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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
20
* 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.
Hospital Auxilio Mutuo Cancer Center
San Juan, PR, Puerto Rico
RECRUITINGSan Juan City Hospital / Puerto Rico Medical Center
San Juan, Puerto Rico
RECRUITINGClinical complete response criteria
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
Time frame: 14 days
Clinical Partial Response criteria
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
Time frame: 14 days
Secondary response criteria
Decrease of at least 25% in anyone of the following markers: IL-6, Ferritin, D-dimer, C reactive protein (CRP) or LDH by day 14 \- Improvement of absolute lymphocyte count in those presenting with lymphopenia. Improvement is defined as increase by 25% or more by day 14.
Time frame: 14 days
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