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.
Drug: MethylPREDNISolone 80 Mg/mL Injectable Suspension
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.
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
San Juan City Hospital / Puerto Rico Medical Center
San Juan, Puerto Rico
Hospital Auxilio Mutuo Cancer Center
San Juan, Puerto Rico
Fernando Cabanillas, MD
787-758-2000 - 3503
cabanillasmd@gmail.com
Idalia Liboy, MD
787-758-2000 - 3569
iliboy@auxiliomutuo.com
Fernando Cabanillas, MD, Principal Investigator
Hospital Español Auxilio Mutuo