Randomised Evaluation of COVID-19 Therapy

Who is this study for? Children with PIMS-TS (hyper-inflammatory state associated with COVID-19)
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

⁃ 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:

• 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

• objective evidence of acute lung disease (e.g. consolidation or ground-glass shadowing on X-ray or CT, hypoxia, or compatible clinical examination); and

• 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:

• Confirmed SARS-CoV-2 infection (including patients with influenza co-infection)

• Confirmed influenza A or B infection (including patients with SARS-CoV-2 co-infection)

• Community-acquired pneumonia with planned antibiotic treatment (excluding patients with suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia)

Locations
Other Locations
Ghana
Kumasi Center for Collaborative Research in Tropical Medicine KNUST
RECRUITING
Kumasi
India
Indian Council of Medical Research, Division of Epidemiology and Communicable Diseases
RECRUITING
New Delhi
Indonesia
Eijkman Oxford Clinical Research Unit (EOCRU), Eijkman Institute for Molecular Biology
RECRUITING
Jakarta
Nepal
Clinical Trial Unit, Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Sciences
RECRUITING
Kathmandu
South Africa
Wits Health Consortium
RECRUITING
Johannesburg
United Kingdom
Nuffield Department of Population Health, University of Oxford
RECRUITING
Oxford
Viet Nam
Oxford University Clinical Research Unit, Centre for Tropical Medicine
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Richard Haynes
recoverytrial@ndph.ox.ac.uk
+44 (0)1865 743743
Time Frame
Start Date: 2020-03-19
Estimated Completion Date: 2036-06-30
Participants
Target number of participants: 70000
Treatments
No_intervention: Standard Care
Patient receives usual hospital care
Active_comparator: Low dose corticosteroids
First (main) randomisation part A~\[This arm is now closed to recruitment\]
Active_comparator: Hydroxychloroquine
First (main) randomisation part A~\[This arm is now closed to recruitment\]
Active_comparator: Lopinavir-Ritonavir
First (main) randomisation part A~\[This arm is now closed to recruitment\]
Active_comparator: Azithromycin
First (main) randomisation part A~\[This arm is now closed to recruitment\]
Active_comparator: Convalescent plasma
First (main) randomisation part B~\[This arm is now closed to recruitment\]
Active_comparator: Tocilizumab
Participants with progressive COVID-19 (as evidenced by hypoxia and an inflammatory state) may undergo randomisation between Tocilizumab and no additional treatment.~(Children with COVID-19 pneumonia are not eligible for this comparison).~\[This arm is now closed to recruitment\]
Active_comparator: Intravenous Immunoglobulin
First (main) randomisation part A (children only)~\[This arm is now closed to recruitment\]
Active_comparator: Synthetic neutralising antibodies
First (main) randomisation part B.~\[This arm is now closed to recruitment\]
Active_comparator: Aspirin
First (main) randomisation part C~\[This arm is now closed to recruitment\]
Active_comparator: Colchicine
First (main) randomisation part A~\[This arm is now closed to recruitment\]
Active_comparator: Baricitinib
First (main) randomisation part D~\[This arm is now closed to recruitment\]
Active_comparator: Anakinra
Randomisation for children only with PIMS-TS~(Children with COVID-19 pneumonia are not eligible for this comparison).~\[This arm is now closed to recruitment\]
Active_comparator: Dimethyl fumarate
First (main) randomisation part A (UK adults only; early phase assessment)~\[This arm is now closed to recruitment\]
Active_comparator: High Dose Corticosteroids
First (main) randomisation part E
Active_comparator: Empagliflozin
First (main) randomisation part F~\[This arm is now closed to recruitment\]
Active_comparator: Sotrovimab
First (main) randomisation part J
Active_comparator: Molnupiravir
First (main) randomisation part K~\[This arm is now closed to recruitment\]
Active_comparator: Paxlovid
First (main) randomisation part L~\[This arm is now closed to recruitment\]
Active_comparator: Baloxavir marboxil
Randomisation part G (influenza)
Active_comparator: Oseltamivir
Randomisation part H (influenza)
Active_comparator: Low-dose corticosteroids: Dexamethasone (influenza arm)
Randomisation part I (influenza)
Active_comparator: Low-dose corticosteroids: Dexamethasone (pneumonia arm)
Randomisation part M (community-acquired pneumonia)
Sponsors
Collaborators: UK Research and Innovation, Bill and Melinda Gates Foundation, Wellcome Trust, Medical Research Council Population Health Research Unit, Health Data Research UK, NIHR Health Protection Research Unit in Emerging and Zoonotic Infections, Flu Lab, Department for International Development, United Kingdom, National Institute for Health Research, United Kingdom
Leads: University of Oxford

This content was sourced from clinicaltrials.gov

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