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

• Status: Completed
• Trial end date: 2020-10-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OncoImmune, Inc.

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)>/= 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)