SARS-CoV-2Phase 2/3NCT04324021
Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection.
A Phase 2/3 study testing Emapalumab and Anakinra in people with SARS-CoV-2, run by Swedish Orphan Biovitrum at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Emapalumab and Anakinra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 2 Apr 2020to 13 Nov 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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:
- Ferritin > 500ng/mL
- LDH > 300 U/L
- D-Dimers > 1000 ng/mL
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Italy7 sites
ASST Spedali Civili di Brescia Dipartimento di Reumatologia e Immunologia Clinica
Brescia
S.C. Malattie Infettive, Ospedale Galliera
Genova
Ospedale Maggiore Policlinico, Dipartimento di Anestesia-Rianimazione e Medicina di Urgenza
Milan
Dipartimento di Medicina - DIMED, Azienda Ospedale - Università Padova
Padova
Azienda Ospedaliero-Universitaria di Parma, Dipartimento di Malattie infettive ed epatologia
Parma
Ospedale Lazzaro Spallanzani, Dipartimento di Malattie Infettive ad alta Intensità di cura ed altamente contagiose,Ospedale Lazzaro Spallanzani
Roma
ASL Città di Torino, Unit of Infectious Diseases, Medicine, Rheumatology
Torino
United States5 sites
NewYork-Presbyterian Queens
Flushing, New York, 11355
Temple University Hospital
Philadelphia, Pennsylvania, 19140
The Valley hospital
Ridgewood, New Jersey, 07450
Regions hospital
Saint Paul, Minnesota, 55101
University of Utah Health
Salt Lake City, Utah, 84108
About this study
Official title: A Phase 2/3, Randomized, Open-label, Parallel Group, 3-arm, Multicenter Study Investigating the Efficacy and Safety of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and Anakinra, an Interleukin-1(IL-1) Receptor Antagonist, Versus Standard of Care, in Reducing Hyper-inflammation and Respiratory Distress in Patients With SARS-CoV-2 Infection.
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.
- Conditions
- SARS-CoV-2
- Being tested
- Emapalumab, Anakinra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmapalumabBiological
Also called Gamifant
I.v. infusion every third day
AnakinraBiological
Also called Kineret
Daily i.v. infusion
| Study group | Role | What they receive |
|---|---|---|
| Emapalumab | Active comparator | 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 Receives: Biological: Emapalumab |
| Anakinra | Active comparator | Anakinra i.v. infusion four times daily for 15 days. 400 mg/day in total, divided into 4 doses given every 6 hours Receives: Biological: Anakinra |
| Standard of care | No intervention | Standard of care according to local practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Success
Defined as the number of patients not requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)
Measured: Up to Day 15
Secondary outcomes (31)
Number of Participants Requiring Mechanical Ventilation
Measured in number of participants
Measured: Date of randomization to date of mechanical ventilation, up to 15 Days
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
Measured: Baseline, Day 15
Change From Baseline in Ferritin
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Lactate Dehydrogenase (LDH)
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in D-dimers
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2)
Measured in percent (%)
Measured: Baseline, 3 assessments every Days 4, 7, 10, 13 and 15
Change From Baseline in Oxygen Supplementation
Measured in l/min
Measured: Baseline, Days 4, 7, 10, 13 and 15.
Change From Baseline in Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2)
Measured in mmHg
Measured: Baseline, Day 15
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
Measured: Screening, Day 15
Overall Survival
Confirmation of death
Measured: Weeks 6 and 10
Number of Patients With Hospital Discharge
Measured in number of patients
Measured: Until discharge up to Week 10
Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change of Potassium in Hemogasanalysis From Baseline
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change of Sodium in Hemogasanalysis From Baseline
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change of Chloride in Hemogasanalysis From Baseline
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change of Lactic Acid in Hemogasanalysis From Baseline
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change of Hemoglobin in Hemogasanalysis From Baseline
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in White Blood Cells With Differential Counts
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Red Blood Counts
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Hemoglobin
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Platelet Count
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Fibrinogen
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Complement Factors C3/C4
Measured in local units
Measured: Day 15
Change From Baseline in Prothrombin Time
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Cardiac Troponin
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Aspartate Aminotransferase (AST)
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Alanine Aminotransferase (ALT)
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Total Bilirubin Levels
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in C-Reactive Protein
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Creatinine
Measured in local units
Measured: Baseline, Days 4, 7, 10, 13 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start2 Apr 2020
- Primary completion13 Nov 2020
- Study completion13 Nov 2020
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emanuele Nicastri, MD, Principal investigator, Direttore Dipartimento di Malattie Infettive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324021
- Sponsor's protocol ID
- Sobi.IMMUNO-101
- Other IDs
- 2020-001167-93
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2020
- Last updated
- 10 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Randomized, Open-label, Parallel Group, 3-arm, Multicenter Study Investigating the Efficacy and Safety of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and Anakinra, an Interleukin-1(IL-1) Receptor Antagonist, Versus Standard of Care, in Reducing Hyper-inflammation and Respiratory Distress in Patients With SARS-CoV-2 Infection.
- ClinicalTrials.gov ID
- NCT04324021
- Acronym / sponsor ID
- Sobi.IMMUNO-101
- Conditions
- SARS-CoV-2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 13 Nov 2020 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Posted 10 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Emapalumab | Active comparator | Biological: EmapalumabEmapalumab i.v. infusion every 3rd day for a total 5 infusions. Day 1: 6mg/kg. Days 4, 7, 10 and 13: 3 mg/kg |
| Anakinra | Active comparator | Biological: AnakinraAnakinra i.v. infusion four times daily for 15 days. 400 mg/day in total, divided into 4 doses given every 6 hours |
| Standard of care | No intervention | –Standard of care according to local practice |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- Lymphocyte counts:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmapalumabAlso: GamifantI.v. infusion every third day | Biological | Emapalumab |
| AnakinraAlso: KineretDaily i.v. infusion | Biological | Anakinra |
Primary outcome
Number of Participants With Treatment Success
Time frame: Up to Day 15
Defined as the number of patients not requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)
31 secondary outcomes
Number of Participants Requiring Mechanical Ventilation
Time frame: Date of randomization to date of mechanical ventilation, up to 15 Days
Change From Baseline in Modified Early Warning System Score
Time frame: Baseline, Day 15
Change From Baseline in Ferritin
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Lactate Dehydrogenase (LDH)
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in D-dimers
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Resting Peripheral Capillary Oxygen Saturation (SpO2)
Time frame: Baseline, 3 assessments every Days 4, 7, 10, 13 and 15
Change From Baseline in Oxygen Supplementation
Time frame: Baseline, Days 4, 7, 10, 13 and 15.
Change From Baseline in Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2)
Time frame: Baseline, Day 15
Number of Participants With Changes in High-resolution Computed Tomography (CT) Scan of the Chest
Time frame: Screening, Day 15
Overall Survival
Time frame: Weeks 6 and 10
Number of Patients With Hospital Discharge
Time frame: Until discharge up to Week 10
Change of Carbon Dioxide Tension (pCO2) in Hemogasanalysis From Baseline
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change of Oxygen Tension (pO2) in Hemogasanalysis From Baseline
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change of Potassium in Hemogasanalysis From Baseline
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change of Sodium in Hemogasanalysis From Baseline
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change of Chloride in Hemogasanalysis From Baseline
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change of Lactic Acid in Hemogasanalysis From Baseline
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change of Hemoglobin in Hemogasanalysis From Baseline
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in White Blood Cells With Differential Counts
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Red Blood Counts
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Hemoglobin
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Platelet Count
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Fibrinogen
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Complement Factors C3/C4
Time frame: Day 15
Change From Baseline in Prothrombin Time
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Cardiac Troponin
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Aspartate Aminotransferase (AST)
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Alanine Aminotransferase (ALT)
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Total Bilirubin Levels
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in C-Reactive Protein
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Change From Baseline in Creatinine
Time frame: Baseline, Days 4, 7, 10, 13 and 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33935163Brands 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuele Nicastri, MD principal investigator
Direttore Dipartimento di Malattie Infettive
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Emapalumab and Anakinra in people with SARS-CoV-2, run by Swedish Orphan Biovitrum at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Success (time frame: Up to Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.