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RECRUITINGPhase 3INTERVENTIONAL

Randomised Evaluation of COVID-19 Therapy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

RECOVERY is a randomised trial of treatments to prevent death in patients hospitalised with pneumonia. The treatments being investigated are: COVID-19: Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Colchicine, IV Immunoglobulin (children only), Convalescent plasma, Casirivimab+Imdevimab, Tocilizumab, Aspirin, Baricitinib, Empagliflozin, Sotrovimab, Molnupiravir, Paxlovid or Anakinra (children only) Influenza: Baloxavir marboxil, Oseltamivir, Low-dose corticosteroids - Dexamethasone Community-acquired pneumonia: Low-dose corticosteroids - Dexamethasone

Who May Be Eligible (Plain English)

Who May Qualify: Patients are eligible for the study if all of the following are true: (i) Hospitalised (ii) Pneumonia syndrome In general, pneumonia should be suspected when a patient presents with: 1. typical symptoms of a new respiratory tract infection (e.g. influenza-like illness with fever and muscle pain, or respiratory illness with cough and shortness of breath); and 2. objective evidence of acute lung disease (e.g. consolidation or ground-glass shadowing on X-ray or CT, hypoxia, or compatible clinical examination); and 3. alternative causes have been considered unlikely or excluded (e.g. heart failure). However, the diagnosis remains a clinical one based on the opinion of the managing doctor (the above criteria are just a guide). (iii) One of the following diagnoses: 1. Confirmed SARS-CoV-2 infection (including patients with influenza co-infection) 2. Confirmed influenza A or B infection (including patients with SARS-CoV-2 co-infection) 3. Community-acquired pneumonia with planned antibiotic treatment (excluding patients with suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia) Who Should NOT Join This Trial: (iv) No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Patients are eligible for the study if all of the following are true: (i) Hospitalised (ii) Pneumonia syndrome In general, pneumonia should be suspected when a patient presents with: 1. typical symptoms of a new respiratory tract infection (e.g. influenza-like illness with fever and muscle pain, or respiratory illness with cough and shortness of breath); and 2. objective evidence of acute lung disease (e.g. consolidation or ground-glass shadowing on X-ray or CT, hypoxia, or compatible clinical examination); and 3. alternative causes have been considered unlikely or excluded (e.g. heart failure). However, the diagnosis remains a clinical one based on the opinion of the managing doctor (the above criteria are just a guide). (iii) One of the following diagnoses: 1. Confirmed SARS-CoV-2 infection (including patients with influenza co-infection) 2. Confirmed influenza A or B infection (including patients with SARS-CoV-2 co-infection) 3. Community-acquired pneumonia with planned antibiotic treatment (excluding patients with suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia) Exclusion criteria: (iv) No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial Participants will be excluded if the attending clinician believes that there is a specific contra-indication to one of the active drug treatment arms (see Protocol Appendix 2; section 8.2, and Appendix 3; section 8.3 for children, and Appendix 4 for pregnant and breastfeeding women), or that the patient should definitely be receiving one of the active drug treatment arms then that arm will not be available for randomisation for that patient. For patients who lack capacity, an advanced directive or behaviour that clearly indicates that they would not wish to participate in the trial would be considered sufficient reason to exclude them from the trial.

Treatments Being Tested

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)

Locations (7)

Kumasi Center for Collaborative Research in Tropical Medicine KNUST
Kumasi, Ghana
Indian Council of Medical Research, Division of Epidemiology and Communicable Diseases
New Delhi, India
Eijkman Oxford Clinical Research Unit (EOCRU), Eijkman Institute for Molecular Biology
Jakarta, Indonesia
Clinical Trial Unit, Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Sciences
Kathmandu, Nepal
Wits Health Consortium
Johannesburg, South Africa
Nuffield Department of Population Health, University of Oxford
Oxford, United Kingdom
Oxford University Clinical Research Unit, Centre for Tropical Medicine
Ho Chi Minh City, Vietnam