UNITED: At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19
Sponsor
Daniel Griffin (Industry)
Overall Status
Terminated
CT.gov ID
NCT04656691
Collaborator
Eli Lilly and Company (Industry), Optum, Inc. (Industry)
139
1
1
3.4
40.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
139 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab.Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19
Actual Study Start Date
:
Jan 4, 2021
Actual Primary Completion Date
:
Apr 18, 2021
Actual Study Completion Date
:
Apr 18, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
65 Years
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | QueryLab | Minnetonka | Minnesota | United States | 55343 |
Sponsors and Collaborators
- Daniel Griffin
- Eli Lilly and Company
- Optum, Inc.
Investigators
- Principal Investigator: Dan Griffin, MD, PHD, ProHealth New York - UnitedHealth Group
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Daniel Griffin,
Daniel Griffin, MD PhD CTropMed CTH,
UnitedHealth Group
ClinicalTrials.gov Identifier:
NCT04656691
Other Study ID Numbers:
- 2020-0081_
First Posted:
Dec 7, 2020
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Daniel Griffin,
Daniel Griffin, MD PhD CTropMed CTH,
UnitedHealth Group
Additional relevant MeSH terms:
Study Results
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 Detail | 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 |
| Arm/Group Title | Treatment: Participants With COVID-19 |
|---|---|
| Arm/Group Description | 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.. |
| Period Title: Overall Study | |
| STARTED | 139 |
| COMPLETED | 138 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Participants With COVID-19 |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 139 |
| Age, Customized (Count of Participants) | |
| 64 years or younger |
4
2.9%
|
| 65 years to 69 years |
51
36.7%
|
| 70 years to 74 years |
46
33.1%
|
| 75 years to 79 years |
21
15.1%
|
| 80 years or older |
16
11.5%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
75
54%
|
| Male |
64
46%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Pacific Islander |
0
0%
|
| Black or African American |
3
2.2%
|
| White |
72
51.8%
|
| Other |
2
1.4%
|
| Race Unknown or Not Reported |
62
44.6%
|
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
0
0%
|
| Ethnicity Unknown or Not Reported |
139
100%
|
| Days since COVID-19 symptom onset (count) (Count of Participants) | |
| Equal to or less than 8 days since COVID-19 symptom onset |
128
92.1%
|
| Greater than 8 days since COVID-19 symptom onset |
1
0.7%
|
| Unknown |
10
7.2%
|
| Days since COVID-19 symptom onset (mean) (Days) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Days] |
3.7
(2.24)
|
| Elixhauser comorbidity score (Mean) (units on a scale) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [units on a scale] |
9.3
(13.09)
|
| Elixhauser conditions (Count of Participants) | |
| Acquired Immune Deficiency Syndrome |
0
0%
|
| Alcohol Abuse |
2
1.4%
|
| Deficiency Anemia |
14
10.1%
|
| Rheumatoid arthritis/collagen vascular diseases |
1
0.7%
|
| Chronic blood loss anemia |
2
1.4%
|
| Congestive heart failure |
5
3.6%
|
| Chronic pulmonary disease |
12
8.6%
|
| Coagulopathy |
4
2.9%
|
| Depression |
9
6.5%
|
| Diabetes, Uncomplicated |
17
12.2%
|
| Diabetes, With Chronic Complications |
12
8.6%
|
| Drug Abuse |
1
0.7%
|
| Hypertension, Complicated or Uncomplicated |
51
36.7%
|
| Hypothyroidism |
13
9.4%
|
| Liver Disease |
3
2.2%
|
| Lymphoma |
0
0%
|
| Fluid and electrolyte disorders |
7
5%
|
| Metastatic Cancer |
0
0%
|
| Other Neurological Disorders |
7
5%
|
| Obesity |
21
15.1%
|
| Paralysis |
1
0.7%
|
| Peripheral Vascular Disorders |
9
6.5%
|
| Psychoses |
5
3.6%
|
| Pulmonary Circulation disorders |
1
0.7%
|
| Renal Failure |
8
5.8%
|
| Solid Tumor without Metastasis |
7
5%
|
| Peptic ulcer disease excluding bleeding |
1
0.7%
|
| Valvular Disease |
9
6.5%
|
| Weight Loss |
1
0.7%
|
| Immunosuppressive treatments 6 months prior to date of COVID-19 diagnosis (Count of Participants) | |
| Received Immunosuppressive Treatment 6 months prior |
1
0.7%
|
| Did Not Receive Immunosuppressive Treatment 6 months prior |
116
83.5%
|
Outcome Measures
| Title | Number of Participants With Incidence of COVID-19 Related Hospitalization at Day 28 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All eligible participants for primary outcome analysis |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group Description | Participants testing positive for COVID-19 who received One-time at-home infusion of 700 mg Bamlanivimab |
| Measure Participants | 138 |
| Count of Participants [Participants] |
6
4.3%
|
| Title | Safety - Documenting Adverse Events After Infusion |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group Description | Participants testing positive for COVID-19 who received One-time at-home infusion of 700 mg Bamlanivimab |
| Measure Participants | 138 |
| COVID-19 related hospitalization |
6
4.3%
|
| All-Cause ER visits |
4
2.9%
|
Adverse Events
| Time Frame | Days 1-28 after at-home infusion of Bamlanivimab | |
|---|---|---|
| Adverse Event Reporting Description | The reporting includes all-cause mortality, COVID-19 related hospitalizations, and all-cause emergency room (ER) visits. All adverse events were considered serious. | |
| Arm/Group Title | Treatment | |
| Arm/Group Description | Participants testing positive for COVID-19 who received One-time at-home infusion of 700 mg Bamlanivimab | |
All Cause Mortality |
||
| Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/139 (0.7%) | |
Serious Adverse Events |
||
| Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/139 (7.2%) | |
| General disorders | ||
| Syncope | 1/139 (0.7%) | 1 |
| Hypokalemia | 1/139 (0.7%) | 1 |
| Dysarthria | 1/139 (0.7%) | 1 |
| Shaking | 1/139 (0.7%) | 1 |
| Asthenia | 1/139 (0.7%) | 1 |
| Fever | 1/139 (0.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Hypoxia | 1/139 (0.7%) | 1 |
| Shorness of Breath | 1/139 (0.7%) | 1 |
| Increased Coughing | 1/139 (0.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Itching | 1/139 (0.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/139 (0%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Tracy Ziolek , Vice President, Human Research Affairs |
|---|---|
| Organization | UnitedHealth Group/Optum Labs |
| Phone | 215-868-3114 |
| tracy_ziolek@uhg.com |
Responsible Party:
Daniel Griffin,
Daniel Griffin, MD PhD CTropMed CTH,
UnitedHealth Group
ClinicalTrials.gov Identifier:
NCT04656691
Other Study ID Numbers:
- 2020-0081_
First Posted:
Dec 7, 2020
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022