A Study to Evaluate the Safety, Tolerability and Efficacy of XC221 in Patients With Uncomplicated… (NCT05030324) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Safety, Tolerability and Efficacy of XC221 in Patients With Uncomplicated Influenza or Other Acute Viral Upper Respiratory Infections
Russia255 participantsStarted 2021-10-01
Plain-language summary
A multicenter, randomized, double-blind, placebo controlled comparative study to evaluate the safety, tolerability and efficacy of XC221 used at 100 mg daily and at 200 mg daily in patients with uncomplicated influenza or other acute viral upper respiratory infections (URIs) for 5 days of treatment.
The primary objective of the study is to evaluate the efficacy of ХС221 at 100 mg and at 200 mg in comparison with placebo regarding its effect on the severity and duration of influenza symptoms and symptoms of other viral URIs (fever and other major signs and symptoms).
The secondary objective of the study is to evaluate the safety of ХС221 at 100 mg and at 200 mg in comparison with placebo in the treatment of influenza ad other viral URIs.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Men and women aged 18 to 65 years (inclusive);
✓. Signed Informed Consent Form;
✓. Clinical symptoms of mild to moderate influenza and other viral URIs:
✓. Absence of indications for hospitalization at the time of enrollment;
✓. Duration of illness from symptom manifestation to the first drug dose/placebo no more than 48 h;
✓. Negative pregnancy test for women of childbearing potential;
✓. A consent to use adequate birth control methods throughout the treatment and for 30 days thereafter;
✓. Patients who are able to understand and comply with treatment and procedures during the study.
Exclusion criteria
✕. Pregnant and lactating women;
✕. Known or suspected hypersensitivity to the active substance or to excipients of the drug XC221 or placebo;
What they're measuring
1
Time (in hours) from the first dose of the drug to the resolution of all of the following symptoms/events.
✕. An established or currently suspected diagnosis (based on the assessment of the patient's health and epidemiological medical history) of COVID-19;