Timepoint | D0 | D1 | D2 | D3 | D4 | D5 | D6 | D7 | D14 | D15–20 | D21 | D22–27 | D28 | D90 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Consent collection | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Pursuit consent collection | Â | x | x | x | x | x | x | x | x | x | x | x | x | Â |
Demographics, medical history, disease characteristics | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Administration of IVIG or placebo therapy | Â | x | x | x | x | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Main outcome measurement | Â | x | x | x | x | x | x | x | x | x | x | x | x | Â |
Collection of clinical data | x | x | x | x | x | x | x | x | x | x | x | x | x | Â |
Complete blood count, blood gas, creatinine | x | x | Â | Â | Â | Â | Â | x | x | Â | x | Â | x | Â |
Leukocytosis, C-reactive protein, biobank collection | x | x | Â | Â | Â | Â | Â | x | Â | Â | x | Â | Â | Â |
SOFA score | x | x | x | x | x | x | x | x | x | x | x | x | x | Â |
Adverse events | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
Final assessment of main outcome | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | x | Â |
Final assessment of secondary outcomes | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | x | x |