Status:
COMPLETED
Glucocorticoids in COVID-19 (CORTIVID)
Lead Sponsor:
Fundacion Miguel Servet
Collaborating Sponsors:
Complejo Hospitalario de Navarra
Hospital Sant Joan Despí Moisès Broggi
Conditions:
Covid-19 Pneumonia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04438980
Start Date
May 15 2020
End Date
April 9 2021
Last Update
May 17 2021
Active Locations (2)
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1
Hospital Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, Spain
2
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain, 31008