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

OncoImmune

Status and phase

Completed

Phase 3

Conditions

Coronavirus Disease 2019 (COVID-19)

Treatments

Drug: Efprezimod alfa

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04317040

7110-007

CD24Fc-007-US (Other Identifier)

20200674 (Other Identifier)

MK-7110-007 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

234 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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)