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

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ClinicalTrials.gov Identifier: NCT04317040
Recruitment Status : Completed
First Posted : March 20, 2020
Results First Posted : October 15, 2021
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
OncoImmune, Inc.

Brief Summary:

This study evaluates the efficacy and safety of CD24Fc (MK-7110) 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.


Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 (COVID-19) Drug: CD24Fc Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CD24Fc
Participants receive single dose of 480 mg CD24Fc, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.
Drug: CD24Fc
CD24Fc is given on Day 1.
Other Names:
  • Human CD24
  • Human IgG Fc Fusion Protein
  • MK-7110

Placebo Comparator: Placebo
Participants receive single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes, on Day 1.
Drug: Placebo
Placebo is given on Day 1.
Other Name: Saline




Primary Outcome Measures :
  1. Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status [ Time Frame: Up to Day 29 ]
    Time to improvement in COVID-19 clinical status: defined as time (days) required from start of treatment to improvement of clinical status severe - moderate/mild or improvement from score 2-4 to ≥5 sustained without drop below 5 within 28 days from randomization, total follow-up period 29 days (Randomization Day 1 + 28 days follow up) per National Institute of Allergy & Infectious Diseases (NIAID) ordinal scale graded: 1=Death; 2=Hospitalized, on invasive mechanical ventilation (IMV)/extracorporeal membrane oxygenation (ECMO); 3=Hospitalized, on non-invasive ventilation (NIV)/high flow oxygen devices; 4=Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, don't require medical care; 7=Not hospitalized, limitation on activities &/or require home oxygen; 8=Not hospitalized, no limitations on activities. Median time & 95% confidence intervals (CIs) were reported using Brookmeyer-Crowley method.

  2. Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to 30 days ]
    An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, only AEs with Common Terminology Criteria for AE (CTACAE) grade ≥3 were included. The number of participants who experienced an AE were reported.


Secondary Outcome Measures :
  1. Percentage of Participants Who Died or Had Respiratory Failure (RF) [ Time Frame: Up to Day 29 ]
    RF was defined as the need for any of the following: 1) mechanical ventilation (MV), 2) ECMO, 3) NIV, or 4) high flow oxygen devices. Percentage of participants who died or had respiratory failure by Day 29 were reported.

  2. Time to Disease Progression in Clinical Status of COVID-19 [ Time Frame: Up to Day 29 ]
    Time to disease progression in clinical status is defined as the time (days) for progression from NIAID score (3 or 4) to (2 or 1) or from 2 to 1 within 28 days from randomization, total follow-up period 29 days (Randomization Day 1 + 28 days follow up). NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not Hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities.

  3. Number of Participants Who Died Due to Any Cause [ Time Frame: Up to Day 29 ]
    Number of participants who died due to any cause were assessed per protocol on Day 15 and Day 29.

  4. Rate of Clinical Relapse [ Time Frame: Up to Day 29 ]
    Rate of clinical relapse was defined as the percentage of participants who had initially reached score 5 on NIAID ordinal scale for more than one day but subsequently became dependent on oxygen support for more than 1 day within 28 days from randomization after initial recovery with a total follow-up period of 29 days (Day 1 of randomization plus 28 days of follow-up). NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities. Clopper-Pearson method was used to report the 95% CI.

  5. Conversion Rate of COVID-19 Clinical Status [ Time Frame: Up to Day 15 ]
    Conversion rate of COVID-19 clinical status on days 8 and 15 was defined as the percentage of participants who changed from NIAID ordinal score 2, 3, 4 to score 5 or higher and reported. NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities.

  6. Time to Hospital Discharge [ Time Frame: Up to Day 29 ]
    The hospital discharge time was defined as the time from randomization to discharge from the hospital and reported. Time to Hospital Discharge (days) from randomization is calculated as: Time to hospital discharge = Date of hospital discharge - Date of randomization.

  7. Duration of MV [ Time Frame: Up to Day 29 ]
    MV included IMV and NIV. Duration of MV (days) was calculated as: End Date of MV - Start Date of MV + 1 and reported.

  8. Duration of Pressors [ Time Frame: Up to Day 29 ]
    Pressor administration included norepinephrine, epinephrine, vasopressin, dopamine and phenylephrine. Duration of pressor (days) was defined as: End Date of Pressor - Start Date of Pressor + 1 and reported.

  9. Duration of ECMO [ Time Frame: Up to Day 29 ]
    Duration of ECMO treatment (days) was calculated as: End Date of ECMO Treatment - Start Date of ECMO Treatment + 1 and reported.

  10. Duration of High Flow Oxygen Therapy [ Time Frame: Up to Day 29 ]
    Duration of oxygen therapy (oxygen inhalation by high flow nasal cannula or mask) (days) was calculated as: End Date of high flow oxygen therapy - Start Date of high flow oxygen therapy + 1 and reported.

  11. Length of Hospital Stay [ Time Frame: Up to 90 days ]
    Length of Hospital Stay (Days) was defined as date of discharge - date of admission + 1 and reported. Data presented below include hospitalization time prior to enrollment in the study with total duration of up to 90 days.

  12. Change From Baseline in Absolute Lymphocyte Count [ Time Frame: Baseline and up to Day 15 ]
    Blood samples were collected to present the change from baseline in the absolute lymphocyte count on days 1, 4, 8, and 15 in peripheral blood. To calculate the change from baseline in absolute lymphocyte count at specific timepoints (Days 1, 4, 8 and 15), only the participants who had both, a baseline, and a post baseline value at the specific timepoint (Days 1, 4, 8 and 15) were included in the analysis.

  13. Change From Baseline in D-Dimer Concentration [ Time Frame: Baseline and up to Day 15 ]
    Blood samples were collected to present the change from baseline in the D-dimer concentration on days 4, 8 and 15 in peripheral blood. To calculate change from baseline in D-dimer concentration at specific timepoints (Days 4, 8 and 15), only the participants who had both, a baseline, and a post baseline value at the specific timepoint (Days 4, 8 and 15) were included in the analysis.



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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:

  • 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) </= 94% or tachypnea (respiratory rate >/= 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 CD24Fc 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)

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


Locations
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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.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
  Study Documents (Full-Text)

Documents provided by OncoImmune, Inc.:
Publications:

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Responsible Party: OncoImmune, Inc.
ClinicalTrials.gov Identifier: NCT04317040    
Other Study ID Numbers: 7110-007
20200674 ( Other Identifier: WIRB )
CD24Fc-007-US ( Other Identifier: OncoImmune )
MK-7110-007 ( Other Identifier: Merck )
First Posted: March 20, 2020    Key Record Dates
Results First Posted: October 15, 2021
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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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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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases