Tolerability: urinalysis (microscopy) - bacteria

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Bacteria in the urine (number in sight)

  66. Safety and Tolerability: urinalysis (microscopy) - mucus

    Time frame: Screening, day 6, or on the early termination visit, whichever came first, within 20 days of study participation

    Presence of mucus in the urine

Sponsors and collaborators

Lead sponsor

Valenta Pharm JSC

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2022
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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