Clinical Trials Logo
  1. Home
  2. Covid19
  3. NCT04603651
  4. Details
NCT04603651 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT04603651
Other study ID # 18165
Secondary ID J2X-MC-Y001
Status No longer available
Phase
First received
Last updated

Study information
Verified date September 15, 2023
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 12 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bamlanivimab
Administered intravenously (IV).

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Eli Lilly and Company AbCellera Biologics Inc.
See also
  Status Clinical Trial Phase
Recruiting NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Active, not recruiting NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure