Acute Respiratory Viral InfectionsPhase 4NCT03707912
Clinical Trial of Efficacy and Safety of Anaferon in the Treatment of Acute Respiratory Viral Infections
A Phase 4 study testing Anaferon in people with Acute Respiratory Viral Infections, run by Materia Medica Holding at 19 sites in Russia.
Trial summary
Purpose of the study: To obtain additional data on the efficacy and safety of Anaferon in the treatment of acute respiratory viral infections. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Respiratory Viral Infections
- What is being tested?
- Anaferon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 19 sitesRussia
- Study dates
- 9 Oct 2018to 15 Mar 2019
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Russia19 sites
Regional State Budgetary Healthcare Institution "City Hospital No. 5, Barnaul"
Barnaul, 656045
Non-governmental health care institution "Road Clinical Hospital at Chelyabinsk station JSC" Russian Railways "
Chelyabinsk, 454000
Kazan State Medical University
Kazan', 420012
Krasnogorsk city hospital №1
Krasnogorsk, 143408
The Federal State Budgetary Healthcare Institution The Central Clinical Hospital of the Russian Academy of Sciences
Moscow, 117593
Pirogov Russian National Research Medical University
Moscow, 117997
Federal State Institution "Polyclinic No. 5" of the Administrative Department of the President of the Russian Federation
Moscow, 119121
Podolskaya City Clinical Hospital No. 3
Podolsk, 142105
Central City Clinical Hospital of Reutov
Reutov, 143964
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 25"
Saint Petersburg, 193312
St. Petersburg State Health Care Institution "City Polyclinic №117"
Saint Petersburg, 194358
Road Clinical Hospital JSC Russian Railways
Saint Petersburg, 195271
LLC "Research Center Eco-Security"
Saint Petersburg, 196143
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 51"
Saint Petersburg, 196211
St. Petersburg City State Hospital "City Hospital No. 26"
Saint Petersburg, 196247
St. Petersburg State Budgetary Institution of Health "City Polyclinic №34"
Saint Petersburg, 197198
Saratov City Clinical Hospital № 2 named after VI Razumovsky
Saratov, 410028
Regional State Budgetary Healthcare Institution "Clinical Hospital No.1"
Smolensk, 214006
Yaroslavl State Medical University
Yaroslavl, 150000
About this study
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
Purpose of the study:
- To obtain additional data on the efficacy and safety of Anaferon in the treatment of acute respiratory viral infections.
Read the 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".
- Conditions
- Acute Respiratory Viral Infections
- Being tested
- Anaferon, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnaferonDrug
Oral administration.
PlaceboDrug
Oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Anaferon | Experimental | 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. Receives: Drug: Anaferon |
| Placebo | Placebo comparator | Placebo using Anaferon regimen until the end of the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: On days 1-7 of the observation period.
Secondary outcomes (6)
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).
Measured: On days 1-6 of the observation period.
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).
Measured: On day 2, 3, 4, 5, and 6.
Time to Resolution of ARVI (PCR-confirmed) Symptoms.
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 42 (higher scores mean a worse outcome).
Measured: On days 2-6 of the observation period.
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).
Measured: On day 2, 3, 4, 5, and 6.
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.
Measured: On day 1, 2, and 3.
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.
Measured: On days 4-7 of the observation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start9 Oct 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
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 Acute Respiratory Viral InfectionsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707912
- Sponsor's protocol ID
- MMH-AN-005
- Status last verified
- Aug 2020
- First submitted
- 12 Oct 2018
- Last updated
- 2 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03707912
- Acronym / sponsor ID
- MMH-AN-005
- Conditions
- Acute Respiratory Viral Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Posted 2 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anaferon | Experimental | Drug: Anaferon1 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 | Placebo comparator | Drug: PlaceboPlacebo using Anaferon regimen until the end of the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| AnaferonOral administration. | Drug | Anaferon |
| PlaceboOral administration. | Drug | Placebo |
Primary outcome
Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms.
Time frame: On days 1-7 of the observation period.
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).
6 secondary outcomes
ARVI Severity.
Time frame: On days 1-6 of the observation period.
Percentage of Patients With Resolution of ARVI Symptoms (Clinically Diagnosed and/or PCR-confirmed).
Time frame: On day 2, 3, 4, 5, and 6.
Time to Resolution of ARVI (PCR-confirmed) Symptoms.
Time frame: On days 2-6 of the observation period.
Percentage of Patients With Resolution of ARVI Symptoms (PCR-confirmed).
Time frame: On day 2, 3, 4, 5, and 6.
Dosing Frequency of Antipyretics if Indicated.
Time frame: On day 1, 2, and 3.
The Percentage of Patients Requiring Administration of Antibiotics.
Time frame: On days 4-7 of the observation period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anaferon in people with Acute Respiratory Viral Infections, run by Materia Medica Holding at 19 sites in Russia.
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 17 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 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2020). 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?
Time to Resolution of Acute Respiratory Viral Infection (ARVI) Symptoms. (time frame: On days 1-7 of the observation period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2020.