A clinical trial investigating efficacy and safety of emapalumab and anakinra in patients with Coronavirus disease (COVID-19)
- Conditions
- SARS-CoV-2 infectionTherapeutic area: Diseases [C] - Virus Diseases [C02]MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2020-001167-93-IT
- Lead Sponsor
- SWEDISH ORPHAN BIOVITRUM AB (PUBL)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 54
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 > 30 to < 80 years at the time of screening.
4. Presence of respiratory distress, defined as:
a. PaO2/FiO2 < 300 mm Hg and >200 mm Hg or
b. RR =30 breaths/min or
c. SpO2 <93% in air at rest.
Note: Patients given CPAP ventilator support are eligible for inclusion.
5. Presence of hyperinflammation defined as:
a. Lymphocyte counts < 1000 cells/µL, and
b. Two of the following three criteria:
i. Ferritin > 500 ng/mL
ii. LDH > 300 U/L
iii. D-Dimers > 1000 ng/mL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14
1. Patients in mechanical ventilation or with MEWS score >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).
2. Impairment of cardiac function defined as poorly controlled heart diseases, such as 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 =30mL/min/1.73 m2) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
4. Uncontrolled hypertension (seated systolic blood pressure >180mmHg, 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to assess the effect of emapalumab and anakinra on hyperinflammation and pulmonary function in patients with SARS-CoV-2 infection.;Secondary Objective: The secondary objective of this study is to evaluate the safety and tolerability profile of intravenous (i.v.) administrations of emapalumab and anakinra in patients with SARS-CoV-2 infection.;Primary end point(s): The primary endpoint is treatment success, defined as not requiring any of the following by Day 15:<br>• Invasive mechanical ventilation or<br>• Extracorporeal membrane oxygenation (ECMO).;Timepoint(s) of evaluation of this end point: Day 15
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Treatment-emergent severe fatal and life-threatening serious adverse events (SAEs).<br>• Adverse events leading to premature discontinuation of study treatment.<br>• Anaphylactic/anaphylactoid reactions.<br>• Treatment emergent adverse events of special interest:<br> o Emapalumab treatment group: Infections caused by pathogens potentially favored by IFN-gamma neutralizations such as mycobacteria, salmonella, shigella, herpes zoster and histoplasma capsulatum, and severe infusion-related reactions.<br> o Anakinra treatment group: Severe neutropenia.<br>• Treatment-emergent laboratory abnormalities.;Timepoint(s) of evaluation of this end point: Safety is followed throughout the study