NCT04355247

Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Auxilio Mutuo Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid-19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-14
• Primary completion: 2020-07-31
• Completion: 2021-04-30
• First posted: 2020-04-21
• Last updated: 2020-04-21

Locations

2 sites across 1 country: Puerto Rico