Trial Outcomes & Findings for At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19 (NCT NCT04656691)
NCT ID: NCT04656691
Last Updated: 2022-03-18
Results Overview
Binary outcome; 1 if participants have one or more COVID-19 related hospitalizations during Days 1-28 after at-home infusion, and 0 otherwise
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
139 participants
Primary outcome timeframe
Days 1-28 after at-home infusion of Bamlanivimab
Results posted on
2022-03-18
Participant Flow
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)
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
Participant milestones
| Measure |
Treatment: 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 followed by 1 hour of observation..
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|---|---|
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Overall Study
STARTED
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139
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Overall Study
COMPLETED
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138
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Treatment: 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 followed by 1 hour of observation..
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|---|---|
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Overall Study
Adverse Event
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1
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Baseline Characteristics
139 infusions were started with 138 fusions being completed - that is the discrepancy between the number of infusions started (139) and the number completed (138) and the number considered evaluable (only completed infusions at 138)
Baseline characteristics by cohort
| Measure |
Participants With COVID-19
n=139 Participants
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.
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|---|---|
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Age, Customized
64 years or younger
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4 Participants
n=139 Participants • 139 infusions were started with 138 fusions being completed - that is the discrepancy between the number of infusions started (139) and the number completed (138) and the number considered evaluable (only completed infusions at 138)
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Age, Customized
65 years to 69 years
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51 Participants
n=139 Participants • 139 infusions were started with 138 fusions being completed - that is the discrepancy between the number of infusions started (139) and the number completed (138) and the number considered evaluable (only completed infusions at 138)
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Age, Customized
70 years to 74 years
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46 Participants
n=139 Participants • 139 infusions were started with 138 fusions being completed - that is the discrepancy between the number of infusions started (139) and the number completed (138) and the number considered evaluable (only completed infusions at 138)
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Age, Customized
75 years to 79 years
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21 Participants
n=139 Participants • 139 infusions were started with 138 fusions being completed - that is the discrepancy between the number of infusions started (139) and the number completed (138) and the number considered evaluable (only completed infusions at 138)
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Age, Customized
80 years or older
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16 Participants
n=139 Participants • 139 infusions were started with 138 fusions being completed - that is the discrepancy between the number of infusions started (139) and the number completed (138) and the number considered evaluable (only completed infusions at 138)
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Sex: Female, Male
Female
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75 Participants
n=139 Participants
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Sex: Female, Male
Male
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64 Participants
n=139 Participants
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Race/Ethnicity, Customized
American Indian or Alaska Native
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0 Participants
n=139 Participants
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Race/Ethnicity, Customized
Asian
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0 Participants
n=139 Participants
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Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
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0 Participants
n=139 Participants
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Race/Ethnicity, Customized
Black or African American
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3 Participants
n=139 Participants
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Race/Ethnicity, Customized
White
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72 Participants
n=139 Participants
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Race/Ethnicity, Customized
Other
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2 Participants
n=139 Participants
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Race/Ethnicity, Customized
Race Unknown or Not Reported
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62 Participants
n=139 Participants
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Race/Ethnicity, Customized
Hispanic or Latino
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0 Participants
n=139 Participants
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Race/Ethnicity, Customized
Not Hispanic or Latino
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0 Participants
n=139 Participants
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Race/Ethnicity, Customized
Ethnicity Unknown or Not Reported
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139 Participants
n=139 Participants
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Days since COVID-19 symptom onset (count)
Equal to or less than 8 days since COVID-19 symptom onset
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128 Participants
n=139 Participants • Date of COVID-19 symptom onset was confirmed for 128 participants of the total 139 participants
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Days since COVID-19 symptom onset (count)
Greater than 8 days since COVID-19 symptom onset
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1 Participants
n=139 Participants • Date of COVID-19 symptom onset was confirmed for 128 participants of the total 139 participants
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Days since COVID-19 symptom onset (count)
Unknown
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10 Participants
n=139 Participants • Date of COVID-19 symptom onset was confirmed for 128 participants of the total 139 participants
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Days since COVID-19 symptom onset (mean)
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3.7 Days
STANDARD_DEVIATION 2.24 • n=129 Participants • Date of COVID-19 symptom onset was not available for all participants
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Elixhauser comorbidity score (Mean)
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9.3 units on a scale
STANDARD_DEVIATION 13.09 • n=82 Participants • Medical Record and Claims data were not available for all infused participants to establish the Elixhauser comorbidity score. The score provides context for outcome measures and was not required to determine eligibility
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Elixhauser conditions
Acquired Immune Deficiency Syndrome
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0 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Alcohol Abuse
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2 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Deficiency Anemia
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14 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Rheumatoid arthritis/collagen vascular diseases
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1 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Chronic blood loss anemia
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2 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Congestive heart failure
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5 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Chronic pulmonary disease
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12 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Coagulopathy
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4 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Depression
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9 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Diabetes, Uncomplicated
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17 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Diabetes, With Chronic Complications
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12 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Drug Abuse
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1 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Hypertension, Complicated or Uncomplicated
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51 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Hypothyroidism
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13 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Liver Disease
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3 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Lymphoma
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0 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Fluid and electrolyte disorders
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7 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Metastatic Cancer
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0 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Other Neurological Disorders
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7 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Obesity
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21 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Paralysis
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1 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Peripheral Vascular Disorders
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9 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Psychoses
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5 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Pulmonary Circulation disorders
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1 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Renal Failure
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8 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Solid Tumor without Metastasis
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7 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Peptic ulcer disease excluding bleeding
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1 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Valvular Disease
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9 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Elixhauser conditions
Weight Loss
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1 Participants
n=82 Participants • Medical Record and Claims data were not available for all infused participants to identify Elixhauser conditions. The score provides context for outcome measures and was not required to determine eligibility. Some participants had multiple Elixhauser conditions
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Immunosuppressive treatments 6 months prior to date of COVID-19 diagnosis
Received Immunosuppressive Treatment 6 months prior
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1 Participants
n=117 Participants • Medical record and claims data were not available for all infused participants to identify a 6 month history of immunosuppressive treatments. The measure provides context for the outcome measures and was not an eligibility criteria.
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Immunosuppressive treatments 6 months prior to date of COVID-19 diagnosis
Did Not Receive Immunosuppressive Treatment 6 months prior
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116 Participants
n=117 Participants • Medical record and claims data were not available for all infused participants to identify a 6 month history of immunosuppressive treatments. The measure provides context for the outcome measures and was not an eligibility criteria.
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PRIMARY outcome
Timeframe: Days 1-28 after at-home infusion of BamlanivimabPopulation: All eligible participants for primary outcome analysis
Binary outcome; 1 if participants have one or more COVID-19 related hospitalizations during Days 1-28 after at-home infusion, and 0 otherwise
Outcome measures
| Measure |
Treatment
n=138 Participants
Participants testing positive for COVID-19 who received One-time at-home infusion of 700 mg Bamlanivimab
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|---|---|
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Number of Participants With Incidence of COVID-19 Related Hospitalization at Day 28
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6 Participants
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SECONDARY outcome
Timeframe: Days 1-28 after at-home infusion of BamlanivimabDescribe 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.
Outcome measures
| Measure |
Treatment
n=138 Participants
Participants testing positive for COVID-19 who received One-time at-home infusion of 700 mg Bamlanivimab
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|---|---|
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Safety - Documenting Adverse Events After Infusion
COVID-19 related hospitalization
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6 Participants
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Safety - Documenting Adverse Events After Infusion
All-Cause ER visits
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4 Participants
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Adverse Events
Treatment
Serious events: 10 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment
n=139 participants at risk
Participants testing positive for COVID-19 who received One-time at-home infusion of 700 mg Bamlanivimab
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Hypoxia
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0.72%
1/139 • Number of events 1 • Days 1-28 after at-home infusion of Bamlanivimab
The reporting includes all-cause mortality, COVID-19 related hospitalizations, and all-cause emergency room (ER) visits. All adverse events were considered serious.
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General disorders
Syncope
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0.72%
1/139 • Number of events 1 • Days 1-28 after at-home infusion of Bamlanivimab
The reporting includes all-cause mortality, COVID-19 related hospitalizations, and all-cause emergency room (ER) visits. All adverse events were considered serious.
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General disorders
Hypokalemia
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0.72%
1/139 • Number of events 1 • Days 1-28 after at-home infusion of Bamlanivimab
The reporting includes all-cause mortality, COVID-19 related hospitalizations, and all-cause emergency room (ER) visits. All adverse events were considered serious.
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General disorders
Dysarthria
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0.72%
1/139 • Number of events 1 • Days 1-28 after at-home infusion of Bamlanivimab
The reporting includes all-cause mortality, COVID-19 related hospitalizations, and all-cause emergency room (ER) visits. All adverse events were considered serious.
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General disorders
Shaking
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0.72%
1/139 • Number of events 1 • Days 1-28 after at-home infusion of Bamlanivimab
The reporting includes all-cause mortality, COVID-19 related hospitalizations, and all-cause emergency room (ER) visits. All adverse events were considered serious.
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Skin and subcutaneous tissue disorders
Itching
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0.72%
1/139 • Number of events 1 • Days 1-28 after at-home infusion of Bamlanivimab
The reporting includes all-cause mortality, COVID-19 related hospitalizations, and all-cause emergency room (ER) visits. All adverse events were considered serious.
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General disorders
Asthenia
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0.72%
1/139 • Number of events 1 • Days 1-28 after at-home infusion of Bamlanivimab
The reporting includes all-cause mortality, COVID-19 related hospitalizations, and all-cause emergency room (ER) visits. All adverse events were considered serious.
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Respiratory, thoracic and mediastinal disorders
Shorness of Breath
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0.72%
1/139 • Number of events 1 • Days 1-28 after at-home infusion of Bamlanivimab
The reporting includes all-cause mortality, COVID-19 related hospitalizations, and all-cause emergency room (ER) visits. All adverse events were considered serious.
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Respiratory, thoracic and mediastinal disorders
Increased Coughing
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0.72%
1/139 • Number of events 1 • Days 1-28 after at-home infusion of Bamlanivimab
The reporting includes all-cause mortality, COVID-19 related hospitalizations, and all-cause emergency room (ER) visits. All adverse events were considered serious.
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General disorders
Fever
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0.72%
1/139 • Number of events 1 • Days 1-28 after at-home infusion of Bamlanivimab
The reporting includes all-cause mortality, COVID-19 related hospitalizations, and all-cause emergency room (ER) visits. All adverse events were considered serious.
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Other adverse events
Adverse event data not reported
Additional Information
Tracy Ziolek , Vice President, Human Research Affairs
UnitedHealth Group/Optum Labs
Phone: 215-868-3114
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place