Randomised Evaluation of COVID-19 Therapy

PHASE3RecruitingINTERVENTIONAL
Enrollment

70,000

Participants

Timeline

Start Date

March 19, 2020

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2036

Conditions
Severe Acute Respiratory Syndrome
Interventions
DRUG

Lopinavir-Ritonavir

Lopinavir 400mg-Ritonavir 100mg by mouth (or nasogastric tube) every 12 hours for 10 days.

DRUG

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)

DRUG

Hydroxychloroquine

Hydroxychloroquine by mouth for a total of 10 days (see Protocol for timing and dosage).

DRUG

Azithromycin

Azithromycin 500mg by mouth (or nasogastric tube) or intravenously once daily for 10 days.

BIOLOGICAL

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).

DRUG

Tocilizumab

Tocilizumab by intravenous infusion with the dose determined by body weight (see Protocol for dosage)

BIOLOGICAL

Immunoglobulin

Intravenous immunoglobulin (IVIg) for children \>44 weeks gestational age and \<18 years with PIMS-TS only (see Protocol for dosage)

DRUG

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

DRUG

Aspirin

150 mg by mouth (or nasogastric tube) or per rectum once daily until discharge, for adults ≥18 years old.

DRUG

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

DRUG

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.

DRUG

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.

DRUG

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).

DRUG

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.

DRUG

Empagliflozin

Adults ≥18 years old only. 10 mg once daily by mouth for 28 days (or until discharge, if earlier).

DRUG

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.

DRUG

Molnupiravir

Patients ≥18 years old. 800 mg twice daily for 5 days by mouth.

DRUG

Paxlovid

UK patients ≥18 years old. 300/100 mg twice daily for 5 days by mouth.

DRUG

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."

DRUG

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)"

DRUG

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)

DRUG

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)

Trial Locations (7)

Unknown

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

ICMR-110029

RECRUITING

Indian Council of Medical Research, Division of Epidemiology and Communicable Diseases, New Delhi

OX3 7LF

RECRUITING

Nuffield Department of Population Health, University of Oxford, Oxford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

UK Research and Innovation

OTHER

collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

collaborator

Wellcome Trust

OTHER

collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

Department for International Development, United Kingdom

OTHER_GOV

collaborator

Health Data Research UK

UNKNOWN

collaborator

Medical Research Council Population Health Research Unit

UNKNOWN

collaborator

NIHR Health Protection Research Unit in Emerging and Zoonotic Infections

UNKNOWN

collaborator

Flu Lab

UNKNOWN

lead

University of Oxford

OTHER

NCT04381936 - Randomised Evaluation of COVID-19 Therapy | Biotech Hunter | Biotech Hunter