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Completed

NCT Number: NCT04438980

Glucocorticoids in COVID-19 (CORTIVID)

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.

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Key information

Conditions

COVID-19 Pneumonia COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Sant Joan Despí Moisès Broggi, Sant Joan Despí, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

methylprednisolone

Drug

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

Placebo

Other

-An infusion bag of 100 mL of 0.9% saline

Primary outcomes

  1. Proportion of patients developing treatment failure

    Time frame: At 14 days after randomization

    • Death

  2. Proportion of patients developing treatment failure

    Time frame: At 14 days after randomization

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

  3. Proportion of patients developing treatment failure

    Time frame: At 14 days after randomization

    • Need for mechanical ventilation

  4. Proportion of patients developing treatment failure

    Time frame: At 14 days after randomization

    • Decrease in SpO2 <90% (in ambient air) or PaO2 <60 mmHg (in ambient air) or PaO2FiO2 <300 mmHg, associated with radiological impairment

Secondary outcomes

  1. Mortality at day 28

    Time frame: At 28 days after randomization

  2. Proportion of patients requiring ICU admission

    Time frame: At 28 days after randomization

  3. Proportion of patients requiring rescue-therapy with tocilizumab

    Time frame: At 14 days after randomization

  4. Length of hospital stay

    Time frame: At 28 days after randomization

    Time in days from randomization until the date of hospital discharge.

  5. Proportion of severe adverse events

    Time frame: At 28 days after randomization

    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

  6. Proportion of bacterial, fungal or opportunistic infections

    Time frame: At 28 days after randomization

  7. Evolution of inflammatory biomarkers related to COVID-19

    Time frame: At 14 days after randomization

    Change in plasma levels of C-reactive protein (CRP)

  8. Evolution of inflammatory biomarkers related to COVID-19

    Time frame: At 14 days after randomization

    Change in plasma levels of ferritin

  9. Evolution of inflammatory biomarkers related to COVID-19

    Time frame: At 14 days after randomization

    Change in plasma levels of interleukin-6 (IL-6)

  10. Evolution of inflammatory biomarkers related to COVID-19

    Time frame: At 14 days after randomization

    Change in plasma levels of lactate dehydrogenase (LDH)

  11. Evolution of inflammatory biomarkers related to COVID-19

    Time frame: At 14 days after randomization

    Change in plasma levels of D-dimer (DD)

  12. Proportion of SARS-CoV-2 clearance.

    Time frame: At 7 days after randomization

    Negativization of RT-PCR for SARS-CoV-2 on nasopharyngeal swab or sputum

Sponsors and collaborators

Lead sponsor

Fundacion Miguel Servet

Other

Collaborators

  • Complejo Hospitalario de Navarra
  • Hospital Sant Joan Despí Moisès Broggi

Registry information

Official study title

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

Acronym: CORTIVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2020
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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