NCT04603651

Brief Summary

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
Last Updated

October 2, 2023

Status Verified

September 15, 2023

First QC Date

October 23, 2020

Last Update Submit

September 29, 2023

Conditions

COVID-19

Interventions

BamlanivimabDRUG

Administered intravenously (IV).

Also known as: LY3819253, LY-CoV555

Eligibility Criteria

Age12 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Reside in a country where there are ongoing Lilly-sponsored clinical trials (currently this is only the United States)
  • Present within 10 days of symptom onset
  • Have severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) confirmed by reverse transcription polymerase chain reaction (RT-PCR) within the last three days
  • Participants greater than or equal to (≥) 65 years of age OR
  • Participants ≥ 12 years of age who weigh at least 40 kilograms AND have at least one of the following:
  • Cancer
  • Chronic kidney disease
  • Chronic obstructive pulmonary disease (COPD) or other chronic lung disease
  • Immunocompromised state (weakened immune system or on immunomodulatory medications)
  • Obesity (body mass index \[BMI\] of 35 or higher)
  • Serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies
  • Sickle cell disease
  • Diabetes mellitus (Types 1 or 2)

You may not qualify if:

  • Bamlanivimab should not be used in patients hospitalized with severe COVID-19 respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 34473343DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

bamlanivimab

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Contact Lilly at 1-800-LillyRx (1-800-545-5979)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2020

First Posted

October 27, 2020

Last Updated

October 2, 2023

Record last verified: 2023-09-15