Overview

Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With COVID-19 Lung Injury

Status:
Recruiting
Trial end date:
2020-07-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of the study is to evaluate the days until reaching clinical stability after starting randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital Universitari de Bellvitge
Collaborator:
Institut d'Investigació Biomèdica de Bellvitge
Treatments:
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Tacrolimus
Criteria
Inclusion Criteria:

- COVID-19 infection confirmed by PCR

- New onset radiological infiltrates

- Respiratory failure (PaO2 / FiO2 <300 or satO2 / FiO2 <220)

- PCR>100 mg/L and/or D-Dimer>1000 µg/L and/or Ferritin>1000 ug/L

- Informed consent.

Exclusion Criteria:

- Life expectancy ≤ 24h

- Glomerular filtration ≤ 30 ml / min / 1.73 m2

- Leukopenia ≤ 4000 cells / µL

- Concomitant potentially serious infections.

- Contraindication for the use of tacrolimus according to the specifications of the
product

- Known adverse reactions to treatment

- Have participated in a clinical trial in the last 3 months