Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With COVID-19 Lung Injury (TACROVID)
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|ClinicalTrials.gov Identifier: NCT04341038|
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : April 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Lung Injury||Drug: Tacrolimus Drug: Methylprednisolone||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The statistician who will finally carry out the analyses will be blind to the treatment received by the patients|
|Official Title:||Open Randomized Single Centre Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With Severe Lung Injury Secondary to COVID-19|
|Actual Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||July 1, 2020|
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.
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®
No Intervention: Usual care
These patients can receive all the treatments considered necessary for their clinical management, except cyclosporine and tacrolimus.
- Time to reach clinical stability [ Time Frame: 28 days ]
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
- Time to reach an afebrile state for 48 hours. [ Time Frame: 56 days ]days
- Time to reach PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300 [ Time Frame: 56 days ]days
- Time to reach FR ≤ 24 rpm for 48 hours [ Time Frame: 56 days ]days
- Time to normalization of D-dimer (<250 ug / L) [ Time Frame: 56 days ]days
- Time until PCR normalization (<5mg / L). [ Time Frame: 56 days ]days
- Time until normalization of ferritin (<400ug / L) [ Time Frame: 56 days ]days
- Study the impact of immunosuppressive treatment on viral load using quantitative PCR [ Time Frame: 56 days ]viral load
- Time until hospital discharge [ Time Frame: 56 days ]days
- Need for ventilatory support devices [ Time Frame: 56 days ]days
- Duration that it is necessary to maintain ventilatory support. [ Time Frame: 56 days ]days
- COVID-19 mortality [ Time Frame: 56 days ]days
- all-cause mortality [ Time Frame: 56 days ]days
- Analyze the expanded cytokine profile before the start of treatment and their evolution every 7 days after admission [ Time Frame: 56 days ]cytokines quantification technique by Luminex
- Describe the side effects and their severity attributed to tacrolimus and / or methylprednisolone. [ Time Frame: 56 days ]IDIBELL Clinical Research and Clinical Trials Unit will oversee the monitoring and pharmacovigilance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341038
|Contact: Xavier Solanich, MD||0034 932607500 ext email@example.com|
|Hospital Universitari de Bellvitge||Recruiting|
|L'Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Contact: Xavier Solanich, MD 0034 932607500 ext 8946 firstname.lastname@example.org|
|Principal Investigator: Xavier Solanich, MD|
|Sub-Investigator: Arnau Antolí, MD|
|Study Director:||Xavier Corbella, MD, PhD||Hospital Universitari de Bellvige|