Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections
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|ClinicalTrials.gov Identifier: NCT03455491|
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
A multicenter double-blinded, randomized, placebo-controlled, parallel-group comparative Phase II clinical study to assess safety, tolerability, efficacy and optimal dose of XC221 vs. placebo in patients with uncomplicated influenza or other ARVI during a 3-day treatment.
The primary objective of the study is to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Modified Jackson Scale for ARVI and to determine the optimal dose of XC221 in the treatment of influenza and other ARVI.
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Viral Infections Influenza||Drug: XC221 100 mg Drug: XC221 200 mg Drug: Placebo||Phase 2|
11 Russian centers were planned for participation in this study. The study consists of three periods: screening, treatment and follow-up.
All eligible patients will be randomized into 3 groups (groups A, B and C) in a 1:1:1 ratio:
Group A - XC221 100 mg daily (40 patients); Group B - XC221 200 mg daily (40 patients); Group C - Placebo (40 patients).
During the treatment period (3 days), patients will receive XC221 / placebo daily on a background of standard symptomatic therapy. The follow-up period lasts for 11 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Blinding will carried out by using Placebo equivalent to XC221 tablets without active substance and the corresponding labeling of the study drug.|
|Official Title:||Multicenter Double-blinded Placebo-Controlled Parallel-Group Randomized Clinical Trial of Efficacy, Safety and Choice of an Optimum Dose of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections in Adults|
|Actual Study Start Date :||February 12, 2018|
|Estimated Primary Completion Date :||January 31, 2019|
|Estimated Study Completion Date :||January 31, 2019|
Experimental: Group A
XC221 100 mg orally.
1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period
Drug: XC221 100 mg
once daily during 3 days.
Experimental: Group B
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
Drug: XC221 200 mg
once daily during 3 days.
Placebo Comparator: Group C
Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period
once daily during 3 days.
- Time to sustained improvement in clinical symptoms based on Modified Jackson Scale for ARVI [ Time Frame: From the time of randomization up to Day 14 ]Measured in hours Severity Rating Scale for ARVI
- Body temperature below 37°C without further elevation [ Time Frame: From the time of randomization until the time of body temperature below 37°C, assessed up to Day 14 ]Time to normalization of body temperature, measured in hours
- Percentage of patients with complications of ARVI or Influenza [ Time Frame: From the time of randomization up to Day 14 ]Existence of complications of ARVI or Influenza will be estimated, including secondary complications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455491
|City Clinical Hospital №9||Recruiting|
|Izhevsk, Russian Federation, 426063|
|Contact: Andrey V. Ejov +7 (912) 465 6758 firstname.lastname@example.org|
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|Krasnodar, Russian Federation, 350063|
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|Contact: Alina S. Agafina, PhD +7 921) 583 7808 firstname.lastname@example.org|
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|Saransk, Russian Federation, 430024|
|Contact: Vera F. Pavelkina, Prof +7 (906) 379 5641 email@example.com|
|Volgograd State Medical University, Clinical site - Infectious Regional Clinical Hospital № 1||Recruiting|
|Volgograd, Russian Federation, 400131|
|Contact: Mihail E. Statsenko, Prof +7 (927) 501 9583 firstname.lastname@example.org|
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