A Study to Evaluate the Safety and Efficacy of XC221 in Patients With Uncomplicated Influenza or … (NCT05544916) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Safety and Efficacy of XC221 in Patients With Uncomplicated Influenza or Other Acute Viral Upper Respiratory Infections
Russia260 participantsStarted 2022-08-05
Plain-language 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).
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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;
What they're measuring
1
Time (in hours) from the first dose of the drug to the resolution of all of the ARI symptoms/events