Table 1

Current inclusion and exclusion criteria for the PRINCIPLE trial

Inclusion criteriaExclusion criteria*

  • Willing and able to give informed consent for participation in the study.

  • Willing to comply with all trial procedures.

  • Symptoms of possible COVID-19 (any of fever, cough, change in taste/smell or other symptoms with a positive SARS-CoV-2 test). Onset of symptoms or a positive test for SARS-CoV-2 with symptoms of COVID-19 must be within the last 14 days.

  • Patients aged ≥65 years.

OR
Patients aged ≥50–64 years with any of the following listed comorbidities:

  • Known weakened immune system due to a serious illness or medication (eg, chemotherapy).

  • Known heart disease and/or a diagnosis of high blood pressure.

  • Known asthma or lung disease.

  • Known diabetes.

  • Known mild hepatic impairment.

  • Known stroke or neurological problem.

  • Self-report obesity or body mass index ≥35 kg/m2.

  • Currently admitted in hospital.

  • Almost recovered (generally much improved and symptoms now mild or almost absent).

  • Judgement of the recruiting clinician deems ineligible.

  • Patient already taking an intervention arm medication.

  • Previous randomisation to an arm of the PRINCIPLE trial.

  • *Exclusion criteria for specific intervention arms detailed in intervention specific appendices to the master protocol.

  • PRINCIPLE, Platform Randomised trial of INterventions against COVID-19 In older peoPLE.