Clinical trial to perform immunomodulatory treatment in adult patients with severe COVID-19 pneumonia with the aim of helping to define the standard treatment for this disease
Description of the Study:
- Title: Randomised, controlled, open, one-site clinical trial in adult patients with COVID-19 severe pneumonia treated with immunomodulatory drugs.
- Principal Investigator: Salvador Augustin.
- Centres of Implementation: Hospital Universitari Vall d’Hebron.
- Study Population: 290 individuals aged 18-80 years with severe COVID-19 pneumonia.
- Study Type: Randomised, controlled, open, one-site clinical trial.
- Methods: The drugs to be evaluated in this trial are:
– Sandimmun concentrate for solution for infusion (intravenous route), the active substance of which is Cyclosporine.
– Sandimmun soft capsule (oral route), the active substance of which is Cyclosporine.
– Roactemra concentrate for solution for infusion (intravenous route), the active substance of which is Tocilizumab.
Objectives of the Study:
Principal Objective: To assess the mortality impact at 28 days of an immunomodulatory strategy with 2 treatment regimens stratified according to IL-6 plasma levels, administered in addition to standard treatment, in adult patients with severe COVID-19 pneumonia.
Secondary Objective: To assess the impact of this strategy on the following variables: premature mortality (48 hours, 7 days and at hospital), mortality at intensive care unit, days of mechanical ventilation, virus clearance (viral clearance / viral shedding), time to normalization of oxygen saturation , time to defervescence (fever reduction), improvement of inflammatory reaction, days of hospitalization, days of intubation, safety and tolerability of the intervention
More about this Study:
Rationale: The aim is to study the response of patients with severe COVID-19 pneumonia to an immunomodulatory strategy with 2 treatment regimens stratified according to plasma IL-6 levels administered in addition to standard treatment aimed at reducing the inflammatory/immunological response and obtaining a therapeutic benefit in these patients. Positive results could help define the standard treatment of severe COVID-19 pneumonia and have a dramatic impact on both local and global morbidity and mortality. Negative results would also constitute useful scientific evidence to abandon unsubstantiated empirical approaches and help redirect/prioritise resources and efforts in other more promising directions.
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