A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)

NCT04701658 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 18216J2X-MC-PYAJ
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

  Percentage of Participants who Experience COVID-19 Related Hospitalization or Death From Any Cause. Hospitalization is defined as ≥24 hours of acute care.

  Baseline through Days 29, 60, and 90

Secondary Outcomes (2)

• Percentage of Participants With a COVID-19-related Hospitalization

  Baseline through Days 29, 60, and 90

• Percentage of Participants With a COVID-related Emergency Department (ED) Visit

  Baseline through Days 29, 60, and 90

Study Arms (2)

Bamlanivimab

EXPERIMENTAL

Participants received 700 milligram single intravenous infusion of Bamlanivimab.

Drug: Bamlanivimab

Controls

NO INTERVENTION

Matched controls who received standard of care. \[The study was originally designed to include a matched control arm. However, due to low enrollment, it was amended to be a single arm study with Bamlanivimab arm only. No matched controls were utilized.\]

Interventions

Bamlanivimab DRUG

Administered intravenously.

Also known as: LY3819253, LY-CoV555

Bamlanivimab

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• AbCellera Biologics Inc.: collaborator

Study Sites (1)

Presbyterian Medical Center

Albuquerque, New Mexico, 87110, United States

Location

Related Publications (1)

• 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.

  PMID: 34473343 DERIVED

Related Links

• A Real World Study of Bamlanivimab in Participants With Mild-to-moderate Coronavirus Disease 2019 (COVID-19) (BLAZE-5)

MeSH Terms

Conditions

COVID-19

Interventions

bamlanivimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The study was originally designed to include a matched control arm. However, due to low enrollment, it was amended to be a single arm study with Bamlanivimab arm only. No matched controls were utilized. Therefore, no comparative analyses were conducted. All analyses were descriptive in nature and conducted only on Bamlanivimab-treated participants.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 8, 2021
• Study Start: February 1, 2021
• Primary Completion: June 22, 2021
• Study Completion: June 22, 2021
• Last Updated: November 16, 2021
• Results First Posted: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (1)