Immune Modulators for Treating COVID-19

Summary

ACTIV-1 IM is a master protocol designed to evaluate multiple investigational agents for the treatment of moderately or severely ill patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in use at the local clinics, including remdesivir (provided). The SoC may change during the course of the study based on other research findings. Comparisons of the agents among themselves is not a research objective.

The study population corresponds to moderately and severely ill patients infected with the coronavirus disease 2019 (COVID-19) virus. Recruitment will target patients already hospitalized for treatment of COVID-19 infection as well as patients being treated for COVID-19 infection in Emergency Departments while waiting to be admitted to the hospital. Patients both in and out of the ICU are included in the study population.

Conditions

• Covid19

Interventions

DRUG

Infliximab

study drug or matching placebo

DRUG

Abatacept

study drug or matching placebo

DRUG

Remdesivir

Standard of Care

DRUG

cenicriviroc (closed to enrollment as of 3-Sep-2021)

study drug or matching placebo

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• Biomedical Advanced Research and Development Authority

  collaborator FED

• Daniel Benjamin

  lead OTHER

Principal Investigators

• Daniel K Benjamin, MD, PhD · Duke University

• Bill Powderly, MD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-15

Primary Completion

2022-01-30

Completion

2022-03-05

FDA Drug

Yes

Countries

• United States
• Argentina
• Brazil
• Mexico
• Peru

Study Locations