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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 May 2020

At a glance

  • Drugs CD24Fc (Primary)
  • Indications COVID 2019 infections; Severe acute respiratory syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms SAC-COVID
  • Sponsors OncoImmune
  • Most Recent Events

    • 22 May 2020 Planned End Date changed from 1 May 2022 to 1 Dec 2020.
    • 22 May 2020 Planned primary completion date changed from 1 May 2021 to 1 Sep 2020.
    • 21 Apr 2020 According to an Oncoimmune media release, as the drug has a novel mechanism of action, it will likely synergize with other drugs, including antiviral treatments such as chloroquine and Remdesivir, or other immune modulators targeting cytokines or their receptors. Therefore, the trial will accept patients undergoing, or intending to enroll in trials testing other experimental therapies.

Trial Overview

Purpose

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.

Primary Endpoints

Improvement of COVID-19 disease status

description: 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.
time_frame: 28 days

Other Endpoints

Proportion of patients who died or had respiratory failure.

description: 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 time_frame: 29 days

Disease progression of COVID-19

description: Time for disease progression from NIAID scale 3 or 4 to need to be on invasive mechanical ventilation, or ESMO, or death. time_frame: 29 days

All cause of death

description: All cause of death time_frame: 29 days

Proportion of clinical relapse

description: 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 time_frame: 29 days

Conversion rate of clinical status at Day 8

description: 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") time_frame: 8 days

Conversion rate of clinical status at Day 15

description: 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") time_frame: 15 days

Hospital discharge time

description: The discharge time, calculated after the randomization. time_frame: 29 days

Duration of mechanical ventilation

description: Duration of mechanical ventilation (IMV, NIV) (days) time_frame: 29 days

Duration of pressors

description: Duration of pressors (days) time_frame: 29 days

Duration of ECMO

description: Duration of extracorporeal membrane oxygenation (days) time_frame: 29 days

Duration of high flow oxygen therapy

description: Duration of oxygen therapy (oxygen inhalation by high flow nasal cannula or mask) (days) time_frame: 29 days

Absolute lymphocyte count

description: Changes of absolute lymphocyte count in peripheral blood time_frame: 29 days

Change of D-dimers

description: The changes of plasma concentration of D-dimers time_frame: 15 and 29 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Severe acute respiratory syndrome treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 230

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient 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).

Patient 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).

Trial Details

Identifiers

Identifier Owner
NCT04317040 ClinicalTrials.gov: US National Institutes of Health
CD24Fc007 -
20200674 -

Organisations

  • Sponsors OncoImmune
  • Affiliations OncoImmune

Trial Dates

  • Initiation Dates

    Planned : 01 May 2020

    Actual : 08 Apr 2020

  • Primary Completion Dates

    Planned : 01 Sep 2020

  • End Dates

    Planned : 01 Dec 2020

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location USA
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
CD24FcPrimary Drug Intravenous Infusion

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

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

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
James Welker, MD Anne Arundel Medical Center
-
Martin Devenport, PhD
(410) 2070582
mdevenport@oncoimmune.com
show details
, OncoImmune, Inc.
-
Pan Zheng, MD, PhD
(202) 7516823
pzheng@oncoimmune.com
show details
, OncoImmune, Inc.
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Anne Anundel Medical Center Annapolis, Maryland USA
Anne Arundel Medical Center
-
-
Atlantic Health System Morristown, New Jersey USA
Baptist Health Research Institute Jacksonville, Florida USA
Cooper University Hospital Camden, New Jersey USA
Henry Ford Health System Detroit, Michigan USA
Institute of Human Virology, University of Maryland Baltimore Baltimore, Maryland USA
Martin Army Community Hospital Fort Benning, Georgia USA
OncoImmune, Inc.
-
-
Shady Grove Medical Center Rockville, Maryland USA
The Ohio State University Medical Center Columbus, Ohio USA
Thomas Jefferson University Medical Center Philadelphia, Pennsylvania USA
University Hospitals of Cleveland Cleveland, Ohio USA
White Oak Medical Center Silver Spring, Maryland USA

Trial History

Event Date Event Type Comment
30 May 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 30 May 2020
22 May 2020 Completion date Planned End Date changed from 1 May 2022 to 1 Dec 2020. Updated 28 May 2020
22 May 2020 Other trial event Planned primary completion date changed from 1 May 2021 to 1 Sep 2020. Updated 28 May 2020
21 Apr 2020 Other trial event According to an Oncoimmune media release, as the drug has a novel mechanism of action, it will likely synergize with other drugs, including antiviral treatments such as chloroquine and Remdesivir, or other immune modulators targeting cytokines or their receptors. Therefore, the trial will accept patients undergoing, or intending to enroll in trials testing other experimental therapies. Updated 22 Apr 2020
21 Apr 2020 Other trial event According to an OncoImmune media release, this study will involve 10 centers across the country. Dr. Joel Chua Assistant Professor of Medicine, Division of Clinical Care and Research, Institute of Human Virology at the University of Maryland School of Medicine is the clinical principle investigator for the University of Maryland Medical Center. ClinSmart, LLC of Newton, Pennsylvania is the Clinical Research Organization contracted to manage the trial. Updated 22 Apr 2020
08 Apr 2020 Other trial event According to an OncoImmune media release, the company has received a study-may-proceed letter from the FDA. Updated 14 Apr 2020
08 Apr 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 13 Apr 2020
23 Mar 2020 New trial record New trial record Updated 23 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. OncoImmune. OncoImmune Receives FDA Approval for COVID-19 Clinical Trial. Media-Rel 2020;.

    Media Release
  3. OncoImmune. OncoImmune Starts Phase III Clinical Trial Testing the Power of Dampening Inflammation to Virus-induced Cellular Injury in Severe COVID-19 Patients. Media-Rel 2020;.

    Media Release
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