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Glucocorticoids in COVID-19 (CORTIVID) (CORTIVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04438980
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : June 22, 2020
Sponsor:
Collaborators:
Complejo Hospitalario de Navarra
Hospital Sant Joan Despí Moisès Broggi
Information provided by (Responsible Party):
Fundacion Miguel Servet

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.

Condition or disease Intervention/treatment Phase
Covid-19 Pneumonia Drug: Methylprednisolone Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial
Actual Study Start Date : May 15, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Experimental: Methylprednisolone Arm
Standard of care plus Methylprednisolone
Drug: Methylprednisolone
-A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusión

Placebo Comparator: Placebo Arm
Standard of care plus placebo
Other: Placebo
-An infusion bag of 100 mL of 0.9% saline




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04438980


Contacts
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Contact: Iñigo Les Bujanda, PhD 0034636346833 ilesbujanda@gmail.com
Contact: Ruth Garcia Rey, MS 0034848422163 ruth.garcia.rey@navarra.es

Locations
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Spain
Hospital Sant Joan Despí Moisès Broggi Recruiting
Sant Joan Despí, Barcelona, Spain
Contact: Jose Loureiro Amigo, MD       Jose.LoureiroAmigo@sanitatintegral.org   
Complejo Hospitalario de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Iñigo Les Bujanda, PhD    0034636346833    ilesbujanda@gmail.com   
Sponsors and Collaborators
Fundacion Miguel Servet
Complejo Hospitalario de Navarra
Hospital Sant Joan Despí Moisès Broggi
Investigators
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Principal Investigator: Iñigo Les Bujanda, PhD Complejo Hospitalario de Navarra
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Responsible Party: Fundacion Miguel Servet
ClinicalTrials.gov Identifier: NCT04438980    
Other Study ID Numbers: CORTIVID
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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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
Keywords provided by Fundacion Miguel Servet:
Covid-19
pneumonia
Inflammatory phase
Glucocorticoids
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents