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