Trial · NCT04317040

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

NCT04317040, Phase 3, Completed, Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2021-10-15

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Efprezimod Alfa (CD24Fc, MK-7110) as a Non-antiviral Immunomodulator in COVID-19 Treatment (MK-7110-007). Trials, record NCT04317040. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04317040

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efprezimod Alfa (CD24Fc, MK-7110) as a Non-antiviral Immunomodulator in COVID-19 Treatment (MK-7110-007)
NCT number: NCT04317040
Status: Completed
Phases: Phase 3
Enrollment: 234 participants, actual
Lead sponsor: Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions: Coronavirus Disease 2019 (COVID-19)
Interventions: Efprezimod alfa, Placebo
First posted: 2020-03-20
Last updated: 2023-02-08
Results first posted: 2021-10-15

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status	Up to Day 29	Time to improvement in COVID-19 clinical status: defined as time (days) required from start of treatment to improvement of clinical status severe - moderate/mild or improvement from score 2-4 to ≥5 sustained without drop below 5 within 28 days from randomization, total follow-up period 29 days (Randomization Day 1 + 28 days follow up) per National Institute of Allergy \& Infectious Diseases (NIAID) ordinal scale graded: 1=Death; 2=Hospitalized, on invasive mechanical ventilation (IMV)/extracorporeal membrane oxygenation (ECMO); 3=Hospitalized, on non-invasive ventilation (NIV)/high flow oxygen devices; 4=Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, don't require medical care; 7=Not hospitalized, limitation on activities \&/or require home oxygen; 8=Not hospitalized, no limitations on activities. Median time \& 95% confidence intervals (CIs) were reported using Brookmeyer-Crowley method.
Primary	Number of Participants Who Experience an Adverse Event (AE)	Up to 30 days	An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, only AEs with Common Terminology Criteria for AE (CTACAE) grade ≥3 were included. The number of participants who experienced an AE were reported.
Secondary	Percentage of Participants Who Died or Had Respiratory Failure (RF)	Up to Day 29	RF was defined as the need for any of the following: 1) mechanical ventilation (MV), 2) ECMO, 3) NIV, or 4) high flow oxygen devices. Percentage of participants who died or had respiratory failure by Day 29 were reported.
Secondary	Time to Disease Progression in Clinical Status of COVID-19	Up to Day 29	Time to disease progression in clinical status is defined as the time (days) for progression from NIAID score (3 or 4) to (2 or 1) or from 2 to 1 within 28 days from randomization, total follow-up period 29 days (Randomization Day 1 + 28 days follow up). NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not Hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities.
Secondary	Number of Participants Who Died Due to Any Cause	Up to Day 29	Number of participants who died due to any cause were assessed per protocol on Day 15 and Day 29.
Secondary	Rate of Clinical Relapse	Up to Day 29	Rate of clinical relapse was defined as the percentage of participants who had initially reached score 5 on NIAID ordinal scale for more than one day but subsequently became dependent on oxygen support for more than 1 day within 28 days from randomization after initial recovery with a total follow-up period of 29 days (Day 1 of randomization plus 28 days of follow-up). NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities. Clopper-Pearson method was used to report the 95% CI.
Secondary	Conversion Rate of COVID-19 Clinical Status	Up to Day 15	Conversion rate of COVID-19 clinical status on days 8 and 15 was defined as the percentage of participants who changed from NIAID ordinal score 2, 3, 4 to score 5 or higher and reported. NIAID ordinal scale graded as: 1=Death; 2=Hospitalized, on IMV/ECMO; 3=Hospitalized, on NIV/high flow oxygen devices; 4= Hospitalized, require supplemental oxygen; 5=Hospitalized, no supplemental oxygen, require medical care; 6=Hospitalized, no supplemental oxygen, do not require medical care; 7=Not hospitalized, limitation on activities and/or require home oxygen; 8=Not hospitalized, no limitations on activities.
Secondary	Time to Hospital Discharge	Up to Day 29	The hospital discharge time was defined as the time from randomization to discharge from the hospital and reported. Time to Hospital Discharge (days) from randomization is calculated as: Time to hospital discharge = Date of hospital discharge - Date of randomization.
Secondary	Duration of MV	Up to Day 29	MV included IMV and NIV. Duration of MV (days) was calculated as: End Date of MV - Start Date of MV + 1 and reported.
Secondary	Duration of Pressors	Up to Day 29	Pressor administration included norepinephrine, epinephrine, vasopressin, dopamine and phenylephrine. Duration of pressor (days) was defined as: End Date of Pressor - Start Date of Pressor + 1 and reported.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status	Up to Day 29	All randomized participants	Days	MEDIAN
PRIMARY	Number of Participants Who Experience an Adverse Event (AE)	Up to 30 days	All randomized participants who received at least one dose of treatment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants Who Died or Had Respiratory Failure (RF)	Up to Day 29	All randomized participants	Percentage of Participants	NUMBER
SECONDARY	Time to Disease Progression in Clinical Status of COVID-19	Up to Day 29	All randomized participants	Days	MEDIAN
SECONDARY	Number of Participants Who Died Due to Any Cause	Up to Day 29	All randomized participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Rate of Clinical Relapse	Up to Day 29	All randomized participants	Percentage of Participants	NUMBER
SECONDARY	Conversion Rate of COVID-19 Clinical Status	Up to Day 15	All randomized participants	Percentage of participants	NUMBER
SECONDARY	Time to Hospital Discharge	Up to Day 29	All randomized participants	Days	MEDIAN
SECONDARY	Duration of MV	Up to Day 29	All randomized participants who received MV	Days	MEAN
SECONDARY	Duration of Pressors	Up to Day 29	All randomized participants who received pressors	Days	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group61

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status	CD24Fc		6.0	95% Confidence Interval 5.0 to 9.0	Days
Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status	Placebo		10.5	95% Confidence Interval 7.0 to 15.0	Days
Number of Participants Who Experience an Adverse Event (AE)	CD24Fc		32		Participants
Number of Participants Who Experience an Adverse Event (AE)	Placebo		35		Participants
Percentage of Participants Who Died or Had Respiratory Failure (RF)	CD24Fc		22.4		Percentage of Participants
Percentage of Participants Who Died or Had Respiratory Failure (RF)	Placebo		28.0		Percentage of Participants
Time to Disease Progression in Clinical Status of COVID-19	CD24Fc		NA	95% Confidence Interval NA to NA	Days
Time to Disease Progression in Clinical Status of COVID-19	Placebo		NA	95% Confidence Interval NA to NA	Days
Number of Participants Who Died Due to Any Cause	CD24Fc	Day 15	11		Participants
Number of Participants Who Died Due to Any Cause	Placebo	Day 15	8		Participants

1 to 10 of 61Source ClinicalTrials.gov

See all 61 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	CD24Fc	116
Overall Study	STARTED	Placebo	118
Overall Study	Treated	CD24Fc	114
Overall Study	Treated	Placebo	115
Overall Study	COMPLETED	CD24Fc	98
Overall Study	COMPLETED	Placebo	98
Overall Study	NOT COMPLETED	CD24Fc	18
Overall Study	NOT COMPLETED	Placebo	20

Source ClinicalTrials.gov

Adverse events64

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Anaemia	Blood and lymphatic system disorders	CD24Fc	4	114	4
serious	Anaemia	Blood and lymphatic system disorders	Placebo	1	115	1
serious	Cardiac arrest	Cardiac disorders	CD24Fc	3	114	3
serious	Cardiac arrest	Cardiac disorders	Placebo	2	115	2
serious	Cardio-respiratory arrest	Cardiac disorders	CD24Fc	2	114	2
serious	Cardio-respiratory arrest	Cardiac disorders	Placebo	1	115	1
serious	Pulseless electrical activity	Cardiac disorders	CD24Fc	1	114	1
serious	Pulseless electrical activity	Cardiac disorders	Placebo	0	115	0
serious	Gastrointestinal haemorrhage	Gastrointestinal disorders	CD24Fc	1	114	1
serious	Gastrointestinal haemorrhage	Gastrointestinal disorders	Placebo	0	115	0

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CD24Fc	16	116
Total, all-cause mortality	Placebo	18	118
Total, other adverse events	CD24Fc	0	114
Total, other adverse events	Placebo	0	115
Total, serious adverse events	CD24Fc	26	114
Total, serious adverse events	Placebo	27	115

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19264983	BACKGROUND	PubMed
21208791	BACKGROUND	PubMed
21478876	BACKGROUND	PubMed
24996822	BACKGROUND	PubMed
29983395	BACKGROUND	PubMed
32382131	BACKGROUND	PubMed
35012610	DERIVED	PubMed
35286843	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
CD24Fc vs Placebo: Number of Participants Who Experience an Adverse Event (AE)	Trial comparisons
CD24Fc vs Placebo: deaths from any cause	Trial comparisons
CD24Fc vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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