Trial NCT04438980 ; EudraCT 2020-001827-15
Publication CORTIVID - Les I, Front Med (2022) (published paper)
Dates: 2020-05-08 to 2021-03-13
Funding: Public/non profit (ISCIII - Instituto de Salud Carlos III (Carlos III Health Institute) )
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Multicenter / Spain
Follow-up duration (days): 28
Inclusion criteria
  • ≥18 years old
  • had been admitted with SARS-CoV-2 pneumonia confirmed by a positive reverse-transcription polymerase chain reaction (RT-PCR) of nasopharyngeal swab, defined as a cycle threshold (Ct) ≤ 35
  • presented with symptoms compatible with COVID-19 for at least 7 days
  • and had at least one of the following - C-reactive protein (CRP) >60 mg/L, interleukin (IL)-6 > 40 pg/ml, or ferritin >1,000 μg/L.
Exclusion criteria
  • Allergy to or contraindication for corticosteroids
  • an indication other than COVID-19 for treatment with corticosteroids or immunosuppressants
  • respiratory failure, defined as a peripheral oxygen saturation (SpO2) below 90% in ambient air or a ratio between the arterial partial pressure of oxygen (PaO2) and the fraction of inspired oxygen (PaO2/FiO2) below 300
  • as a result of the use of dexamethasone as the standard of care in June 2020, patients with a SpO2 < 94% in ambient air were excluded from the study as of July 2020
  • decompensated diabetes mellitus
  • uncontrolled hypertension
  • active cancer
  • conservative or palliative management
  • a suspected or confirmed active infection other than SARS-CoV-2
  • pregnancy or breastfeeding
  • or participation in another clinical trial.
Interventions
Treatment
IVMP Pulse
120 mg intravenously once a day for 3 days
Control
Placebo

Participants
Randomized
participants :
IVMP Pulse=34
Placebo=38
Characteristics of participants
N= 72
Mean age : NR
49 males
Severity : Mild: n=0 / Moderate: n=71 / Severe: n=0 Critical: n=0
Number of vaccinated participants: 0
Primary outcome
In the register
Proportion of patients developing treatment failure [ Time Frame: At 14 days after randomization ] Death; Need for admission in an intensive care unit (ICU); Need for mechanical ventilation; Decrease in SpO2 <90% (in ambient air) or PaO2 <60 mmHg (in ambient air) or PaO2FiO2 <300 mmHg, associated with radiological impairment
In the report
Treatment failure, defined as death, ICU admission, initiation of MV, or clinical worsening up to 14 days post-randomization. Clinical worsening was considered when at least one of the following two conditions was met: (1) SpO2 in ambient air below 90%, PaO2 in ambient air below 60 mmHg, or PaO2/FiO2 ratio below 300 mmHg; or (2) at least 15% decrease in the PaO2 from baseline, together with an increase in the levels of any inflammatory marker (CRP, IL-6, or ferritin) or radiological progression.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published article, the trial registries, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The primary and secondary outcomes in the article reflect those in the registries. The trial (n = 72) achieved its target sample size (n = 72).
This study was updated on August 4th, 2022 with data extracted after contact with authors.