Table 3 Visit schedule, assessments as well as data and outcomes to be collected

Visit number

1

2

Phone call number

1

2

3

Trial drug intake

X

X

X

X

X

X

X

X

information, verification of in-/exclusion criteria, informed consent

X

demographic and baseline data, medical history, MoCA

X

biosamples, vital signs

X

X

SARS-CoV-2 antigen test

X

pregnancy test

X

X

Outcomes

- tailored PROMIS total score and subscores

X

X

X

X

X

X

X

- MYMOP

X

X

X

X

X

- PC19 symptom list

X

X

X

X

X

PCFS scale

X

X

X

X

X

- EQ-5D-5L and visual analogue scale

X

X

X

X

X

- PHQ 8

X

X

X

X

X

- Chalder Fatigue Scale

X

X

X

X

X

- Visual analogue scale for pain

X

X

X

X

X

- Tests Alertness, divided attention, distractibility, flexibility and visual scanning (TAP)

X

X

- 1 min-Sit-to-Stand-Test, physical examination

X

X

- Patient diary (on-demand medication)

X

X

X

X

X

X

X

X

- Feasibility & acceptance questionnaire

X

- Feasibility & Acceptance Interviews (subgroup of patients)

X

Safety outcomes

- adverse events

X

X

X

X

- serious adverse events

as necessary

- number of patients with worsening symptoms

as necessary

Drug accountability

X

X