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Clinical Trial of Efficacy and Safety of Anaferon in the Treatment of Acute Respiratory Viral Infections

Primary Purpose

Acute Respiratory Viral Infections

Status

Completed

Phase

Phase 4

Locations

Russian Federation

Study Type

Interventional

Intervention

Anaferon

Placebo

About this trial

This is an interventional treatment trial for Acute Respiratory Viral Infections

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients of either gender aged 18-70 years.
Diagnosis of acute respiratory viral infection (ARVI) based on medical examination: axillary temperature ≥ 37,8 ° C at examination + non-specific/flu-like symptom score ≥4, nasal/throat/chest symptom score ≥2.
The first 24 hours after ARVI onset.
Seasonal rise in ARVI incidence.
Patients giving their consent to use reliable contraception during the study.
Signed patient information sheet (informed consent form).

Exclusion Criteria:

Suspected pneumonia, bacterial infection (including otitis media, sinuitis, urinary tract infection, meningitis, sepsis, etc.), requiring the administration of antibacterial drugs from the first day of the disease.
Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic diseases of connective tissue, oncohaematological and other diseases).
Clinical symptoms of severe influenza/ARVI requiring hospitalization.
Subjects requiring concurrent antiviral products forbidden by the study.
Medical history of primary and secondary immunodeficiency.
Oncologic conditions /suspected oncologic conditions.
Aggravation or decompensation of chronic diseases affecting a patient's ability to participate in the clinical trial.
Impaired glucose tolerance, diabetes mellitus.
Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
Allergy/ hypersensitivity to any component of the study drug.
Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.
Consumption of narcotics, alcohol > 2 alcohol units per day, mental diseases.
Course administration of the drug products specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study.
Patients who will not fulfill the requirements during the study or follow the order of administration of the studied drug products, from the Investigator's point of view.
Participation in other clinical trials for 3 months prior to enrollment in this study.
Patients who are related to any of the on-site research personnel directly involved in the study or are an immediate relative of the investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
Patients who work for OOO "NPF "Materia Medica Holding" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).

Sites / Locations

Regional State Budgetary Healthcare Institution "City Hospital No. 5, Barnaul"
Non-governmental health care institution "Road Clinical Hospital at Chelyabinsk station JSC" Russian Railways "
Kazan State Medical University
Krasnogorsk city hospital №1
The Federal State Budgetary Healthcare Institution The Central Clinical Hospital of the Russian Academy of Sciences
Pirogov Russian National Research Medical University
Federal State Institution "Polyclinic No. 5" of the Administrative Department of the President of the Russian Federation
Podolskaya City Clinical Hospital No. 3
Central City Clinical Hospital of Reutov
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 25"
St. Petersburg State Health Care Institution "City Polyclinic №117"
Road Clinical Hospital JSC Russian Railways
LLC "Research Center Eco-Security"
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 51"
St. Petersburg City State Hospital "City Hospital No. 26"
St. Petersburg State Budgetary Institution of Health "City Polyclinic №34"
Saratov City Clinical Hospital № 2 named after VI Razumovsky
Regional State Budgetary Healthcare Institution "Clinical Hospital No.1"
Yaroslavl State Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anaferon

Placebo

Arm Description

1 tablet per administration. Day 1: 1 tablet every 30 minutes for the first 2 hours, followed by 3 more tablets taken at regular intervals through the rest of the day. Days 2-5: 1 tablet 3 times a day. The drug is taken out of the meal (in the interval between meals or 15-30 minutes before eating), keep the tablet in the mouth, without swallowing, until completely dissolved.

Placebo using Anaferon regimen until the end of the study.

Outcomes

Primary Outcome Measures

Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms.

Based on a patient diary. ARVI is clinically diagnosed and/or Real-time reverse transcription polymerase chain reaction (PCR) confirmed. Criteria of resolution of ARVI symptoms: body/axillary temperature ≤37.30С for 24 hours (without subsequent increase within the observation period) + absence/presence of general ARVI symptoms with ≤2 points of Total Severity (TS) score according to the 4-point scale for each of 14 ARVI symptoms (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). ARVI symptoms are body temperature, 6 nonspecific/flu-like symptoms, and 7 nasal/throat and chest symptoms. Absolute body temperature (in degrees Celsius) is converted to arbitrary units (or scores) using the following scale: ≤37.30С=0 points; 37.4-38.00С=1 point; 38.1-39.00С=2 points; ≥39.10С=3 points. TS ranges from 0 to 42 (higher scores mean a worse outcome).

Secondary Outcome Measures

ARVI Severity.

ARVI severity is assessed using the "Area under the curve" (AUC) for the Total Symptom (TS) score for 6 days of the treatment and observation. TS score is calculated every day according to the 4-point scale for each of 14 ARVI symptoms (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). ARVI symptoms are body temperature, 6 nonspecific/flu-like symptoms, and 7 nasal/throat and chest symptoms. Absolute body temperature (in degrees Celsius) is converted to arbitrary units (or scores) using the following scale: ≤37.30С=0 points; 37.4-38.00С=1 point; 38.1-39.00С=2 points; ≥39.10С=3 points. TS ranges from 0 to 42 (higher scores mean a worse outcome). AUC is calculated between 6 points (by TS for every 6 days of the treatment and observation). AUC is calculated using integration with given limits (TS score). The minimum value for the AUC is "0" and the maximum value is "252" units (day*score). The higher score means a worse outcome (ARVI severity).

Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).

Based on patient diary data. Criteria of resolution of ARVI symptoms: body/axillary temperature ≤37.30С for 24 hours (without subsequent increase within the observation period) + absence/presence of general ARVI symptoms with ≤2 points of Total Severity (TS) score according to the 4-point scale for each of 14 ARVI symptoms (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). ARVI symptoms are body temperature, 6 nonspecific/flu-like symptoms, and 7 nasal/throat and chest symptoms. Absolute body temperature (in degrees Celsius) is converted to arbitrary units (or scores) using the following scale: ≤37.30С=0 points; 37.4-38.00С=1 point; 38.1-39.00С=2 points; ≥39.10С=3 points. TS ranges from 0 to 30 (higher scores mean a worse outcome).

Time to Resolution of ARVI (PCR-confirmed) Symptoms.

Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed).

Based on patient diary data. ARVI is PCR confirmed. Criteria of resolution of ARVI symptoms: body/axillary temperature ≤37.30С for 24 hours (without subsequent increase within the observation period) + absence/presence of general ARVI symptoms with ≤2 points of Total Severity (TS) score according to the 4-point scale for each of 14 ARVI symptoms (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). ARVI symptoms are body temperature, 6 nonspecific/flu-like symptoms, and 7 nasal/throat and chest symptoms. Absolute body temperature (in degrees Celsius) is converted to arbitrary units (or scores) using the following scale: ≤37.30С=0 points; 37.4-38.00С=1 point; 38.1-39.00С=2 points; ≥39.10С=3 points. TS ranges from 0 to 30 (higher scores mean a worse outcome).

Dosing Frequency of Antipyretics if Indicated.

Based on patient diary data. Dosing frequency is calculated as the number of antipyretic doses per 1 patient in a day.

The Percentage of Patients Requiring Administration of Antibiotics.

Based on medical records. This Outcome Measure is calculated as the number of patients who were administered antibiotics for the treatment of secondary bacterial complications.

Full Information

NCT ID

NCT03707912

First Posted

October 12, 2018

Last Updated

August 18, 2020

Sponsor

Materia Medica Holding

1. Study Identification

Unique Protocol Identification Number

NCT03707912

Brief Title

Clinical Trial of Efficacy and Safety of Anaferon in the Treatment of Acute Respiratory Viral Infections

Official Title

Multicentre Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Anaferon in the Treatment of Acute Respiratory Viral Infections

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

October 9, 2018 (Actual)

Primary Completion Date

March 15, 2019 (Actual)

Study Completion Date

March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Materia Medica Holding

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Purpose of the study: • To obtain additional data on the efficacy and safety of Anaferon in the treatment of acute respiratory viral infections.

Detailed Description

Design: a multicenter, double-blind, placebo-controlled, parallel-group randomized trial. The study will enroll patients of either gender aged 18-70 years old with clinical manifestations of ARVI within the first day after the onset of the disease. Signed information sheet for patient will be obtained from all participants prior to the screening procedures. Medical history, concomitant medication, thermometry, patient examination by a doctor, assessment of ARVI symptoms severity will be performed at screening visit. The nasopharyngeal swabs will be performed for Real-time reverse transcription polymerase chain reaction (PCR) assay to confirm viral etiology of ARVI and to verify respiratory viruses prior to the therapy. If a patient meets all inclusion criteria and does not have any exclusion criteria, at Visit 1 (Day 1) he/she will be randomized into one of two groups: the 1st group patients will take Anaferon according to the dosage regimen until the end of the study; the 2nd group patients will take Placebo according to Anaferon dosage regimen until the end of the study. The patients will be provided with a patient diary (paper or electronic) where daily they will record axillary body temperature (using a Geratherm Classic thermometer) and each ARVI symptom severity twice a day (in the morning and in the evening). In addition, antipyretic administration (if applicable) as well as any possible worsening of the patient's condition (if applicable, for safety evaluation/AEs documentation) will also be recorded in a patient diary. An investigator will provide the instructions on filling out the diary and will help the patient to make first records of ARVI symptom severity and body temperature in the diary. Patients are observed up for 7 days (screening, randomization - 1 day, study therapy - 5 days, follow-up period - 2 days). During treatment and follow-up period two visits are scheduled (at home or at the study site) on days 5 (Visit 2) and day 7 (Visit 3). At Visits 2 and 3, the investigator will carry out physical examination, record dynamics of ARVI symptoms and concomitant therapy and check patient diaries. Treatment compliance will be evaluated at Visit 3. During the study, symptomatic therapy and therapy for underlying chronic conditions are allowed with the exception of the drugs indicated in the section "Prohibited Concomitant Treatment".

6. Conditions and Keywords

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

Acute Respiratory Viral Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

204 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Anaferon

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo using Anaferon regimen until the end of the study.

Intervention Type

Drug

Intervention Name(s)

Anaferon

Intervention Description

Oral administration.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral administration.

Primary Outcome Measure Information:

Title

Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms.

Description

Time Frame

On days 1-7 of the observation period.

Secondary Outcome Measure Information:

Title

ARVI Severity.

Description

Time Frame

On days 1-6 of the observation period.

Title

Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).

Description

Time Frame

On day 2, 3, 4, 5, and 6.

Title

Time to Resolution of ARVI (PCR-confirmed) Symptoms.

Description

Time Frame

On days 2-6 of the observation period.

Title

Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed).

Description

Time Frame

On day 2, 3, 4, 5, and 6.

Title

Dosing Frequency of Antipyretics if Indicated.

Description

Based on patient diary data. Dosing frequency is calculated as the number of antipyretic doses per 1 patient in a day.

Time Frame

On day 1, 2, and 3.

Title

The Percentage of Patients Requiring Administration of Antibiotics.

Description

Based on medical records. This Outcome Measure is calculated as the number of patients who were administered antibiotics for the treatment of secondary bacterial complications.

Time Frame

On days 4-7 of the observation period.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients of either gender aged 18-70 years. Diagnosis of acute respiratory viral infection (ARVI) based on medical examination: axillary temperature ≥ 37,8 ° C at examination + non-specific/flu-like symptom score ≥4, nasal/throat/chest symptom score ≥2. The first 24 hours after ARVI onset. Seasonal rise in ARVI incidence. Patients giving their consent to use reliable contraception during the study. Signed patient information sheet (informed consent form). Exclusion Criteria: Suspected pneumonia, bacterial infection (including otitis media, sinuitis, urinary tract infection, meningitis, sepsis, etc.), requiring the administration of antibacterial drugs from the first day of the disease. Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic diseases of connective tissue, oncohaematological and other diseases). Clinical symptoms of severe influenza/ARVI requiring hospitalization. Subjects requiring concurrent antiviral products forbidden by the study. Medical history of primary and secondary immunodeficiency. Oncologic conditions /suspected oncologic conditions. Aggravation or decompensation of chronic diseases affecting a patient's ability to participate in the clinical trial. Impaired glucose tolerance, diabetes mellitus. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia. Allergy/ hypersensitivity to any component of the study drug. Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial. Consumption of narcotics, alcohol > 2 alcohol units per day, mental diseases. Course administration of the drug products specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study. Patients who will not fulfill the requirements during the study or follow the order of administration of the studied drug products, from the Investigator's point of view. Participation in other clinical trials for 3 months prior to enrollment in this study. Patients who are related to any of the on-site research personnel directly involved in the study or are an immediate relative of the investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted). Patients who work for OOO "NPF "Materia Medica Holding" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned).

Facility Information:

Facility Name

Regional State Budgetary Healthcare Institution "City Hospital No. 5, Barnaul"

City

Barnaul

ZIP/Postal Code

656045

Country

Russian Federation

Facility Name

Non-governmental health care institution "Road Clinical Hospital at Chelyabinsk station JSC" Russian Railways "

City

Chelyabinsk

ZIP/Postal Code

454000

Country

Russian Federation

Facility Name

Kazan State Medical University

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Krasnogorsk city hospital №1

City

Krasnogorsk

ZIP/Postal Code

143408

Country

Russian Federation

Facility Name

The Federal State Budgetary Healthcare Institution The Central Clinical Hospital of the Russian Academy of Sciences

City

Moscow

ZIP/Postal Code

117593

Country

Russian Federation

Facility Name

Pirogov Russian National Research Medical University

City

Moscow

ZIP/Postal Code

117997

Country

Russian Federation

Facility Name

Federal State Institution "Polyclinic No. 5" of the Administrative Department of the President of the Russian Federation

City

Moscow

ZIP/Postal Code

119121

Country

Russian Federation

Facility Name

Podolskaya City Clinical Hospital No. 3

City

Podolsk

ZIP/Postal Code

142105

Country

Russian Federation

Facility Name

Central City Clinical Hospital of Reutov

City

Reutov

ZIP/Postal Code

143964

Country

Russian Federation

Facility Name

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 25"

City

Saint Petersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

St. Petersburg State Health Care Institution "City Polyclinic №117"

City

Saint Petersburg

ZIP/Postal Code

194358

Country

Russian Federation

Facility Name

Road Clinical Hospital JSC Russian Railways

City

Saint Petersburg

ZIP/Postal Code

195271

Country

Russian Federation

Facility Name

LLC "Research Center Eco-Security"

City

Saint Petersburg

ZIP/Postal Code

196143

Country

Russian Federation

Facility Name

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 51"

City

Saint Petersburg

ZIP/Postal Code

196211

Country

Russian Federation

Facility Name

St. Petersburg City State Hospital "City Hospital No. 26"

City

Saint Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

Facility Name

St. Petersburg State Budgetary Institution of Health "City Polyclinic №34"

City

Saint Petersburg

ZIP/Postal Code

197198

Country

Russian Federation

Facility Name

Saratov City Clinical Hospital № 2 named after VI Razumovsky

City

Saratov

ZIP/Postal Code

410028

Country

Russian Federation

Facility Name

Regional State Budgetary Healthcare Institution "Clinical Hospital No.1"

City

Smolensk

ZIP/Postal Code

214006

Country

Russian Federation

Facility Name

Yaroslavl State Medical University

City

Yaroslavl

ZIP/Postal Code

150000

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial of Efficacy and Safety of Anaferon in the Treatment of Acute Respiratory Viral Infections

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