A phase I/II dose-escalation multi-center study to evaluate the safety of infusion of natural killer cells or memory T cells as adoptive therapy in coronavirus pneumonia and/or lymphopenia: RELEASE study protocol

Table 2 Schedule of activities of phase I. Standard Protocol Items: Recommendations for Interventional Trials checklist (SPIRIT) figure

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)		X²	X²	X²
Pregnancy test	x
Scales (NEWS and 7 point scale)	x	x	x	x	x	x	x
Improvement according to the investigator/second dose**			x
DLTs	x
Evaluation of patient recovery				x
Adverse events	X

¹Performed at screening and weekly
²Days 3 and 7. If donor chimerism persists by day 7, repeat on days 14, 21, and 28 and then continue weekly (until disappearance). Stop once it is negative
³Day 3
^**Those patients showing clinical improvement at day 7 according to the investigator (based on respiratory status and blood-test result) who have not shown previous toxicities of grade 3 or higher and if donor chimerism does not persist can receive a second cycle with the same dose at day 7, if the investigator considers it appropriate
Patients will be followed until day 90, discharge, or death, whichever occurs earlier. However, if the patient is discharged before day 30, weekly ambulatory visits (days 7, 14, 21, and 28) will be performed if the investigator considers it appropriate

ISSN: 1745-6215