Schedule of events
| Evaluation | Phase I | Phase II (long-term follow-up) | ||||||||
| Screening/baseline | Treatment period* | End of trial/early withdrawal | 3 months | 6 months | 12 months | |||||
| Days −4 to 0† | Day 1† | Days 2–6 | Day 7 | Days 8–14 | Day 15 (EoT) | Days 15–28 or up to 14 days after last assessment (discharge/withdrawal) | ||||
| Assessments | ||||||||||
| Eligibility assessment | X | |||||||||
| Informed consent | X | |||||||||
| Demographics | X | |||||||||
| Relevant clinical history (including COVID-19) | X | |||||||||
| Current medication | X | |||||||||
| Inclusion/exclusion criteria | X | |||||||||
| Randomisation | X | |||||||||
| Concomitant medications/interventions | X | |||||||||
| Physical examination | X | |||||||||
| Clinical status | X | X | X (daily) | X | X (daily) | X‡ | ||||
| Laboratory assessments | ||||||||||
| Screening labs (including pregnancy test)§ | X§ | |||||||||
| Routine blood tests—U&E (sodium, potassium, urea and creatinine), GFR, glucose and HbA1c* | X§ | X* | X* | X§ | X* | X§ | ||||
| Liver function test (LFT)§ | X§ | X* | X* | X§ | X* | X§ | ||||
| RBC urine (dipstick)§ | X* | X* | X§ | X* | X§ | |||||
| Viral load¶ | X¶ | X* | X* | X¶ | X* | X¶ | X¶ | |||
| Safety assessments | ||||||||||
| AE and SAE assessment | X‡ | X‡ | X‡ | X‡ | X‡ | |||||
| IMP | ||||||||||
| IMP administration | X (lMU-838 loading dose/oseltamivir single dose, PM) | X (two times per day) | X (two times per day) | X (two times per day) | X (oseltamivir single dose, AM) | |||||
| Long-term follow-up | ||||||||||
| HRQOL EQ-5D | X‡ | X‡ | ||||||||
| Clinical status | X‡ | X‡ | X‡ | |||||||
| All-cause mortality and morbidity | X‡ | X‡ | X‡ | |||||||
*Standard treatment pathway: Assessments/laboratory assessments/investigations (eg, clinical, laboratory) conducted as per standard care/requested by the healthcare team. Existing local lab values obtained within 48 hours of randomisation can be used for the assessment of eligibility.
†Screening, randomisation and first IMP administration can be performed on the same day. If these occur on the same day, treatment will start with the evening dose (loading dose of IMU-838/single dose of oseltamivir) on day 1.
‡Follow-up assessment: Conducted remotely by reviewing medical history, patient notes and/or by telephone if the patient has been discharged from hospital. Long-term follow-up will be conducted remotely: by reviewing patient notes and medical records, clinical status and HRQOL questionnaires will be conducted via telephone, based on capacity and capability of the delivery team.
§Research activity: Conducted if not assessed as part of standard care for participants in intervention arm. No further laboratory assessments are required following discharge.
¶Research activity: Conducted if not assessed as part of standard care, however may be dependent on capacity and availability of kits. No further assessment required following discharge.
AE, adverse event; EoT, End of Treatment; EQ-5D, EuroQol-5 Dimension; GFR, glomerular filtration rate; HbA1c, glycated haemoglobin ; HRQOL, health-related quality of life ; IMP, investigational medicinal product; RBC, red blood cell; SAE, serious adverse event.