Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm
Overview
- Phase
- Phase 2
- Intervention
- MethylPREDNISolone 80 Mg/mL Injectable Suspension
- Conditions
- Covid-19
- Sponsor
- Auxilio Mutuo Cancer Center
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Clinical complete response criteria
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a Phase II pilot exploratory study designed to investigate if prophylactic treatment with short term steroids administered to high risk Covid-19 patient might prevent cytokine storm and progression to respiratory failure. High risk is defined based on serologic markers of inflammation that include abnormalities of Interleukin 6 (IL-6), Ferritin , D-dimer, Lactate Dehydrogenase (LDH), as well as lymphopenia and impaired O2 saturation prior to or on the 7th day of first symptom of Covid-19.
Detailed Description
To decrease the rate of progression to hypoxemic respiratory failure in high risk patients with Covid-19, treated with prophylactic steroids during the first phase of the disease.
Investigators
Fernando Cabanillas
Medicine Doctor/Medical Director
Auxilio Mutuo Cancer Center
Eligibility Criteria
Inclusion Criteria
- •All patients diagnosed with Covid-19 will be registered on the study regardless pf their severity, but only those who meet high risk criteria will be treated with steroids. Those who don't meet the criteria will only be registered with no need to collect further data except baseline labs and CT Chest. They should sign the consent form and the data manager can collect the rest of the information.
- •Patients older than 18 years diagnosed with Covid-19 by Polymerase Chain Reaction (PCR) or by rapid serological test will be eligible. Cases who are Immunoglobulin G (IgG) positive but Immunoglobulin M (IgM) negative, will not be considered eligible unless they are positive for molecular PCR test. Eligible patients will be registered on study on or before 7 days from first onset of symptoms.
Exclusion Criteria
- •Any patient with life expectancy \< 1 month
- •Any patient who is oxygen dependent
- •Any patient with long standing history of severe Chronic Obstructive Pulmonary Disease (COPD)
- •Any patient who is chronically oxygen dependent because of previous existing lung disease
- •Anyone with severely uncontrolled diabetes despite adequate management
- •Anyone with active serious bacterial infection such as septicemia or pneumonia
- •Anyone receiving Tocilizumab (anti IL-6 therapy) or plasma therapy
- •Any patient already receiving steroids from another pre-existing illness
Arms & Interventions
Single Arm
* Patients will be admitted to a regular room in the hospital (not ICU) * They will be monitored closely with vital signs every 4 hours to ensure their respiratory and cardiovascular status do not deteriorate. * Methylprednisolone 80 mg IV bolus injection will be given daily x 5 days starting upon day 1 of admission to hospital.
Intervention: MethylPREDNISolone 80 Mg/mL Injectable Suspension
Outcomes
Primary Outcomes
Clinical complete response criteria
Time Frame: 14 days
Clinical complete response criteria requires all the following: * No need for ventilatory support at any point * O2 Saturation of \>/= 93% by day 14 of therapy * Alive by day 28 from registration * CT chest with minimal or no evidence of disease by day 28 from registration
Clinical Partial Response criteria
Time Frame: 14 days
Clinical Partial Response criteria require that 2 of the following be present by day 14 of therapy: * No need for ventilatory support at any point O2 saturation \> 93% bay day 14 from registration * CT chest stable to improve over baseline by day 28 from registration
Secondary Outcomes
- Secondary response criteria(14 days)