Trial Outcomes & Findings for Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury (NCT NCT04412057)

NCT ID: NCT04412057

Last Updated: 2022-03-24

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

88 participants

Primary outcome timeframe

Baseline to Day 28

Results posted on

2022-03-24

Participant Flow

Of the 88 enrolled patients, 83 met inclusion criteria and were randomized to treatment.

Participant milestones

Participant milestones
Measure	CERC-002 CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.	Placebo Placebo: Administered once subcutaneously
Overall Study STARTED	41	42
Overall Study Randomized Analysis Set	41	42
Overall Study Safety Analysis Set	40	42
Overall Study Full Analysis Set	40	42
Overall Study Primary Analysis Set	31	31
Overall Study COMPLETED	37	35
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	CERC-002 CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.	Placebo Placebo: Administered once subcutaneously
Overall Study Death	3	7
Overall Study Discharged prior to receiving study treatment	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CERC-002 n=41 Participants CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.	Placebo n=42 Participants Placebo: Administered once subcutaneously	Total n=83 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=99 Participants	31 Participants n=107 Participants	55 Participants n=206 Participants
Age, Categorical >=65 years	17 Participants n=99 Participants	11 Participants n=107 Participants	28 Participants n=206 Participants
Age, Continuous	59.2 years STANDARD_DEVIATION 14.5 • n=99 Participants	58.1 years STANDARD_DEVIATION 14.21 • n=107 Participants	58.7 years STANDARD_DEVIATION 14.28 • n=206 Participants
Sex: Female, Male Female	16 Participants n=99 Participants	10 Participants n=107 Participants	26 Participants n=206 Participants
Sex: Female, Male Male	25 Participants n=99 Participants	32 Participants n=107 Participants	57 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=99 Participants	10 Participants n=107 Participants	19 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=99 Participants	31 Participants n=107 Participants	63 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	7 Participants n=99 Participants	3 Participants n=107 Participants	10 Participants n=206 Participants
Race (NIH/OMB) White	31 Participants n=99 Participants	37 Participants n=107 Participants	68 Participants n=206 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Region of Enrollment United States	41 Participants n=99 Participants	42 Participants n=107 Participants	83 Participants n=206 Participants
Corticosteroid Use Yes	37 Participants n=99 Participants	36 Participants n=107 Participants	73 Participants n=206 Participants
Corticosteroid Use No	4 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants
Remdesivir Use Yes	21 Participants n=99 Participants	27 Participants n=107 Participants	48 Participants n=206 Participants
Remdesivir Use No	20 Participants n=99 Participants	15 Participants n=107 Participants	35 Participants n=206 Participants
Body Mass Index (BMI)	34.3 kg/m^2 STANDARD_DEVIATION 8.58 • n=99 Participants	32.3 kg/m^2 STANDARD_DEVIATION 6.46 • n=107 Participants	33.3 kg/m^2 STANDARD_DEVIATION 7.63 • n=206 Participants

PRIMARY outcome

Timeframe: Baseline to Day 28

Population: 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).

Outcome measures

Outcome measures
Measure	CERC-002 n=31 Participants CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.	Placebo n=31 Participants Placebo: Administered once subcutaneously
Number of Subjects Alive and Free of Respiratory Failure	26 Participants	20 Participants

SECONDARY outcome

Timeframe: Baseline to Day 28

Population: 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.

1-month mortality defined as the number of subjects who are alive at the Day 28/ET visit

Outcome measures

Outcome measures
Measure	CERC-002 n=39 Participants CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.	Placebo n=42 Participants Placebo: Administered once subcutaneously
Number of Subjects Who Are Alive at Day 28	36 Participants	36 Participants

Adverse Events

CERC-002

Serious events: 8 serious events

Other events: 10 other events

Deaths: 4 deaths

Placebo

Serious events: 12 serious events

Other events: 6 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	CERC-002 n=40 participants at risk CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.	Placebo n=42 participants at risk Placebo: Administered once subcutaneously
Blood and lymphatic system disorders Anaemia	10.0% 4/40 • Number of events 7 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	7.1% 3/42 • Number of events 3 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Blood and lymphatic system disorders Leukocytosis	15.0% 6/40 • Number of events 8 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	9.5% 4/42 • Number of events 4 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Investigations Hepatic Enzyme Increased	10.0% 4/40 • Number of events 5 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	4.8% 2/42 • Number of events 2 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Renal and urinary disorders Acute Kidney Injury	7.5% 3/40 • Number of events 3 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	2.4% 1/42 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).

Additional Information

Scott White, MD

Avalo Therapeutics, Inc.

Phone: 484-763-3080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	CERC-002 n=40 participants at risk CERC-002: Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.	Placebo n=42 participants at risk Placebo: Administered once subcutaneously
Cardiac disorders Acute myocardial infarction	2.5% 1/40 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	0.00% 0/42 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Cardiac disorders Cardiac arrest	5.0% 2/40 • Number of events 3 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	4.8% 2/42 • Number of events 2 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Cardiac disorders Ventricular Fibrillation	2.5% 1/40 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	2.4% 1/42 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
General disorders Non-cardiac chest pain	2.5% 1/40 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	0.00% 0/42 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Infections and infestations Sepsis	2.5% 1/40 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	0.00% 0/42 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Infections and infestations Urinary tract infection	2.5% 1/40 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	0.00% 0/42 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Nervous system disorders Cerebral infarction	2.5% 1/40 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	0.00% 0/42 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Renal and urinary disorders Renal failure	2.5% 1/40 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	0.00% 0/42 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.5% 1/40 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	4.8% 2/42 • Number of events 3 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	2.5% 1/40 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	0.00% 0/42 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.5% 1/40 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	0.00% 0/42 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Vascular disorders Hypotension	2.5% 1/40 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	2.4% 1/42 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Cardiac disorders Bradycardia	0.00% 0/40 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	2.4% 1/42 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Cardiac disorders Pulseless electrical activity	0.00% 0/40 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	2.4% 1/42 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/40 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	2.4% 1/42 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
General disorders Adverse event	0.00% 0/40 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	2.4% 1/42 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Infections and infestations COVID-19 pneumonia	0.00% 0/40 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	4.8% 2/42 • Number of events 2 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Infections and infestations Septic shock	0.00% 0/40 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	4.8% 2/42 • Number of events 2 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/40 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	4.8% 2/42 • Number of events 2 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/40 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	2.4% 1/42 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Respiratory, thoracic and mediastinal disorders Respiratory failure	7.5% 3/40 • Number of events 3 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	11.9% 5/42 • Number of events 6 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).
Renal and urinary disorders Acute kidney injury	0.00% 0/40 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).	2.4% 1/42 • Number of events 1 • All adverse events were collected from the time of the informed consent until the end of study (Day 60). Therefore all serious and non-serious events are included regardless of meeting or not meeting the study definition of treatment emergent (eg, pre-treatment events are included).