Status:
COMPLETED
Efprezimod Alfa (CD24Fc, MK-7110) as a Non-antiviral Immunomodulator in COVID-19 Treatment (MK-7110-007)
Lead Sponsor:
Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Coronavirus Disease 2019 (COVID-19)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2020
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT04317040
Start Date
April 24 2020
End Date
October 20 2020
Last Update
February 8 2023
Active Locations (10)
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1
Baptist Health Research Institute
Jacksonville, Florida, United States, 32207
2
Anne Anundel Medical Center
Annapolis, Maryland, United States, 21401
3
Institute of Human Virology, University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
4
Shady Grove Medical Center
Rockville, Maryland, United States, 20850