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

Stopped early · Phase 2/Phase 3

Conditions studied: SARS-CoV-2

In brief

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.

Key facts

Study ID: NCT04324021
Run by: Swedish Orphan Biovitrum
People needed: 16
Starts: 2020-04-02
Expected to finish: 2020-11-13
Last updated by the study team: 2022-03-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Signed informed consent provided by the patient, or by the patient's legally authorized representative(s), as applicable.
Documented presence of SARS-CoV-2 infection as per hospital routine.
Age > 18 to < 85 years at the time of screening.
Presence of respiratory distress, defined as:
PaO2/FiO2 < 300 mm Hg and >200 mm Hg or
Respiratory Rate (RR) ≥30 breaths/min or
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:
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
One of the following three criteria:
i. Ferritin > 500ng/mL
ii. LDH > 300 U/L
iii. D-Dimers > 1000 ng/mL

You may not qualify if…

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
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.
Severe renal dysfunction (estimated glomerular filtration rate ≤ 30 mL/min/1.73 m2) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
Uncontrolled hypertension (seated systolic blood pressure >180 mmHg, or diastolic blood pressure >110mmHg) .
Administration of plasma from convalescent patients who recovered from SARS-CoV-2 infection.
Clinical suspicion of latent tuberculosis.
History of hypersensitivity or allergy to any component of the study drug.
Pregnant women.
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.
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.
Foreseeable inability to cooperate with given instructions or study procedures.
Clinical suspicion of active mycobacteria, histoplasma capsulatum, herpes zoster, salmonella, and shigella Infections.
Patients with liver dysfunction defined as AST or ALT > 5 × ULN

Where it is running

Regions hospital — Saint Paul, Minnesota, United States
The Valley hospital — Ridgewood, New Jersey, United States
NewYork-Presbyterian Queens — Flushing, New York, United States
Temple University Hospital — Philadelphia, Pennsylvania, United States
University of Utah Health — Salt Lake City, Utah, 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 — Milan, 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

Full record on ClinicalTrials.gov

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