Phase 3
Completed N=234
Efprezimod Alfa (CD24Fc, MK-7110) as a Non-antiviral Immunomodulator in COVID-19 Treatment (MK-7110-007)
Coronavirus Disease 2019 (COVID-19)
Source: ClinicalTrials.gov NCT04317040 ↗
Enrolled (actual)
234
Serious AEs
23.1%
Results posted
Oct 2021
Primary outcomePrimary: Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status — 6.0; 10.5 Days — p=0.0367
◆ Published Evidence
Established
42citations · ~11 / year
Treatment with soluble CD24 attenuates COVID-19-associated systemic immunopathology.
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.
Linked Publications (2)
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Treatment with soluble CD24 attenuates COVID-19-associated systemic immunopathology.
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Efficacy and safety of CD24Fc in hospitalised patients with COVID-19: a randomised, double-blind, placebo-controlled, phase 3 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status |
6.0; 10.5 | 0.0367 sig |
| PRIMARY Number of Participants Who Experience an Adverse Event (AE) |
32; 35 | — |
| SECONDARY Percentage of Participants Who Died or Had Respiratory Failure (RF) |
22.4; 28.0 | 0.3281 |
| SECONDARY Time to Disease Progression in Clinical Status of COVID-19 |
NA; NA | 0.0306 sig |
| SECONDARY Number of Participants Who Died Due to Any Cause |
11; 8; 16; 18 | 0.4491 |
| SECONDARY Rate of Clinical Relapse |
4.3; 6.8 | — |
| SECONDARY Conversion Rate of COVID-19 Clinical Status |
55.2; 42.4; 71.6; 55.9 | — |
| SECONDARY Time to Hospital Discharge |
7.0; 10.5 | 0.0311 sig |
| SECONDARY Duration of MV |
14.3; 14.3 | — |
| SECONDARY Duration of Pressors |
6.3; 7.9 | — |
| SECONDARY Duration of ECMO |
11.0 | — |
| SECONDARY Duration of High Flow Oxygen Therapy |
13.8; 13.0 | — |
| SECONDARY Length of Hospital Stay |
16.6; 18.2 | — |
| SECONDARY Change From Baseline in Absolute Lymphocyte Count |
2.357; 2.437; 5.317; 5.125; 2.373; 2.461 | — |
| SECONDARY Change From Baseline in D-Dimer Concentration |
153.717; 9.767; 10.451; 13.885; 13.224; 13.349 | — |
Eligibility 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 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)
Data sourced from ClinicalTrials.gov (NCT04317040) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.