Glucocorticoids in COVID-19 (CORTIVID)

Covid-19 Pneumonia Clinical Trial

— CORTIVID  

Official title:

Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04438980
• Other study ID #: CORTIVID
• Status: Completed
• Phase: Phase 3
• Start date: May 15, 2020
• Est. completion date: April 9, 2021

Study information

• Verified date: May 2021
• Source: Fundacion Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 9, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19 Pneumonia
• Pneumonia

Intervention

Drug:
• Methylprednisolone
-A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusión

Other:
• Placebo
-An infusion bag of 100 mL of 0.9% saline

Locations

Country	Name	City	State
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Sant Joan Despí Moisès Broggi	Sant Joan Despí	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion Miguel Servet	Complejo Hospitalario de Navarra, Hospital Sant Joan Despí Moisès Broggi

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients developing treatment failure	• Death	At 14 days after randomization
Primary	Proportion of patients developing treatment failure	• Need for admission in an intensive care unit (ICU)	At 14 days after randomization
Primary	Proportion of patients developing treatment failure	• Need for mechanical ventilation	At 14 days after randomization
Primary	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	At 14 days after randomization
Secondary	Mortality at day 28		At 28 days after randomization
Secondary	Proportion of patients requiring ICU admission		At 28 days after randomization
Secondary	Proportion of patients requiring rescue-therapy with tocilizumab		At 14 days after randomization
Secondary	Length of hospital stay	Time in days from randomization until the date of hospital discharge.	At 28 days after randomization
Secondary	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	At 28 days after randomization
Secondary	Proportion of bacterial, fungal or opportunistic infections		At 28 days after randomization
Secondary	Evolution of inflammatory biomarkers related to COVID-19	Change in plasma levels of C-reactive protein (CRP)	At 14 days after randomization
Secondary	Evolution of inflammatory biomarkers related to COVID-19	Change in plasma levels of ferritin	At 14 days after randomization
Secondary	Evolution of inflammatory biomarkers related to COVID-19	Change in plasma levels of interleukin-6 (IL-6)	At 14 days after randomization
Secondary	Evolution of inflammatory biomarkers related to COVID-19	Change in plasma levels of lactate dehydrogenase (LDH)	At 14 days after randomization
Secondary	Evolution of inflammatory biomarkers related to COVID-19	Change in plasma levels of D-dimer (DD)	At 14 days after randomization
Secondary	Proportion of SARS-CoV-2 clearance.	Negativization of RT-PCR for SARS-CoV-2 on nasopharyngeal swab or sputum	At 7 days after randomization