All the visits have a window of ± 1 day | Screening/D0 | D1–D90 or until discharge | D7 | D14 | D21 | D28 | D90 |
---|---|---|---|---|---|---|---|
Informed consent | x | ||||||
SARS-CoV-2 PCR testing | x | x | x | x | x | ||
Medical history | x | ||||||
Concomitant medications | x | x | x | x | x | x | x |
Physical examination | x | x | x | x | x | x | x |
Vital signs | x | x | x | x | x | x | x |
Respiratory status | x | x | x | x | x | x | |
Hematology | x | X3 (day 3) | x | x | x | x | |
Biochemistry | x | X3 (day 3) | x | x | x | x | |
Markers of immunological function1 | x | x | x | x | x | x | |
Blood sample for additional investigational studies | x | x | x | x | x | ||
Donor chimerism | X2 (day 3) | x | X2 | X2 | X2 | ||
Pregnancy test | x | ||||||
Scales (NEWS and 7 point scale) | x | x | x | x | x | x | x |
Evaluation of patient recovery | x | ||||||
Improvement according to the investigator/second dose** | x | ||||||
Adverse events | x |