Official Title
A Randomized, Double-blind, Placebo-controlled, Multi-site, Phase III Study to Evaluate the Safety and Efficacy of CD24Fc in COVID-19 Treatment
Brief 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.

Detailed Description

As the newest global medical emergency, the COVID-19 (diagnosed SARS-CoV2 infection with lung

involvement) exhibits features that are unlikely ameliorated by antivirals-based approaches

alone. First, although the new coronavirus (SARS-CoV-2) infect lung and intestine, many

patients suddenly take a turn for the worse even when the viral replication appears to be

under control. Second, patients with serious or critical clinical symptoms show remarked T

cell lymphopenia that are more severe and more acute than human immunodeficiency virus (HIV)

infection. Functional exhaustion of T cells is suggested by high expression of T-cell

exhaustion markers, which again appears more acute than in HIV patients. Third, multiple

cytokines are elevated among patients with severe clinical symptoms, which potentially

explains the multiple organ failure associated with COVID-19. For these reasons, treatment of

COVID-19 likely requires a combination of both antivirals and non-antivirals-based


CD24Fc is a biological immunomodulator in Phase II/III clinical trial stage. CD24Fc comprises

the nonpolymorphic regions of CD24 attached to the Fc region of human IgG1. We have shown

that CD24 is an innate checkpoint against the inflammatory response to tissue injuries or

danger-associated molecular patterns (DAMPs). Preclinical and clinical studies have

demonstrated that CD24Fc effectively address the major challenges associated with COVID-19.

First, a Phase I clinical trial on healthy volunteers not only demonstrated safety of CD24Fc,

but also demonstrated its biological activity in suppressing expression of multiple

inflammatory cytokines. Second, in Phase II clinical trial in leukemia patients undergoing

hematopoietic stem cell transplantation (HCT), three doses of CD24Fc effectively eliminated

severe (Grade 3-4) acute graft vs host diseases (GVHD), which is caused by over reacting

immune system and transplanted T cells attacking recipient target tissues. Third, in

preclinical models of HIV/SIV infections, we have shown that CD24Fc ameliorated production of

multiple inflammatory cytokines, reversed the loss of T lymphocytes as well as functional T

cell exhaustion and reduced the leukocyte infiltration of multiple organs. It is particularly

noteworthy that CD24Fc reduced the rate of pneumonia in SIV-infected Chinese rhesus monkey

from 83% to 33%. Therefore, CD24Fc maybe a prime candidate for non-antiviral biological

modifier for COVID-19 therapy. The phase III trial will involve 270 patients randomized into

blinded placebo and CD24Fc arms, with time to clinical improvement from critical or severe to

mild symptom as the primary endpoint.

Coronavirus Disease 2019 (COVID-19)

Drug: Efprezimod alfa

Efprezimod alfa is given on Day 1.
Other Name: Array

Drug: Placebo

Placebo is given on Day 1.
Other Name: Saline

Eligibility Criteria

Inclusion Criteria:

- 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) >/= 24 breaths/min). Intubation should be within 7 days

Exclusion Criteria:

- 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)

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
United States

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

Medical Director, Study Director
Merck Sharp & Dohme LLC

OncoImmune, Inc.
NCT Number
MeSH Terms