COVID-19Phase 2COVIFERONNCT04343768

An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial

A Phase 2 study testing Hydroxychloroquine, Lopinavir / Ritonavir and Interferon Beta-1A in people with COVID-19, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: Hydroxychloroquine, Lopinavir / Ritonavir and Interferon Beta-1A
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteIran
Study dates: 9 Apr 2020to 27 Apr 2020
Phase: Phase 2
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18
COVID-19 Confirmed Cases By Means of RT-PCR
Oxygen saturation (SPO2) ≤ 93% OR respiratory rate ≥ 24
At least one of the following: Calibrated contactless infrared forehead thermometry temperature of ≥37.8, cough, sputum production, nasal discharge, myalgia, headache or fatigue on admission.
Time of onset of the symptoms should be acute ( Days ≤ 14)

Who cannot join

Refusal to participate expressed by patient or legally authorized representative if they are present
Patients with prolonged QT or PR intervals, Second or Third Degree heart block, Arrhythmias including torsade de pointes
Patients using drugs with potential interaction with Hydroxychloroquine + Lopinavir/Ritonavir, Interferon-β 1a، Interferon-β 1b.
Pregnant or lactating women.
History of alcohol or drug addiction in the past 5 years.
Blood ALT/AST levels > 5 times the upper limit of normal on laboratory results.

Trial locations and contacts

1 site in 1 country.

Iran1 site

Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services
Tehran

Other trials in Iran

About this study

The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the three arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

Read the detailed description

According to previous studies, IFN-β has strong antiviral activity and also has an acceptable safety profile. Based on possible therapeutic effects, We decided to lead An Investigation into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19. In a 2003 study, SARS was treated with different human interferons and found that IFN-β was 5 to 10 times more effective than other types of interferons and the strongest antiviral drug possible against SARS-CoV.

Patients will be allocated to three therapeutic arms (Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a group and Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b group and the Base Therapeutic Regiment Group, i.e., Hydropinchloroquine + / Ritonavir. For this purpose, we will use the method of Balance Block Randomization for three groups.

After completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

Conditions: COVID-19
Being tested: Hydroxychloroquine, Lopinavir / Ritonavir, Interferon Beta-1A, Interferon Beta-1B
Keywords: COVID-19, Novel Coronavirus, Interferon Beta 1a, Interferon Beta 1b
Medical subject headings: COVID-19

What participants receive

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

HydroxychloroquineDrug
This Drug will be used in all arms.
Lopinavir / RitonavirDrug
This Drug will be used in all arms.
Interferon Beta-1ADrug
This drug will be only used in Arm 1.
Interferon Beta-1BDrug
This drug will be only used in Arm 2.

Study groups in NCT04343768
Study group	Role	What they receive
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a	Experimental	Not described Receives: Drug: Hydroxychloroquine; Drug: Lopinavir / Ritonavir; Drug: Interferon Beta-1A
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b	Experimental	Not described Receives: Drug: Hydroxychloroquine; Drug: Lopinavir / Ritonavir; Drug: Interferon Beta-1B
Control group: hydroxychloroquine + Lopinavir / Ritonavir	Active comparator	Not described Receives: Drug: Hydroxychloroquine; Drug: Lopinavir / Ritonavir

What is being measured

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

Time to clinical improvement
Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R\&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.
Measured: From date of randomization until 14 days later.

Secondary outcomes (4)

Mortality
If the patient dies, we have reached an outcome.
Measured: From date of randomization until 14 days later.
SpO2 Improvement
Pulse-oxymetry
Measured: Days 1, 2, 3, 4, 5, 6, 7 and 14.
Incidence of new mechanical ventilation use
Incidence of new mechanical ventilation use
Measured: From date of randomization until 14 days later.
Duration of hospitalization
Duration of hospitalization (days)
Measured: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.

Timeline

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

9 Apr 202027 Apr 2020

First posted13 Apr 2020
Study start9 Apr 2020
Primary completion27 Apr 2020
Study completion27 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the three arms of the study. Patients will be allocated to three therapeutic arms (Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a group and Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b group and the Base Therapeutic Regiment Group, i.e., Hydropinchloroquine + / Ritonavir. For this purpose, we will use the method of Balance Block Randomization for three groups.
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04343768
Sponsor's protocol ID: Different Interferons in COVID
Acronym: COVIFERON
Status last verified: May 2020
First submitted: 8 Apr 2020
Last updated: 5 May 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: One year after the publication of the results in a journal, Qualifying researchers who reach out to Dr. Seyed Sina Naghibi Irvani at "sina.irvani@sbmu.ac.ir" or "sina.irvani@gmail.com" and submit a proposal with a valuable research question can have access to data and supporting information.

Publications

Zu ZY, Jiang MD, Xu PP, Chen W, Ni QQ, Lu GM, Zhang LJ. Coronavirus Disease 2019 (COVID-19): A Perspective from China. Radiology. 2020 Aug;296(2):E15-E25. doi: 10.1148/radiol.2020200490. Epub 2020 Feb 21.
PubMed 32083985
Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, Wang W, Song H, Huang B, Zhu N, Bi Y, Ma X, Zhan F, Wang L, Hu T, Zhou H, Hu Z, Zhou W, Zhao L, Chen J, Meng Y, Wang J, Lin Y, Yuan J, Xie Z, Ma J, Liu WJ, Wang D, Xu W, Holmes EC, Gao GF, Wu G, Chen W, Shi W, Tan W. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020 Feb 22;395(10224):565-574. doi: 10.1016/S0140-6736(20)30251-8. Epub 2020 Jan 30.
PubMed 32007145
Chen Y, Liu Q, Guo D. Emerging coronaviruses: Genome structure, replication, and pathogenesis. J Med Virol. 2020 Apr;92(4):418-423. doi: 10.1002/jmv.25681. Epub 2020 Feb 7.
PubMed 31967327
Spiegel M, Pichlmair A, Muhlberger E, Haller O, Weber F. The antiviral effect of interferon-beta against SARS-coronavirus is not mediated by MxA protein. J Clin Virol. 2004 Jul;30(3):211-3. doi: 10.1016/j.jcv.2003.11.013.
PubMed 15135736
Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2.
PubMed 28466096
Cinatl J, Morgenstern B, Bauer G, Chandra P, Rabenau H, Doerr HW. Treatment of SARS with human interferons. Lancet. 2003 Jul 26;362(9380):293-4. doi: 10.1016/s0140-6736(03)13973-6.
PubMed 12892961
Hensley LE, Fritz LE, Jahrling PB, Karp CL, Huggins JW, Geisbert TW. Interferon-beta 1a and SARS coronavirus replication. Emerg Infect Dis. 2004 Feb;10(2):317-9. doi: 10.3201/eid1002.030482.
PubMed 15030704
Zeng YM, Xu XL, He XQ, Tang SQ, Li Y, Huang YQ, Harypursat V, Chen YK. Comparative effectiveness and safety of ribavirin plus interferon-alpha, lopinavir/ritonavir plus interferon-alpha, and ribavirin plus lopinavir/ritonavir plus interferon-alpha in patients with mild to moderate novel coronavirus disease 2019: study protocol. Chin Med J (Engl). 2020 May 5;133(9):1132-1134. doi: 10.1097/CM9.0000000000000790. No abstract available.
PubMed 32149772
Alavi Darazam I, Shokouhi S, Pourhoseingholi MA, Naghibi Irvani SS, Mokhtari M, Shabani M, Amirdosara M, Torabinavid P, Golmohammadi M, Hashemi S, Azimi A, Jafarazadeh Maivan MH, Rezaei O, Zali A, Hajiesmaeili M, Shabanpour Dehbsneh H, Hoseyni Kusha A, Taleb Shoushtari M, Khalili N, Soleymaninia A, Gachkar L, Khoshkar A. Role of interferon therapy in severe COVID-19: the COVIFERON randomized controlled trial. Sci Rep. 2021 Apr 13;11(1):8059. doi: 10.1038/s41598-021-86859-y.
PubMed 33850184
Irvani SSN, Golmohammadi M, Pourhoseingholi MA, Shokouhi S, Darazam IA. Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Jun 3;21(1):473. doi: 10.1186/s13063-020-04382-3.
PubMed 32493468

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?

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Study at a glance

From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04343768
Acronym / sponsor ID: COVIFERON / Different Interferons in COVID
Conditions: COVID-19
Keywords: COVID-19, Novel Coronavirus, Interferon Beta 1a, Interferon Beta 1b
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Shahid Beheshti University of Medical SciencesUniversity, hospital or other
Study start: 9 Apr 2020 (actual)
Primary completion: 27 Apr 2020 (actual)
Study completion: 27 Apr 2020 (actual)
First posted: 13 Apr 2020 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the three arms of the study. Patients will be allocated to three therapeutic arms (Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a group and Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b group and the Base Therapeutic Regiment Group, i.e., Hydropinchloroquine + / Ritonavir. For this purpose, we will use the method of Balance Block Randomization for three groups.

Arm	Type	Receives
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a	Experimental	Drug: Hydroxychloroquine, Drug: Lopinavir / Ritonavir, Drug: Interferon Beta-1A
Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b	Experimental	Drug: Hydroxychloroquine, Drug: Lopinavir / Ritonavir, Drug: Interferon Beta-1B
Control group: hydroxychloroquine + Lopinavir / Ritonavir	Active comparator	Drug: Hydroxychloroquine, Drug: Lopinavir / Ritonavir

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age ≥ 18
COVID-19 Confirmed Cases By Means of RT-PCR
Oxygen saturation (SPO2) ≤ 93% OR respiratory rate ≥ 24
At least one of the following: Calibrated contactless infrared forehead thermometry temperature of ≥37.8, cough, sputum production, nasal discharge, myalgia, headache or fatigue on admission.
Time of onset of the symptoms should be acute ( Days ≤ 14)

Key exclusion criteria (6 listed)

Refusal to participate expressed by patient or legally authorized representative if they are present
Patients with prolonged QT or PR intervals, Second or Third Degree heart block, Arrhythmias including torsade de pointes
Patients using drugs with potential interaction with Hydroxychloroquine + Lopinavir/Ritonavir, Interferon-β 1a، Interferon-β 1b.
Pregnant or lactating women.
History of alcohol or drug addiction in the past 5 years.

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
HydroxychloroquineThis Drug will be used in all arms.	Drug	Control group: hydroxychloroquine + Lopinavir / Ritonavir, Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a, Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b
Lopinavir / RitonavirThis Drug will be used in all arms.	Drug	Control group: hydroxychloroquine + Lopinavir / Ritonavir, Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a, Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b
Interferon Beta-1AThis drug will be only used in Arm 1.	Drug	Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a
Interferon Beta-1BThis drug will be only used in Arm 2.	Drug	Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b

Primary outcome

Time to clinical improvement
Time frame: From date of randomization until 14 days later.
Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R\&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.

4 secondary outcomes

Mortality
Time frame: From date of randomization until 14 days later.
SpO2 Improvement
Time frame: Days 1, 2, 3, 4, 5, 6, 7 and 14.
Incidence of new mechanical ventilation use
Time frame: From date of randomization until 14 days later.
Duration of hospitalization
Time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
Background: PubMed 32083985Zu ZY, Jiang MD, Xu PP, Chen W, Ni QQ, Lu GM, Zhang LJ. Coronavirus Disease 2019 (COVID-19): A Perspective from China. Radiology. 2020 Aug;296(2):E15-E25. doi: 10.1148/radiol.2020200490. Epub 2020 Feb 21.
Background: PubMed 32007145Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, Wang W, Song H, Huang B, Zhu N, Bi Y, Ma X, Zhan F, Wang L, Hu T, Zhou H, Hu Z, Zhou W, Zhao L, Chen J, Meng Y, Wang J, Lin Y, Yuan J, Xie Z, Ma J, Liu WJ, Wang D, Xu W, Holmes EC, Gao GF, Wu G, Chen W, Shi W, Tan W. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020 Feb 22;395(10224):565-574. doi: 10.1016/S0140-6736(20)30251-8. Epub 2020 Jan 30.
Background: PubMed 31967327Chen Y, Liu Q, Guo D. Emerging coronaviruses: Genome structure, replication, and pathogenesis. J Med Virol. 2020 Apr;92(4):418-423. doi: 10.1002/jmv.25681. Epub 2020 Feb 7.
Background: PubMed 15135736Spiegel M, Pichlmair A, Muhlberger E, Haller O, Weber F. The antiviral effect of interferon-beta against SARS-coronavirus is not mediated by MxA protein. J Clin Virol. 2004 Jul;30(3):211-3. doi: 10.1016/j.jcv.2003.11.013.
Background: PubMed 28466096Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2.
Background: PubMed 12892961Cinatl J, Morgenstern B, Bauer G, Chandra P, Rabenau H, Doerr HW. Treatment of SARS with human interferons. Lancet. 2003 Jul 26;362(9380):293-4. doi: 10.1016/s0140-6736(03)13973-6.
Background: PubMed 15030704Hensley LE, Fritz LE, Jahrling PB, Karp CL, Huggins JW, Geisbert TW. Interferon-beta 1a and SARS coronavirus replication. Emerg Infect Dis. 2004 Feb;10(2):317-9. doi: 10.3201/eid1002.030482.
Background: PubMed 32149772Zeng YM, Xu XL, He XQ, Tang SQ, Li Y, Huang YQ, Harypursat V, Chen YK. Comparative effectiveness and safety of ribavirin plus interferon-alpha, lopinavir/ritonavir plus interferon-alpha, and ribavirin plus lopinavir/ritonavir plus interferon-alpha in patients with mild to moderate novel coronavirus disease 2019: study protocol. Chin Med J (Engl). 2020 May 5;133(9):1132-1134. doi: 10.1097/CM9.0000000000000790. No abstract available.
Derived from this study: PubMed 33850184Alavi Darazam I, Shokouhi S, Pourhoseingholi MA, Naghibi Irvani SS, Mokhtari M, Shabani M, Amirdosara M, Torabinavid P, Golmohammadi M, Hashemi S, Azimi A, Jafarazadeh Maivan MH, Rezaei O, Zali A, Hajiesmaeili M, Shabanpour Dehbsneh H, Hoseyni Kusha A, Taleb Shoushtari M, Khalili N, Soleymaninia A, Gachkar L, Khoshkar A. Role of interferon therapy in severe COVID-19: the COVIFERON randomized controlled trial. Sci Rep. 2021 Apr 13;11(1):8059. doi: 10.1038/s41598-021-86859-y.
Derived from this study: PubMed 32493468Irvani SSN, Golmohammadi M, Pourhoseingholi MA, Shokouhi S, Darazam IA. Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Jun 3;21(1):473. doi: 10.1186/s13063-020-04382-3.
Individual participant dataSharing planned: Yes. One year after the publication of the results in a journal, Qualifying researchers who reach out to Dr. Seyed Sina Naghibi Irvani at "sina.irvani@sbmu.ac.ir" or "sina.irvani@gmail.com" and submit a proposal with a valuable research question can have access to data and supporting information.

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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.

Ilad Alavi Darazam, MD study chair

Shahid Beheshti University of Medical Sciences

Shervin Shokouhi, MD study director

Shahid Beheshti University of Medical Sciences

Minoosh Shabani, MD principal investigator

Shahid Beheshti University of Medical Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hydroxychloroquine, Lopinavir / Ritonavir and Interferon Beta-1A in people with COVID-19, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.

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 5 inclusion and 6 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 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 clinical improvement (time frame: From date of randomization until 14 days later.). 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 NCT04343768, which also lists 10 linked publications.

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 5 May 2020.