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.

Unknown status
Lung Injury

Drug: Tacrolimus

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

Drug: Methylprednisolone

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

Eligibility 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

- Known adverse reactions to treatment

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

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A

Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain

Investigator: Xavier Solanich, MD
Contact: 0034 932607500



Xavier Solanich, MD
0034 932607500 - 8946

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

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