XC8 in the Treatment of Patients With Acute Respiratory Viral Infection

NCT03441373 | Completed Phase 2

• 1 other identifier: FLU-XC8-01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 18

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.

Conditions

Influenza; Acute Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  up to Day 5

Secondary Outcomes (1)

• Body temperature below 37°C without further elevation

  up to Day 8

Study Arms (4)

XC8 20 mg and Placebo (Group A)

EXPERIMENTAL

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

Drug: XC8 20 mg

XC8 100 mg and Placebo (Group B)

EXPERIMENTAL

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

Drug: XC8 100 mg

XC8 200 mg and Placebo (Group C)

EXPERIMENTAL

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.

Drug: XC8 200 mg

Placebo (Group D)

PLACEBO COMPARATOR

Placebo orally.

Drug: XC8 20 mg; Drug: XC8 100 mg; Drug: XC8 200 mg; Drug: Placebo

Interventions

XC8 20 mg DRUG

once daily during 5 days.

Also known as: Нistamine glutarimide

Placebo (Group D); XC8 20 mg and Placebo (Group A)

XC8 100 mg DRUG

once daily during 5 days.

Also known as: Нistamine glutarimide

Placebo (Group D); XC8 100 mg and Placebo (Group B)

XC8 200 mg DRUG

once daily during 5 days.

Also known as: Нistamine glutarimide

Placebo (Group D); XC8 200 mg and Placebo (Group C)

Placebo DRUG

once daily during 5 days.

Placebo (Group D)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PHARMENTERPRISES LLC: lead

Study Sites (18)

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

Izhevsk, 426063, Russia

Location

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",

Kazan', 420012, Russia

Location

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

Krasnodar, 350063, Russia

Location

Nizhegorodsky region SBHI Nizhniy Novgorod Infectious Regional Clinical Hospital № 2

Nizhny Novgorod, 603022, Russia

Location

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

Novosibirsk, 630068, Russia

Location

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

Novosibirsk, 630099, Russia

Location

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

Podolsk, 142105, Russia

Location

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

Rostov-on-Don, 344000, Russia

Location

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"

Ryazan, 390026, Russia

Location

ArsVite Severo-Zapad LLC

Saint Petersburg, 194223, Russia

Location

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

Saint Petersburg, 197110, Russia

Location

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

Saint Petersburg, 197376, Russia

Location

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

Saint Petersburg, 197706, Russia

Location

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

Saransk, 430024, Russia

Location

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

Tomsk, , 634050, Russia

Location

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

Volgograd, 400131, Russia

Location

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

Yaroslavl, 150000, Russia

Location

State Budgetary Healthcare Institution (SBHI) of Yaroslavl region

Yaroslavl, 150007, Russia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: February 22, 2018
• Study Start: February 3, 2016
• Primary Completion: February 9, 2017
• Study Completion: February 9, 2017
• Last Updated: February 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (18)