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OpenTrials
Completed

NCT Number: NCT04411628

A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19

The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection into a vein to participants hospitalized with COVID-19. Blood tests will be done to check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it. Participation could last about 8 weeks and may include up to 15 visits in the hospital or the home.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cedars Sinai Medical Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are hospitalized or in the process of being admitted to hospital and have an initial laboratory determination of current COVID-19 infection less than or equal to (≤)72 hours prior to randomization
  • Are men or non-pregnant women
  • Women of childbearing potential must agree to use at least one highly effective form of contraception for the entirety of the study
  • Agree to the collection of nasopharyngeal swabs and venous blood

Exclusion criteria

  • Require mechanical ventilation or anticipated impending need for mechanical ventilation
  • Received convalescent COVID-19 plasma treatment prior to enrollment
  • Were resident in a nursing home or long-term care facility immediately prior to current hospitalization
  • 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 investigational product
  • Have an oxygen saturation (SpO2) less than (<)88 percent (%) while breathing room air at rest at randomization.

Treatment and study plan

LY3819253

Drug

Administered IV.

Other names: LY-CoV555, Bamlanivimab

Placebo

Drug

Administered IV.

Primary outcomes

  1. Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline through Day 60

    An SAE is any adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.

Secondary outcomes

  1. Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29

    Time frame: Day 29

    Pharmacokinetics (PK): Mean Concentration of LY3819253 on Day 29.

  2. Pharmacodynamics (PD): Change From Baseline to Day 29 in Viral Load

    Time frame: Baseline, Day 29

    Pharmacodynamics (PD): Change from Baseline to Day 29 in Viral Load.

  3. Pharmacodynamics (PD): SARS-CoV-2 Viral Load AUC

    Time frame: Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose

    The SARS-CoV-2 viral load was derived from the cycle time (CT) values using a polymerase chain reaction (PCR) assay. Higher CT values indicate a lower viral load.

  4. Pharmacodynamics (PD): Time to SARS-CoV-2 Clearance

    Time frame: Day 1 pre-dose, Days 3, 7, 11, 15, 22, 29 post dose

    Pharmacodynamics (PD): Time to SARS-CoV-2 clearance.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • AbCellera Biologics Inc.

Registry information

Official study title

A Randomized, Placebo-Controlled, Double-Blind, Sponsor Unblinded, Single Ascending Dose, Phase 1 First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous LY3819253 in Participants Hospitalized for COVID-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2020
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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