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In April 2021 FDA revoked the Emergency Use Authorization after determining that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use.
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
| Optum, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with COVID-19 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bamlanivimab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Days 1-28 after at-home infusion of Bamlanivimab |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 1-28 after at-home infusion of Bamlanivimab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Griffin, MD, PHD | ProHealth New York - UnitedHealth Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QueryLab | Minnetonka | Minnesota | 55343 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | 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. |
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No plan to share participant level data with other projects or researchers.
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Inclusion:
Exclusion Criteria:
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)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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.. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count percentage of participants aged 64 years and older in customized age groups |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All eligible participants for primary outcome analysis | Posted | Count of Participants | Participants | Days 1-28 after at-home infusion of Bamlanivimab |
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|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Participants testing positive for COVID-19 who received One-time at-home infusion of 700 mg Bamlanivimab |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tracy Ziolek , Vice President, Human Research Affairs | UnitedHealth Group/Optum Labs | 215-868-3114 | tracy_ziolek@uhg.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2021 | Mar 11, 2022 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2021 | Mar 11, 2022 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000711749 | bamlanivimab |
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Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab.
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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)
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Days since COVID-19 symptom onset (count) | This measure describes when study participants got an at-home infusion since COVID-19 symptom onset in days. | Date of COVID-19 symptom onset was confirmed for 128 participants of the total 139 participants | Count of Participants | Participants |
|
| Days since COVID-19 symptom onset (mean) | Date of COVID-19 symptom onset was not available for all participants | Mean | Standard Deviation | Days |
|
| Elixhauser comorbidity score (Mean) | It is a weighted score of the 29 Elixhauser comorbid conditions designed to predict risk of in-hospital mortality or 30-day, all-cause readmission (Moore et al., 2017). The conditions include deficiency anemia, depression, uncomplicated diabetes, diabetes with chronic complications, etc. We used the 2019 version for the outcome of 30-day, all-cause readmission by Agency for Healthcare Research and Quality (AHRQ). The Elixhauser score ranges from -4 to 219, with higher scores indicating a higher patient comorbidity | 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 | Mean | Standard Deviation | units on a scale |
|
| Elixhauser conditions | 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 | Count of Participants | Participants |
|
| Immunosuppressive treatments 6 months prior to date of COVID-19 diagnosis | 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. | Count of Participants | 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. | Posted | Count of Participants | Participants | Days 1-28 after at-home infusion of Bamlanivimab |
|
|
|
| 1 |
| 139 |
| 10 |
| 139 |
| 0 |
| 139 |
| Syncope | General disorders | Non-systematic Assessment | participant fainted at start of infusion. Infusion was stopped and participant went to ER. Was discharged without being admitted |
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| Hypokalemia | General disorders | Non-systematic Assessment |
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| Dysarthria | General disorders | Non-systematic Assessment | Participant had shaking, slurring of speech, weakness, and itching and was referred to Emergency Department. Became stable and continued to improve after discharge |
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| Shaking | General disorders | Non-systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Asthenia | General disorders | Non-systematic Assessment |
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| Shorness of Breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Participant had shortness of breath, increased coughing and febrile. Hospitalized overnight and discharged with improvement |
|
| Increased Coughing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |