Covid19Phase 4B-EPICNCT04796402
A Study to Assess if a Medicine Called Bamlanivimab is Safe and Effective in Reducing Hospitalization Due to COVID-19
A Phase 4 study testing Bamlanivimab in people with Covid19, run by Fraser Health at 1 site in Canada.
Trial summary
The purpose of this research is to test whether a new medication called bamlanivimab is safe and effective at reducing the need for hospitalization due to COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Bamlanivimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 1 siteCanada
- Study dates
- 17 Mar 2021to 31 Dec 2021
- Phase
- Phase 4
- 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 at the time of SARS-CoV2 test:
- Age > 65
- Age 55-64 and 1 or more of:
- BMI>35, ii. chronic kidney disease, iii. diabetes mellitus, iv. immunosuppressive disease v. current immunosuppressive treatment vi. hypertension vii. coronary artery disease viii. chronic lung disease
- Age 18-54 and 1 or more of: i. BMI>35 ii. chronic kidney disease iii. diabetes mellitus iv. immunosuppressive disease v. current immunosuppressive treatment
- Disease Characteristics:
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- Not hospitalized
- Sample collection for first SARS-CoV2 test positive within 3 days prior to consent.
- One or more mild COVID-19 symptoms and within 10 days from onset
- Fever ii. Cough iii. Sore throat iv. Malaise v. Headache vi. Muscle pain vii. Gastrointestinal symptoms viii. Shortness of breath with/without exertion
- Study Procedures:
- Resident of British Columbia
- Understand and agree to planned study procedures
- Ability and Willingness to Provide Informed Consent:
- The participant will provide informed consent by telephone
Who cannot join
- Medical Conditions
- Allergies to any of the components used in the formulation of the bamlanivimab
- Hospitalization or expected to need hospitalization in the next 24 hours at the time of recruitment for COVID-19
- Suspected or proven infection other than COVID-19 that in the opinion of the clinicians could pose a risk to study inclusion
- Any co-morbidity considered life-threatening in <28 days, or requiring surgery in <7 days.
- Any serious disease, condition or disorder that in the opinion of the clinicians should preclude participation.
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- Require oxygen therapy due to COVID-19
- Require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
- Weighs < 40 kg
- History of vaccination against SARS-CoV2
- History of convalescent plasma or IVIG therapy within 3 months of first SARS-CoV2 viral determination positive
- History of previous SARS-CoV2 infection
- History of participation in any clinical study involving an investigational intervention within 30 days or 5 half-lives of the previous intervention, whichever is longer.
- Unable to achieve informed consent for any reason
- Known Pregnancy
- Actively breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pragmatic Eight Week Phase IV Study of Bamlanivimab/LY-CoV555 for Emergency Passive Immunity Against COVID-19
The purpose of this research is to test whether a new medication called bamlanivimab is safe and effective at reducing the need for hospitalization due to COVID-19.
Read the detailed description
The study aims to examine the effectiveness of adding bamlanivimab provided by COVID-19 Clinics to standard of care on the incidence of hospitalization for high-risk patients infected with SARS-CoV2. Furthermore, we aim to test the effect on the following secondary outcomes: mortality and health-related quality of life and patients' satisfaction with care. We will also assess the recruitment rate from the three primary strategies for rapid identification and consent of eligible patients. The data from this study will inform clinical decisions about the use of bamlanivimab in high risk COVID-19 patients and the operational requirements necessary for research in passive immunity therapeutics.
- Conditions
- Covid19
- Being tested
- Bamlanivimab, Standard of Care
- Keywords
- Bamlanivimab, monoclonal antibody, hospitalization, mortality, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BamlanivimabBiological
700 mg/20mL IV over at least one hour OD
Standard of CareOther
Standard of care includes primary care and specialist care as indicated by the patient's primary care provider
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard of care Receives: Other: Standard of Care |
| Intervention | Experimental | Administration of Bamlanivimab Receives: Biological: Bamlanivimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any incidence of admission to hospital for >24 hours in the 28 days following first positive test for SARS-CoV2.
Measured: 0 - 28 days following first positive test for COVID 19
Secondary outcomes (8)
Any incidence of admission to hospital for >24 hours following first positive test for SARS-CoV2.
Measured: 0 - 28 days following first positive test for COVID-19
Mortality following first positive test for SARS-CoV2.
Measured: 28 days, 3 month and 6 months post-treatment
Health-related quality of life assessment.
Medical Outcomes Study: 20-Item Short Form Survey Instrument (SF-20)
Measured: Screening and 6 months post-treatment
Hospitalization by age and comorbidities.
Measured: Treatment day and up to 6 months post-treatment
Incidence and types of adverse reactions including anaphylaxis.
Measured: Treatment day and up to 6 months post-treatment
Recruitment rate.
Measured: Upto 8 weeks from day of first patient recruited to day of last patient recruited
Overall satisfaction with participation in research.
Likert Scale
Measured: 6 months post-treatment
Type and frequency of viral variants in patients receiving bamlanivimab.
Measured: Up to 8 weeks from day of first patient recruited to day of last patient recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start17 Mar 2021
- Primary completion7 Jun 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- None (open label)
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Collaborators
- Fraser Health Authrority Department of Evaluation and Research Services, Surrey Memorial Hospital Clinical Research Unit, Centre for Health Evaluation and Outcome Sciences, Surrey Hospital Foundation, BC Support Unit, University of British Columbia, Ministry of Health, British Columbia, Clinical Trials BC (part of the BC Academic Health Science Network)
- Responsible party
- Principal investigator, Gregory Haljan, MD, Fraser Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796402
- Sponsor's protocol ID
- FHREB 2021-023
- Acronym
- B-EPIC
- Status last verified
- Aug 2021
- First submitted
- 10 Mar 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Eight Week Phase IV Study of Bamlanivimab/LY-CoV555 for Emergency Passive Immunity Against COVID-19
- ClinicalTrials.gov ID
- NCT04796402
- Acronym / sponsor ID
- B-EPIC / FHREB 2021-023
- Conditions
- Covid19
- Keywords
- Bamlanivimab, monoclonal antibody, hospitalization, mortality, COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Collaborators
- Fraser Health Authrority Department of Evaluation and Research Services, Surrey Memorial Hospital Clinical Research Unit, Centre for Health Evaluation and Outcome Sciences, Surrey Hospital Foundation, BC Support Unit, University of British Columbia, Ministry of Health, British Columbia, Clinical Trials BC (part of the BC Academic Health Science Network)
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 12 Mar 2021 (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.
The purpose of this research is to test whether a new medication called bamlanivimab is safe and effective at reducing the need for hospitalization due to COVID-19.
Detailed description
The study aims to examine the effectiveness of adding bamlanivimab provided by COVID-19 Clinics to standard of care on the incidence of hospitalization for high-risk patients infected with SARS-CoV2. Furthermore, we aim to test the effect on the following secondary outcomes: mortality and health-related quality of life and patients' satisfaction with care. We will also assess the recruitment rate from the three primary strategies for rapid identification and consent of eligible patients. The data from this study will inform clinical decisions about the use of bamlanivimab in high risk COVID-19 patients and the operational requirements necessary for research in passive immunity therapeutics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Standard of CareStandard of care |
| Intervention | Experimental | Biological: BamlanivimabAdministration of Bamlanivimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age at the time of SARS-CoV2 test:
- Disease Characteristics:
- Study Procedures:
- Ability and Willingness to Provide Informed Consent:
- The participant will provide informed consent by telephone
Key exclusion criteria (16 listed)
- Medical Conditions
- Weighs < 40 kg
- History of vaccination against SARS-CoV2
- History of convalescent plasma or IVIG therapy within 3 months of first SARS-CoV2 viral determination positive
- History of previous SARS-CoV2 infection
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 |
|---|---|---|
| Bamlanivimab700 mg/20mL IV over at least one hour OD | Biological | Intervention |
| Standard of CareStandard of care includes primary care and specialist care as indicated by the patient's primary care provider | Other | Control |
Primary outcome
Any incidence of admission to hospital for >24 hours in the 28 days following first positive test for SARS-CoV2.
Time frame: 0 - 28 days following first positive test for COVID 19
8 secondary outcomes
Any incidence of admission to hospital for >24 hours following first positive test for SARS-CoV2.
Time frame: 0 - 28 days following first positive test for COVID-19
Mortality following first positive test for SARS-CoV2.
Time frame: 28 days, 3 month and 6 months post-treatment
Health-related quality of life assessment.
Time frame: Screening and 6 months post-treatment
Hospitalization by age and comorbidities.
Time frame: Treatment day and up to 6 months post-treatment
Incidence and types of adverse reactions including anaphylaxis.
Time frame: Treatment day and up to 6 months post-treatment
Recruitment rate.
Time frame: Upto 8 weeks from day of first patient recruited to day of last patient recruited
Overall satisfaction with participation in research.
Time frame: 6 months post-treatment
Type and frequency of viral variants in patients receiving bamlanivimab.
Time frame: Up to 8 weeks from day of first patient recruited to day of last patient recruited
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bamlanivimab in people with Covid19, run by Fraser Health at 1 site in Canada.
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 15 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 26 Aug 2021. 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 Canada. 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 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?
Results are not available in the source record.
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?
Any incidence of admission to hospital for >24 hours in the 28 days following first positive test for SARS-CoV2. (time frame: 0 - 28 days following first positive test for COVID 19). 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 NCT04796402, which also lists 1 linked publication.
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 26 Aug 2021.