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Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections

Primary Purpose

Acute Respiratory Viral Infections, Influenza

Status

Completed

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

XC221 100 mg

XC221 200 mg

Placebo

About this trial

This is an interventional treatment trial for Acute Respiratory Viral Infections

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women aged 18 to 45 years (inclusively).
Clinically diagnosed influenza or ARVI.
Patient's body temperature ≥37.5ºС and at least 1 symptom from Modified Jackson Scale estimated more than 2 points.
Uncomplicated course of influenza or ARVI based on clinical estimations.
The first 36 hours from the beginning of symptoms of influenza or ARVI.
Women of reproductive age (who are not in menopause and who have not undergone surgical sterilization) and men who have sexual activity should use a reliable method of contraception (acceptable methods of contraception in this study are: intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, a double barrier method (condom and diaphragm with spermicide) throughout the study period.
Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol.
Signed Informed Consent Form.

Exclusion Criteria:

Existence of complications of influenza or ARVI (including the presence / development of bacterial infection).
Hypersensitivity to excipients of the drug XC221 or placebo.
Antiviral medications in 7 days prior to screening (antiviral agents, interferons and interferon inducers, drugs that have immunomodulating action) or anti-infective agents of systemic or local action.
Severe infection with signs of cardiovascular insufficiency development and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions, polyradiculoneuritis, neuritis).
Signs of the development of viral pneumonia (the presence of two or more of the following symptoms): dyspnea, chest pain when coughing, systemic cyanosis, dullness of percussion sound with a symmetrical evaluation of the upper and lower sections of the lungs).
Infectious diseases during the last week before including into the study.
History of bronchial asthma.
History of increased convulsive activity.
Severe, decompensated or unstable somatic diseases (any diseases or conditions that are life-threatening or may worsen the patient's prognosis, and make him/her ineligible for the clinical study).
History of oncological diseases, HIV, tuberculosis.
Diabetes mellitus.
Drug or alcohol abuse.
Participation in any other clinical trial in the last 90 days.
Pregnancy or lactation.
Military or prison populations.
Impossibility or inability to comply with the study procedures.
A member of the investigator's family or other person interested in the results of the study.
Abnormal laboratory results, which, according to the study doctor, interfere with the patient's inclusion in the study.
History of renal insufficiency.

Sites / Locations

City Clinical Hospital №9
Kuban State Medical University
City Clinical Hospital №1 n.a. Semashko
Ryazan State Medical University n.a. Pavlov
The Center for Prevention and Fight about AIDS and Infectious Diseases
The Consulting and Diagnostic Center with out-patient help of the Administration of the President of the Russian Federation
Research Institute of Influenza
City Clinical Hospital №40 of Kurortny District
Mordovia State Medical University n.a. N.P.Ogarev, Clinical site - Republic Infectious Clinical Hospital
Volgograd State Medical University, Clinical site - Infectious Regional Clinical Hospital № 1
Сlinical Hospital №3

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

XC221 100 mg

XC221 200 mg

Placebo

Arm Description

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

XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period

Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period

Outcomes

Primary Outcome Measures

Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI

The time before the onset of sustained improvement in clinical symptoms according to the Modified Jackson Scale (no more than 1 point for each symptom), measured in hours from the moment of the first dose of the drug. Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.

Secondary Outcome Measures

Time to Body Temperature Normalization

Time to body temperature normalization since treatment initiation, measured in hours (normalization is regarded as setting of body temperature below 37°C without elevation above these values)

Percentage of Patients With Complications

The percentage of patients with complications of influenza/acute viral URI

The Area Under the Curve "Modified Jackson Scale Score" During 3-day Therapy

Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.

Full Information

NCT ID

NCT03455491

First Posted

February 28, 2018

Last Updated

October 14, 2019

Sponsor

PHARMENTERPRISES LLC

1. Study Identification

Unique Protocol Identification Number

NCT03455491

Brief Title

Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

February 12, 2018 (Actual)

Primary Completion Date

June 28, 2018 (Actual)

Study Completion Date

June 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PHARMENTERPRISES LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Viral Infections, Influenza

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Blinding will carried out by using Placebo equivalent to XC221 tablets without active substance and the corresponding labeling of the study drug.

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

XC221 100 mg

Arm Type

Experimental

Arm Description

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

Arm Title

XC221 200 mg

Arm Type

Experimental

Arm Description

XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period

Intervention Type

Drug

Intervention Name(s)

XC221 100 mg

Intervention Description

once daily during 3 days.

Intervention Type

Drug

Intervention Name(s)

XC221 200 mg

Intervention Description

once daily during 3 days.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

once daily during 3 days.

Primary Outcome Measure Information:

Title

Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI

Description

Time Frame

From the time of randomization up to Day 14

Secondary Outcome Measure Information:

Title

Time to Body Temperature Normalization

Description

Time to body temperature normalization since treatment initiation, measured in hours (normalization is regarded as setting of body temperature below 37°C without elevation above these values)

Time Frame

From the time of randomization assessed up to Day 14

Title

Percentage of Patients With Complications

Description

The percentage of patients with complications of influenza/acute viral URI

Time Frame

From the time of randomization up to Day 14

Title

The Area Under the Curve "Modified Jackson Scale Score" During 3-day Therapy

Description

Time Frame

From randomization up to 3 days of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women aged 18 to 45 years (inclusively). Clinically diagnosed influenza or ARVI. Patient's body temperature ≥37.5ºС and at least 1 symptom from Modified Jackson Scale estimated more than 2 points. Uncomplicated course of influenza or ARVI based on clinical estimations. The first 36 hours from the beginning of symptoms of influenza or ARVI. Women of reproductive age (who are not in menopause and who have not undergone surgical sterilization) and men who have sexual activity should use a reliable method of contraception (acceptable methods of contraception in this study are: intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, a double barrier method (condom and diaphragm with spermicide) throughout the study period. Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol. Signed Informed Consent Form. Exclusion Criteria: Existence of complications of influenza or ARVI (including the presence / development of bacterial infection). Hypersensitivity to excipients of the drug XC221 or placebo. Antiviral medications in 7 days prior to screening (antiviral agents, interferons and interferon inducers, drugs that have immunomodulating action) or anti-infective agents of systemic or local action. Severe infection with signs of cardiovascular insufficiency development and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions, polyradiculoneuritis, neuritis). Signs of the development of viral pneumonia (the presence of two or more of the following symptoms): dyspnea, chest pain when coughing, systemic cyanosis, dullness of percussion sound with a symmetrical evaluation of the upper and lower sections of the lungs). Infectious diseases during the last week before including into the study. History of bronchial asthma. History of increased convulsive activity. Severe, decompensated or unstable somatic diseases (any diseases or conditions that are life-threatening or may worsen the patient's prognosis, and make him/her ineligible for the clinical study). History of oncological diseases, HIV, tuberculosis. Diabetes mellitus. Drug or alcohol abuse. Participation in any other clinical trial in the last 90 days. Pregnancy or lactation. Military or prison populations. Impossibility or inability to comply with the study procedures. A member of the investigator's family or other person interested in the results of the study. Abnormal laboratory results, which, according to the study doctor, interfere with the patient's inclusion in the study. History of renal insufficiency.

Facility Information:

Facility Name

City Clinical Hospital №9

City

Izhevsk

ZIP/Postal Code

426063

Country

Russian Federation

Facility Name

Kuban State Medical University

City

Krasnodar

ZIP/Postal Code

350063

Country

Russian Federation

Facility Name

City Clinical Hospital №1 n.a. Semashko

City

Rostov-on-Don

ZIP/Postal Code

344000

Country

Russian Federation

Facility Name

Ryazan State Medical University n.a. Pavlov

City

Ryazan'

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

The Center for Prevention and Fight about AIDS and Infectious Diseases

City

Saint Petersburg

ZIP/Postal Code

190103

Country

Russian Federation

Facility Name

The Consulting and Diagnostic Center with out-patient help of the Administration of the President of the Russian Federation

City

Saint Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

Research Institute of Influenza

City

Saint Petersburg

ZIP/Postal Code

197376

Country

Russian Federation

Facility Name

City Clinical Hospital №40 of Kurortny District

City

Saint Petersburg

ZIP/Postal Code

197706

Country

Russian Federation

Facility Name

Mordovia State Medical University n.a. N.P.Ogarev, Clinical site - Republic Infectious Clinical Hospital

City

Saransk

ZIP/Postal Code

430024

Country

Russian Federation

Facility Name

Volgograd State Medical University, Clinical site - Infectious Regional Clinical Hospital № 1

City

Volgograd

ZIP/Postal Code

400131

Country

Russian Federation

Facility Name

Сlinical Hospital №3

City

Yaroslavl

ZIP/Postal Code

150007

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections

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