COVID-19
Conditions
Brief 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. 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.
Interventions
DRUGBamlanivimab
Administered intravenously.
Sponsors
AbCellera Biologics Inc.
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a COVID-19-related Hospitalization | Baseline through Days 29, 60, and 90 | Hospitalization is defined as ≥24 hours of acute care. |
| Percentage of Participants With a COVID-related Emergency Department (ED) Visit | Baseline through Days 29, 60, and 90 | Percentage of Participants with a COVID-related ED Visit. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Bamlanivimab 700 mg Participants received 700 mg single IV infusion of Bamlanivimab. | 109 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
Baseline characteristics
| Characteristic | Bamlanivimab 700 mg |
|---|---|
| Age, Continuous | 55.40 years STANDARD_DEVIATION 15.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 83 Participants |
| Region of Enrollment United States | 109 Participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 109 |
| other Total, other adverse events | 9 / 109 |
| serious Total, serious adverse events | 2 / 109 |
Outcome results
Primary
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.
Time frame: Baseline through Days 29, 60, and 90
Population: All participants who received single dose of Bamlanivimab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bamlanivimab 700 mg | Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | Baseline through Day 29 | 0.9 Percentage of participants |
| Bamlanivimab 700 mg | Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | Baseline through Day 60 | 0.9 Percentage of participants |
| Bamlanivimab 700 mg | Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | Baseline through Day 90 | 0.9 Percentage of participants |
Secondary
Percentage of Participants With a COVID-19-related Hospitalization
Hospitalization is defined as ≥24 hours of acute care.
Time frame: Baseline through Days 29, 60, and 90
Population: All participants who received single dose of Bamlanivimab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bamlanivimab 700 mg | Percentage of Participants With a COVID-19-related Hospitalization | Baseline through Day 29 | 0.9 Percentage of participants |
| Bamlanivimab 700 mg | Percentage of Participants With a COVID-19-related Hospitalization | Baseline through Day 60 | 0.9 Percentage of participants |
| Bamlanivimab 700 mg | Percentage of Participants With a COVID-19-related Hospitalization | Baseline through Day 90 | 0.9 Percentage of participants |
Secondary
Percentage of Participants With a COVID-related Emergency Department (ED) Visit
Percentage of Participants with a COVID-related ED Visit.
Time frame: Baseline through Days 29, 60, and 90
Population: All participants who received single dose of Bamlanivimab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bamlanivimab 700 mg | Percentage of Participants With a COVID-related Emergency Department (ED) Visit | Baseline through Day 29 | 5.5 Percentage of participants |
| Bamlanivimab 700 mg | Percentage of Participants With a COVID-related Emergency Department (ED) Visit | Baseline through Day 60 | 5.5 Percentage of participants |
| Bamlanivimab 700 mg | Percentage of Participants With a COVID-related Emergency Department (ED) Visit | Baseline through Day 90 | 5.5 Percentage of participants |