Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19

September 29, 2023 updated by: Eli Lilly and Company

Expanded Access Information for Physicians for Bamlanivimab (LY3819253) Emergency Investigational New Drug [EIND]

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Require hospitalization greater than (>) 24 hours or hospice care. Residents in long term care or skilled nursing facilities that meet the inclusion criteria and are not on mechanical ventilation will be considered
  • Bamlanivimab should not be used in patients hospitalized with severe COVID-19 respiratory disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

AbCellera Biologics Inc.

Investigators

  • Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

October 23, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 15, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18165
  • J2X-MC-Y001 (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Bamlanivimab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe