Covid-19 Pneumonia Clinical Trial
— CORTIVIDOfficial title:
Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial
NCT number | NCT04438980 |
Other study ID # | CORTIVID |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 15, 2020 |
Est. completion date | April 9, 2021 |
Verified date | May 2021 |
Source | Fundacion Miguel Servet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Hospitalario de Navarra | Pamplona | Navarra |
Spain | Hospital Sant Joan Despí Moisès Broggi | Sant Joan Despí | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundacion Miguel Servet | Complejo Hospitalario de Navarra, Hospital Sant Joan Despí Moisès Broggi |
Spain,
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 |
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