Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With COVID-19 Lung Injury
NCT ID: NCT04341038
Last Updated: 2020-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
84 participants
INTERVENTIONAL
2020-04-01
2020-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention
Methylprednisolone pulses 120mg/day for 3 consecutive days (if they were not previously administered) with Tacrolimus at the necessary dose to achieve plasma levels of 8-10 ng/ml.
In addition, these patients can receive all the treatments considered necessary for their clinical management.
Tacrolimus
the necessary dose to obtain blood levels of 8-10 ng / ml
Methylprednisolone
120mg of methylprednisolone daily for 3 consecutive days
Usual care
These patients can receive all the treatments considered necessary for their clinical management, except cyclosporine and tacrolimus.
No interventions assigned to this group
Interventions
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Tacrolimus
the necessary dose to obtain blood levels of 8-10 ng / ml
Methylprednisolone
120mg of methylprednisolone daily for 3 consecutive days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Institut d'Investigació Biomèdica de Bellvitge
OTHER
Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Xavier Solanich
Xavier Solanich, MD
Principal Investigators
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Xavier Corbella, MD, PhD
Role: STUDY_DIRECTOR
Hospital Universitari de Bellvige
Locations
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Solanich X, Antoli A, Rocamora-Blanch G, Padulles N, Fanlo-Maresma M, Iriarte A, Mitjavila F, Capdevila O, Riera-Mestre A, Bas J, Vicens-Zygmunt V, Niubo J, Calvo N, Bolivar S, Rigo-Bonnin R, Mensa-Vilaro A, Arregui L, Tebe C, Videla S, Hereu P, Corbella X. Methylprednisolone Pulses Plus Tacrolimus in Addition to Standard of Care vs. Standard of Care Alone in Patients With Severe COVID-19. A Randomized Controlled Trial. Front Med (Lausanne). 2021 Jun 14;8:691712. doi: 10.3389/fmed.2021.691712. eCollection 2021.
Solanich X, Antoli A, Padulles N, Fanlo-Maresma M, Iriarte A, Mitjavila F, Capdevila O, Molina M, Sabater J, Bas J, Mensa-Vilaro A, Niubo J, Calvo N, Bolivar S, Rigo-Bonnin R, Arregui L, Tebe C, Hereu P, Videla S, Corbella X. Pragmatic, open-label, single-center, randomized, phase II clinical trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus in patients with severe pneumonia secondary to COVID-19: The TACROVID trial protocol. Contemp Clin Trials Commun. 2021 Mar;21:100716. doi: 10.1016/j.conctc.2021.100716. Epub 2021 Jan 19.
Other Identifiers
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2020-001445-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TACRO-BELL-COVID
Identifier Type: -
Identifier Source: org_study_id
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