SARS-CoV-2 infection MedDRA version: 23.0 Level: LLT Classification code 10070267 Term: SARS virus test positive System Organ Class: 100000004848
Conditions
Interventions
Trade Name: RoActemra
Product Name: Tocilizumab
Pharmaceutical Form: Infusion
INN or Proposed INN: Tocilizumab
CAS Number: 375823-41-9
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - SARS-CoV-2 infection confirmed by real time-PCR - Positive imaging: consolidation, ground glass opacities, or bilateral pulmonary infiltration either by CT-scan or chest x-ray; - Need of oxygen therapy to maintain SO2>94% OR FiO2/PaO2 70 mg/L or CRP level >= 40 mg/L and doubled within 48 hours (without other confirmed infectious or non-infectious course), * Lactatdehydrogenase > 250 U/L, * thrombocytopenia 1 ug/mL, * serum ferritin > 300 ug/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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Age <18 years, pregnancy suspected or confirmed, severe heart failure, suspected or confirmed bacterial infection, current solid or haematological malignancy, neutropenia, ALAT elevation more than three times the laboratory upper limit, ASA class 5 (after COVID19 admission) or higher at inclusion (prior admission), severe chronic obstructive pulmonary disease or heart failure (NYHA class II or higher), current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents including IL-6 inhibitors, or with Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period, current use of chronic oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, previous or active tuberculosis (TB), HIV infection regardless of immunological status, hepatitis, evidence of recent (30 days) invasive bacterial or fungal infections, patients who have received immunosuppressive antibody therapy within the past 5 months, including intravenous immunoglobulin or plans to receive during the study period, IV drug abuse, history of inflammatory bowel disease, diverticulitis, ulcer, perforated gastrointestinal tract, participation in any clinical research study evaluating an investigational product (IP) or therapy within 3 months and less than five half-lives of IP prior inclusion to the study, any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study, inability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of different types of IL-6 inhibition versus no adjuvant treatment compared to standard of care in patients with severe SARS-CoV-2 pneumonia. ;Secondary Objective: Not applicable;Primary end point(s): Time to independence from supplementary oxygen therapy in days ;Timepoint(s) of evaluation of this end point: Up to 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Number of deaths 2) Days out of hospital and alive at 28-day follow-up 3) Time to critical illness rate of subjects defined as requiring mechanical respiratory support (time frame: during treatment, 14 days, 28 days) 4) C-reactive protein (CRP) level (time frame: baseline, peak during treatment, 14 days, 28 days) 5) number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) (time frame: during treatment, 14 days, 28 days) ;Timepoint(s) of evaluation of this end point: up to 28 days | — |
Countries
Denmark
Contacts
Public ContactSponsor/Investigator
The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark
Outcome results
None listed