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TerminatedNCT04324021Updated Mar 10, 2022Results posted

Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection.

A Phase 2/3 interventional study of Emapalumab and Anakinra in SARS-CoV-2, sponsored by Swedish Orphan Biovitrum. Terminated at 12 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-03-10.

Sponsored by Swedish Orphan Biovitrum · Phase 2/3, Interventional, and Treatment

Why this study was terminated
Standard of care evolved during the timeframe of the study and had critical impact on recruitment. Early termination was not based on safety reasons but due to the reasons mentoined above. The ongoing patients were completed.
Phase
Phase 2/3
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Hyper-inflammation, caused by a cytokine storm resulting from an exaggerated response of the immune system in the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is considered to represent one of the most important negative prognostic factors in patients infected with sSARS-CoV-2. The objective of this study is to investigate new treatment options to reduce the number of patients requiring mechanical ventilation. This is intended to address the most urgent need to preserve the access to intensive care unit support to the lowest possible number of patients and may potentially reduce mortality.

Read the detailed description

This is an open label, controlled, parallel group, 3-arm, multicenter study to assess the efficacy and safety of Emapalumab or Anakinra, versus standard of care (SoC). Patients between 30 and 80 years will be eligible to participate in the study. The study is planned to consist of three groups, each comprising 18 patients. Treatment will be randomized to either Emapalumab+SoC, Anakinra+SoC or only SoC for two weeks. Follow-up visit or phone calls will be made 4 and 8 weeks after end of treatment period.

02

Conditions studied

  • SARS-CoV-2

Browse trials for

03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 16 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Swedish Orphan Biovitrum is the lead sponsor of 78 studies on the registry; 4 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signed informed consent provided by the patient, or by the patient's legally authorized representative(s), as applicable.
  2. Documented presence of SARS-CoV-2 infection as per hospital routine.
  3. Age > 18 to \< 85 years at the time of screening.

  4. Presence of respiratory distress, defined as:

    1. PaO2/FiO2 \< 300 mm Hg and >200 mm Hg or
    2. Respiratory Rate (RR) ≥30 breaths/min or
    3. SpO2 \< 93 percent in air at rest. Note: Patients given continous positive airway pressure (CPAP) ventilator support are eligible for inclusion.

Presence of hyperinflammation defined as:

  1. Lymphocyte counts:

    • \< 1000 cells/µL, in patients who have not received systemic glucocorticoids for at least 2 days prior to the assessment of the lymphocyte count
    • \< 1200 cells/µL, in patients who have received systemic glucocorticoids for at least 2 days prior to the assessment of the lymphocyte count

    and

  2. One of the following three criteria:

i. Ferritin > 500ng/mL

ii. LDH > 300 U/L

iii. D-Dimers > 1000 ng/mL

Exclusion criteria

Exclusion Criteria:

  1. Patients in mechanical ventilation or with modified early warning score (MEWS) >4 with evidence of moderate or above ARDS (Berlin definition, namely with PaO2/FiO2 >100, but \<200 mm Hg) or severe respiratory insufficiency or evidence of rapid worsening (respiratory distress requiring mechanical ventilation or presence of shock or presence of concomitant organ failure requiring ICU admission). Note: For the evaluation of patient eligibility, temperature will not be considered in the calculation of the total MEWS score since presence of fever is a hallmark of SARS-CoV-2 infection
  2. Impairment of cardiac function defined as poorly controlled heart diseases, such as New York heart association (NYHA) class II (mild) and above, cardiac insufficiency, unstable angina pectoris, myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia need treatment or intervention.
  3. Severe renal dysfunction (estimated glomerular filtration rate ≤ 30 mL/min/1.73 m2) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
  4. Uncontrolled hypertension (seated systolic blood pressure >180 mmHg, or diastolic blood pressure >110mmHg) .
  5. Administration of plasma from convalescent patients who recovered from SARS-CoV-2 infection.
  6. Clinical suspicion of latent tuberculosis.
  7. History of hypersensitivity or allergy to any component of the study drug.
  8. Pregnant women.
  9. Existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.
  10. Enrollment in another concurrent clinical interventional study, or intake of an investigational drug within three months or 5 half-lives prior to inclusion in this study, if considered interfering with this study objectives as assessed by the Investigator.
  11. Foreseeable inability to cooperate with given instructions or study procedures.
  12. Clinical suspicion of active mycobacteria, histoplasma capsulatum, herpes zoster, salmonella, and shigella Infections.
  13. Patients with liver dysfunction defined as AST or ALT > 5 × ULN
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    Emapalumab

    Emapalumab i.v. infusion every 3rd day for a total 5 infusions. Day 1: 6mg/kg. Days 4, 7, 10 and 13: 3 mg/kg

    Biological: Emapalumab

  • Active comparator
    Anakinra

    Anakinra i.v. infusion four times daily for 15 days. 400 mg/day in total, divided into 4 doses given every 6 hours

    Biological: Anakinra

  • No intervention
    Standard of care

    Standard of care according to local practice

Interventions

  • BiologicalEmapalumab

    I.v. infusion every third day

    Also known as: Gamifant

  • BiologicalAnakinra

    Daily i.v. infusion

    Also known as: Kineret

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment Success

    Defined as the number of patients not requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)

    Time frame: Up to Day 15

Secondary outcomes

  1. Number of Participants Requiring Mechanical Ventilation

    Measured in number of participants

    Time frame: Date of randomization to date of mechanical ventilation, up to 15 Days

  2. Change From Baseline in Modified Early Warning System Score

    The full (unabbreviated) scale name is Modified Early Warning system score (MEWS score) Measured in total score Total score is the sum of 5 categorized components (blood pressure, heart rate, respiratory rate, temperature and alert/voice/pain/unresponsive score) that are assigned a score between 0 and 2 or 0 and 3. MEWS total score range is 0 to 14. Higher score= worse outcome

    Time frame: Baseline, Day 15

  3. Change From Baseline in Ferritin

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  4. Change From Baseline in Lactate Dehydrogenase (LDH)

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  5. Change From Baseline in D-dimers

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  6. Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2)

    Measured in percent (%)

    Time frame: Baseline, 3 assessments every Days 4, 7, 10, 13 and 15

  7. Change From Baseline in Oxygen Supplementation

    Measured in l/min

    Time frame: Baseline, Days 4, 7, 10, 13 and 15.

  8. Change From Baseline in Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2)

    Measured in mmHg

    Time frame: Baseline, Day 15

  9. Number of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest

    Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done

    Time frame: Screening, Day 15

  10. Overall Survival

    Confirmation of death

    Time frame: Weeks 6 and 10

  11. Number of Patients With Hospital Discharge

    Measured in number of patients

    Time frame: Until discharge up to Week 10

  12. Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  13. Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  14. Change of Potassium in Hemogasanalysis From Baseline

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  15. Change of Sodium in Hemogasanalysis From Baseline

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  16. Change of Chloride in Hemogasanalysis From Baseline

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  17. Change of Lactic Acid in Hemogasanalysis From Baseline

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  18. Change of Hemoglobin in Hemogasanalysis From Baseline

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  19. Change From Baseline in White Blood Cells With Differential Counts

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  20. Change From Baseline in Red Blood Counts

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  21. Change From Baseline in Hemoglobin

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  22. Change From Baseline in Platelet Count

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  23. Change From Baseline in Fibrinogen

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  24. Change From Baseline in Complement Factors C3/C4

    Measured in local units

    Time frame: Day 15

  25. Change From Baseline in Prothrombin Time

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  26. Change From Baseline in Cardiac Troponin

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  27. Change From Baseline in Aspartate Aminotransferase (AST)

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  28. Change From Baseline in Alanine Aminotransferase (ALT)

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  29. Change From Baseline in Total Bilirubin Levels

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  30. Change From Baseline in C-Reactive Protein

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

  31. Change From Baseline in Creatinine

    Measured in local units

    Time frame: Baseline, Days 4, 7, 10, 13 and 15

07

Results

Posted Mar 10, 2022

Participant flow

Participant flow — Overall Study
MilestoneEmapalumabAnakinraStandard of Care
Started556
Completed345
Not completed211
Withdrew: Adverse event100
Withdrew: Lack of efficacy001
Withdrew: Death110

Outcome measures

PrimaryNumber of Participants With Treatment Success

Defined as the number of patients not requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)

Time frame:
Up to Day 15
Reported as:
Count of participants · Participants
Number of Participants With Treatment Success
ParticipantsEmapalumabAnakinraStandard of Care
Number of Participants With Treatment Success345
SecondaryNumber of Participants Requiring Mechanical Ventilation

Measured in number of participants

Time frame:
Date of randomization to date of mechanical ventilation, up to 15 Days
Reported as:
Count of participants · Participants
Number of Participants Requiring Mechanical Ventilation
ParticipantsEmapalumabAnakinraStandard of Care
Number of Participants Requiring Mechanical Ventilation111
SecondaryChange From Baseline in Modified Early Warning System Score

The full (unabbreviated) scale name is Modified Early Warning system score (MEWS score) Measured in total score Total score is the sum of 5 categorized components (blood pressure, heart rate, respiratory rate, temperature and alert/voice/pain/unresponsive score) that are assigned a score between 0 and 2 or 0 and 3. MEWS total score range is 0 to 14. Higher score= worse outcome

Time frame:
Baseline, Day 15
Reported as:
Mean · scores on a scale
Change From Baseline in Modified Early Warning System Score
scores on a scaleEmapalumabAnakinraStandard of Care
Change From Baseline in Modified Early Warning System Score-1.00 ± 0.000.00 ± 0.82-0.75 ± 0.96
SecondaryChange From Baseline in Ferritin

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · pmol/L
Change From Baseline in Ferritin
pmol/LEmapalumabAnakinraStandard of Care
Change from Baseline at D4-380.8 ± 3026.3-2864.2 ± 3789.3-770.2 ± 1093.0
Change from Baselind at D760.5 ± 2503.4-2179.6 ± 3108.3-1103.3 ± 168.4
Change from Baselind at D10-527.5 ± 3086.3-2066.8 ± 3342.9-1295.0 ± 359.8
Change from Baseline at D13-823.1 ± 2792.5-1931.1 ± 3601.8-1260.6 ± 781.7
Change from baseline at D15-506.6 ± 2518.2-2045.2 ± 3627.7-842.6 ± 1020.0
SecondaryChange From Baseline in Lactate Dehydrogenase (LDH)

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · U/L
Change From Baseline in Lactate Dehydrogenase (LDH)
U/LEmapalumabAnakinraStandard of Care
Change from Baseline at D4-128.3 ± 160.9-31.8 ± 13.0-70.4 ± 85.5
Change from Baseline at D7-164.3 ± 267.4-16.8 ± 162.9-96.0 ± 107.3
Change from Baseline at D10-184.3 ± 200.2-60.4 ± 76.4-143.5 ± 128.7
Change from Baseline at D13-185.3 ± 260.9-2.6 ± 264.4-155.0 ± 121.0
Change from Baseline at D15-163.6 ± 252.4-20.6 ± 274.8-158.4 ± 108.3
SecondaryChange From Baseline in D-dimers

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · nmol/L
Change From Baseline in D-dimers
nmol/LEmapalumabAnakinraStandard of Care
Change from Baseline at D4-0.19 ± 0.345.13 ± 14.73-2.05 ± 1.65
Change from Baseline at D7-7.37 ± 13.846.78 ± 19.41-4.30 ± 1.96
Change from Baseline at D10-10.07 ± 18.164.66 ± 12.82-7.18 ± 5.96
Change from Baseline at D13-7.99 ± 13.406.84 ± 19.39-5.67 ± 7.11
Change from Baseline at D15-6.84 ± 12.676.64 ± 19.51-5.55 ± 6.45
SecondaryChange From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2)

Measured in percent (%)

Time frame:
Baseline, 3 assessments every Days 4, 7, 10, 13 and 15
Reported as:
Mean · SpO2%
Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2)
SpO2%EmapalumabAnakinraStandard of Care
Change from baseline at D4-0.667 ± 3.5980.267 ± 2.0600.722 ± 2.603
Change from baseline at D70.867 ± 2.9230.667 ± 1.7482.000 ± 2.415
Change from baseline at D100.625 ± 3.5230.267 ± 1.7542.333 ± 3.528
Change from baseline at D131.358 ± 2.140-2.233 ± 6.0981.600 ± 3.639
Change from baseline at D15-1.640 ± 3.383-2.400 ± 5.7712.944 ± 2.840
SecondaryChange From Baseline in Oxygen Supplementation

Measured in l/min

Time frame:
Baseline, Days 4, 7, 10, 13 and 15.
Reported as:
Mean · L/min
Change From Baseline in Oxygen Supplementation
L/minEmapalumabAnakinraStandard of Care
Change from baseline at D40.0 ± 0.02.8 ± 5.5-0.2 ± 9.5
Change from baseline at D7-1.0 ± 5.8-1.8 ± 4.8-7.8 ± 9.1
Change from baseline at D10-3.3 ± 6.9-2.3 ± 6.2-17.8 ± 18.2
Change from baseline at D13-4.3 ± 8.1-3.3 ± 7.8-20.0 ± 17.0
Change from baseline at D15-3.6 ± 9.3-4.3 ± 7.9-15.3 ± 19.3
SecondaryChange From Baseline in Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2)

Measured in mmHg

Time frame:
Baseline, Day 15
Reported as:
Mean · mmHg
Change From Baseline in Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2)
mmHgEmapalumabAnakinraStandard of Care
Change From Baseline in Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2)28.98 ± 106.6651.19156.72 ± 113.53
SecondaryNumber of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest

Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done

Time frame:
Screening, Day 15
Reported as:
Count of participants · Participants
Number of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest
ParticipantsEmapalumabAnakinraStandard of Care
Normal001
Abnormal (NC)131
Abnormal (CS)312
SecondaryOverall Survival

Confirmation of death

Time frame:
Weeks 6 and 10
Reported as:
Count of participants · Participants
Overall Survival
ParticipantsEmapalumabAnakinraStandard of Care
Overall Survival210
SecondaryNumber of Patients With Hospital Discharge

Measured in number of patients

Time frame:
Until discharge up to Week 10
Reported as:
Count of participants · Participants
Number of Patients With Hospital Discharge
ParticipantsEmapalumabAnakinraStandard of Care
Hospital Discharge345
Terminated prior to discharge211
SecondaryChange of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · mmHg
Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline
mmHgEmapalumabAnakinraStandard of Care
Change from baseline at D40.00 ± 7.21-1.00 ± 3.462.00 ± 5.77
Change from baseline at D7-0.33 ± 9.451.00 ± 1.415.46 ± 5.68
Change from baseline at D102.33 ± 6.033.67 ± 8.084.20 ± 5.12
Change from baseline at D130.30 ± 9.486.50 ± 3.540.25 ± 4.11
Change from baseline at D150.77 ± 8.333.75 ± 5.744.00 ± 5.10
SecondaryChange of Oxygen Tension (pO2) in Hemogasanalysis From Baseline

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · mmHg
Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline
mmHgEmapalumabAnakinraStandard of Care
Change from baseline at D419.33 ± 44.2840.67 ± 34.785.75 ± 16.92
Change from baseline at D719.33 ± 36.5618.50 ± 13.4423.64 ± 35.04
Change from baseline at D104.00 ± 37.36-1.33 ± 11.934.00 ± 43.73
Change from baseline at D1318.00 ± 84.85-12.00 ± 5.6624.25 ± 36.04
Change from baseline at D1517.57 ± 61.058.75 ± 47.848.80 ± 21.37
SecondaryChange of Potassium in Hemogasanalysis From Baseline

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · mmol/L
Change of Potassium in Hemogasanalysis From Baseline
mmol/LEmapalumabAnakinraStandard of Care
Change from baseline at D40.55 ± 0.92-0.35 ± 0.490.45 ± 1.34
Change from baseline at D70.45 ± 1.200.400.53 ± 0.93
Change from baseline at D100.25 ± 0.920.25 ± 0.490.43 ± 1.22
Change from baseline at D13-0.500.100.10 ± 0.85
Change from baseline at D150.00 ± 0.710.03 ± 0.750.17 ± 0.47
SecondaryChange of Sodium in Hemogasanalysis From Baseline

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · mmol/L
Change of Sodium in Hemogasanalysis From Baseline
mmol/LEmapalumabAnakinraStandard of Care
Change from baseline at D43.0 ± 5.7-0.5 ± 2.1-4.5 ± 2.1
Change from baseline at D71.0 ± 1.4-5.00.3 ± 4.0
Change from baseline at D102.0 ± 4.2-3.0 ± 7.11.3 ± 1.2
Change from baseline at D13-2.0-6.0-1.0 ± 1.4
Change from Baseline at D152.5 ± 6.40.0 ± 2.60.7 ± 2.1
SecondaryChange of Chloride in Hemogasanalysis From Baseline

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · mmol/L
Change of Chloride in Hemogasanalysis From Baseline
mmol/LEmapalumabAnakinraStandard of Care
Change from baseline at D42.0 ± 5.7-0.5 ± 2.11.5 ± 2.1
Change from baseline at D70.5 ± 0.7-4.02.5 ± 0.7
Change from baseline at D100.0 ± 2.8-4.5 ± 3.54.0 ± 1.4
Change from baseline at D13-1.0-4.03.0
Change from baseline at D152.0 ± 4.2-2.0 ± 3.03.0 ± 2.8
SecondaryChange of Lactic Acid in Hemogasanalysis From Baseline

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · mmol/L
Change of Lactic Acid in Hemogasanalysis From Baseline
mmol/LEmapalumabAnakinraStandard of Care
Change from baseline at D40.200.00 ± 0.28-0.45 ± 1.20
Change from baseline at D70.701.800.00 ± 0.85
Change from baseline at D100.901.20 ± 0.17-0.50 ± 0.28
Change from baseline at D13—0.100.20
Change from baseline at D150.001.27 ± 1.16-0.05 ± 0.07
SecondaryChange of Hemoglobin in Hemogasanalysis From Baseline

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · g/L
Change of Hemoglobin in Hemogasanalysis From Baseline
g/LEmapalumabAnakinraStandard of Care
Change from baseline at D4-34.0 ± 46.7-15.5 ± 10.68.0 ± 2.8
Change from baseline at D7-41.0 ± 65.13.06.7 ± 1.5
Change from baseline at D10-34.0 ± 62.27.5 ± 6.4-1.7 ± 9.5
Change from baseline at D13-73.02.0-6.5 ± 20.5
Change from baseline at D15-38.0 ± 49.5-3.0 ± 18.0-4.0 ± 15.9
SecondaryChange From Baseline in White Blood Cells With Differential Counts

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · 10^9 cells /L
Change From Baseline in White Blood Cells With Differential Counts
10^9 cells /LEmapalumabAnakinraStandard of Care
Change from baseline at D41.000 ± 4.4080.294 ± 0.8860.332 ± 3.009
Change from baseline at D70.340 ± 2.6232.812 ± 2.9531.738 ± 4.165
Change from baseline at D102.728 ± 1.8674.796 ± 3.0910.806 ± 3.643
Change from baseline at D131.548 ± 5.2651.588 ± 2.653-0.318 ± 4.079
Change from baseline at D151.686 ± 4.3951.070 ± 2.4201.878 ± 4.788
SecondaryChange From Baseline in Red Blood Counts

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · 10^12 cells/L
Change From Baseline in Red Blood Counts
10^12 cells/LEmapalumabAnakinraStandard of Care
Change from baseline at D4-0.260 ± 0.470-0.022 ± 0.351-0.108 ± 0.359
Change from baseline at D7-0.385 ± 0.7320.016 ± 0.422-0.196 ± 0.465
Change from baseline at D10-0.415 ± 0.8750.220 ± 0.435-0.262 ± 0.549
Change from baseline at D13-0.350 ± 1.2540.106 ± 0.395-0.275 ± 0.564
Change from baseline at D15-0.510 ± 0.9690.004 ± 0.531-0.163 ± 0.571
SecondaryChange From Baseline in Hemoglobin

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · g/L
Change From Baseline in Hemoglobin
g/LEmapalumabAnakinraStandard of Care
Change from baseline at D4-6.2 ± 14.60.8 ± 7.0-3.5 ± 9.1
Change from baseline at D7-9.3 ± 21.30.8 ± 13.1-6.2 ± 10.7
Change from baseline at D10-11.3 ± 24.56.6 ± 11.9-8.0 ± 16.0
Change from baseline at D13-10.8 ± 36.82.8 ± 13.6-8.2 ± 17.3
Change from baseline at D15-14.0 ± 28.80.00 ± 15.6-3.7 ± 16.9
SecondaryChange From Baseline in Platelet Count

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · 10^9 cells /L
Change From Baseline in Platelet Count
10^9 cells /LEmapalumabAnakinraStandard of Care
Change from baseline at D429.0 ± 77.285.4 ± 76.79.8 ± 153.7
Change from baseline at D719.8 ± 116.6140.4 ± 191.847.4 ± 232.9
Change from baseline at D10-3.8 ± 142.5129.8 ± 223.99.0 ± 232.8
Change from baseline at D13-32.0 ± 126.580.8 ± 213.2-53.8 ± 191.9
Change from baseline at D15-37.6 ± 129.041.2 ± 169.3-67.2 ± 158.1
SecondaryChange From Baseline in Fibrinogen

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · umol/L
Change From Baseline in Fibrinogen
umol/LEmapalumabAnakinraStandard of Care
Change from baseline at D4-1.435 ± 3.137-2.434 ± 1.830-0.088 ± 4.582
Change from baseline at D7-3.925 ± 6.113-4.898 ± 2.610-1.147 ± 7.883
Change from baseline at D10-3.535 ± 8.998-4.980 ± 2.625-5.562 ± 5.089
Change from baseline at D13-2.587 ± 9.308-6.227 ± 2.627-5.479 ± 5.027
Change from baseline at D15-0.588 ± 9.210-6.380 ± 2.357-4.596 ± 5.624
SecondaryChange From Baseline in Complement Factors C3/C4

Measured in local units

Time frame:
Day 15
Reported as:
Mean · g/L
Change From Baseline in Complement Factors C3/C4
g/LEmapalumabAnakinraStandard of Care
C30.054 ± 0.094-0.068 ± 0.222-0.020 ± 0.581
C40.024 ± 0.043-0.108 ± 0.080-0.007 ± 0.192
SecondaryChange From Baseline in Prothrombin Time

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · sec
Change From Baseline in Prothrombin Time
secEmapalumabAnakinraStandard of Care
Change from baseline at D4-0.867 ± 0.0580750 ± 0.071-0.550 ± 1.344
Change from baseline at D7-1.250 ± 0.0710.300 ± 0.283-2.100
Change from Baseline at D10-1.003 ± 0.895-0.150 ± 0.919-1.700
Change from Baseline at D13-2.250 ± 0.3540.050 ± 0.495-1.600
Change from baseline at D15-1.278 ± 1.087-0.150 ± 0.778-0.800 ± 1.697
SecondaryChange From Baseline in Cardiac Troponin

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · ug/L
Change From Baseline in Cardiac Troponin
ug/LEmapalumabAnakinraStandard of Care
Change from Baseline at D4-0.017—0.002 ± 0.002
Change from Baseline at D7-0.022—0.001 ± 0.001
Change from Baseline at D10-0.022—-0.001 ± 0.001
Change from Baseline at D13-0.021—-0.001 ± 0.001
Change from Baseline at D15-0.022—-0.001 ± 0.001
SecondaryChange From Baseline in Aspartate Aminotransferase (AST)

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · U/L
Change From Baseline in Aspartate Aminotransferase (AST)
U/LEmapalumabAnakinraStandard of Care
Change from baseline at D4-46.0 ± 79.8-19.2 ± 32.0-63.2 ± 146.0
Change from Baseline at D7-52.8 ± 107.0-27.6 ± 36.8-65.4 ± 171.1
Change from Baseline at D10-53.3 ± 108.6-27.8 ± 32.9-79.8 ± 170.6
Change from Baseline at D13-44.0 ± 119.3-25.2 ± 28.9-83.6 ± 163.2
Change from baseline at D15-35.4 ± 105.3-25.8 ± 28.3-77.7 ± 151.0
SecondaryChange From Baseline in Alanine Aminotransferase (ALT)

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · U/L
Change From Baseline in Alanine Aminotransferase (ALT)
U/LEmapalumabAnakinraStandard of Care
Change from Baseline D4-74.8 ± 152.92.6 ± 38.8-23.6 ± 148.8
Change from Baseline D7-97.5 ± 237.116.6 ± 66.9-62.0 ± 251.3
Change from Baseline D10-107.8 ± 258.35.0 ± 54.5-107.0 ± 350.0
Change from Baseline D13-111.0 ± 293.3-4.8 ± 51.9-119.2 ± 352.2
Change from Baseline at D15-90.6 ± 260.7-5.8 ± 53.2-121.8 ± 309.1
SecondaryChange From Baseline in Total Bilirubin Levels

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · umol/L
Change From Baseline in Total Bilirubin Levels
umol/LEmapalumabAnakinraStandard of Care
Change from Baseline at D4-0.171 ± 3.519-1.129 ± 12.3140.376 ± 2.600
Change from Baseline D7-1.496 ± 4.011-0.376 ± 15.4920.684 ± 9.922
Change from Baseline D10-0.385 ± 4.5984.685 ± 21.1080.787 ± 11.931
Change from Baseline D13-1.710 ± 4.41313.885 ± 30.2763.591 ± 14.146
Change from Baseline at D15-3.523 ± 4.47314.125 ± 29.771-0.057 ± 9.046
SecondaryChange From Baseline in C-Reactive Protein

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · mg/L
Change From Baseline in C-Reactive Protein
mg/LEmapalumabAnakinraStandard of Care
Change from Baseline D4-53.73 ± 98.88-20.66 ± 22.29-12.65 ± 12.81
Change from Baseline D7-63.65 ± 101.74-19.20 ± 30.95-10.98 ± 19.57
Change from Baseline D10-60.05 ± 106.21-20.70 ± 30.57-14.60 ± 15.72
Change from Baseline D13-60.50 ± 106.66-8.26 ± 50.51-16.33 ± 14.27
Change from Baseline D15-38.96 ± 103.48-8.32 ± 50.53-15.26 ± 12.71
SecondaryChange From Baseline in Creatinine

Measured in local units

Time frame:
Baseline, Days 4, 7, 10, 13 and 15
Reported as:
Mean · umol/L
Change From Baseline in Creatinine
umol/LEmapalumabAnakinraStandard of Care
Change from Baseline D4-6.542 ± 9.4301.414 ± 8.516-6.041 ± 8.148
Change from Baseline D7-8.840 ± 14.4540.530 ± 6.8930.000 ± 6.156
Change from Baseline D10-7.514 ± 14.4810.000 ± 5.830-0.530 ± 5.506
Change from Baseline D13-5.304 ± 20.1710.000 ± 8.928-1.945 ± 3.088
Change from Baseline D15-9.901 ± 19.281-0.354 ± 9.756-5.746 ± 24.292

Adverse events

Collected over All fatal and life-threatening SAEs occurring after study drug initiation and up to the end of study visit (Visit 9, Week 10) were reported. All adverse event data were collected from Day 1 to follow-up Week 10.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Emapalumab2/5 (40%)2/5 (40%)1/5 (20%)
Anakinra1/5 (20%)1/5 (20%)1/5 (20%)
Standard of Care0/6 (0%)0/6 (0%)1/6 (16.7%)
Most frequent serious events
Most frequent serious events
EventEmapalumabAnakinraStandard of Care
End-stage respiratory failureRespiratory, thoracic and mediastinal disorders2/50/50/6
Respiratory failureRespiratory, thoracic and mediastinal disorders1/51/50/6
Most frequent other events
Most frequent other events
EventEmapalumabAnakinraStandard of Care
Atrial FibrillationCardiac disorders1/50/50/6
Muscle HematomaMusculoskeletal and connective tissue disorders1/50/50/6
ThrombocytopeniaBlood and lymphatic system disorders0/51/50/6
HypertransaminasaemiaHepatobiliary disorders0/50/51/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)EmapalumabAnakinraStandard of CareTotal
Mean65.0 ± 14.862.4 ± 11.162.5 ± 62.563.3 ± 12.3
Sex: Female, Male
Sex: Female, Male(Participants)EmapalumabAnakinraStandard of CareTotal
Female1102
Male44614
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)EmapalumabAnakinraStandard of CareTotal
Hispanic or Latino1102
Not Hispanic or Latino43512
Unknown or Not Reported0112
Region of Enrollment
Region of Enrollment(participants)EmapalumabAnakinraStandard of CareTotal
Italy55616
Hospitalization
Hospitalization(Participants)EmapalumabAnakinraStandard of CareTotal
Count of participants55616
Height (cm)
Height (cm)(cm)EmapalumabAnakinraStandard of CareTotal
Mean170.8 ± 10.9170.2 ± 4.4172.3 ± 14.4171 ± 9.5
Weight (kg)
Weight (kg)(kg)EmapalumabAnakinraStandard of CareTotal
Mean77.4 ± 15.079.4 ± 13.483.0 ± 12.879.7 ± 13
Symptom duration (days)
Symptom duration (days)(days)EmapalumabAnakinraStandard of CareTotal
Mean4.0 ± 4.21.0 ± 05.3 ± 4.83.6 ± 4.0

2 further baseline measures are reported on the registry.

08

Study locations

12 sites
  • Regions hospital
    Saint Paul, Minnesota 55101, United States
  • The Valley hospital
    Ridgewood, New Jersey 07450, United States
  • NewYork-Presbyterian Queens
    Flushing, New York 11355, United States
  • Temple University Hospital
    Philadelphia, Pennsylvania 19140, United States
  • University of Utah Health
    Salt Lake City, Utah 84108, United States
  • ASST Spedali Civili di Brescia Dipartimento di Reumatologia e Immunologia Clinica
    Brescia, Italy
  • S.C. Malattie Infettive, Ospedale Galliera
    Genova, Italy
  • Ospedale Maggiore Policlinico, Dipartimento di Anestesia-Rianimazione e Medicina di Urgenza
    Milano, Italy
  • Dipartimento di Medicina - DIMED, Azienda Ospedale - Università Padova
    Padova, Italy
  • Azienda Ospedaliero-Universitaria di Parma, Dipartimento di Malattie infettive ed epatologia
    Parma, Italy
  • Ospedale Lazzaro Spallanzani, Dipartimento di Malattie Infettive ad alta Intensità di cura ed altamente contagiose,Ospedale Lazzaro Spallanzani
    Roma, Italy
  • ASL Città di Torino, Unit of Infectious Diseases, Medicine, Rheumatology
    Torino, Italy
09

References and documents

Publications

  • Brands X, de Vries FMC, Uhel F, Haak BW, Peters-Sengers H, Schuurman AR, van Engelen TSR, Lutter R, Cremer OL, Bonten MJ, Schultz MJ, Scicluna BP, van der Poll T; MARS Consortium. Plasma Ferritin as Marker of Macrophage Activation-Like Syndrome in Critically Ill Patients With Community-Acquired Pneumonia. Crit Care Med. 2021 Nov 1;49(11):1901-1911. doi: 10.1097/CCM.0000000000005072. PubMed 33935163 ↗

Study documents

  • Study protocol · Jun 24, 2020
  • Statistical analysis plan · Aug 10, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04324021
Lead sponsor
Swedish Orphan Biovitrum
Responsible party
Sponsor
First posted
Mar 27, 2020
Start date
Apr 2, 2020
Primary completion
Nov 13, 2020
Completion
Nov 13, 2020
Results posted
Mar 10, 2022
Last update
Mar 10, 2022

Study contacts

Emanuele Nicastri, MD
principal investigator · Direttore Dipartimento di Malattie Infettive

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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