Glucocorticoids in COVID-19 (CORTIVID)

NCT04438980 | Completed Phase 3

• 1 other identifier: CORTIVID
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid-19 Pneumonia

Keywords

Covid-19; pneumonia; Inflammatory phase; Glucocorticoids

Outcome Measures

Primary Outcomes (4)

• Proportion of patients developing treatment failure

  • Death

  At 14 days after randomization

• Proportion of patients developing treatment failure

  • Need for admission in an intensive care unit (ICU)

  At 14 days after randomization

• Proportion of patients developing treatment failure

  • Need for mechanical ventilation

  At 14 days after randomization

• 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 Outcomes (12)

• Mortality at day 28

  At 28 days after randomization

• Proportion of patients requiring ICU admission

  At 28 days after randomization

• Proportion of patients requiring rescue-therapy with tocilizumab

  At 14 days after randomization

• Length of hospital stay

  At 28 days after randomization

• Proportion of severe adverse events

  At 28 days after randomization

Study Arms (2)

Methylprednisolone Arm

EXPERIMENTAL

Standard of care plus Methylprednisolone

Drug: Methylprednisolone

Placebo Arm

PLACEBO COMPARATOR

Standard of care plus placebo

Other: Placebo

Interventions

Methylprednisolone DRUG

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

Methylprednisolone Arm

Placebo OTHER

-An infusion bag of 100 mL of 0.9% saline

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Miguel Servet: lead
• Complejo Hospitalario de Navarra: collaborator
• Hospital Sant Joan Despí Moisès Broggi: collaborator

Study Sites (2)

Hospital Sant Joan Despí Moisès Broggi

Sant Joan Despí, Barcelona, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

• 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.

  PMID: 33430891 DERIVED

MeSH Terms

Conditions

COVID-19; Pneumonia

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Iñigo Les Bujanda, PhD

  Complejo Hospitalario de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 19, 2020
• Study Start: May 15, 2020
• Primary Completion: March 12, 2021
• Study Completion: April 9, 2021
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (2)