Clinical trial NCT04701658: A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
Official title: A Prospective Cohort Study to Evaluate the Real-world Effectiveness of Bamlanivimab in Participants With Mild-to-moderate COVID-19 at High Risk for Progressing to Severe Illness, With Matched Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: AbCellera Biologics Inc.
First posted: 2021-01-08
Enrollment: 109
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
timeFrame: Baseline through Days 29, 60, and 90
Secondary outcomes:
measure: Percentage of Participants With a COVID-19-related Hospitalization
timeFrame: Baseline through Days 29, 60, and 90
measure: Percentage of Participants With a COVID-related Emergency Department (ED) Visit
timeFrame: Baseline through Days 29, 60, and 90
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Presbyterian Medical Center
state: New Mexico
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: 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.