. 2021 Jun 9;21:544. doi: 10.1186/s12879-021-06233-1

Table 1.

Schedule of study visits and sample collections

Clinic Visit Schedule	Baseline visit	Year 1	Year 2	Years 3 and 4
Clinic Visit Schedule	Baseline visit	Every month through August 2021	Every three months through August 2022	Every six months through August 2024
Risk Exposure Questionnaire	Monthly	Monthly	Quarterly ^b	Semiannually
Symptoms Review Questionnaire	Baseline and daily if symptoms present	B-monthly, or daily if symptoms present	–	–
Saliva for Coronavirus IgA	1 × 0.3 ml	0–1 × 0.3 ml^a	0–1 × 0.3 ml^a	0–1 × 0.3 ml^a
Seurm Separator Tubes (SST) for CoVID multiplex serology analysis	1 × 7.5 ml	1 × 7.5 ml	1 × 7.5 ml	1 × 7.5 ml
Mononuclear Cell Preparation Tube (CPT Na Citrate or CPT Na heparin) for PBMCs and plasma isolation	4–6 × 8 ml	0–6 × 8 ml^a	0–6 × 8 ml^a	0–6 × 8 ml^a
PAXgene for WB RNA transcriptonics	1 × 3 ml	0–1 × 3 ml^a	0–1 × 3 ml^a	0–1 × 3 ml^a
WB in EDTA tube for DNA analysis of B cell and T cell repertoires	1 × 2 ml	0–1 × 2 ml^a	0–1 × 2 ml^a	0–1 × 2 ml^a
Total blood volume (ml)	44.5–60.5 ml	7.5 ml - 60.5 ml	7.5 ml - 60.5 ml	7.5 ml - 60.5 ml

^a Intermittent sample collections (e.g. at key timepoints after infection or vaccination)

The exact tubes to be drawn at each follow-up visit may change as determined by the primary investigator, but will not exceed 60.5 ml

> Study participants will visit the clinic once a month through August 2021, and then switch to quarterly and semiannual intervals as indicated below

^b Participants that become COVID-19 infected or vaccinated after April of 2021 may be asked to continue monthly visits for the first quarter of year 2

> Symptom questionnaires will end in August 2021

> Risk exposure questionnaires will continue quarterly or semiannually after August 2021

^a Details on alternative sample collections:

Participants that remain uninfected and unvaccinated -- > once yearly collection of saliva and all blood samples, except the PAXgene RNA tube

Participants that test COVID-19 positive by PCR, antigen, or antibody test

> first monthly visit after infection: collection of saliva and all blood samples, including EDTA and PAXgene RNA tubes

> visits 3 and 6 months after positive test, twice yearly in year 2, yearly in years 3 and 4: collection of saliva and all blood samples, except the PAXgene RNA

Participants vaccinated against COVID 19

> visits within 1 week of the first COVID-19 vaccination: collection of saliva and all blood samples, including EDTA and PAXgene RNA tubes

> visits within 1 week of the second COVID-19 vaccination: collection of saliva tube, 1x SST tube, 1x PAXgene RNA tube, and an EDTA tube

> visits 1, 6, and 12 months after final vaccination, twice yearly in year 2, yearly in years 3 and 4: collection of saliva and all blood samples, except the PAXgene