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

NCT04317040 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: 7110-00720200674CD24Fc-007-USMK-7110-007
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 10

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.

Conditions

Coronavirus Disease 2019 (COVID-19)

Outcome Measures

Primary Outcomes (2)

• Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status

  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.

  Up to Day 29

• Number of Participants Who Experience an Adverse Event (AE)

  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.

  Up to 30 days

Secondary Outcomes (13)

• Percentage of Participants Who Died or Had Respiratory Failure (RF)

  Up to Day 29

• Time to Disease Progression in Clinical Status of COVID-19

  Up to Day 29

• Number of Participants Who Died Due to Any Cause

  Up to Day 29

• Rate of Clinical Relapse

  Up to Day 29

• Conversion Rate of COVID-19 Clinical Status

  Up to Day 15

Study Arms (2)

Efprezimod alfa

EXPERIMENTAL

Participants receive single dose of 480 mg efprezimod alfa, diluted to 100 ml with normal saline, intravenous (IV) infusion in 60 minutes on Day 1.

Drug: Efprezimod alfa

Placebo

PLACEBO COMPARATOR

Participants receive single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes, on Day 1.

Drug: Placebo

Interventions

Efprezimod alfa DRUG

Efprezimod alfa is given on Day 1.

Also known as: Human CD24, Human IgG Fc Fusion Protein, MK-7110

Efprezimod alfa

Placebo DRUG

Placebo is given on Day 1.

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

Study Sites (10)

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

Location

Anne Anundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Institute of Human Virology, University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Shady Grove Medical Center

Rockville, Maryland, 20850, United States

Location

White Oak Medical Center

Silver Spring, Maryland, 20904, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

University of Texas at Houston

Houston, Texas, 77030, United States

Location

Related Publications (8)

• Chen GY, Brown NK, Zheng P, Liu Y. Siglec-G/10 in self-nonself discrimination of innate and adaptive immunity. Glycobiology. 2014 Sep;24(9):800-6. doi: 10.1093/glycob/cwu068. Epub 2014 Jul 4.

  PMID: 24996822 BACKGROUND

• Liu Y, Chen GY, Zheng P. Sialoside-based pattern recognitions discriminating infections from tissue injuries. Curr Opin Immunol. 2011 Feb;23(1):41-5. doi: 10.1016/j.coi.2010.10.004. Epub 2011 Jan 3.

  PMID: 21208791 BACKGROUND

• Chen GY, Chen X, King S, Cavassani KA, Cheng J, Zheng X, Cao H, Yu H, Qu J, Fang D, Wu W, Bai XF, Liu JQ, Woodiga SA, Chen C, Sun L, Hogaboam CM, Kunkel SL, Zheng P, Liu Y. Amelioration of sepsis by inhibiting sialidase-mediated disruption of the CD24-SiglecG interaction. Nat Biotechnol. 2011 May;29(5):428-35. doi: 10.1038/nbt.1846. Epub 2011 Apr 10.

  PMID: 21478876 BACKGROUND

• Chen GY, Tang J, Zheng P, Liu Y. CD24 and Siglec-10 selectively repress tissue damage-induced immune responses. Science. 2009 Mar 27;323(5922):1722-5. doi: 10.1126/science.1168988. Epub 2009 Mar 5.

  PMID: 19264983 BACKGROUND

• Tian RR, Zhang MX, Zhang LT, Zhang P, Ma JP, Liu M, Devenport M, Zheng P, Zhang XL, Lian XD, Ye M, Zheng HY, Pang W, Zhang GH, Zhang LG, Liu Y, Zheng YT. CD24 and Fc fusion protein protects SIVmac239-infected Chinese rhesus macaque against progression to AIDS. Antiviral Res. 2018 Sep;157:9-17. doi: 10.1016/j.antiviral.2018.07.004. Epub 2018 Jul 3.

  PMID: 29983395 BACKGROUND

• Tian RR, Zhang MX, Liu M, Fang X, Li D, Zhang L, Zheng P, Zheng YT, Liu Y. CD24Fc protects against viral pneumonia in simian immunodeficiency virus-infected Chinese rhesus monkeys. Cell Mol Immunol. 2020 Aug;17(8):887-888. doi: 10.1038/s41423-020-0452-5. Epub 2020 May 7. No abstract available.

  PMID: 32382131 BACKGROUND

• Welker J, Pulido JD, Catanzaro AT, Malvestutto CD, Li Z, Cohen JB, Whitman ED, Byrne D, Giddings OK, Lake JE, Chua JV, Li E, Chen J, Zhou X, He K, Gates D, Kaur A, Chen J, Chou HY, Devenport M, Touomou R, Kottilil S, Liu Y, Zheng P; SAC-COVID Study Team. Efficacy and safety of CD24Fc in hospitalised patients with COVID-19: a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Infect Dis. 2022 May;22(5):611-621. doi: 10.1016/S1473-3099(22)00058-5. Epub 2022 Mar 11.

  PMID: 35286843 DERIVED

• Song NJ, Allen C, Vilgelm AE, Riesenberg BP, Weller KP, Reynolds K, Chakravarthy KB, Kumar A, Khatiwada A, Sun Z, Ma A, Chang Y, Yusuf M, Li A, Zeng C, Evans JP, Bucci D, Gunasena M, Xu M, Liyanage NPM, Bolyard C, Velegraki M, Liu SL, Ma Q, Devenport M, Liu Y, Zheng P, Malvestutto CD, Chung D, Li Z. Treatment with soluble CD24 attenuates COVID-19-associated systemic immunopathology. J Hematol Oncol. 2022 Jan 10;15(1):5. doi: 10.1186/s13045-021-01222-y.

  PMID: 35012610 DERIVED

Related Links

• Merck Oncology Clinical Trials Information

MeSH Terms

Conditions

COVID-19

Interventions

CD24 protein, human; Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 20, 2020
• Study Start: April 24, 2020
• Primary Completion: October 20, 2020
• Study Completion: October 20, 2020
• Last Updated: February 8, 2023
• Results First Posted: October 15, 2021

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

US (10)