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.
the necessary dose to obtain blood levels of 8-10 ng / ml
Other Name: Advagraf®, Modigraf®
120mg of methylprednisolone daily for 3 consecutive days
Other Name: Urbason®, Solu-Moderín®
- 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.
- 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
Xavier Solanich, MD
0034 932607500 8946
Xavier Corbella, MD, PhD
Hospital Universitari de Bellvige