Background
Methods/design
Aim, study design and settings
Study population
1) Adults (≥18 years old), | |
2) Confirmed SARS-CoV-2 infection based on a positive RT-PCR test | |
3) Requiring in-hospital care | |
4) Imaging study compatible with pneumonia, | |
5) At least one of the following criteria | |
a). Dyspnea | |
b). Lung infiltrates occupying > 50% of lung fields by CT scan | |
c) PaO2/FiO2 ratio < 300 mmHg | |
d). Peripheral oxygen saturation (SpO2) < 90% while breathing room air, a ≥ 3% drop in baseline SpO2, or the need of increased flow rates of supplemental oxygen in the case of chronic hypoxia; and the need for supplemental oxygen therapy according to the treating medical team’s judgment. | |
e). Alteration of one or more of the following laboratory parameters | |
• D-dimer > 1 μg/mL | |
• Ferritin level > 300 ng/mL | |
• C-reactive protein (CRP) > 3 mg/L | |
• Lactate dehydrogenase (LDH) > 245 U/L | |
• Lymphopenia, defined as < 800 lymphocytes/uL | |
• Creatine kinase (CK) level > 800 IU/L |
Procedures
Randomization
Intervention
Outcomes and definition of variables
Baseline | Day 3 | Day 5 | Day 7 | Day 14 | Day 28 | |
---|---|---|---|---|---|---|
Eligibility preliminary assessment | X | |||||
Eligibility confirmation | X | |||||
Informed consent & enrollment | X | |||||
Study medication supply | X | |||||
Adverse-effect assessmenta | X | X | X | X | X | |
Laboratory evaluationsa | ||||||
• D-dimer | X | X | X | X | X | |
• Ferritin | X | X | X | X | X | |
• CPK | X | X | X | X | X | |
• Fibrinogen | X | X | X | X | X | |
• Creatinine | X | X | X | X | X | |
• Bilirubin | X | X | X | X | X | |
• CBC | X | X | X | X | X | |
• ABG | X | |||||
Storage of samples for posterior pooled analysisa | ||||||
• IL-6 measurement | X | X | X | X | X | |
• Mass cytometry | X | X | X | X | X | |
Follow-up phone call | X |