Official Title
Open Randomized Single Centre Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With Severe Lung Injury Secondary to COVID-19
Brief 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.

Detailed Description

Unfortunately, the treatment of COVID-19 disease is still based on life support therapies. Nowadays, there is no scientific evidence from clinical trials regarding the efficacy or safety of different drugs to treat COVID-19 patients, despite some of them evolving to fatal severe lung injury due to important inflammatory process secondary to pro-inflammatory cytokines. Interestingly, Tacrolimus has been shown to inhibit both pro-inflammatory cytokines and, also, human coronavirus SARS-Cov replication, but it has not specifically been tested in COVID-19 patients.

Our working hypothesis is that severe SARS-CoV-2 (COVID-19) pneumonia is secondary to a deleterious inflammatory process; so, the use of Methylprednisolone pulses and Tacrolimus in hospitalized severe COVID-19 lung injury patients might have a positive clinical effect.

Given the COVID-19 current health emergency, this study could provide useful evidence to treat some COVID-19 patients with Methylprednisolona and Tacrolimus, which might represent a new therapeutic option for them. Tacrolimus is a drug with more than 20 years of experience, and therefore, its side effects are well known and usually reversible. In addition, since tacrolimus is a low-cost and easy to produce at large-scale drug, it could be used to treat a large number of patients. The administration of this drugs could not only decrease mortality secondary to lung involvement by COVID-19, but also decrease the excessive burden of care that intensive care units are bearing.

Recruiting
COVID-19
Lung Injury

Drug: Tacrolimus
the necessary dose to obtain blood levels of 8-10 ng / ml
Intervention
Other Name: Advagraf®, Modigraf®

Drug: Methylprednisolone
120mg of methylprednisolone daily for 3 consecutive days
Intervention
Other Name: Urbason®, Solu-Moderín®

Eligibility Criteria

Inclusion Criteria:

- COVID-19 infection confirmed by PCR

- New onset radiological infiltrates

- Respiratory failure (PaO2 / FiO2 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
Spain
Contacts

Xavier Solanich, MD
0034 932607500 8946
xsolanich@bellvitgehospital.cat

Xavier Corbella, MD, PhD
Study Director
Hospital Universitari de Bellvige

Hospital Universitari de Bellvitge
Institut d'Investigació Biomèdica de Bellvitge
NCT Number
MeSH Terms
Lung Injury
Wounds and Injuries
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Tacrolimus
Prednisolone hemisuccinate
Prednisolone phosphate