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.
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.
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®
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
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Investigator: Xavier Solanich, MD
Contact: 0034 932607500
xsolanich@bellvitgehospital.cat
Investigator:
Xavier Solanich, MD
0034 932607500 - 8946
xsolanich@bellvitgehospital.cat
Xavier Corbella, MD, PhD, Study Director
Hospital Universitari de Bellvige