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

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ClinicalTrials.gov Identifier: NCT04317040
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : May 29, 2020
Sponsor:
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 subjects who are diagnosed with severe COVID 19.

Arm A: CD24Fc/Best Available Treatment; Arm B: placebo/ Best Available Treatment. CD24Fc will be administered as single dose of 480 mg via IV infusion on Day 1. Total of 230 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.


Condition or disease Intervention/treatment Phase
Severe Coronavirus Disease (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 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 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 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 230 patients randomized into blinded placebo and CD24Fc arms, with time to clinical improvement from severe to mild symptom as the primary endpoint.

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Study Type : Interventional
Estimated Enrollment : 230 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 8, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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. Improvement of COVID-19 disease status [ Time Frame: 29 days ]
    Time to improve in clinical status: the time (days) required from the start of treatment to the improvement of clinical status "severe" to "moderate/mild"; or improvement from "scale 3 or 4" to "scale 5 or higher" based on NIAID ordinal scales.


Secondary Outcome Measures :
  1. Proportion of patients who died or had respiratory failure. [ Time Frame: 29 days ]
    Proportion of patients who died or had respiratory failure, defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high flow oxygen devices, at Day 29

  2. 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, or ESMO, or death.

  3. All cause of death [ Time Frame: 29 days ]
    All cause of death

  4. Proportion of clinical relapse [ Time Frame: 29 days ]
    Proportion of clinical relapse, as 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 days 8 (proportion of subjects who changed from NIAID ordinal "scale 3 or 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 days 15 (proportion of subjects who changed from NIAID ordinal "scale 3 or 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. Absolute lymphocyte count [ Time Frame: 29 days ]
    Changes of absolute lymphocyte count in peripheral blood

  13. 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.


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

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.
  5. Severe COVID-19 (Appendix A), or NIAID 8-point ordinal score 3 to 4 (requiring non-invasive ventilation or oxygen, a SpO2 </= 94% or tachypnea (respiratory rate >/= 24 breaths/min), Appendix B).

Exclusion Criteria:

  1. Patients with COVID 19 in critical condition or ARDS (Appendix A) or NIAID 8-point ordinal score 2 (Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)).
  2. Patients with documented bacterial / fungal infections.
  3. Patients with sepsis or septic shock.
  4. Patients who are pregnant, breastfeeding, or have a positive pregnancy test result before enrollment.
  5. Severe liver damage (Child-Pugh score ≥ C, AST> 5 times the upper limit).
  6. Patients with known severe renal impairment (creatinine clearance ≤ 30 mL / min) or patients receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
  7. 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 ClinicalTrials.gov identifier (NCT number): NCT04317040


Contacts
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Contact: Pan Zheng, MD, PhD 2027516823 pzheng@oncoimmune.com
Contact: Martin Devenport, PhD (410) 2070582 mdevenport@oncoimmune.com

Locations
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United States, Florida
Baptist Health Research Institute Recruiting
Jacksonville, Florida, United States, 32207
United States, Georgia
Martin Army Community Hospital Not yet recruiting
Fort Benning, Georgia, United States, 31905
United States, Maryland
Anne Anundel Medical Center Recruiting
Annapolis, Maryland, United States, 21401
Institute of Human Virology, University of Maryland Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Shady Grove Medical Center Recruiting
Rockville, Maryland, United States, 20850
White Oak Medical Center Recruiting
Silver Spring, Maryland, United States, 20904
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Atlantic Health System Recruiting
Morristown, New Jersey, United States, 07960
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Thomas Jefferson University Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
OncoImmune, Inc.
Investigators
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Principal Investigator: James Welker, MD Anne Arundel Medical Center
Publications:
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Responsible Party: OncoImmune, Inc.
ClinicalTrials.gov Identifier: NCT04317040    
Other Study ID Numbers: CD24Fc-007
20200674 ( Other Identifier: WIRB )
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases