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XC8 in the Treatment of Patients With Acute Respiratory Viral Infection

Primary Purpose

Influenza, Acute Respiratory Infection

Status

Completed

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

XC8 20 mg

XC8 100 mg

XC8 200 mg

Placebo

About this trial

This is an interventional treatment trial for Influenza

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 other acute or moderate ARVI based on the patient's body temperature ≥37.5ºС, nasal congestion or profuse rhinorrhea and at least 1 of the following symptoms of intoxication: headache, general malaise, myalgia, pain in the eyeballs.
Uncomplicated course of ARVI or influenza.
The onset of symptoms no more than 36h prior to the inclusion into the study.
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 Informant Consent Form.

Exclusion Criteria:

The patient will be deemed ineligible for the study meeting any of the following criteria:

Complicated course of influenza or ARVI (including the presence / development of bacterial infection).
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.
Hypersensitivity to excipients of the XC8.
Diabetes mellitus, lactose intolerance, lactase deficiency.
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.
Only for patients participating in Phase III study: Patient involvement in the first part of the study (Phase II) of FLU-XC8-01.
-

Sites / Locations

Udmurt Republic Budgetary Healthcare Institution "City clinical Hospital #9 of the Ministry of Health of the Udmurt Republic
State Educational Institution for further vocational education "Kazan State Medical Academy of Federal Healthcare Agency", Clinical site - State Independent Healthcare Institution "Republic Infectious Clinical Hospital n.a. professor Agafonov",
State Budgetary Institution of Higher Professional Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation
Nizhegorodsky region SBHI Nizhniy Novgorod Infectious Regional Clinical Hospital № 2
Novosibirsk Municipal Healthcare Budgetary Institution "City Clinical Hospital # 19",
Novosibirsk region SBHI "City Infectious Clinical Hospital # 1",
; Moscow region State Budgetary Institution "Podolsk City Clinical Hospital № 3"
Municipal State Budgetary Institution "Rostov-on-Don City Clinical Hospital# 1 n.a. Semashko",
State Budgetary Institution of Higher Professional Education "Ryazan State Medical University n.a. Pavlov" of the Ministry of Health of the Russian Federation, Clinical site - SBHI of Ryazan region "Clinical Hospital n.a. Semashko"
ArsVite Severo-Zapad LLC
Federal State Budgetary institution "Diagnostic center with polyclinics" of the Administrative Department of the President of the Russian Federation
Federal State Budgetary Institution "Research institute of influenza" of the Ministry of Health of the Russian Federation
Saint Petersburg SHBI "City Clinical Hospital #40 of health resort administrative region"
Federal State Budgetary Institution Mordovia State Medical University n..a. N.P.Ogarev, Mordovia Republic SHBI "Republic Infectious Clinical Hospital"
State Budgetary Institution of Higher Professional Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation
State Budgetary Institution of Higher Professional Education "Volgograd State Medical University" of the Ministry of Health of the Russian Federation, Clinical site - Infectious Regional Clinical Hospital № 1
State Budgetary Institution of Higher Professional Education "Yaroslavl State Medical University" of the Ministry of Health of the Russian Federation, Clinical site - Yaroslavl region State Healthcare Institution Infectious Regional Clinical Hospital # 1
State Budgetary Healthcare Institution (SBHI) of Yaroslavl region

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

XC8 20 mg and Placebo (Group A)

XC8 100 mg and Placebo (Group B)

XC8 200 mg and Placebo (Group C)

Placebo (Group D)

Arm Description

XC8 20 mg orally. 2 tablets of XC8 10 mg +2 tablets of Placebo 100 mg (in total 4 tablets) once daily during 5 days of treatment period

XC8 100 mg orally. 1 tablet of XC8 100 mg +2 tablets of Placebo 10 mg + 1 tablet of Placebo 100 mg (in total 4 tablets) once daily during 5 days of treatment period

XC8 200 mg orally. 2 tablets of XC8 100 mg +2 tablets of Placebo 10 mg (in total 4 tablets) once daily during 5 days of treatment period.

Placebo orally.

Outcomes

Primary Outcome Measures

Time to sustained improvement in clinical symptoms

Severity Rating Scale for ARVI (<2 points, provided that there is ≤ 1 point for one symptom) with temperature normalization (<37°C) (estimated by Kaplan-Meier), established according to patient diaries.

Secondary Outcome Measures

Body temperature below 37°C without further elevation

Time to normalization of body temperature since the symptoms onset, measured in hours

Full Information

NCT ID

NCT03441373

First Posted

February 14, 2018

Last Updated

February 21, 2018

Sponsor

PHARMENTERPRISES LLC

1. Study Identification

Unique Protocol Identification Number

NCT03441373

Brief Title

XC8 in the Treatment of Patients With Acute Respiratory Viral Infection

Official Title

Clinical Study to Assess Efficacy, Safety, Tolerability and Optimal Dose Ranging of XC8 in Doses 20, 100 and 200 mg Once Daily in Patients With Uncomplicated Influenza or Other Acute Respiratory Viral Infections (ARVI)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

February 3, 2016 (Actual)

Primary Completion Date

February 9, 2017 (Actual)

Study Completion Date

February 9, 2017 (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-blind, randomized, placebo-controlled, parallel-group comparative Phase II / III clinical study to assess safety, tolerability, efficacy and optimal dose ranging of XC8 vs. placebo in patients with uncomplicated influenza or other ARVI during a 5-day treatment. The primary objective of the study was to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Severity Rating Scale for ARVI, and to determine the optimal dose of XC8 in the treatment of influenza and other ARVI.

Detailed Description

Twenty-three Russian centers were approved for participation in this study. Twenty centers were initiated. Patients were enrolled in 18 centers. The study consisted of two parts: phase II and phase III. Each of the parts included 3 periods: screening, treatment, follow-up. In the first part of the study (Phase II), all eligible patients were randomized into 4 groups (groups A, B, C, and D) in a 1:1:1:1 ratio: Group A - XC8 20 mg daily (40 patients); Group B - XC8 100 mg daily (40 patients); Group C - XC8 200 mg daily (40 patients); Group D - placebo (40 patients). Interim analysis was planned after the end of the first part of the study (Phase II). Based on the results of the interim analysis, the most promising XC8 dose group was selected and the necessary set was calculated to compare this group with the placebo group by the primary endpoint in a pooled set using an adaptive design with type I error control. In the second part of the study (Phase III), all eligible patients were randomized into 2 groups (groups C and D) in a 1:1 ratio: Group C - XC8 200 mg daily (80 patients); Group D - placebo (80 Patients). During the treatment period (5 days), patients received XC8 / placebo daily on a background of standard symptomatic therapy. The follow-up period lasted for 9 days.

6. Conditions and Keywords

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

Influenza, Acute Respiratory Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

320 (Actual)

8. Arms, Groups, and Interventions

Arm Title

XC8 20 mg and Placebo (Group A)

Arm Type

Experimental

Arm Description

XC8 20 mg orally. 2 tablets of XC8 10 mg +2 tablets of Placebo 100 mg (in total 4 tablets) once daily during 5 days of treatment period

Arm Title

XC8 100 mg and Placebo (Group B)

Arm Type

Experimental

Arm Description

XC8 100 mg orally. 1 tablet of XC8 100 mg +2 tablets of Placebo 10 mg + 1 tablet of Placebo 100 mg (in total 4 tablets) once daily during 5 days of treatment period

Arm Title

XC8 200 mg and Placebo (Group C)

Arm Type

Experimental

Arm Description

XC8 200 mg orally. 2 tablets of XC8 100 mg +2 tablets of Placebo 10 mg (in total 4 tablets) once daily during 5 days of treatment period.

Arm Title

Placebo (Group D)

Arm Type

Placebo Comparator

Arm Description

Placebo orally.

Intervention Type

Drug

Intervention Name(s)

XC8 20 mg

Other Intervention Name(s)

Нistamine glutarimide

Intervention Description

once daily during 5 days.

Intervention Type

Drug

Intervention Name(s)

XC8 100 mg

Other Intervention Name(s)

Нistamine glutarimide

Intervention Description

once daily during 5 days.

Intervention Type

Drug

Intervention Name(s)

XC8 200 mg

Other Intervention Name(s)

Нistamine glutarimide

Intervention Description

once daily during 5 days.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

once daily during 5 days.

Primary Outcome Measure Information:

Title

Time to sustained improvement in clinical symptoms

Description

Time Frame

up to Day 5

Secondary Outcome Measure Information:

Title

Body temperature below 37°C without further elevation

Description

Time to normalization of body temperature since the symptoms onset, measured in hours

Time Frame

up to Day 8

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 other acute or moderate ARVI based on the patient's body temperature ≥37.5ºС, nasal congestion or profuse rhinorrhea and at least 1 of the following symptoms of intoxication: headache, general malaise, myalgia, pain in the eyeballs. Uncomplicated course of ARVI or influenza. The onset of symptoms no more than 36h prior to the inclusion into the study. 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 Informant Consent Form. Exclusion Criteria: The patient will be deemed ineligible for the study meeting any of the following criteria: Complicated course of influenza or ARVI (including the presence / development of bacterial infection). 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. Hypersensitivity to excipients of the XC8. Diabetes mellitus, lactose intolerance, lactase deficiency. 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. Only for patients participating in Phase III study: Patient involvement in the first part of the study (Phase II) of FLU-XC8-01. -

Facility Information:

Facility Name

Udmurt Republic Budgetary Healthcare Institution "City clinical Hospital #9 of the Ministry of Health of the Udmurt Republic

City

Izhevsk

ZIP/Postal Code

426063

Country

Russian Federation

Facility Name

State Educational Institution for further vocational education "Kazan State Medical Academy of Federal Healthcare Agency", Clinical site - State Independent Healthcare Institution "Republic Infectious Clinical Hospital n.a. professor Agafonov",

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

State Budgetary Institution of Higher Professional Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation

City

Krasnodar

ZIP/Postal Code

350063

Country

Russian Federation

Facility Name

Nizhegorodsky region SBHI Nizhniy Novgorod Infectious Regional Clinical Hospital № 2

City

Nizhny Novgorod

ZIP/Postal Code

603022

Country

Russian Federation

Facility Name

Novosibirsk Municipal Healthcare Budgetary Institution "City Clinical Hospital # 19",

City

Novosibirsk

ZIP/Postal Code

630068

Country

Russian Federation

Facility Name

Novosibirsk region SBHI "City Infectious Clinical Hospital # 1",

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

; Moscow region State Budgetary Institution "Podolsk City Clinical Hospital № 3"

City

Podolsk

ZIP/Postal Code

142105

Country

Russian Federation

Facility Name

Municipal State Budgetary Institution "Rostov-on-Don City Clinical Hospital# 1 n.a. Semashko",

City

Rostov-on-Don

ZIP/Postal Code

344000

Country

Russian Federation

Facility Name

State Budgetary Institution of Higher Professional Education "Ryazan State Medical University n.a. Pavlov" of the Ministry of Health of the Russian Federation, Clinical site - SBHI of Ryazan region "Clinical Hospital n.a. Semashko"

City

Ryazan'

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

ArsVite Severo-Zapad LLC

City

Saint Petersburg

ZIP/Postal Code

194223

Country

Russian Federation

Facility Name

Federal State Budgetary institution "Diagnostic center with polyclinics" of the Administrative Department of the President of the Russian Federation

City

Saint Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

Federal State Budgetary Institution "Research institute of influenza" of the Ministry of Health of the Russian Federation

City

Saint Petersburg

ZIP/Postal Code

197376

Country

Russian Federation

Facility Name

Saint Petersburg SHBI "City Clinical Hospital #40 of health resort administrative region"

City

Saint Petersburg

ZIP/Postal Code

197706

Country

Russian Federation

Facility Name

Federal State Budgetary Institution Mordovia State Medical University n..a. N.P.Ogarev, Mordovia Republic SHBI "Republic Infectious Clinical Hospital"

City

Saransk

ZIP/Postal Code

430024

Country

Russian Federation

Facility Name

State Budgetary Institution of Higher Professional Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation

City

Tomsk

ZIP/Postal Code

, 634050

Country

Russian Federation

Facility Name

State Budgetary Institution of Higher Professional Education "Volgograd State Medical University" of the Ministry of Health of the Russian Federation, Clinical site - Infectious Regional Clinical Hospital № 1

City

Volgograd

ZIP/Postal Code

400131

Country

Russian Federation

Facility Name

State Budgetary Institution of Higher Professional Education "Yaroslavl State Medical University" of the Ministry of Health of the Russian Federation, Clinical site - Yaroslavl region State Healthcare Institution Infectious Regional Clinical Hospital # 1

City

Yaroslavl

ZIP/Postal Code

150000

Country

Russian Federation

Facility Name

State Budgetary Healthcare Institution (SBHI) of Yaroslavl region

City

Yaroslavl

ZIP/Postal Code

150007

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

XC8 in the Treatment of Patients With Acute Respiratory Viral Infection

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