70,000
Participants
Start Date
March 19, 2020
Primary Completion Date
June 30, 2026
Study Completion Date
June 30, 2036
Lopinavir-Ritonavir
Lopinavir 400mg-Ritonavir 100mg by mouth (or nasogastric tube) every 12 hours for 10 days.
Corticosteroid
Corticosteroid in the form of dexamethasone administered as an oral (liquid or tablets) or intravenous preparation 6 mg once daily for 10 days. In pregnancy or breastfeeding women, prednisolone 40 mg administered by mouth (or intravenous hydrocortisone 80 mg twice daily) should be used instead of dexamethasone. Corticosteroid (in children ≤44 weeks gestational age, or \>44 weeks gestational age with PIMS-TS only) in the form of Hydrocortisone or Methylprednisolone sodium succinate (see Protocol for timing and dosage)
Hydroxychloroquine
Hydroxychloroquine by mouth for a total of 10 days (see Protocol for timing and dosage).
Azithromycin
Azithromycin 500mg by mouth (or nasogastric tube) or intravenously once daily for 10 days.
Convalescent plasma
Single unit of ABO compatible convalescent plasma (275mls +/- 75 mls) intravenous per day on study days 1 (as soon as possible after randomisation) and 2 (with a minimum of 12 hour interval between 1st and 2nd units).
Tocilizumab
Tocilizumab by intravenous infusion with the dose determined by body weight (see Protocol for dosage)
Immunoglobulin
Intravenous immunoglobulin (IVIg) for children \>44 weeks gestational age and \<18 years with PIMS-TS only (see Protocol for dosage)
Synthetic neutralising antibodies
Patients ≥12 years only with COVID-19 pneumonia: A single dose of REGN10933 + REGN10987 8 g (4 g of each monoclonal antibody) in 250ml 0.9% saline infused intravenously over 60 minutes +/- 15 minutes as soon as possible after randomisation
Aspirin
150 mg by mouth (or nasogastric tube) or per rectum once daily until discharge, for adults ≥18 years old.
Colchicine
1 mg after randomisation followed by 500mcg 12 hours later and then 500 mcg twice daily by mouth or nasogastric tube for 10 days in total, for men ≥18 years old and women ≥55 years old only
Baricitinib
UK \[age ≥2 years with COVID pneumonia\] and India \[age ≥18 years with COVID-19 pneumonia\]: 4 mg once daily by mouth or nasogastric tube for 10 days in total.
Anakinra
For children ≥1 \<18 years old only: subcutaneously or intravenously once daily for 7 days or discharge (if sooner). NB Anakinra will be excluded from the randomisation of children \<10 kg in weight.
Dimethyl fumarate
Early phase assessment. UK adults ≥18 years old only (excluding those on ECMO). 120 mg every 12 hours for 4 doses followed by 240 mg every 12 hours by mouth for 8 days (10 days in total).
High Dose Corticosteroid
Adults ≥18 years old with hypoxia only. Dexamethasone 20 mg (base) once daily by mouth, nasogastric tube or intravenous infusion for 5 days follow by dexamethasone 10 mg (base) once daily by mouth, nasogastric tube or intravenous infusion for 5 days.
Empagliflozin
Adults ≥18 years old only. 10 mg once daily by mouth for 28 days (or until discharge, if earlier).
Sotrovimab
UK patients ≥12 years old. 1000 mg in 100 mL 0.9% sodium chloride or 5% dextrose by intravenous infusion over 1 hour as soon as possible after randomisation.
Molnupiravir
Patients ≥18 years old. 800 mg twice daily for 5 days by mouth.
Paxlovid
UK patients ≥18 years old. 300/100 mg twice daily for 5 days by mouth.
Baloxavir Marboxil
"Patients ≥12 years old in the UK (or ≥18 years old in other countries), with or without SARS-CoV-2 co-infection.~40mg (or 80mg if weight ≥80kg) once daily by mouth or nasogastic tube to be given on day 1 and day 4."
Oseltamivir
"Any age in the UK (or ≥18 years old in other countries), with or without SARS-CoV-2 co-infection.~75mg twice daily by mouth or nasogastric tube for five days. (See Protocol for detailed dosage information)"
Low-dose corticosteroids: Dexamethasone
Any age in the UK (or ≥18 years old in other countries), without suspected or confirmed SARS-CoV-2 infection, and with clinical evidence of hypoxia (i.e. receiving oxygen or with oxygen saturations \<92% on room air) 6mg once daily given orally or intravenously for ten days or until discharge (whichever happens earliest)
Low-dose corticosteroids: Dexamethasone
≥18 years old) with a diagnosis of community-acquired pneumonia (with planned antibiotic use and without suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis, or Pneumocystis jirovecii infection) 6mg once daily given orally or intravenously for ten days or until discharge (whichever happens earliest)
RECRUITING
Kumasi Center for Collaborative Research in Tropical Medicine KNUST, Kumasi
RECRUITING
Eijkman Oxford Clinical Research Unit (EOCRU), Eijkman Institute for Molecular Biology, Jakarta
RECRUITING
Clinical Trial Unit, Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Sciences, Kathmandu
RECRUITING
Wits Health Consortium, Johannesburg
RECRUITING
Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City
RECRUITING
Indian Council of Medical Research, Division of Epidemiology and Communicable Diseases, New Delhi
RECRUITING
Nuffield Department of Population Health, University of Oxford, Oxford
Collaborators (1)
UK Research and Innovation
OTHER
National Institute for Health Research, United Kingdom
OTHER_GOV
Wellcome Trust
OTHER
Bill and Melinda Gates Foundation
OTHER
Department for International Development, United Kingdom
OTHER_GOV
Health Data Research UK
UNKNOWN
Medical Research Council Population Health Research Unit
UNKNOWN
NIHR Health Protection Research Unit in Emerging and Zoonotic Infections
UNKNOWN
Flu Lab
UNKNOWN
University of Oxford
OTHER