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

Last updated: January 11, 2023
Sponsor: OncoImmune, Inc.
Overall Status: Completed

Phase

3

Condition

Covid-19

Treatment

Efprezimod alfa

Placebo

Clinical Study ID

NCT04317040
7110-007
CD24Fc-007-US
20200674
MK-7110-007
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with coronavirus disease 2019 (COVID-19) and confirmed severe acuterespiratory 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 mechanicalventilation or extracorporeal membrane oxygenation (ECMO); Scale 3: non-invasiveventilation or high flow oxygen devices; Scale 4: supplemental oxygen support; aperipheral capillary oxygen saturation (SpO2) </= 94% or tachypnea (respiratory rate >/= 24 breaths/min). Intubation should be within 7 days

Exclusion

Exclusion Criteria:

  • Participants who are pregnant, breastfeeding, or have a positive pregnancy test resultbefore 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 interestsof the participant, or the investigator considers unsuitable for enrollment (such asunpredictable risks or subject compliance issues)

Study Design

Total Participants: 234
Treatment Group(s): 2
Primary Treatment: Efprezimod alfa
Phase: 3
Study Start date:
April 24, 2020
Estimated Completion Date:
October 20, 2020

Connect with a study center

  • Baptist Health Research Institute

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Martin Army Community Hospital

    Fort Benning, Georgia 31905
    United States

    Site Not Available

  • Anne Anundel Medical Center

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Institute of Human Virology, University of Maryland Baltimore

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Shady Grove Medical Center

    Rockville, Maryland 20850
    United States

    Site Not Available

  • White Oak Medical Center

    Silver Spring, Maryland 20904
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Atlantic Health System

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University Hospitals of Cleveland

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Thomas Jefferson University Medical Center

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Texas at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Site Not Available

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