Back to resultsGlucocorticoids in COVID-19 (CORTIVID) (CORTIVID)
Primary Purpose
Covid-19 Pneumonia
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Methylprednisolone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid-19 Pneumonia focused on measuring Covid-19, pneumonia, Inflammatory phase, Glucocorticoids
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years old.
- Diagnosis of SARS-CoV-2 pneumonia confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) on nasopharyngeal swab or sputum according to the recommendations of the Spanish Ministry of Health.
- Length of symptoms consistent with COVID-19 ≥7 days.
- Hospital admission.
- At least one of the following: CRP >60 mg/L, IL-6 >40 pg/mL, ferritin >1000 μg/L.
- Acceptation of informed consent
Exclusion Criteria:
- Allergy or contraindication to any of the drugs under study.
- SpO2 <90% (in air ambient) or PaO2 <60 mmHg (in ambient air) or PaO2/FiO2 <300 mmHg.
- Ongoing treatment with glucocorticoids, immunosuppressive, or biologic drugs with another indication.
- Decompensated diabetes mellitus.
- Uncontrolled hypertension.
- Psychotic or manic disorder.
- Active cancer.
- Pregnancy or lactation.
- Clinical or biochemical suspicion (procalcitonin >0.5 ng/mL) of active infection other than SARS-CoV-2.
- Out-of-hospital management patient.
- Conservative or palliative management patient.
- Participation in another clinical trial.
- Any important and uncontrolled medical, psychological, psychiatric, geographic or social problem that contraindicates the patient's participation in the trial or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.
Sites / Locations
- Hospital Sant Joan Despí Moisès Broggi
- Complejo Hospitalario de Navarra
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Methylprednisolone Arm
Placebo Arm
Arm Description
Standard of care plus Methylprednisolone
Standard of care plus placebo
Outcomes
Primary Outcome Measures
Proportion of patients developing treatment failure
• Death
Proportion of patients developing treatment failure
• Need for admission in an intensive care unit (ICU)
Proportion of patients developing treatment failure
• Need for mechanical ventilation
Proportion of patients developing treatment failure
• Decrease in SpO2 <90% (in ambient air) or PaO2 <60 mmHg (in ambient air) or PaO2FiO2 <300 mmHg, associated with radiological impairment
Secondary Outcome Measures
Mortality at day 28
Proportion of patients requiring ICU admission
Proportion of patients requiring rescue-therapy with tocilizumab
Length of hospital stay
Time in days from randomization until the date of hospital discharge.
Proportion of severe adverse events
Any undesirable experience related to the use of the studied drugs, which causes patient's death, life-threatening risk, hospitalization or extension of a previous hospitalization, disability or permanent damage, requires intervention to prevent permanent impairment or damage, or is considered medically relevant
Proportion of bacterial, fungal or opportunistic infections
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of C-reactive protein (CRP)
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of ferritin
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of interleukin-6 (IL-6)
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of lactate dehydrogenase (LDH)
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of D-dimer (DD)
Proportion of SARS-CoV-2 clearance.
Negativization of RT-PCR for SARS-CoV-2 on nasopharyngeal swab or sputum
Full Information
NCT ID
NCT04438980
First Posted
June 18, 2020
Last Updated
May 14, 2021
Sponsor
Fundacion Miguel Servet
Collaborators
Complejo Hospitalario de Navarra, Hospital Sant Joan Despí Moisès Broggi
1. Study Identification
Unique Protocol Identification Number
NCT04438980
Brief Title
Glucocorticoids in COVID-19 (CORTIVID)
Acronym
CORTIVID
Official Title
Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
April 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion Miguel Servet
Collaborators
Complejo Hospitalario de Navarra, Hospital Sant Joan Despí Moisès Broggi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this setting remains controversial. This study aims to assess the safety and effectiveness of GC pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen inflammatory biomarkers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19 Pneumonia
Keywords
Covid-19, pneumonia, Inflammatory phase, Glucocorticoids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylprednisolone Arm
Arm Type
Experimental
Arm Description
Standard of care plus Methylprednisolone
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Standard of care plus placebo
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
-A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusión
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
-An infusion bag of 100 mL of 0.9% saline
Primary Outcome Measure Information:
Title
Proportion of patients developing treatment failure
Description
• Death
Time Frame
At 14 days after randomization
Title
Proportion of patients developing treatment failure
Description
• Need for admission in an intensive care unit (ICU)
Time Frame
At 14 days after randomization
Title
Proportion of patients developing treatment failure
Description
• Need for mechanical ventilation
Time Frame
At 14 days after randomization
Title
Proportion of patients developing treatment failure
Description
• Decrease in SpO2 <90% (in ambient air) or PaO2 <60 mmHg (in ambient air) or PaO2FiO2 <300 mmHg, associated with radiological impairment
Time Frame
At 14 days after randomization
Secondary Outcome Measure Information:
Title
Mortality at day 28
Time Frame
At 28 days after randomization
Title
Proportion of patients requiring ICU admission
Time Frame
At 28 days after randomization
Title
Proportion of patients requiring rescue-therapy with tocilizumab
Time Frame
At 14 days after randomization
Title
Length of hospital stay
Description
Time in days from randomization until the date of hospital discharge.
Time Frame
At 28 days after randomization
Title
Proportion of severe adverse events
Description
Any undesirable experience related to the use of the studied drugs, which causes patient's death, life-threatening risk, hospitalization or extension of a previous hospitalization, disability or permanent damage, requires intervention to prevent permanent impairment or damage, or is considered medically relevant
Time Frame
At 28 days after randomization
Title
Proportion of bacterial, fungal or opportunistic infections
Time Frame
At 28 days after randomization
Title
Evolution of inflammatory biomarkers related to COVID-19
Description
Change in plasma levels of C-reactive protein (CRP)
Time Frame
At 14 days after randomization
Title
Evolution of inflammatory biomarkers related to COVID-19
Description
Change in plasma levels of ferritin
Time Frame
At 14 days after randomization
Title
Evolution of inflammatory biomarkers related to COVID-19
Description
Change in plasma levels of interleukin-6 (IL-6)
Time Frame
At 14 days after randomization
Title
Evolution of inflammatory biomarkers related to COVID-19
Description
Change in plasma levels of lactate dehydrogenase (LDH)
Time Frame
At 14 days after randomization
Title
Evolution of inflammatory biomarkers related to COVID-19
Description
Change in plasma levels of D-dimer (DD)
Time Frame
At 14 days after randomization
Title
Proportion of SARS-CoV-2 clearance.
Description
Negativization of RT-PCR for SARS-CoV-2 on nasopharyngeal swab or sputum
Time Frame
At 7 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years old.
Diagnosis of SARS-CoV-2 pneumonia confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) on nasopharyngeal swab or sputum according to the recommendations of the Spanish Ministry of Health.
Length of symptoms consistent with COVID-19 ≥7 days.
Hospital admission.
At least one of the following: CRP >60 mg/L, IL-6 >40 pg/mL, ferritin >1000 μg/L.
Acceptation of informed consent
Exclusion Criteria:
Allergy or contraindication to any of the drugs under study.
SpO2 <90% (in air ambient) or PaO2 <60 mmHg (in ambient air) or PaO2/FiO2 <300 mmHg.
Ongoing treatment with glucocorticoids, immunosuppressive, or biologic drugs with another indication.
Decompensated diabetes mellitus.
Uncontrolled hypertension.
Psychotic or manic disorder.
Active cancer.
Pregnancy or lactation.
Clinical or biochemical suspicion (procalcitonin >0.5 ng/mL) of active infection other than SARS-CoV-2.
Out-of-hospital management patient.
Conservative or palliative management patient.
Participation in another clinical trial.
Any important and uncontrolled medical, psychological, psychiatric, geographic or social problem that contraindicates the patient's participation in the trial or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iñigo Les Bujanda, PhD
Organizational Affiliation
Complejo Hospitalario de Navarra
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sant Joan Despí Moisès Broggi
City
Sant Joan Despí
State/Province
Barcelona
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD will be available for exploitation in future research projects. This statement also includes the availability of the study protocol, the statistical analysis plan, the informed consent form, the clinical study report and the analytic code.
Citations:
PubMed Identifier
33430891
Citation
Les Bujanda I, Loureiro-Amigo J, Bastons FC, Guerra IE, Sanchez JA, Murgadella-Sancho A, Rey RG, Lopez JL, Alvarez JS. Treatment of COVID-19 pneumonia with glucocorticoids (CORTIVID): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 11;22(1):43. doi: 10.1186/s13063-020-04999-4.
Results Reference
derived
Learn more about this trial
Glucocorticoids in COVID-19 (CORTIVID)
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