Trial · NCT04412057

Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury

NCT04412057, Phase 2, Completed, Aevi Genomic Medicine, LLC, a Cerecor company; results first posted 2022-03-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury. Trials, record NCT04412057. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04412057

On this page

Trial

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

Title: Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury
NCT number: NCT04412057
Status: Completed
Phases: Phase 2
Enrollment: 88 participants, actual
Lead sponsor: Aevi Genomic Medicine, LLC, a Cerecor company
Conditions: COVID-19 Pneumonia, Acute Lung Injury, ARDS
Interventions: CERC-002, Placebo
First posted: 2020-06-02
Last updated: 2022-03-24
Results first posted: 2022-03-04
Limitations and caveats: The study was designed to use broad eligibility criteria including patients who received high-flow oxygen or positive-pressure oxygen prior to randomization. Some overlap was expected between the entry criteria and the primary endpoint. Therefore patients who were in respiratory failure before dosing or who required an elevation in their ventilation support were excluded (N=20). In addition, to increase statistical power, a 1-sided χ2 test was used.

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Number of Subjects Alive and Free of Respiratory Failure	Baseline to Day 28	Respiratory failure defined based on resource utilization requiring at least one of the following: * Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula (heated, humidified oxygen delivered via reinforced nasal cannula at flow rates \>20L/min with fraction of delivered oxygen ≥0.5) * Noninvasive positive pressure ventilation, * Extracorporeal membrane oxygenation
Secondary	Number of Subjects Who Are Alive at Day 28	Baseline to Day 28	1-month mortality defined as the number of subjects who are alive at the Day 28/ET visit

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects Alive and Free of Respiratory Failure	Baseline to Day 28	The number of subjects alive and free of respiratory failure up to Day 28/Early Termination (ET). The study was designed with broad eligibility criteria allowing patients who received high-flow oxygen or positive-pressure oxygen prior to dosing to be enrolled. As overlap was expected patients who were in respiratory failure before dosing or who required elevation in their ventilation support were excluded from the primary analysis (N=20, 9 CERC-002 patients and 11 placebo patients).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Subjects Who Are Alive at Day 28	Baseline to Day 28	The Full Analysis Set included all subjects who received at least one dose of investigational product and had a baseline and at least one post-baseline efficacy assessment. There was 1 subject who did not have a survival status at Day 28 so is therefore excluded from the secondary analysis of the number of subjects who were alive at Day 28.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Number of Subjects Alive and Free of Respiratory Failure	CERC-002	26	Participants
Number of Subjects Alive and Free of Respiratory Failure	Placebo	20	Participants
Number of Subjects Who Are Alive at Day 28	CERC-002	36	Participants
Number of Subjects Who Are Alive at Day 28	Placebo	36	Participants

Source ClinicalTrials.gov

Participant flow14

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

Period	Milestone	Group	Participants
Overall Study	STARTED	CERC-002	41
Overall Study	STARTED	Placebo	42
Overall Study	Randomized Analysis Set	CERC-002	41
Overall Study	Randomized Analysis Set	Placebo	42
Overall Study	Safety Analysis Set	CERC-002	40
Overall Study	Safety Analysis Set	Placebo	42
Overall Study	Full Analysis Set	CERC-002	40
Overall Study	Full Analysis Set	Placebo	42
Overall Study	Primary Analysis Set	CERC-002	31
Overall Study	Primary Analysis Set	Placebo	31

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events52

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	Anaemia	Blood and lymphatic system disorders	CERC-002	4	40	7
other	Anaemia	Blood and lymphatic system disorders	Placebo	3	42	3
other	Leukocytosis	Blood and lymphatic system disorders	CERC-002	6	40	8
other	Leukocytosis	Blood and lymphatic system disorders	Placebo	4	42	4
other	Hepatic Enzyme Increased	Investigations	CERC-002	4	40	5
other	Hepatic Enzyme Increased	Investigations	Placebo	2	42	2
other	Acute Kidney Injury	Renal and urinary disorders	CERC-002	3	40	3
other	Acute Kidney Injury	Renal and urinary disorders	Placebo	1	42	1
serious	Acute myocardial infarction	Cardiac disorders	CERC-002	1	40	1
serious	Acute myocardial infarction	Cardiac disorders	Placebo	0	42	0

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CERC-002	4	40
Total, all-cause mortality	Placebo	9	42
Total, other adverse events	CERC-002	10	40
Total, other adverse events	Placebo	6	42
Total, serious adverse events	CERC-002	8	40
Total, serious adverse events	Placebo	12	42

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32817460	DERIVED	PubMed
34871182	RESULT	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 comparisons4

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

Comparison	Source
CERC-002 vs Placebo: Number of Subjects Who Are Alive at Day 28	Trial comparisons
CERC-002 vs Placebo: Number of Subjects Alive and Free of Respiratory Failure	Trial comparisons
CERC-002 vs Placebo: deaths from any cause	Trial comparisons
CERC-002 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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04412057

GET https://conductscience.org/api/trials/v1/NCT04412057/events?page=2

API reference For AI assistants