Enrollment | Allocation | Post-allocation | Discharge | Close-out | ||||
---|---|---|---|---|---|---|---|---|
Time point | − 1 | 0 | D1–D4 | D5–D7 | D8–D14 | D15–D28 | ||
Enrollment | ||||||||
Screening | x | |||||||
Eligibility criteria | x | |||||||
Informed consent | x | |||||||
Allocation | x | |||||||
Randomization | x | |||||||
Baseline data collection | x | |||||||
Interventions | ||||||||
Icatibant/std care | x | |||||||
C1 inhib./std care | x | |||||||
Std care | x | x | x | x | x | x | x | |
Outcome/safety assessments | ||||||||
CT of the chest | x | X (D14) | X (D28) | X | ||||
Primary outcome | x | x | x | x | x | |||
Clinical symptoms | x | x | x | x | x | x | ||
Vital signs | x | x | x | x | x | x | x | x |
ECG | x | |||||||
Adverse events | x | x | x | x | x | x | x | x |
Time mechanical ventilation | x | |||||||
Death | x | |||||||
Length of stay | x | |||||||
Laboratory tests* | Only every 4 days or at the discretion of the assistant physician | |||||||
RT-PCR SARS-CoV-2 | x | |||||||
Bradykinin | x | x | x | |||||
SOFA score | x | x | x | x | x | x | ||
Blood routine | x | x | x | x | x | x | ||
Coagulation routine | x | x | x | x | x | x | ||
CRP | x | x | x | x | x | x | ||
Liver function | x | x | x | x | x | x | ||
Kidney function | x | x | x | x | x | x | ||
d-dimer | x | x | x | x | x | x | ||
High-sensitivity troponin | x | x | x | x | x | x | ||
Pro-BNP | x | x | x | x | x | x | ||
Aspergillus antigen | x | x | x | x | x |