CLINICAL TRIAL TO EVALUATE METHYLPREDNISOLONE PULSES AND TACROLIMUS IN HOSPITALIZED PATIENTS WITH SEVERE PNEUMONIA SECONDARY TO COVID-19 (TACROVID)

PRAGMATIC, CONTROLLED, OPEN, SINGLE CENTER, RANDOMIZED, PHASE II CLINICAL TRIAL TO EVALUATE METHYLPREDNISOLONE PULSES AND TACROLIMUS IN HOSPITALIZED PATIENTS WITH SEVERE PNEUMONIA SECONDARY TO COVID-19 (TACROVID)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001445-39-ES

Enrollment

Registered

2020-04-03

Start date

2020-03-31

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospitalized patients with severe pneumonia secondary to COVID-19. MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862 MedDRA version: 20.0 Level: PT Classification code 10070255 Term: Coronavirus test positive System Organ Class: 10022891 - Investigations

Interventions

Product Name: Metilprednisolona Pharmaceutical Form: Tablet INN or Proposed INN: METHYLPREDNISOLONE Other descriptive name: METHYLPREDNISOLONE Concentration unit: mg milligram(s) Concentration type: r

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients admitted to the HUB with COVID-19 infection confirmed by fluorescent RT-PCR who meet all of the following criteria: 1 New-onset radiological infiltrates (either by plain chest radiography, computed tomography or chest ultrasound) attributed to COVID-19, 2. Respiratory failure (PaO2/FiO2 100 mg/L and/or D-Dimer > 1000 µg/L and/or Ferritin > 1000 ug/L attributed to 1, 4. Age = 18 years. 5. The subject, his legal representative or closest relative (in case of the subject's incapacity due to the seriousness of the clinical situation) that gives informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Imminent death (life expectancy = 24h). 2. Contraindication for the use of tacrolimus according to the summary of product charactheristics . 3. Known adverse reactions to treatment 4. Have participated in a clinical trial in the last 3 months.

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective: - To study the time (days) to reach clinical stability after randomization in hospitalized patients with severe pneumonia secondary to COVID-19, and elevated inflammatory parameters.;Secondary Objective: Clinical -time to reach an afebrile state during 48 hours. -time to reach PaO2/FiO2 >400 and/or SatO2/FiO2 >400 -time until you reach a FR = 24 rpm for 48 hours -time to D-dimer normalization (<250 ug/L) -time until PCR is normalized (<5mg/L). -time to normalisation of ferritin (<400ug/L). -impact of immunosuppressive treatment on viral dynamics using quantitative PCR. -duration of treatment with tacrolimus. -duration of the inpatient stay. -Percentage of patients requiring artificial respiratory support -duration of artificial respiratory support needs to be maintained. -mortality Incidence COVID at 28 and 56 days -mortality incidence all-cause at 28 and 56 days -relapses of COVID-19 pneumonia at 28 and 56 days -Analysis of expanded cytokine profile (day 0 and every 7 days) Safety -side effects according to the severity attributed to tacrolimus during its administration. -side effects according to the severity attributed to other treatments administered;Primary end point(s): Primary endpoint (for the main objective of effectiveness): - Time (days) to clinical stability after initiation of trial treatment in hospitalised patients with severe pneumonia secondary to COVID-19 and elevated inflammatory parameters;Timepoint(s) of evaluation of this end point: Throughout the study until clinical stability	—

Measure

Time frame

Main Objective: Main objective: - To study the time (days) to reach clinical stability after randomization in hospitalized patients with severe pneumonia secondary to COVID-19, and elevated inflammatory parameters.;Secondary Objective: Clinical -time to reach an afebrile state during 48 hours. -time to reach PaO2/FiO2 >400 and/or SatO2/FiO2 >400 -time until you reach a FR = 24 rpm for 48 hours -time to D-dimer normalization (<250 ug/L) -time until PCR is normalized (<5mg/L). -time to normalisation of ferritin (<400ug/L). -impact of immunosuppressive treatment on viral dynamics using quantitative PCR. -duration of treatment with tacrolimus. -duration of the inpatient stay. -Percentage of patients requiring artificial respiratory support -duration of artificial respiratory support needs to be maintained. -mortality Incidence COVID at 28 and 56 days -mortality incidence all-cause at 28 and 56 days -relapses of COVID-19 pneumonia at 28 and 56 days -Analysis of expanded cytokine profile (day 0 and every 7 days) Safety -side effects according to the severity attributed to tacrolimus during its administration. -side effects according to the severity attributed to other treatments administered;Primary end point(s): Primary endpoint (for the main objective of effectiveness): - Time (days) to clinical stability after initiation of trial treatment in hospitalised patients with severe pneumonia secondary to COVID-19 and elevated inflammatory parameters;Timepoint(s) of evaluation of this end point: Throughout the study until clinical stability

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints (for secondary objectives): Clinical and analytical: - Time ('days') to reach an afebrile state for 48 hours - Time ('days') to PaO2/FiO2 >400 and/or SatO2/FiO2 >400 for 48 hours. - Time ('days') to reach a FR = 24 rpm for 48 hours - Time ('days') until normalization of D-dimer (<250 ug/L), - Time ('days') until IL-6 normalization (<5mg/L). - Time ('days') to Ferritin normalization (<400ug/L) - Change (percentage) in the viral load (PCR) before the start of the drug from day 7. - Number of patients requiring non-invasive artificial respiratory support devices (NIV, FNG, etc.) - Number of patients requiring invasive artificial respiratory support devices (VM) - Time ('days') in intensive care unit. - Time ('days') in semi-intensive care unit. - Number of days of inpatient stay (from the day of treatment inititation to discharge from hospital) - Number of days with the trial treatment. - Quantify the cytokines studied in the expanded cytokine profile before the start of treatment and after 7 days of trial treatment. - Long-term efficacy (at 28 and 56 days after trial treatment initiation) will be assessed by measuring whether clinical stability is maintained and the incidence of relapses of COVID-19 peumonia. Safety: - Incidence of adverse events according to their severity and relationship to clinical trial treatment. - Incidence of adverse events according to their severity for other reasons than clinical trial treatment Mortality: - Incidence of mortality due to COVID-19 at 28 and 56 days after the beginning of the clinical trial treatment. - Incidence of all-cause mortality at 28 and 56 days after starting clinical trial treatment.;Timepoint(s) of evaluation of this end point: Throughout the study	—

Measure

Time frame

Secondary end point(s): Secondary endpoints (for secondary objectives): Clinical and analytical: - Time ('days') to reach an afebrile state for 48 hours - Time ('days') to PaO2/FiO2 >400 and/or SatO2/FiO2 >400 for 48 hours. - Time ('days') to reach a FR = 24 rpm for 48 hours - Time ('days') until normalization of D-dimer (<250 ug/L), - Time ('days') until IL-6 normalization (<5mg/L). - Time ('days') to Ferritin normalization (<400ug/L) - Change (percentage) in the viral load (PCR) before the start of the drug from day 7. - Number of patients requiring non-invasive artificial respiratory support devices (NIV, FNG, etc.) - Number of patients requiring invasive artificial respiratory support devices (VM) - Time ('days') in intensive care unit. - Time ('days') in semi-intensive care unit. - Number of days of inpatient stay (from the day of treatment inititation to discharge from hospital) - Number of days with the trial treatment. - Quantify the cytokines studied in the expanded cytokine profile before the start of treatment and after 7 days of trial treatment. - Long-term efficacy (at 28 and 56 days after trial treatment initiation) will be assessed by measuring whether clinical stability is maintained and the incidence of relapses of COVID-19 peumonia. Safety: - Incidence of adverse events according to their severity and relationship to clinical trial treatment. - Incidence of adverse events according to their severity for other reasons than clinical trial treatment Mortality: - Incidence of mortality due to COVID-19 at 28 and 56 days after the beginning of the clinical trial treatment. - Incidence of all-cause mortality at 28 and 56 days after starting clinical trial treatment.;Timepoint(s) of evaluation of this end point: Throughout the study

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Countries

Spain

Contacts

Public ContactXavier Solanich Moreno

Dr. Xavier Solanich Moreno. Servei Medicina Interna. Hospital de Bellvitge

xsolanich@bellvitgehospital.cat0034932602324

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 24, 2026