Trial · NCT04391309

COVID-19 and Anti-CD14 Treatment Trial

NCT04391309, Phase 2, Terminated, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2023-06-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. COVID-19 and Anti-CD14 Treatment Trial. Trials, record NCT04391309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04391309

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Trial

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

Title: COVID-19 and Anti-CD14 Treatment Trial
NCT number: NCT04391309
Status: Terminated
Phases: Phase 2
Enrollment: 49 participants, actual
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions: Coronavirus Disease 2019 (COVID-19), Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Interventions: anti-CD14, Placebo, remdesivir
First posted: 2020-05-18
Last updated: 2023-06-26
Results first posted: 2023-06-15
Limitations and caveats: The trial was terminated early because of slow recruitment and cannot be considered fully powered.

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	The Time to Clinical Recovery, Defined as the Time From Baseline to the First Day That Subject is in Categories 1, 2, or 3 on the Eight-Point Ordinal Scale Through Day 28.	Within the 28 day period following baseline	The Primary Endpoint is time to clinical recovery, defined as the time from baseline to the first day that a subject is in categories 1, 2, or 3 on the Eight-Point Ordinal Scale through Day 28 (range 1 \[best\] to 8 \[worst\]). The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day. The Scale is defined as follows: 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care 4. Hospitalized, not requiring supplemental oxygen-requiring ongoing medical care (COVID-19-related or otherwise) 5. Hospitalized, requiring supplemental oxygen 6. Hospitalized, on non-invasive ventilation or high-flow oxygen devices 7. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 8. Death
Secondary	Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28	Within the 28 day period following baseline.	Episodes of acute respiratory failure are defined as by need for the following oxygen delivery resources: 1. High-flow nasal cannula (flow rates ≥30L/min with FiO2 ≥0.4) 2. Noninvasive positive-pressure ventilation through nasal or face mask, or nasal plugs 3. Endotracheal intubation and mechanical 4. Extracorporeal membrane oxygenation
Secondary	Change in the Ordinal Scale From Baseline to Day 14	Within the 14 day period following baseline.	A larger negative change indicates a greater improvement in clinical status from baseline. The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day (1 is best, 8 is worst). The Scale is defined as follows: 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities and/or requiring home oxygen. 3. Hospitalized, not requiring supplemental oxygen; no longer requires ongoing medical care. 4. Hospitalized, not requiring supplemental oxygen; requiring ongoing medical care (COVID-19-related or otherwise). 5. Hospitalized, requiring supplemental oxygen. 6. Hospitalized, on non-invasive ventilation or high-flow oxygen devices. 7. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 8. Death.
Secondary	Change in Ordinal Scale From Baseline to Day 28.	Within the 28 day period following baseline.	A larger negative change indicates a greater improvement in clinical status from baseline. The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day (1 is best, 8 is worst). The Scale is defined as follows: 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities and/or requiring home oxygen. 3. Hospitalized, not requiring supplemental oxygen; no longer requires ongoing medical care. 4. Hospitalized, not requiring supplemental oxygen; requiring ongoing medical care (COVID-19-related or otherwise). 5. Hospitalized, requiring supplemental oxygen. 6. Hospitalized, on non-invasive ventilation or high-flow oxygen devices. 7. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 8. Death.
Secondary	Ordinal Scale Value on Day 14.	Day 14 following baseline.	The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day (1 is best, 8 is worst). The Scale is defined as follows: 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities and/or requiring home oxygen. 3. Hospitalized, not requiring supplemental oxygen; no longer requires ongoing medical care. 4. Hospitalized, not requiring supplemental oxygen; requiring ongoing medical care (COVID-19-related or otherwise). 5. Hospitalized, requiring supplemental oxygen. 6. Hospitalized, on non-invasive ventilation or high-flow oxygen devices. 7. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 8. Death.
Secondary	All-Cause Mortality Through Day 28.	Within the 28 day period following baseline.	Mortality due to all causes during the observation period.
Secondary	All-Cause Mortality Through Day 60.	Within the 60 day period following baseline.	Mortality due to all causes during the observation period.
Secondary	Percentage of Participants Alive and Free of Any Episode of Acute Respiratory Failure Through Day 28	Within the 28 day period following baseline.	Episodes of acute respiratory failure are defined as by need for the following oxygen delivery resources: 1. High-flow nasal cannula (flow rates ≥30L/min with FiO2 ≥0.4) 2. Noninvasive positive-pressure ventilation through nasal or face mask, or nasal plugs 3. Endotracheal intubation and mechanical ventilation 4. Extracorporeal membrane oxygenation
Secondary	Days Alive and Free of Invasive Mechanical Ventilation Through Day 28	Within the 28 day period following baseline.	Endotracheal intubation and mechanical ventilation.
Secondary	Percentage of Participants Alive and Free of Invasive Mechanical Ventilation Through Day 28	Within the 28 day period following baseline.	Endotracheal intubation and mechanical ventilation.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Time to Clinical Recovery, Defined as the Time From Baseline to the First Day That Subject is in Categories 1, 2, or 3 on the Eight-Point Ordinal Scale Through Day 28.	Within the 28 day period following baseline	Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.	days	MEDIAN
SECONDARY	Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28	Within the 28 day period following baseline.	Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in the Ordinal Scale From Baseline to Day 14	Within the 14 day period following baseline.	Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product, who additionally had data collected on Day 14.	units on a scale	MEAN
SECONDARY	Change in Ordinal Scale From Baseline to Day 28.	Within the 28 day period following baseline.	Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product, who additionally had data collected on Day 28.	units on a scale	MEAN
SECONDARY	Ordinal Scale Value on Day 14.	Day 14 following baseline.	Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product, who additionally had data collected on Day 14.	units on a scale	MEAN
SECONDARY	All-Cause Mortality Through Day 28.	Within the 28 day period following baseline.	Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	All-Cause Mortality Through Day 60.	Within the 60 day period following baseline.	Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants Alive and Free of Any Episode of Acute Respiratory Failure Through Day 28	Within the 28 day period following baseline.	Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Days Alive and Free of Invasive Mechanical Ventilation Through Day 28	Within the 28 day period following baseline.	Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants Alive and Free of Invasive Mechanical Ventilation Through Day 28	Within the 28 day period following baseline.	Modified Intent to Treat population (mITT), that included all participants who were randomized and treated with at least one dose of investigational product.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group50

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

Outcome	Group	Category	Value	Spread	Units
The Time to Clinical Recovery, Defined as the Time From Baseline to the First Day That Subject is in Categories 1, 2, or 3 on the Eight-Point Ordinal Scale Through Day 28.	IC14		6	95% Confidence Interval 5 to 11	days
The Time to Clinical Recovery, Defined as the Time From Baseline to the First Day That Subject is in Categories 1, 2, or 3 on the Eight-Point Ordinal Scale Through Day 28.	Placebo		5	95% Confidence Interval 4 to 10	days
Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28	IC14	0 days	1		Participants
Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28	Placebo	0 days	1		Participants
Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28	IC14	24 days	1		Participants
Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28	Placebo	24 days	0		Participants
Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28	IC14	27 days	0		Participants
Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28	Placebo	27 days	1		Participants
Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28	IC14	28 days	18		Participants
Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28	Placebo	28 days	18		Participants

1 to 10 of 50Source ClinicalTrials.gov

See all 50 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	IC14	21
Overall Study	STARTED	Placebo	20
Overall Study	Included in the Modified Intent to Treat Population (miTT)	IC14	20
Overall Study	Included in the Modified Intent to Treat Population (miTT)	Placebo	20
Overall Study	COMPLETED	IC14	15
Overall Study	COMPLETED	Placebo	15
Overall Study	NOT COMPLETED	IC14	6
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events116

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
other	Leukocytosis	Blood and lymphatic system disorders	IC14	1	20	1
other	Leukocytosis	Blood and lymphatic system disorders	Placebo	2	20	2
other	Myocardial infarction	Cardiac disorders	IC14	0	20	0
other	Myocardial infarction	Cardiac disorders	Placebo	1	20	1
other	Tachycardia	Cardiac disorders	IC14	2	20	2
other	Tachycardia	Cardiac disorders	Placebo	1	20	1
other	Ventricular tachycardia	Cardiac disorders	IC14	0	20	0
other	Ventricular tachycardia	Cardiac disorders	Placebo	1	20	1
other	Blurred vision	Eye disorders	IC14	1	20	1
other	Blurred vision	Eye disorders	Placebo	0	20	0

1 to 10 of 116Source ClinicalTrials.gov

See all 116 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IC14	1	20
Total, all-cause mortality	Placebo	1	20
Total, other adverse events	IC14	16	20
Total, other adverse events	Placebo	13	20
Total, serious adverse events	IC14	4	20
Total, serious adverse events	Placebo	1	20

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UM1AI109565	Immune Tolerance Network	BUCKNER, JANE HOYT; ANDERSON, MARK S	BENAROYA RESEARCH INST AT VIRGINIA MASON	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2014 to 2025

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
IC14 vs Placebo: deaths from any cause	Trial comparisons
IC14 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.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license 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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