Efprezimod Alfa (CD24Fc, MK-7110) as a Non-antiviral Immunomodulator in COVID-19 Treatment (MK-7110-007)
NCT ID: NCT04317040
Last Updated: 2023-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
234 participants
INTERVENTIONAL
2020-04-24
2020-10-20
Brief Summary
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The primary hypothesis of the study is clinical improvement in the experimental group versus the control group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Efprezimod alfa
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.
Efprezimod alfa
Efprezimod alfa is given on Day 1.
Placebo
Participants receive single dose of placebo as normal saline solution 100 ml, IV infusion in 60 minutes, on Day 1.
Placebo
Placebo is given on Day 1.
Interventions
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Efprezimod alfa
Efprezimod alfa is given on Day 1.
Placebo
Placebo is given on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Baptist Health Research Institute
Jacksonville, Florida, United States
Anne Anundel Medical Center
Annapolis, Maryland, United States
Institute of Human Virology, University of Maryland Baltimore
Baltimore, Maryland, United States
Shady Grove Medical Center
Rockville, Maryland, United States
White Oak Medical Center
Silver Spring, Maryland, United States
Cooper University Hospital
Camden, New Jersey, United States
Atlantic Health System
Morristown, New Jersey, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
University of Texas at Houston
Houston, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Oncology Clinical Trials Information
Other Identifiers
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20200674
Identifier Type: OTHER
Identifier Source: secondary_id
CD24Fc-007-US
Identifier Type: OTHER
Identifier Source: secondary_id
MK-7110-007
Identifier Type: OTHER
Identifier Source: secondary_id
7110-007
Identifier Type: -
Identifier Source: org_study_id
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