Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04317040
Recruitment Status : Completed
First Posted : March 20, 2020
Last Update Posted : July 22, 2021
Information provided by (Responsible Party):
OncoImmune, Inc.

Brief Summary:

The study is designed as a randomized, placebo-controlled, double blind, multicenter, Phase III trial to compare two COVID-19 treatment regimens in hospitalized adult participants who are diagnosed with COVID-19 and receiving oxygen support.

Arm A: CD24Fc (MK-7110)/Best Available Treatment; Arm B: placebo/ Best Available Treatment. CD24Fc will be administered as single dose of 480 mg via intravenous (IV) infusion on Day 1. Total of 270 subjects will be enrolled and randomized in 1:1 ratio to receive CD24Fc or placebo. All subjects will be treated with the best available treatment. The follow up period is 28 days.

The primary hypothesis of the study is clinical improvement in the experimental group vs the control group.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: CD24Fc Drug: Placebo Phase 3

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 marked 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 approaches.

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 immunoglobulin G1 (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 addresses 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 a 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 Human immunodeficiency virus (HIV)/ Simian immunodeficiency virus (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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 24, 2020
Actual Primary Completion Date : October 20, 2020
Actual Study Completion Date : October 20, 2020

Arm Intervention/treatment
Experimental: CD24Fc Treatment
Single dose at Day 1, CD24Fc, 480mg, diluted to 100ml with normal saline, IV infusion in 60 minutes.
Drug: CD24Fc
CD24Fc is given on Day 1.
Other Name: Human CD24 and human IgG Fc Fusion Protein

Placebo Comparator: Placebo
Single dose at Day 1, normal saline solution 100ml, IV infusion in 60 minutes.
Drug: Placebo
Placebo is given on Day 1.
Other Name: Saline

Primary Outcome Measures :
  1. Time to Improvement in COVID-19 Clinical Status [ Time Frame: 29 days ]
    Time to improvement in COVID-19 clinical status is defined as the time (days) required from the start of treatment to the improvement of clinical status "severe" to "moderate/mild"; or improvement from "scale 2, 3, or 4" to "scale 5 or higher" based on the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scales.

Secondary Outcome Measures :
  1. Percentage of Participants Who Died or Had Respiratory Failure (RF) [ Time Frame: 29 days ]
    Percentage of participants who died or had respiratory failure, defined as the need for mechanical ventilation, extracorporeal membrane oxygenation (ECMO), non-invasive ventilation (NIV), or high flow oxygen devices, at Day 29

  2. Time to Disease Progression of COVID-19 [ Time Frame: 29 days ]
    Time for disease progression from NIAID scale 3 or 4 to need to be on invasive mechanical ventilation (IMV), or ECMO, or death, or from NIAID scale 2 to death.

  3. All-Cause of Death [ Time Frame: 15 days and 29 days ]
    All cause of death

  4. Rate of Clinical Relapse [ Time Frame: 29 days ]
    Rate of clinical relapse is defined by rate of return to oxygen support for more than 1 day within 29 days from randomization after initial recovery.

  5. Conversion Rate of Clinical Status at Day 8 [ Time Frame: 8 days ]
    Conversion rate of clinical status on day 8 (percentage of participants who changed from NIAID ordinal scale 2, 3, 4 to scale 5 or higher.

  6. Conversion Rate of Clinical Status at Day 15 [ Time Frame: 15 days ]
    Conversion rate of clinical status on day 15 (percentage of participants who changed from NIAID ordinal scale 2, 3, 4 to scale 5 or higher.

  7. Hospital Discharge Time [ Time Frame: 29 days ]
    The discharge time, calculated after the randomization.

  8. Duration of Mechanical Ventilation [ Time Frame: 29 days ]
    Duration of mechanical ventilation (IMV, NIV) (days)

  9. Duration of Pressors [ Time Frame: 29 days ]
    Duration of pressors (days)

  10. Duration of ECMO [ Time Frame: 29 days ]
    Duration of extracorporeal membrane oxygenation (days)

  11. Duration of High Flow Oxygen Therapy [ Time Frame: 29 days ]
    Duration of oxygen therapy (oxygen inhalation by high flow nasal cannula or mask) (days)

  12. Length of Hospital Stay [ Time Frame: 29 days ]
    Length of Hospital Stay (Days) is defined as date of discharge - date of admission +1. Hospital stay for participants will be reported.

  13. Absolute Lymphocyte Count [ Time Frame: 29 days ]
    Changes of absolute lymphocyte count in peripheral blood

  14. Change of D-Dimers [ Time Frame: 15 and 29 days ]
    The changes of plasma concentration of D-dimers

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Should be at least 18 years of age,
  2. Male or female,
  3. Diagnosed with COVID-19 and confirmed SARS-coV-2 viral infection.
  4. Able to sign the consent form by subject or by legal authorized representative.
  5. Severe or critical COVID-19, or NIAID 8-point ordinal score 2, 3 or 4 (Scale 2: requiring invasive mechanical ventilation or 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.

Exclusion Criteria:

  1. Patients who are pregnant, breastfeeding, or have a positive pregnancy test result before enrollment,
  2. Patients previously enrolled in the CD24Fc study,
  3. Intubation for invasive mechanical ventilation is over 7 days,
  4. Documented acute renal or hepatic failure,
  5. The investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04317040

Layout table for location information
United States, Florida
Baptist Health Research Institute
Jacksonville, Florida, United States, 32207
United States, Maryland
Anne Anundel Medical Center
Annapolis, Maryland, United States, 21401
Institute of Human Virology, University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
Shady Grove Medical Center
Rockville, Maryland, United States, 20850
White Oak Medical Center
Silver Spring, Maryland, United States, 20904
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Atlantic Health System
Morristown, New Jersey, United States, 07960
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Texas
University of Texas at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
OncoImmune, Inc.
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.

Layout table for additonal information
Responsible Party: OncoImmune, Inc. Identifier: NCT04317040    
Other Study ID Numbers: 7110-007
20200674 ( Other Identifier: WIRB )
CD24Fc-007 ( Other Identifier: OncoImmune )
MK-7110-007 ( Other Identifier: Merck )
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No