COVID-19Phase 2BLAZE-5NCT04701658
A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
A Phase 2 study testing Bamlanivimab in people with COVID-19, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to find out whether bamlanivimab is able to stop COVID-19 from getting worse. Participants with mild-to-moderate COVID-19 will receive bamlanivimab via an injection into a vein. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- COVID-19
- 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
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 22 Jun 2021
- Phase
- Phase 2
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Are currently not hospitalized.
- Have one or more mild or moderate COVID-19 symptoms.
- Must have first positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral infection determination and as soon as possible within 10 days of symptom onset
- Are males or non-breastfeeding females.
- Contraceptive use by males or females should be consistent with local regulations for those participating in clinical studies.
- Are at high risk for progressing to severe COVID-19 and/or hospitalization.
Who cannot join
- Participants who:
- are hospitalized due to COVID-19, OR
- require oxygen therapy due to COVID-19, OR
- 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.
- Have peripheral capillary oxygen saturation (SpO2) less than or equal to (≤) 90 percent on room air or arterial partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) less than (<) 300, respiratory rate greater than or equal to (≥) 30 per minute, heart rate ≥125 per minute.
- Have body weight <40 kilograms.
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- Require mechanical ventilation or anticipated impending need for mechanical ventilation.
- Have known allergies to any of the components used in the formulation of the interventions.
- Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention.
- Have any comorbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days.
- Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
- Have a history of a positive SARS-CoV-2 serology test.
- Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study.
- Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing.
- Have received treatment with a SARS-CoV-2-specific monoclonal antibody, remdesivir, or other treatment for COVID-19.
- Have received convalescent COVID-19 plasma treatment.
- Have participated in a previous SARS-CoV-2 vaccine study.
- Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
- Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Are breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Presbyterian Medical Center
Albuquerque, New Mexico, 87110
About this study
Official title: A Prospective Cohort Study to Evaluate the Real-world Effectiveness of Bamlanivimab in Participants With Mild-to-moderate COVID-19 at High Risk for Progressing to Severe Illness, With Matched Controls
The purpose of this study is to find out whether bamlanivimab is able to stop COVID-19 from getting worse. Participants with mild-to-moderate COVID-19 will receive bamlanivimab via an injection into a vein. These participants will be matched to similar COVID-19 patients who received other treatment at a local medical center. All participants will be followed to learn how their disease responds. Participation could last about 3 months and includes two required visits to the study site, with the remainder of assessments performed by phone or by medical record review.
- Conditions
- COVID-19
- Being tested
- Bamlanivimab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BamlanivimabDrug
Also called LY3819253, LY-CoV555
Administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Bamlanivimab | Experimental | Participants received 700 milligram single intravenous infusion of Bamlanivimab. Receives: Drug: Bamlanivimab |
| Controls | No intervention | Matched controls who received standard of care. [The study was originally designed to include a matched control arm. However, due to low enrollment, it was amended to be a single arm study with Bamlanivimab arm only. No matched controls were utilized.] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Percentage of Participants who Experience COVID-19 Related Hospitalization or Death From Any Cause. Hospitalization is defined as ≥24 hours of acute care.
Measured: Baseline through Days 29, 60, and 90
Secondary outcomes (2)
Percentage of Participants With a COVID-19-related Hospitalization
Hospitalization is defined as ≥24 hours of acute care.
Measured: Baseline through Days 29, 60, and 90
Percentage of Participants With a COVID-related Emergency Department (ED) Visit
Percentage of Participants with a COVID-related ED Visit.
Measured: Baseline through Days 29, 60, and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Feb 2021
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AbCellera Biologics Inc.
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701658
- Sponsor's protocol ID
- 18216
- Other IDs
- J2X-MC-PYAJ
- Acronym
- BLAZE-5
- Status last verified
- Nov 2021
- First submitted
- 7 Jan 2021
- Last updated
- 16 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study to Evaluate the Real-world Effectiveness of Bamlanivimab in Participants With Mild-to-moderate COVID-19 at High Risk for Progressing to Severe Illness, With Matched Controls
- ClinicalTrials.gov ID
- NCT04701658
- Acronym / sponsor ID
- BLAZE-5 / 18216
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- AbCellera Biologics Inc.
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Posted 16 Nov 2021
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 study is to find out whether bamlanivimab is able to stop COVID-19 from getting worse. Participants with mild-to-moderate COVID-19 will receive bamlanivimab via an injection into a vein. These participants will be matched to similar COVID-19 patients who received other treatment at a local medical center. All participants will be followed to learn how their disease responds. Participation could last about 3 months and includes two required visits to the study site, with the remainder of assessments performed by phone or by medical record review.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bamlanivimab | Experimental | Drug: BamlanivimabParticipants received 700 milligram single intravenous infusion of Bamlanivimab. |
| Controls | No intervention | –Matched controls who received standard of care. [The study was originally designed to include a matched control arm. However, due to low enrollment, it was amended to be a single arm study with Bamlanivimab arm only. No matched controls were utilized.] |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Are currently not hospitalized.
- Have one or more mild or moderate COVID-19 symptoms.
- Must have first positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral infection determination and as soon as possible within 10 days of symptom onset
- Are males or non-breastfeeding females.
- Contraceptive use by males or females should be consistent with local regulations for those participating in clinical studies.
Key exclusion criteria (20 listed)
- Participants who:
- Have peripheral capillary oxygen saturation (SpO2) less than or equal to (≤) 90 percent on room air or arterial partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) less than (<) 300, respiratory rate greater than or equal to (≥) 30 per minute, heart rate ≥125 per minute.
- Have body weight <40 kilograms.
- Require mechanical ventilation or anticipated impending need for mechanical ventilation.
- Have known allergies to any of the components used in the formulation of the interventions.
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 |
|---|---|---|
| BamlanivimabAlso: LY3819253, LY-CoV555Administered intravenously. | Drug | Bamlanivimab |
Primary outcome
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
Time frame: Baseline through Days 29, 60, and 90
Percentage of Participants who Experience COVID-19 Related Hospitalization or Death From Any Cause. Hospitalization is defined as ≥24 hours of acute care.
2 secondary outcomes
Percentage of Participants With a COVID-19-related Hospitalization
Time frame: Baseline through Days 29, 60, and 90
Percentage of Participants With a COVID-related Emergency Department (ED) Visit
Time frame: Baseline through Days 29, 60, and 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- A Real World Study of Bamlanivimab in Participants With Mild-to-moderate Coronavirus Disease 2019 (COVID-19) (BLAZE-5)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
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 Bamlanivimab in people with COVID-19, run by Eli Lilly and Company at 1 site in United States.
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 20 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 16 Nov 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Nov 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?
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause (time frame: Baseline through Days 29, 60, and 90). 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 NCT04701658, 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 16 Nov 2021.