Study of Abatacept in the Treatment of Hospitalized COVID... | NCT04472494

ID	Type	Description	Link
U1111-1250-4217	Other Identifier	WHO

Label	Type	Description	Intervention Names
Abatacept + Standard of care	Experimental		Biological: Abatacept
Placebo infusion + Standard of care	Placebo Comparator		Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Abatacept	Biological	Specified dose on specified days	Abatacept + Standard of care

Measure	Description	Time Frame
Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28	The percentage of participants on invasive mechanical ventilation is defined as the delivery of positive pressure to the lungs via an endotracheal tube (or tracheostomy) or death prior to or on day 28.	From first dose to 28 days post first dose

Measure	Description	Time Frame
Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28	Adjusted mean change from baseline based on the following Ordinal 8-point Clinical Status Scale that was proposed for the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) and is recorded by the worst score (lowest number) state for each day: Death; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Hospitalized, on non-invasive mechanical ventilation or high-flow oxygen devices; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitation on activities Baseline is defined as the last assessment done prior or on Day 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A confirmed virological diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (by reverse-transcription polymerase chain reaction (RT-PCR)).
Hospitalized (or in the Emergency Department awaiting a bed after hospitalization)
Respiratory compromise as defined by requirement of oxygen supplementation to maintain oxygen saturation ≥ 93% but not requiring mechanical ventilation
Abnormal chest X-ray consistent with COVID-19 and not indicating other serious medical condition that would serve as an exclusionary criteria
Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

Women who are breastfeeding
Recent acute infection defined as:

i) Any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics (not COVID-19 related) ii) Any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy
History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis)
Prior exposure to BMS-188667 (abatacept)

Other protocol-defined inclusion/exclusion criteria apply

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alternative Research Associates, Llc		Hialeah	Florida	33012	United States
Alternative Research Associates

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source
FDA Safety Alerts and Recalls

ID	Title	Description
FG000	Abatacept	Abatacept 10 mg/kg IV + Standard of care (SOC)
FG001	Placebo	Placebo infusion + Standard of care (SOC)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 18, 2020	Aug 10, 2022

ID	Title	Description
BG000	Abatacept	Abatacept 10 mg/kg IV + Standard of care (SOC)
BG001	Placebo	Placebo infusion + Standard of care (SOC)
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00042 BG00119 BG00261

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants on Invasive Mechanical Ventilation or Died Prior to or on Day 28

The percentage of participants on invasive mechanical ventilation is defined as the delivery of positive pressure to the lungs via an endotracheal tube (or tracheostomy) or death prior to or on day 28.

All treated participants

Posted

Number

95% Confidence Interval

Percentage of participants

From first dose to 28 days post first dose

ID	Title	Description
OG000	Abatacept	Abatacept 10 mg/kg IV + Standard of care (SOC)
OG001	Placebo	Placebo infusion + Standard of care (SOC)

Units	Counts
Participants	OG00040 OG00119

Title

Denominators

Categories

Title	Measurements
	OG00030.0(15.8 to 44.2) OG00131.6(10.7 to 52.5)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel Chi-Square test		0.9297		Odds Ratio (OR)	1.07			2-Sided	95	0.26	4.49					Superiority

Secondary

Adjusted Mean Change From Baseline in the Ordinal 8-Point Clinical Status Scale on Day 28

Adjusted mean change from baseline based on the following Ordinal 8-point Clinical Status Scale that was proposed for the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) and is recorded by the worst score (lowest number) state for each day:

Death;
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
Hospitalized, on non-invasive mechanical ventilation or high-flow oxygen devices;
Hospitalized, requiring supplemental oxygen;
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;
Not hospitalized, limitation on activities and/or requiring home oxygen;
Not hospitalized, no limitation on activities Baseline is defined as the last assessment done prior or on Day 1

All treated participants

Posted

Mean

Standard Error

Score on a scale

Baseline and on Day 28

ID	Title	Description
OG000	Abatacept	Abatacept 10 mg/kg IV + Standard of care (SOC)
OG001	Placebo	Placebo infusion + Standard of care (SOC)

Secondary

Percentage of Participants Who Died

Percentage of participants who died due to any cause. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:

1) Death

All treated participants

Posted

Number

95% Confidence Interval

Percentage of participants

From first dose to 28 days post first dose

ID	Title	Description
OG000	Abatacept	Abatacept 10 mg/kg IV + Standard of care (SOC)
OG001	Placebo	Placebo infusion + Standard of care (SOC)

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Alive and Free of Respiratory Failure on Day 28±3

Respiratory failure is defined by the type of resources required as defined by the use of any of these: Mechanical ventilation, extracorporeal membrane oxygenation (ECMO) or oxygen delivery by noninvasive positive pressure or high flow nasal cannula.

Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:

4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities

All treated participants

Posted

Number

95% Confidence Interval

Percentage of participants

Day 28±3

ID	Title	Description
OG000	Abatacept	Abatacept 10 mg/kg IV + Standard of care (SOC)
OG001	Placebo	Placebo infusion + Standard of care (SOC)

Units	Counts

Secondary

Percentage of Participants Returned to Room Air on Day 28

Recovery of pulmonary function is assessed by the percentage of participants returned to room air on day 28 after they were oxygen dependent and dependence on oxygen has been noted to be prolonged even after hospital discharge.

Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:

5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 8) Not hospitalized, no limitation on activities

All treated participants

Posted

Number

95% Confidence Interval

Percentage of participants

Day 28

ID	Title	Description
OG000	Abatacept	Abatacept 10 mg/kg IV + Standard of care (SOC)
OG001	Placebo	Placebo infusion + Standard of care (SOC)

Units	Counts
Participants

Secondary

Percentage of Participants Alive and Discharged From the Hospital by Day 28

Percentage of participants alive and discharged from the hospital on day 28. Participants in the following Ordinal 8-point Clinical Status Scale that is recorded by the worst score (lowest number) state for each day meet this definition:

7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitation on activities

All treated participants

Posted

Number

95% Confidence Interval

Percentage of participants

From day 1 up to day 28

ID	Title	Description
OG000	Abatacept	Abatacept 10 mg/kg IV + Standard of care (SOC)
OG001	Placebo	Placebo infusion + Standard of care (SOC)

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Serious Adverse Events

Percentage of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose:

Results in death
Is life threatening
Requires inpatient hospitalization
Results in persistent or significant disability
Is a congenital anomaly/birth defect
Is an important medical event

All treated participants

Posted

Number

Percentage of participants

From first dose to 60 days post first dose

ID	Title	Description
OG000	Abatacept	Abatacept 10 mg/kg IV + Standard of care (SOC)
OG001	Placebo	Placebo infusion + Standard of care (SOC)

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Serious Adverse Events (SAEs) of the Infections and Infestations System Organ Class

Percentage of participants with Serious Adverse Events (SAEs) of the infections and infestations System Organ Class (SOC)

All treated participants

Posted

Number

Percentage of participants

From first dose to 60 days post first dose

ID	Title	Description
OG000	Abatacept	Abatacept 10 mg/kg IV + Standard of care (SOC)
OG001	Placebo	Placebo infusion + Standard of care (SOC)

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected40 at risk EG0012 affected19 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected19 at risk
Mastoid effusion	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Eye haemorrhage	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Catheter site haemorrhage	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Oedema peripheral	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected40 at risk EG0012 affected19 at risk
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected40 at risk EG0012 affected19 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Sepsis syndrome	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Urinary tract candidiasis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected19 at risk
Blood creatinine increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Transaminases increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected19 at risk
Troponin I increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Dizziness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected19 at risk
Azotaemia	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Haematuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected19 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected19 at risk
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected40 at risk EG0012 affected19 at risk
Hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0012 affected19 at risk

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D018796	Immunoconjugates
D000906	Antibodies
D007136	Immunoglobulins
D012712	Serum Globulins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D005916	Globulins

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Abatacept	Abatacept 10 mg/kg IV + Standard of care (SOC)	7	42	8	40	8	40
EG001	Placebo	Placebo infusion + Standard of care (SOC)	5	19	6	19	10	19

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac arrest	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected40 at risk EG0012 affected19 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected19 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected19 at risk
Sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected19 at risk
Seizure	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected19 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected40 at risk EG0012 affected19 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0004 affected40 at risk EG0014 affected19 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected19 at risk