Created at Source Raw Value Validated value
March 28, 2021, 12:31 a.m. usa

inclusion criteria: 6.1. inclusion criteria • male or female - ≥16 years of age - sars-cov-2 infection (clinically suspected+ or laboratory confirmed*). - admitted to hospital as in-patient less than 96 hours prior to randomisation^ - illness of any duration, and at least one of the following: - radiographic infiltrates by imaging (e.g. chest x-ray, computed tomography (ct) scan) or - evidence of rales/crackles on physical examination or - peripheral capillary oxygen saturation (spo2) ≤94% on room air prior to randomization or - requiring supplemental oxygen. or - lymphocyte count <1 x 109 cells per litre (l) - participant (or legally authorized representative) provides written informed consent - able to take oral medication - participant (or legally authorised representative) understands and agrees to comply with planned trial procedures. - laboratory-confirmed: sars-cov-2 infection as determined by polymerase chain reaction (pcr), or other commercial or public health assay in any specimen < 96 hours prior to randomization. - clinically suspected: in general, sars-cov-2 infection should be suspected when a patient presents with (i) typical symptoms (e.g. influenza-like illness with fever and muscle pain, or respiratory illness with cough and shortness of breath); and (ii) compatible chest x-ray findings (consolidation or ground-glass shadowing); and (iii) alternative causes have been considered unlikely or excluded (e.g. heart failure, influenza). however, the diagnosis remains a clinical one based on the opinion of the managing doctor - where a patient has been admitted to hospital for a non covid-19 reason and develops covid-19 symptoms whilst an in-patient, randomisation may occur up to 96 hours from onset of symptoms.

inclusion criteria: 6.1. inclusion criteria • male or female - ≥16 years of age - sars-cov-2 infection (clinically suspected+ or laboratory confirmed*). - admitted to hospital as in-patient less than 96 hours prior to randomisation^ - illness of any duration, and at least one of the following: - radiographic infiltrates by imaging (e.g. chest x-ray, computed tomography (ct) scan) or - evidence of rales/crackles on physical examination or - peripheral capillary oxygen saturation (spo2) ≤94% on room air prior to randomization or - requiring supplemental oxygen. or - lymphocyte count <1 x 109 cells per litre (l) - participant (or legally authorized representative) provides written informed consent - able to take oral medication - participant (or legally authorised representative) understands and agrees to comply with planned trial procedures. - laboratory-confirmed: sars-cov-2 infection as determined by polymerase chain reaction (pcr), or other commercial or public health assay in any specimen < 96 hours prior to randomization. - clinically suspected: in general, sars-cov-2 infection should be suspected when a patient presents with (i) typical symptoms (e.g. influenza-like illness with fever and muscle pain, or respiratory illness with cough and shortness of breath); and (ii) compatible chest x-ray findings (consolidation or ground-glass shadowing); and (iii) alternative causes have been considered unlikely or excluded (e.g. heart failure, influenza). however, the diagnosis remains a clinical one based on the opinion of the managing doctor - where a patient has been admitted to hospital for a non covid-19 reason and develops covid-19 symptoms whilst an in-patient, randomisation may occur up to 96 hours from onset of symptoms.