Status:
UNKNOWN
Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm
Lead Sponsor:
Auxilio Mutuo Cancer Center
Conditions:
Covid-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 progre...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04355247
Start Date
April 14 2020
End Date
April 30 2021
Last Update
April 21 2020
Active Locations (2)
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1
Hospital Auxilio Mutuo Cancer Center
San Juan, PR, Puerto Rico, 00918
2
San Juan City Hospital / Puerto Rico Medical Center
San Juan, Puerto Rico, 00917