COVID INFECTION IS A MILD FLU LIKE CONDITION WITH MILD FEVER, DRY COUGH, WIDESPREAD TENDERNESS AND OLFACTORY DISFUNCTION FOLLOWED BY A SERIOUS SITUATION IN SOME 20% OF PATIENTS WITH OVERT FEVER, MALAISE, CHILLS AND DYSPNEA DUE TO HYPERIMMUNE RESPONSE. OXYGEN IS LIKELY TO BE GIVEN IN ABOUT 70% OF PATIENTS AND MORTALITY RATE VARIES FROM 10 TO 40% OF SEVERE CASES.
Conditions
Interventions
Trade Name: Tocilizumab (Actemra/RoActemra)™ , Roche
Product Name: Tocilizumab (Actemra/RoActemra)™ , Roche
Product Code: L04AC07
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed I
Sponsors
HOSPITAL UNIVERISTARIO DE MOSTOLES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PATIENTS IN A MODERATE TO SEVERE DEGREE (4-7 IN WHO SEVERITY SCALE) NEEDING OXYGEN THERAPY Dímer D> 1.500, CRP> 60 OR Ferritin >800 (AT LEAST 2 OF THEM) Alternatively IL-6 >40 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: PCR - AT ALL TIMES DESPITE BEING CONSIDERED COVID POSITIVE IMMUNE INCOPETENCE BY CANCER TREATED IN THE LAST 12 MONTHS OR MEDICALLY INDUCED. ACTIVE TUBERCULOSIS PREVIOUSLY TREATED WITH TOCILIZUMAB TREATED WITH METILPREDNISOLONE BOLUS. SINGLE DOSIS OF HYDROXYCORISONE OR ORAL CORTICOSTEROIDS ALLOWED ALLERGY TO VITAMIN D TREATED WITH REMDESIVIR AT AN EARLY STAGE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Principal Objective: Reduce number of patients with fatal outcome.;Secondary Objective: Secondary Objectives: - Assessment of the effect of treatment on inflammatory parameters, in particular IL-6 - Assesment of time to change in the scale of severity, WHO scale.;Primary end point(s): GLOBAL SURVIVAL RATE iT IS ACCOUNTED FOR THE MORTALITY RELATED TO THE INFECTIOUS AND IMMUNOLOGICAL COURSE PROVOKED BY SARS-COV2.;Timepoint(s) of evaluation of this end point: FIRST TO OCCUR, DISCHARGE OR DEATH WITHIN 30 DAYS FOROM SCREENING | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): IL-6 LEVELS VARIATION AS A SURROGATE MARKER OF INFLAMMATION PROMOTION. WE THINK THAT THE INCREASED PRODUCTION OF IL-6 MAY NOT BE OVERCOME BY TOCILIZUMAB ALONE VARIATIONS IN CRP, LDH AND FERRITIN . DIMER -D CHANGES. TIME TO GET TO ICU TIME TO DISCHARGE FROM ICU TIME TO GET RID FRO OXYGEN THERAPY.;Timepoint(s) of evaluation of this end point: IL-6 LEVELS DAY 1ST AND 6TH AS DEFINED BY DAY OF OCCURRENCE | — |
Countries
Spain
Contacts
Public ContactMEDICAL DIRECTOR
HOSPITAL DE MOSTOLES
Outcome results
None listed