Clinical trial NCT04438980: Glucocorticoids in COVID-19 (CORTIVID)
Official title: Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid-19 Pneumonia
Keywords: Covid-19
pneumonia
Inflammatory phase
Glucocorticoids
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario de Navarra
name: Hospital Sant Joan Despí Moisès Broggi
First posted: 2020-06-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Proportion of patients developing treatment failure
timeFrame: At 14 days after randomization
measure: Proportion of patients developing treatment failure
timeFrame: At 14 days after randomization
measure: Proportion of patients developing treatment failure
timeFrame: At 14 days after randomization
measure: Proportion of patients developing treatment failure
timeFrame: At 14 days after randomization
Secondary outcomes:
measure: Mortality at day 28
timeFrame: At 28 days after randomization
measure: Proportion of patients requiring ICU admission
timeFrame: At 28 days after randomization
measure: Proportion of patients requiring rescue-therapy with tocilizumab
timeFrame: At 14 days after randomization
measure: Length of hospital stay
timeFrame: At 28 days after randomization
measure: Proportion of severe adverse events
timeFrame: At 28 days after randomization
measure: Proportion of bacterial, fungal or opportunistic infections
timeFrame: At 28 days after randomization
measure: Evolution of inflammatory biomarkers related to COVID-19
timeFrame: At 14 days after randomization
measure: Evolution of inflammatory biomarkers related to COVID-19
timeFrame: At 14 days after randomization
measure: Evolution of inflammatory biomarkers related to COVID-19
timeFrame: At 14 days after randomization
measure: Evolution of inflammatory biomarkers related to COVID-19
timeFrame: At 14 days after randomization
measure: Evolution of inflammatory biomarkers related to COVID-19
timeFrame: At 14 days after randomization
measure: Proportion of SARS-CoV-2 clearance.
timeFrame: At 7 days after randomization
Other outcomes:
Locations:
city: Sant Joan Despí
country: Spain
facility: Hospital Sant Joan Despí Moisès Broggi
state: Barcelona
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
Study officials:
affiliation: Complejo Hospitalario de Navarra
name: Iñigo Les Bujanda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.