Randomised Evaluation of COVID-19 Therapy

NCT04381936 | Recruiting Phase 3 DMC

• 3 other identifiers: NDPHRECOVERY2020-001113-21ISRCTN50189673
• Study Type: interventional
• Target: 70,000
• Locations: 15 countries
• Sites: 15

Brief 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, Corticosteroids (dexamethasone) Community-acquired pneumonia: Corticosteroids (dexamethasone)

Conditions

Pneumonia

Keywords

COVID-19; SARS-CoV-2; SARS coronavirus 2; SARS; Viral pneumonia syndrome; Community-acquired pneumonia; Bacterial pneumonia syndrome; Influenza A; Influenza B

Outcome Measures

Primary Outcomes (3)

• Community-acquired pneumonia: All-cause mortality (with subsidiary analyses of cause of death and of death at various timepoints following discharge)

  For each pairwise comparison with the 'no additional treatment' arm, the primary objective is to provide reliable estimates of the effect of study treatments on all-cause mortality.

  Within 28 days after randomisation

• Influenza co-primary outcome: All-cause mortality (with subsidiary analysis of cause of death and death at various timepoints following discharge)

  Within 28 days after randomisation

• Influenza co-primary outcome: Time to discharge alive from hospital

  Within the first 28-days

Secondary Outcomes (3)

• Community-acquired pneumonia: Duration of hospital stay

  Within 28 days and up to 6 months after the main randomisation

• Community-acquired pneumonia: Composite endpoint of death or need for mechanical ventilation or ECMO

  Within 28 days and up to 6 months after the main randomisation

• Influenza: Composite endpoint of death or need for mechanical ventilation or ECMO

  Within 28 days and up to 6 months after the main randomisation

Other Outcomes (3)

• Need for (and duration of) ventilation

  Within 28 days and up to 6 months after the main randomisation

• Need for renal replacement

  Within 28 days and up to 6 months after the main randomisation

• Number of patients who had thrombotic events

  Within 28 days and up to 6 months after the main randomisation

Study Arms (23)

Standard Care

NO INTERVENTION

Patient receives usual hospital care

Corticosteroids

ACTIVE COMPARATOR

First (main) randomisation part A (COVID-19) \[This arm is now closed to recruitment\]

Drug: Corticosteroid

Hydroxychloroquine

ACTIVE COMPARATOR

First (main) randomisation part A (COVID-19) \[This arm is now closed to recruitment\]

Drug: Hydroxychloroquine

Lopinavir-Ritonavir

ACTIVE COMPARATOR

First (main) randomisation part A (COVID-19) \[This arm is now closed to recruitment\]

Drug: Lopinavir-Ritonavir

Azithromycin

ACTIVE COMPARATOR

First (main) randomisation part A (COVID-19) \[This arm is now closed to recruitment\]

Drug: Azithromycin

Convalescent plasma

ACTIVE COMPARATOR

First (main) randomisation part B (COVID-19) \[This arm is now closed to recruitment\]

Biological: Convalescent plasma

Tocilizumab

ACTIVE COMPARATOR

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). \[This arm is now closed to recruitment\]

Drug: Tocilizumab

Intravenous Immunoglobulin

ACTIVE COMPARATOR

First (main) randomisation part A (children only) \[This arm is now closed to recruitment\]

Biological: Immunoglobulin

Synthetic neutralising antibodies

ACTIVE COMPARATOR

First (main) randomisation part B (COVID-19) \[This arm is now closed to recruitment\]

Drug: Synthetic neutralising antibodies

Aspirin

ACTIVE COMPARATOR

First (main) randomisation part C (COVID-19) \[This arm is now closed to recruitment\]

Drug: Aspirin

Colchicine

ACTIVE COMPARATOR

First (main) randomisation part A (COVID-19) \[This arm is now closed to recruitment\]

Drug: Colchicine

Baricitinib

ACTIVE COMPARATOR

First (main) randomisation part D (COVID-19) \[This arm is now closed to recruitment\]

Drug: Baricitinib

Anakinra

ACTIVE COMPARATOR

Randomisation for children only with PIMS-TS (Children with COVID-19 pneumonia are not eligible for this comparison). \[This arm is now closed to recruitment\]

Drug: Anakinra

Dimethyl fumarate

ACTIVE COMPARATOR

First (main) randomisation part A (COVID-19) (UK adults only; early phase assessment) \[This arm is now closed to recruitment\]

Drug: Dimethyl fumarate

High Dose Corticosteroids

ACTIVE COMPARATOR

First (main) randomisation part E (COVID-19) \[This arm is now closed to recruitment\]

Drug: High Dose Corticosteroid

Empagliflozin

ACTIVE COMPARATOR

First (main) randomisation part F (COVID-19) \[This arm is now closed to recruitment\]

Drug: Empagliflozin

Sotrovimab

ACTIVE COMPARATOR

First (main) randomisation part J (COVID-19) \[This arm is now closed to recruitment\]

Drug: Sotrovimab

Molnupiravir

ACTIVE COMPARATOR

First (main) randomisation part K (COVID-19) \[This arm is now closed to recruitment\]

Drug: Molnupiravir

Paxlovid

ACTIVE COMPARATOR

First (main) randomisation part L (COVID-19) \[This arm is now closed to recruitment\]

Drug: Paxlovid

Baloxavir marboxil

ACTIVE COMPARATOR

Randomisation part G (influenza)

Drug: Baloxavir Marboxil

Oseltamivir

ACTIVE COMPARATOR

Randomisation part H (influenza)

Drug: Oseltamivir

Corticosteroids (dexamethasone) (influenza arm)

ACTIVE COMPARATOR

Randomisation part I (influenza)

Drug: Corticosteroids (dexamethasone)

Corticosteroids (dexamethasone) (community-acquired pneumonia arm)

ACTIVE COMPARATOR

Randomisation part M (community-acquired pneumonia)

Drug: Corticosteroids (dexamethasone)

Interventions

Lopinavir-Ritonavir DRUG

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

Lopinavir-Ritonavir

Corticosteroid DRUG

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)

Corticosteroids

Hydroxychloroquine DRUG

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

Hydroxychloroquine

Sotrovimab DRUG

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.

Sotrovimab

Molnupiravir DRUG

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

Molnupiravir

Paxlovid DRUG

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

Also known as: nirmatrelvir/ritonavir

Paxlovid

Baloxavir Marboxil DRUG

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.

Also known as: Xofluza

Baloxavir marboxil

Oseltamivir DRUG

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)

Also known as: Tamiflu

Oseltamivir

Azithromycin DRUG

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

Azithromycin

Convalescent plasma BIOLOGICAL

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).

Convalescent plasma

Tocilizumab DRUG

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

Tocilizumab

Immunoglobulin BIOLOGICAL

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

Intravenous Immunoglobulin

Synthetic neutralising antibodies DRUG

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

Also known as: REGEN-COV, casirivimab and imdevimab

Synthetic neutralising antibodies

Aspirin DRUG

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

Aspirin

Colchicine DRUG

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

Colchicine

Baricitinib DRUG

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.

Baricitinib

Anakinra DRUG

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.

Anakinra

Dimethyl fumarate DRUG

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).

Dimethyl fumarate

High Dose Corticosteroid DRUG

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.

High Dose Corticosteroids

Empagliflozin DRUG

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

Empagliflozin

Corticosteroids (dexamethasone) DRUG

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)

Corticosteroids (dexamethasone) (influenza arm)

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Eligibility Criteria (as per Protocol v28.0): 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 influenza A or B infection (including patients with SARS-CoV-2 co-infection) 2. Community-acquired pneumonia (CAP) with planned antibiotic treatment (excluding patients with suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia) (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 Patients with suspected or confirmed active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia (also known as PCP or PJP) are excluded from the CAP comparison, as these infections are caused by specific organisms with distinct pathologies, and so are not usually categorised as CAP. Eligibility for the CAP comparison also requires planned antibiotic treatment, so patients being treated solely for fungal or viral pneumonia are not eligible. Patients with SARS-CoV-2 and influenza co-infection are eligible, but would be excluded from certain comparisons if the attending clinician believes that there is a specific contra-indication to one of the active drug treatment arms (see Protocol Appendix 2, Appendix 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. Patients who have been previously recruited into RECOVERY are eligible to be recruited again as long as their previous randomisation was \>6 months ago. Patients will not be recruited into the same randomised comparison (e.g. sotrovimab vs. usual care) on more than one occasion, regardless of how far apart they occur. In some locations, children (aged \<18 years) will not be recruited, to comply with local and national regulatory approvals (see Appendix 6). Note: the eligibility criteria has changed from COVID-19 to pneumonia (Influenza \& CAP). For detailed information about previous eligibility criteria please see the previous Protocol's on the study website: https://www.recoverytrial.net/uk/for-site-staff/site-set-up-1/regulatory-documents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Oxford: lead
• UK Research and Innovation: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• Wellcome Trust: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Department for International Development, United Kingdom: collaborator
• Health Data Research UK: collaborator
• Medical Research Council Population Health Research Unit: collaborator
• NIHR Health Protection Research Unit in Emerging and Zoonotic Infections: collaborator
• Flu Lab: collaborator

Study Sites (16)

Belgian sites are managed by the European Clinical Research Alliance on Infectious Diseases

Brussels, Belgium

RECRUITING

Estonian sites are managed by the European Clinical Research Alliance on Infectious Diseases

Tallinn, Estonia

RECRUITING

French sites are managed by the European Clinical Research Alliance on Infectious Diseases

Paris, France

RECRUITING

Kumasi Center for Collaborative Research in Tropical Medicine KNUST

Kumasi, Ghana

RECRUITING

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

New Delhi, ICMR-110029, India

COMPLETED

Eijkman Oxford Clinical Research Unit (EOCRU), Eijkman Institute for Molecular Biology

Jakarta, Indonesia

RECRUITING

Italian sites are managed by the European Clinical Research Alliance on Infectious Diseases

Roma, Italy

RECRUITING

Clinical Trial Unit, Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Sciences

Kathmandu, Nepal

RECRUITING

Dutch sites are managed by the European Clinical Research Alliance on Infectious Diseases

Utrecht, 3584 BA, Netherlands

RECRUITING

Portuguese sites are managed by the European Clinical Research Alliance on Infectious Diseases

Lisbon, Portugal

RECRUITING

Romanian sites are managed by the European Clinical Research Alliance on Infectious Diseases

Bucharest, Romania

RECRUITING

Wits Health Consortium

Johannesburg, South Africa

RECRUITING

Spanish sites are managed by the European Clinical Research Alliance on Infectious Diseases

Barcelona, Spain

RECRUITING

Swedish sites are managed by the European Clinical Research Alliance on Infectious Diseases

Stockholm, Sweden

RECRUITING

Nuffield Department of Population Health, University of Oxford

Oxford, OX3 7LF, United Kingdom

RECRUITING

Oxford University Clinical Research Unit, Centre for Tropical Medicine

Ho Chi Minh City, Vietnam

RECRUITING

Related Publications (29)

• RECOVERY Collaborative Group. Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2022 Jan 8;399(10320):143-151. doi: 10.1016/S0140-6736(21)01825-0. Epub 2021 Nov 17.

  PMID: 34800427 RESULT

• RECOVERY Collaborative Group. Lopinavir-ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2020 Oct 24;396(10259):1345-1352. doi: 10.1016/S0140-6736(20)32013-4. Epub 2020 Oct 5.

  PMID: 33031764 RESULT

• RECOVERY Collaborative Group. Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Respir Med. 2021 Dec;9(12):1419-1426. doi: 10.1016/S2213-2600(21)00435-5. Epub 2021 Oct 18.

  PMID: 34672950 RESULT

• RECOVERY Collaborative Group; Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, Linsell L, Staplin N, Brightling C, Ustianowski A, Elmahi E, Prudon B, Green C, Felton T, Chadwick D, Rege K, Fegan C, Chappell LC, Faust SN, Jaki T, Jeffery K, Montgomery A, Rowan K, Juszczak E, Baillie JK, Haynes R, Landray MJ. Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med. 2021 Feb 25;384(8):693-704. doi: 10.1056/NEJMoa2021436. Epub 2020 Jul 17.

  PMID: 32678530 RESULT

• RECOVERY Collaborative Group; Horby P, Mafham M, Linsell L, Bell JL, Staplin N, Emberson JR, Wiselka M, Ustianowski A, Elmahi E, Prudon B, Whitehouse T, Felton T, Williams J, Faccenda J, Underwood J, Baillie JK, Chappell LC, Faust SN, Jaki T, Jeffery K, Lim WS, Montgomery A, Rowan K, Tarning J, Watson JA, White NJ, Juszczak E, Haynes R, Landray MJ. Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19. N Engl J Med. 2020 Nov 19;383(21):2030-2040. doi: 10.1056/NEJMoa2022926. Epub 2020 Oct 8.

  PMID: 33031652 RESULT

• RECOVERY Collaborative Group. Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2021 Feb 13;397(10274):605-612. doi: 10.1016/S0140-6736(21)00149-5. Epub 2021 Feb 2.

  PMID: 33545096 RESULT

• RECOVERY Collaborative Group. Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2021 May 1;397(10285):1637-1645. doi: 10.1016/S0140-6736(21)00676-0.

  PMID: 33933206 RESULT

• RECOVERY Collaborative Group. Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial. Lancet. 2021 May 29;397(10289):2049-2059. doi: 10.1016/S0140-6736(21)00897-7. Epub 2021 May 14.

  PMID: 34000257 RESULT

• RECOVERY Collaborative Group. Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2022 Feb 12;399(10325):665-676. doi: 10.1016/S0140-6736(22)00163-5.

  PMID: 35151397 RESULT

• RECOVERY Collaborative Group. Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis. Lancet. 2022 Jul 30;400(10349):359-368. doi: 10.1016/S0140-6736(22)01109-6.

  PMID: 35908569 RESULT

• RECOVERY Collaborative Group. Electronic address: recoverytrial@ndph.ox.ac.uk; RECOVERY Collaborative Group. Higher dose corticosteroids in patients admitted to hospital with COVID-19 who are hypoxic but not requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2023 May 6;401(10387):1499-1507. doi: 10.1016/S0140-6736(23)00510-X. Epub 2023 Apr 13.

  PMID: 37060915 RESULT

• RECOVERY Collaborative Group. Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Diabetes Endocrinol. 2023 Dec;11(12):905-914. doi: 10.1016/S2213-8587(23)00253-X. Epub 2023 Oct 18. Erratum In: Lancet Diabetes Endocrinol. 2024 Jan;12(1):e1. doi: 10.1016/S2213-8587(23)00360-1.

  PMID: 37865101 RESULT

• RECOVERY Collaborative Group; Horby PW, Peto L, Staplin N, Campbell M, Pessoa-Amorim G, Mafham M, Emberson JR, Stewart R, Prudon B, Uriel A, Green CA, Dhasmana DJ, Malein F, Majumdar J, Collini P, Shurmer J, Yates B, Baillie JK, Buch MH, Day J, Faust SN, Jaki T, Jeffery K, Juszczak E, Knight M, Lim WS, Montgomery A, Mumford A, Rowan K, Thwaites G, Haynes R, Landray MJ. Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Nat Commun. 2024 Jan 31;15(1):924. doi: 10.1038/s41467-023-43644-x.

  PMID: 38296965 RESULT

• RECOVERY Collaborative Group. Molnupiravir or nirmatrelvir-ritonavir plus usual care versus usual care alone in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Infect Dis. 2025 Sep;25(9):1000-1010. doi: 10.1016/S1473-3099(25)00093-3. Epub 2025 May 15.

  PMID: 40383127 RESULT

• RECOVERY Collaborative Group. Sotrovimab versus usual care in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Infect Dis. 2026 Jan;26(1):34-45. doi: 10.1016/S1473-3099(25)00361-5. Epub 2025 Aug 28.

  PMID: 40886716 RESULT

• RECOVERY Collaborative Group. Long-term follow-up of treatment comparisons in RECOVERY: a randomised, open-label, platform trial for patients hospitalised with COVID-19. MedRxiv. 02 Sep 2025. doi.org/10.1101/2025.08.29.25334732

  RESULT

• RECOVERY Collaborative Group. Higher dose corticosteroids in hospitalised COVID-19 patients requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial. EClinicalMedicine. 2025 Feb 12;81:103080. doi: 10.1016/j.eclinm.2025.103080. eCollection 2025 Mar.

  PMID: 40036152 DERIVED

• Pessoa-Amorim G, Goldacre R, Crichton C, Stevens W, Nunn M, King A, Murray D, Welsh R, Pinches H, Rees A, Morris EJA, Landray MJ, Haynes R, Horby P, Wallendszus K, Peto L, Campbell M, Harper C, Mafham M. Clinical trial results in context: comparison of baseline characteristics and outcomes of 38,510 RECOVERY trial participants versus a reference population of 346,271 people hospitalised with COVID-19 in England. Trials. 2024 Jun 29;25(1):429. doi: 10.1186/s13063-024-08273-9.

  PMID: 38951929 DERIVED

• RECOVERY Collaborative Group. Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial. Lancet Child Adolesc Health. 2024 Mar;8(3):190-200. doi: 10.1016/S2352-4642(23)00316-4. Epub 2024 Jan 22.

  PMID: 38272046 DERIVED

• Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.

  PMID: 37489818 DERIVED

• Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.

  PMID: 37162745 DERIVED

• Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.

  PMID: 36734509 DERIVED

• Chevret S, Timsit JF, Biard L. Challenges of using external data in clinical trials- an illustration in patients with COVID-19. BMC Med Res Methodol. 2022 Dec 15;22(1):321. doi: 10.1186/s12874-022-01769-5.

  PMID: 36522698 DERIVED

• Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.

  PMID: 35713300 DERIVED

• Kramer A, Prinz C, Fichtner F, Fischer AL, Thieme V, Grundeis F, Spagl M, Seeber C, Piechotta V, Metzendorf MI, Golinski M, Moerer O, Stephani C, Mikolajewska A, Kluge S, Stegemann M, Laudi S, Skoetz N. Janus kinase inhibitors for the treatment of COVID-19. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD015209. doi: 10.1002/14651858.CD015209.

  PMID: 35695334 DERIVED

• Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.

  PMID: 34658014 DERIVED

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

  PMID: 34473343 DERIVED

• Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.

  PMID: 34013969 DERIVED

• Tume LN, Menzies JC, Ray S, Scholefield BR; UK Paediatric Intensive Care Society Study Group. Research Priorities for U.K. Pediatric Critical Care in 2019: Healthcare Professionals' and Parents' Perspectives. Pediatr Crit Care Med. 2021 May 1;22(5):e294-e301. doi: 10.1097/PCC.0000000000002647.

  PMID: 33394942 DERIVED

Related Links

• : RECOVERY Trial website for results, the Protocol, the Statistical Analysis Plan, the Privacy Notice, information for participants, and other trial documents

MeSH Terms

Conditions

Pneumonia; COVID-19; Community-Acquired Pneumonia

Interventions

Lopinavir; Adrenal Cortex Hormones; Hydroxychloroquine; Azithromycin; tocilizumab; Immunoglobulins; casirivimab and imdevimab drug combination; Aspirin; Colchicine; baricitinib; Interleukin 1 Receptor Antagonist Protein; Dimethyl Fumarate; empagliflozin; sotrovimab; molnupiravir; nirmatrelvir and ritonavir drug combination; baloxavir; Oseltamivir; Dexamethasone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Community-Acquired Infections

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Alkaloids; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors; Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Acetamides; Amides; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Peter W Horby

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leon Peto

CONTACT

+44 (0)1865 743743; recoverytrial@ndph.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RECOVERY participants are randomly allocated between one or more treatment arms. Not all treatments are available in all countries. All COVID-19 arms of the protocol (Part A to F, and J to L) have now been discontinued with results reported. The arms currently open to recruitment are as follows: Influenza: Part G: randomisation between no additional treatment vrs baloxavir marboxil Part H: randomisation between no additional treatment vrs oseltamivir Part I: randomisation between no additional treatment vrs corticosteroids (dexamethasone) Community-acquired pneumonia: Part M: randomisation between no additional treatment vrs corticosteroids (dexamethasone)

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 11, 2020
• Study Start: March 19, 2020
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2038
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Datasets are available.
• Access Criteria: RECOVERY data are available via the Infectious Diseases Data Observatory (IDDO), or by contacting the study team (for datasets not held by IDDO).

Locations

ID (1); FR (1); SE (1); ES (1); PT (1); RO (1); IT (1); BE (1); NL (1); GB (1); ZA (1); IN (1); NE (1); VN (1); GH (1)