Table 1.
Timeline and actions in the COVIPLA-R Study.
| Items | Admission Date | Day 1 of Administration | Day 3 of Administration | Day 7 of Administration | Day 14 of Administration | Day 21 of Administration | Day 28 of Administration | Day 90 of Administration | Suspension of Administration | |
|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Administration | Post-Administration | |||||||||
| Allowance | −3 | ― | ±1 | ±1 | ±3 | ±3 | ±3 | +14 | ― | |
| COVIPLA-R Study Count | ― | D1 | D3 | D7 | D14 | D21 | D28 | D90 | ― | |
| Informed consent | X | |||||||||
| Eligibility confirmation | X | |||||||||
| Plasma administration | X | |||||||||
| Basic information on admission/travel information | X | |||||||||
| Comorbidities, signs and symptoms, and pathogen testing | X | |||||||||
| Admission history (including vital signs) | X | X | Xg | X | X | X | (X) | X | Xh | |
| Medical examination, interview, and physical examination | X | X | Xg | X | X | X | X | X | Xh | |
| Swab collection | X | X | X | X | (X) | X | ||||
| Blood test (biochemistry and blood count) | X | X | X | X | (X) | (X) | X | |||
| Blood test (blood type and cross-matching) | X | |||||||||
| Blood test (infectious disease screening) | Xe | Xe | ||||||||
| Urine tests (urinalysis) | X | |||||||||
| Radiology (chest X-ray and/or CT) | X | X | X | X | (X) | (X) | ||||
| Confirmation of concomitant medications | X | X | X | X | X | X | ||||
| Confirmation of adverse events | X | X | X | X | X | X | Xd | X | ||
| Phone contact | Xf | |||||||||
X: Required. (X): Required for continued hospitalization, otherwise at physician’s discretion. d: Serious adverse events only. e: Only events based on infectious disease screening (immunodeficiency virus 1 and 2, hepatitis C virus core protein–heparan sulfate, hepatitis B virus-deoxyribonucleic acid quantitative reverse transcription polymerase chain reaction). f: If the patient was discharged from the hospital, examination via telephone was required. g: Follow-up 3 h after initiation of treatment, including observation of adverse events. h: 24-h follow-up. CT: computed tomography.