LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Summary

This study looks at the safety and effectiveness of LY3819253 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either LY3819253 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H1.

Conditions

• COVID-19

Interventions

BIOLOGICAL

LY3819253

LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2

BIOLOGICAL

Placebo

Commercially available 0.9% sodium chloride solution

BIOLOGICAL

Remdesivir

Antiviral agent

Sponsors & Collaborators

• International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

  collaborator NETWORK

• University of Copenhagen

  collaborator OTHER

• Medical Research Council

  collaborator OTHER_GOV

• Kirby Institute

  collaborator OTHER_GOV

• Washington D.C. Veterans Affairs Medical Center

  collaborator FED

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

  collaborator NETWORK

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• US Department of Veterans Affairs

  collaborator FED

• Prevention and Early Treatment of Acute Lung Injury

  collaborator OTHER

• Cardiothoracic Surgical Trials Network

  collaborator OTHER

• Eli Lilly and Company

  collaborator INDUSTRY

• University of Minnesota

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Jens Lundgren, Prof. · INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen

• James Neaton, Prof. · INSIGHT Statistical and Data Management Center, University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-05

Primary Completion

2021-02-01

Completion

2021-02-01

FDA Drug

Yes

Countries

• United States
• Denmark
• Singapore
• Spain

Study Locations