Assessment and visit schedule
| Enrolment | Screening | Treatment | Follow-up | ||||
| Intervention | Duration | 30 days | 3 months | 3 months | |||
| Assessment | Name | Screening | Randomisation | Month 1 | Month 3/EOT | Unscheduled visit | 6 months |
| Assessment schedule | Time | Within 30 days of day 1 | ≥9 days after screening | ±7 days | ±7 days) | Any day between day 1 and EOT | ±7 days |
| Informed consent | X* | ||||||
| Medical history | X | X† | X† | ||||
| Concomitant therapy | X | X | X | X | X | ||
| Vital signs (seated) (BP, pulse, tympanic temperature) | X | X | X | X | |||
| Height | X | ||||||
| Weight‡ | X | X | X | X | |||
| Dietary intake | X | X | |||||
| Gait speed | X | X | X | ||||
| Handgrip strength | X | X | X | ||||
| SPPB (includes gait speed) | X | X | X | ||||
| Body comp. (impedance) | X | X | X | ||||
| Nutritional profile (blood) | X§ | X§ | X§ | X§ | |||
| Nursing Home Life-Space Diameter instrument | X | X | X | ||||
| Nutritional assessment: MNA | X | X | |||||
| Patient-reported QoL EQ-5D | X | X | |||||
| Immune profile | X¶ | X¶ | X¶ | X¶ | |||
| Respiratory function (spirometry) | X | X | X | ||||
| Study treatment dispensing/return | X | X | X | X | |||
| SAE/AEs | X | X | X | X | |||
*Informed Consent must be obtained prior to study specific assessments being completed.
†Documented cases of COVID-19 and/or respiratory viral infections will be collected from the participants’ charts, including details of adverse outcomes (hospitalisation, complications, or death).
‡Additional monthly data on weight will be collected as part of usual practice at participating RACFs.
§Serum albumin, vitamin D and calcium.
¶Full blood count, T and B cell sub-types, cytokine arrays.
AEs, adverse events; EOT, end of treatment; MNA, mini-nutritional assessment; QoL, quality of life; SPPB, Short Physical Performance Battery.