Viral Respiratory InfectionHERMITAGENCT04413929

Study on Safety and Effectiveness of Ergoferon in the Treatment of Flu / ARVI in Outpatients.

An observational study of Viral Respiratory Infection, run by Materia Medica Holding.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The observational study to get the additional data of the safety and effectiveness of Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients. Read more about this study

Who is it for?: Ages 6 months to 75 years
Conditions the study is for: Viral Respiratory Infection
What is being tested?: Ergoferon
Type of treatment: Pill or oral medicine
How many people: 8,411 participants
Where: No sites listed yet
Study dates: Oct 2016to Apr 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Children from 6 months to 18 years of age and adults over 18 years of age in any gender and demographic proportion.

Who may be able to join

Data of children from 6 months to 18 years old and adults over 18 years old.
Diagnosis: Flu / ARVI.
Axillary temperature above 37.4 °С.
At least one systemic and/or catarrhal symptom lasting 12 hours to 3 days by the time the doctor is consulted, for which treatment with Ergoferon is prescribed.
A specific decision of the doctor to prescribe Ergoferon in strict accordance with the indications, regardless of the factor of including patient data in the program.
CRF, filled by a doctor on the basis of medical documentation, at the end of patient observation.

Who cannot join

Not applicable.

About this study

Official title: International Observational Non-Interventional Retrospective Program for Studying the Efficiency and Safety of Ergoferon in Patients With Influenza and Acute Respiratory Viral Infection (ARVI).

The observational study to get the additional data of the safety and effectiveness of Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients.

Read the detailed description

This observational study is aimed to provide additional safety and effectiveness data for Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients, including cases with delayed treatment initiation of illness, and in allergy patients. Routine clinical practice in the management of outpatients with ARVI is to be studied in Azerbaijan, Armenia, Georgia, Kazakhstan, Kyrgyzstan, Mongolia, Tajikistan and Uzbekistan: the demographic characteristics of patients, duration and time points of treatment with the use of Ergoferon, its safety, and the frequency of additional medication.

Scope of the study: 519 general practitioners; 8411 patients. Physical examinations and tests are performed according to local outpatient clinical practice, and to local and international medical care standards.

Data to be collected and analyzed after the completion of treatment:

demographics (age, gender, and city/town of residence)
severity of illness (mild, moderate, or severe)
comorbidities (chronic ENT conditions, chronic obstructive pulmonary disease (COPD), chronic cardiovascular disease, allergic rhinitis/sinusitis, atopic dermatitis/eczema, asthma, or other)
the time of resolution of infection symptoms (absence of fever - a body temperature below 37.0°С), systemic symptoms (chills, headaches, myalgias, weakness, and loss of appetite), nasal symptoms (nasal congestion/ discharge), laryngeal symptoms (a sore throat, or other), and other symptoms
illness time points: onset of illness, first visit to the doctor's office, and start of treatment.
symptomatic therapy (drug name, date prescribed, and date discontinued)
therapy for bacterial complications (date the antimicrobial drug is prescribed, drug name, diagnosis, hospitalization or no hospitalization required, date of hospitalization)
serious adverse events (description of the event, causality (related/ not related to Ergoferon), severity, date of the onset, and actions taken)
efficacy assessment of the Ergoferon treatment (high efficacy: recovery / satisfactory: improvement/ insufficient: no effect) - observational study model: cohort Cohort study is an observation of outcomes in a group of individuals linked by shared characteristics (an acute respiratory viral infections and use of Ergoferon).

Conditions: Viral Respiratory Infection
Being tested: Ergoferon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ErgoferonDrug
Oral administration

Study groups in NCT04413929
Study group	Role	What they receive
Ergoferon		Oral administration in the therapeutic dosage specified in the instructions for medical use. Receives: Drug: Ergoferon

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Influenza/ARVI Symptoms.
The time from the onset of treatment with Ergoferon to the resolution of the symptoms, i.e. a body temperature ≤37.0 °С remaining at this level for 24 h (with no further increases throughout the rest of the observation period) in the absence of catarrhal signs and systemic symptoms. Based on Case Report Form data.
Measured: through study completion up to 1 month

Secondary outcomes (5)

Duration of Increased Body Temperature.
A body temperature ≥37.0 °С. Based on Case Report Form data.
Measured: through study completion up to 1 month
Duration of Systemic Symptoms.
Symptoms of intoxication (chills, headache, muscle pain, weakness, loss of appetite).
Based on Case Report Form data.
Measured: through study completion up to 1 month
Duration of Nose Symptoms.
Symptoms of the nose (nasal congestion, discharge from the nose), other symptoms. Based on Case Report Form data.
Measured: through study completion up to 1 month
Duration of Throat Symptoms.
Symptoms of the throat (sore throat, etc.). Based on Case Report Form data.
Measured: through study completion up to 1 month
Percentage of Patients With Complications of Influenza/Acute Viral URI.
Patients who got bacterial complications of influenza/acute viral URI, requiring the antibiotics and/or hospitalization during the observation period.
Measured: through study completion up to 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Apr 2017

First posted4 Jun 2020
Study startOct 2016
Primary completionApr 2017
Study completionApr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Viral Respiratory InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 8,411 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04413929
Sponsor's protocol ID: HERMITAGE
Acronym: HERMITAGE
Status last verified: May 2020
First submitted: 25 May 2020
Last updated: 2 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 1
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Enrolling by invitation
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All Viral Respiratory Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: International Observational Non-Interventional Retrospective Program for Studying the Efficiency and Safety of Ergoferon in Patients With Influenza and Acute Respiratory Viral Infection (ARVI).
ClinicalTrials.gov ID: NCT04413929
Acronym / sponsor ID: HERMITAGE / HERMITAGE
Conditions: Viral Respiratory Infection
Study type: Observational
Recruitment status: Completed
Enrolment: 8,411 participants (actual)
Lead sponsor: Materia Medica HoldingIndustry (pharma, biotech, devices)
Study start: Oct 2016 (actual)
Primary completion: Apr 2017 (actual)
Study completion: Apr 2017 (actual)
First posted: 4 Jun 2020 (actual)
Results: Posted 2 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The observational study to get the additional data of the safety and effectiveness of Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients.

Detailed description

Data to be collected and analyzed after the completion of treatment:

demographics (age, gender, and city/town of residence)
severity of illness (mild, moderate, or severe)
comorbidities (chronic ENT conditions, chronic obstructive pulmonary disease (COPD), chronic cardiovascular disease, allergic rhinitis/sinusitis, atopic dermatitis/eczema, asthma, or other)
the time of resolution of infection symptoms (absence of fever - a body temperature below 37.0°С), systemic symptoms (chills, headaches, myalgias, weakness, and loss of appetite), nasal symptoms (nasal congestion/ discharge), laryngeal symptoms (a sore throat, or other), and other symptoms
illness time points: onset of illness, first visit to the doctor's office, and start of treatment.
symptomatic therapy (drug name, date prescribed, and date discontinued)
therapy for bacterial complications (date the antimicrobial drug is prescribed, drug name, diagnosis, hospitalization or no hospitalization required, date of hospitalization)
serious adverse events (description of the event, causality (related/ not related to Ergoferon), severity, date of the onset, and actions taken)
efficacy assessment of the Ergoferon treatment (high efficacy: recovery / satisfactory: improvement/ insufficient: no effect) - observational study model: cohort Cohort study is an observation of outcomes in a group of individuals linked by shared characteristics (an acute respiratory viral infections and use of Ergoferon).

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Ergoferon	–	Drug: ErgoferonOral administration in the therapeutic dosage specified in the instructions for medical use.

Who may qualify

Ages: 6 months to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Children from 6 months to 18 years of age and adults over 18 years of age in any gender and demographic proportion.

Key inclusion criteria (6 listed)

Data of children from 6 months to 18 years old and adults over 18 years old.
Diagnosis: Flu / ARVI.
Axillary temperature above 37.4 °С.
At least one systemic and/or catarrhal symptom lasting 12 hours to 3 days by the time the doctor is consulted, for which treatment with Ergoferon is prescribed.
A specific decision of the doctor to prescribe Ergoferon in strict accordance with the indications, regardless of the factor of including patient data in the program.

Key exclusion criteria (1 listed)

Not applicable.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ErgoferonOral administration	Drug	Ergoferon

Primary outcome

Duration of Influenza/ARVI Symptoms.
Time frame: through study completion up to 1 month
The time from the onset of treatment with Ergoferon to the resolution of the symptoms, i.e. a body temperature ≤37.0 °С remaining at this level for 24 h (with no further increases throughout the rest of the observation period) in the absence of catarrhal signs and systemic symptoms. Based on Case Report Form data.

5 secondary outcomes

Duration of Increased Body Temperature.
Time frame: through study completion up to 1 month
Duration of Systemic Symptoms.
Time frame: through study completion up to 1 month
Duration of Nose Symptoms.
Time frame: through study completion up to 1 month
Duration of Throat Symptoms.
Time frame: through study completion up to 1 month
Percentage of Patients With Complications of Influenza/Acute Viral URI.
Time frame: through study completion up to 1 month

Results and safety

Results posted to the registry on 2 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ergoferon	8,411	8,411

Primary outcome: Duration of Influenza/ARVI Symptoms.

Time frame: through study completion up to 1 month. Mean (Standard Deviation). Unit: days

Measure	Ergoferon n = 8411
Value	4.84 (1.53)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ergoferon	0 of 8,411 (0%)	0 of 8,411 (0%)	0 of 8,411

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Viral Respiratory Infection

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Viral Respiratory Infection, run by Materia Medica Holding.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Influenza/ARVI Symptoms. (time frame: through study completion up to 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04413929.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.