Efprezimod Alfa (CD24Fc, MK-7110) as a Non-antiviral Immunomodulator in COVID-19 Treatment (MK-7110-007)

Completed · Phase 3 · Has a placebo group

Conditions studied: Coronavirus Disease 2019 (COVID-19)

In brief

This study evaluates the efficacy and safety of efprezimod alfa in hospitalized adult participants who are diagnosed with coronavirus disease 2019 (COVID-19) and receiving oxygen support. The primary hypothesis of the study is clinical improvement in the experimental group versus the control group.

Key facts

Study ID

NCT04317040

Run by

Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

234

Starts

2020-04-24

Expected to finish

2020-10-20

Last updated by the study team

2023-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with coronavirus disease 2019 (COVID-19) and confirmed severe acute respiratory syndrome coronavirus 2 (SARS-coV-2) viral infection
• Severe or critical COVID-19, or National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal score 2, 3 or 4 (Scale 2: requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Scale 3: non-invasive ventilation or high flow oxygen devices; Scale 4: supplemental oxygen support; a peripheral capillary oxygen saturation (SpO2) </= 94% or tachypnea (respiratory rate >/= 24 breaths/min). Intubation should be within 7 days

You may not qualify if…

• Participants who are pregnant, breastfeeding, or have a positive pregnancy test result before enrollment
• Participants previously enrolled in the efprezimod alfa study
• Intubation for invasive mechanical ventilation is over 7 days
• Documented acute renal or hepatic failure
• The investigator believes that participating in the trial is not in the best interests of the participant, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues)

Where it is running

• Baptist Health Research Institute — Jacksonville, Florida, United States
• Anne Anundel Medical Center — Annapolis, Maryland, United States
• Institute of Human Virology, University of Maryland Baltimore — Baltimore, Maryland, United States
• Shady Grove Medical Center — Rockville, Maryland, United States
• White Oak Medical Center — Silver Spring, Maryland, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Atlantic Health System — Morristown, New Jersey, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• University of Texas at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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