Covid19
Conditions
Keywords
COVID19, bamlanivimab, UnitedHealth
Brief summary
This is an open-label, pragmatic, single-dose study using matched controls in participants with mild to moderate COVID-19. Participants will track for developing symptoms while at home and upon reporting of symptoms will test for COVID-19. If positive for COVID-19, a one-time at-home infusion of Bamlanivimab (LY3819253) will be provided by Optum Infusion. Participants will then track for 28 days to assess for any additional medical care needed or if hospitalization was required.
Interventions
DRUGbamlanivimab
Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab by a registered nurse. This infusion will last approximately 1 hour followed by 1 hour of observation.
Sponsors
Eli Lilly and Company
Optum, Inc.
Daniel Griffin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* UnitedHealthcare member * confirmed COVID-19 positive * located in an area where Bamlanivimab (LY3819253) is available for infusion
Exclusion criteria
* current (from first symptom report) hospitalization for COVID-19 * prior administration of Bamlanivimab or other COVID-19 therapies * previous COVID-19 diagnosis * prior receipt of a COVID-19 vaccine * not authorized for patient use per the EUA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Incidence of COVID-19 Related Hospitalization at Day 28 | Days 1-28 after at-home infusion of Bamlanivimab | Binary outcome; 1 if participants have one or more COVID-19 related hospitalizations during Days 1-28 after at-home infusion, and 0 otherwise |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Documenting Adverse Events After Infusion | Days 1-28 after at-home infusion of Bamlanivimab | Describe the incidence of infusion reactions recorded by the Optum Infusion nurse on the Case Report Form (CRF) during receipt of infusion and during the defined infusion follow-up period. The reporting includes all-cause mortality, COVID-19 related hospitalizations, and all-cause emergency room (ER) visits. |
Countries
United States
Participant flow
Recruitment details
The treatment group was identified by the following inclusion and exclusion criteria once they report symptoms and test positive of COVID-19. They were offered an in-home infusion of 700 mg Bamlanivimab by a nurse within 10 days of their symptom onset if they consent. Email/mail invitations to consider participation will be sent to those who qualify to consider joining to track for symptoms (located in an area where Bamlanivimab (LY3819253) is currently available)
Pre-assignment details
Inclusion: * Age 65+, confirmed SARS-CoV-2 positive, located in an area where Bamlanivimab (LY3819253) is available for infusion, * Have mild or moderate COVID-19 symptoms OR * Individuals who are at high risk for progression to severe COVID-19 in the Emergency Use Authorization (EUA) of Bamlanivimab (page 4 at the EUA; EUA revoked on April 16, 2021) Exclusion Criteria: * Current (from first symptom report) hospitalization for COVID-19 * Prior administration of Bamlanivimab
Participants by arm
| Arm | Count |
|---|---|
| Participants With COVID-19 Participants testing positive for COVID-19 may be eligible to receive a one-time dose of bamlanivimab 700 mg, delivered via infusion through the vein, lasting around 60 minutes. This infusion will be done in-home and administered by a registered nurse.
bamlanivimab: Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab by a registered nurse. This infusion will last approximately 1 hour followed by 1 hour of observation. | 139 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Participants With COVID-19 |
|---|---|
| Age, Customized 64 years or younger | 4 Participants |
| Age, Customized 65 years to 69 years | 51 Participants |
| Age, Customized 70 years to 74 years | 46 Participants |
| Age, Customized 75 years to 79 years | 21 Participants |
| Age, Customized 80 years or older | 16 Participants |
| Days since COVID-19 symptom onset (count) Equal to or less than 8 days since COVID-19 symptom onset | 128 Participants |
| Days since COVID-19 symptom onset (count) Greater than 8 days since COVID-19 symptom onset | 1 Participants |
| Days since COVID-19 symptom onset (count) Unknown | 10 Participants |
| Days since COVID-19 symptom onset (mean) | 3.7 Days STANDARD_DEVIATION 2.24 |
| Elixhauser comorbidity score (Mean) | 9.3 units on a scale STANDARD_DEVIATION 13.09 |
| Elixhauser conditions Acquired Immune Deficiency Syndrome | 0 Participants |
| Elixhauser conditions Alcohol Abuse | 2 Participants |
| Elixhauser conditions Chronic blood loss anemia | 2 Participants |
| Elixhauser conditions Chronic pulmonary disease | 12 Participants |
| Elixhauser conditions Coagulopathy | 4 Participants |
| Elixhauser conditions Congestive heart failure | 5 Participants |
| Elixhauser conditions Deficiency Anemia | 14 Participants |
| Elixhauser conditions Depression | 9 Participants |
| Elixhauser conditions Diabetes, Uncomplicated | 17 Participants |
| Elixhauser conditions Diabetes, With Chronic Complications | 12 Participants |
| Elixhauser conditions Drug Abuse | 1 Participants |
| Elixhauser conditions Fluid and electrolyte disorders | 7 Participants |
| Elixhauser conditions Hypertension, Complicated or Uncomplicated | 51 Participants |
| Elixhauser conditions Hypothyroidism | 13 Participants |
| Elixhauser conditions Liver Disease | 3 Participants |
| Elixhauser conditions Lymphoma | 0 Participants |
| Elixhauser conditions Metastatic Cancer | 0 Participants |
| Elixhauser conditions Obesity | 21 Participants |
| Elixhauser conditions Other Neurological Disorders | 7 Participants |
| Elixhauser conditions Paralysis | 1 Participants |
| Elixhauser conditions Peptic ulcer disease excluding bleeding | 1 Participants |
| Elixhauser conditions Peripheral Vascular Disorders | 9 Participants |
| Elixhauser conditions Psychoses | 5 Participants |
| Elixhauser conditions Pulmonary Circulation disorders | 1 Participants |
| Elixhauser conditions Renal Failure | 8 Participants |
| Elixhauser conditions Rheumatoid arthritis/collagen vascular diseases | 1 Participants |
| Elixhauser conditions Solid Tumor without Metastasis | 7 Participants |
| Elixhauser conditions Valvular Disease | 9 Participants |
| Elixhauser conditions Weight Loss | 1 Participants |
| Immunosuppressive treatments 6 months prior to date of COVID-19 diagnosis Did Not Receive Immunosuppressive Treatment 6 months prior | 116 Participants |
| Immunosuppressive treatments 6 months prior to date of COVID-19 diagnosis Received Immunosuppressive Treatment 6 months prior | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown or Not Reported | 139 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized Race Unknown or Not Reported | 62 Participants |
| Race/Ethnicity, Customized White | 72 Participants |
| Sex: Female, Male Female | 75 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 139 |
| other Total, other adverse events | 0 / 139 |
| serious Total, serious adverse events | 10 / 139 |
Outcome results
Primary
Number of Participants With Incidence of COVID-19 Related Hospitalization at Day 28
Binary outcome; 1 if participants have one or more COVID-19 related hospitalizations during Days 1-28 after at-home infusion, and 0 otherwise
Time frame: Days 1-28 after at-home infusion of Bamlanivimab
Population: All eligible participants for primary outcome analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants With Incidence of COVID-19 Related Hospitalization at Day 28 | 6 Participants |
Secondary
Safety - Documenting Adverse Events After Infusion
Describe the incidence of infusion reactions recorded by the Optum Infusion nurse on the Case Report Form (CRF) during receipt of infusion and during the defined infusion follow-up period. The reporting includes all-cause mortality, COVID-19 related hospitalizations, and all-cause emergency room (ER) visits.
Time frame: Days 1-28 after at-home infusion of Bamlanivimab
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment | Safety - Documenting Adverse Events After Infusion | COVID-19 related hospitalization | 6 Participants |
| Treatment | Safety - Documenting Adverse Events After Infusion | All-Cause ER visits | 4 Participants |