ACTIV-3: Therapeutics for Inpatients With COVID-19

(TICO Trial)

Recruiting in Palo Alto (17 mi)

+178 other locations

Overseen by Prof. Jens Lundgren

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.

Research Team

Prof. Jens Lundgren

Principal Investigator

INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen

Prof. James Neaton

Principal Investigator

INSIGHT Statistical and Coordinating Centre, University of Minnesota

Eligibility Criteria

Inclusion Criteria

You have had symptoms of COVID-19 for 12 or fewer days.

Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19 infection.

Signed informed consent.

Exclusion Criteria

Patients who have received plasma from a person who recovered from COVID-19 or who have received neutralizing monoclonal antibodies at any time prior to hospitalization.

Any condition which, in the opinion of the responsible investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.

Patients considered unable to participate in study procedures.

Treatment Details

Interventions

• AZD7442 (Monoclonal Antibodies)
• BRII-196/BRII-198 (Monoclonal Antibodies)
• LY3819253 (Monoclonal Antibodies)
• PF-07304814 (Antiviral)
• Placebo (Other)
• Remdesivir (Antiviral)
• VIR-7831 (Monoclonal Antibodies)

Participant Groups

Group I: ACTIV-3 Drug plus SOC Experimental Treatment 7 Interventions

Participants in this study will be randomized to receive one of the ACTIV-3 drug treatments plus Standard of Care (SOC) or placebo plus SOC

Group II: Placebo plus SOC Placebo Group 2 Interventions

The placebo arm may be pooled across more than one experimental arm if multiple investigational drugs are available to be tested at the same time. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Dr. Jeanne Marrazzo

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Executive Officer since 2023

MD, MPH

Dr. H. Clifford Lane

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Medical Officer

MD

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Collaborator

Trials

103

Recruited

74,200+

Dr. Joseph J. Eron Jr.

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Chief Executive Officer

MD from Harvard Medical School

Dr. James McNamara

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Chief Medical Officer since 2023

MD from Harvard Medical School

Cardiothoracic Surgical Trials Network

Collaborator

Trials

9

Recruited

6,300+

Prevention and Early Treatment of Acute Lung Injury

Collaborator

Trials

9

Recruited

6,300+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Shashank Priya

University of Minnesota

Chief Executive Officer since 2023

PhD in Materials Engineering from Penn State

Charles Semba

University of Minnesota

Chief Medical Officer since 2021

MD from the University of Minnesota Medical School

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

Collaborator

Trials

15

Recruited

8,800+

University of Copenhagen

Collaborator

Trials

963

Recruited

13,350,000+

Dr. Eva Ehrnrooth

University of Copenhagen

Chief Medical Officer since 2023

MD and Ph.D. in Clinical Oncology

Dr. Mai-Britt Zocca

University of Copenhagen

Chief Executive Officer since 2015

M.Sc in Biochemistry and Ph.D. in Medicine from the University of Copenhagen and NIH, NCI, MD, US

Medical Research Council

Collaborator

Trials

327

Recruited

1,999,000+

Dr. Ceri Williams

Medical Research Council

Chief Medical Officer

MD

Professor Patrick Chinnery

Medical Research Council

Executive Chair

MBBS, PhD in Clinical Neuroscience

Kirby Institute

Collaborator

Trials

115

Recruited

194,000+

Professor Anthony Kelleher

Kirby Institute

Chief Executive Officer since 2019

PhD in Immunology

Kyle Minor

Kirby Institute

Chief Medical Officer

MD

Washington D.C. Veterans Affairs Medical Center

Collaborator

Trials

45

Recruited

18,500+