XC8 in the Treatment of Patients With Acute Respiratory Viral Infection

Influenza Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441373
• Other study ID #: FLU-XC8-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 14, 2018
• Last updated: February 21, 2018
• Start date: February 3, 2016
• Est. completion date: February 9, 2017

Study information

• Verified date: February 2018
• Source: PHARMENTERPRISES LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: February 9, 2017
• Est. primary completion date: February 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Men and women aged 18 to 45 years (inclusively).

2. Clinically diagnosed influenza or other acute or moderate ARVI based on the patient's body temperature =37.5º?, nasal congestion or profuse rhinorrhea and at least 1 of the following symptoms of intoxication: headache, general malaise, myalgia, pain in the eyeballs.

3. Uncomplicated course of ARVI or influenza.

4. The onset of symptoms no more than 36h prior to the inclusion into the study.

5. 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.

6. Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol.

7. Signed Informant Consent Form.

Exclusion Criteria:

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

1. Complicated course of influenza or ARVI (including the presence / development of bacterial infection).

2. 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.

3. 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).

4. 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).

5. Infectious diseases during the last week before including into the study.

6. History of bronchial asthma.

7. History of increased convulsive activity.

8. 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).

9. History of oncological diseases, HIV, tuberculosis.

10. Hypersensitivity to excipients of the XC8.

11. Diabetes mellitus, lactose intolerance, lactase deficiency.

12. Drug or alcohol abuse.

13. Participation in any other clinical trial in the last 90 days.

14. Pregnancy or lactation.

15. Military or prison populations.

16. Impossibility or inability to comply with the study procedures.

17. A member of the investigator's family or other person interested in the results of the study

18. Abnormal laboratory results, which, according to the study doctor, interfere with the patient's inclusion in the study.

19. History of renal insufficiency.

20. Only for patients participating in Phase III study: Patient involvement in the first part of the study (Phase II) of FLU-XC8-01.

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Communicable Diseases
• Infection
• Influenza
• Influenza, Human
• Respiratory Tract Infections
• Virus Diseases

Intervention

Drug:
• XC8 20 mg
once daily during 5 days.
• XC8 100 mg
once daily during 5 days.
• XC8 200 mg
once daily during 5 days.
• Placebo
once daily during 5 days.

Locations

Country	Name	City	State
Russian Federation	Udmurt Republic Budgetary Healthcare Institution "City clinical Hospital #9 of the Ministry of Health of the Udmurt Republic	Izhevsk
Russian Federation	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
Russian Federation	State Budgetary Institution of Higher Professional Education "Kuban State Medical University" of the Ministry of Health of the Russian Federation	Krasnodar
Russian Federation	Nizhegorodsky region SBHI Nizhniy Novgorod Infectious Regional Clinical Hospital ? 2	Nizhny Novgorod
Russian Federation	Novosibirsk Municipal Healthcare Budgetary Institution "City Clinical Hospital # 19",	Novosibirsk
Russian Federation	Novosibirsk region SBHI "City Infectious Clinical Hospital # 1",	Novosibirsk
Russian Federation	; Moscow region State Budgetary Institution "Podolsk City Clinical Hospital ? 3"	Podolsk
Russian Federation	Municipal State Budgetary Institution "Rostov-on-Don City Clinical Hospital# 1 n.a. Semashko",	Rostov-on-Don
Russian Federation	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'
Russian Federation	ArsVite Severo-Zapad LLC	Saint Petersburg
Russian Federation	Federal State Budgetary institution "Diagnostic center with polyclinics" of the Administrative Department of the President of the Russian Federation	Saint Petersburg
Russian Federation	Federal State Budgetary Institution "Research institute of influenza" of the Ministry of Health of the Russian Federation	Saint Petersburg
Russian Federation	Saint Petersburg SHBI "City Clinical Hospital #40 of health resort administrative region"	Saint Petersburg
Russian Federation	Federal State Budgetary Institution Mordovia State Medical University n..a. N.P.Ogarev, Mordovia Republic SHBI "Republic Infectious Clinical Hospital"	Saransk
Russian Federation	State Budgetary Institution of Higher Professional Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation	Tomsk
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	Volgograd
Russian Federation	State Budgetary Healthcare Institution (SBHI) of Yaroslavl region	Yaroslavl
Russian Federation	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

Sponsors (1)

Lead Sponsor	Collaborator
PHARMENTERPRISES LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body temperature below 37°C without further elevation	Time to normalization of body temperature since the symptoms onset, measured in hours	up to Day 8