Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With COVID-19 Lung Injury
TACROVID
Open Randomized Single Centre Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With Severe Lung Injury Secondary to COVID-19
2 other identifiers
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 covid19
Started Apr 2020
Shorter than P25 for phase_3 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 7, 2020
CompletedFirst Posted
Study publicly available on registry
April 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedApril 10, 2020
April 1, 2020
2 months
April 7, 2020
April 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Time to reach clinical stability
Assess the days until clinical stability is achieved after initiating randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury. Clinical stability is defined if all the following criteria are met for 48 consecutive hours: Body temperature ≤ 37.0ºC; PaO2 / FiO2\> 400 and / or SatO2 / FiO2\> 300; Respiratory rate ≤ 24 rpm
28 days
Secondary Outcomes (14)
Time to reach an afebrile state for 48 hours.
56 days
Time to reach PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300
56 days
Time to reach FR ≤ 24 rpm for 48 hours
56 days
Time to normalization of D-dimer (<250 ug / L)
56 days
Time until PCR normalization (<5mg / L).
56 days
- +9 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALMethylprednisolone 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.
Usual care
NO INTERVENTIONThese patients can receive all the treatments considered necessary for their clinical management, except cyclosporine and tacrolimus.
Interventions
the necessary dose to obtain blood levels of 8-10 ng / ml
120mg of methylprednisolone daily for 3 consecutive days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Related Publications (2)
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.
PMID: 34195214DERIVEDSolanich 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.
PMID: 33495742DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xavier Corbella, MD, PhD
Hospital Universitari de Bellvige
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The statistician who will finally carry out the analyses will be blind to the treatment received by the patients
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Xavier Solanich, MD
Study Record Dates
First Submitted
April 7, 2020
First Posted
April 10, 2020
Study Start
April 1, 2020
Primary Completion
June 1, 2020
Study Completion
July 1, 2020
Last Updated
April 10, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share