Randomised Evaluation of COVID-19 Therapy

NCT ID: NCT04381936

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 70000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-19
• Study Completion Date: 2036-06-30

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, Low-dose corticosteroids - Dexamethasone

Community-acquired pneumonia: Low-dose corticosteroids - Dexamethasone

Detailed Description

The RECOVERY trial has already shown that:

• Dexamethasone (a type of steroid) reduces the risk of dying for patients hospitalised with COVID-19 receiving oxygen,
• Regeneron's monoclonal antibody combination reduces deaths for hospitalised COVID-19 patients who have not mounted their own immune response,
• Tocilizumab reduces the risk of death when given to hospitalised patients with severe COVID-19. It also shortens the time until patients are successfully discharged from hospital and reduces the need for a mechanical ventilator.
• Baricitinib reduces the risk of death when given to hospitalised patients with severe COVID-19.
• In patients hospitalised for COVID-19 with clinical hypoxia but requiring either no oxygen or simple oxygen only, higher dose corticosteroids significantly increased the risk of death compared to usual care, which included low dose corticosteroids.

The trial also concluded that there is no beneficial effect of hydroxychloroquine, lopinavir-ritonavir, azithromycin, convalescent plasma, colchicine, aspirin, dimethyl fumarate or empagliflozin in patients hospitalised with COVID-19, and these arms have been closed to recruitment.

BACKGROUND: In early 2020, as this protocol was being developed, there were no approved treatments for COVID-19, a disease induced by the novel coronavirus SARSCoV-2 that emerged in China in late 2019. The UK New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) advised that several possible treatments should be evaluated, including Lopinavir-Ritonavir, low-dose corticosteroids, and Hydroxychloroquine (which has now been done). A World Health Organization (WHO) expert group issued broadly similar advice. These groups also advised that other treatments will soon emerge that require evaluation.

Since then, progress in COVID-19 treatment has highlighted the need for better evidence for the treatment of pneumonia caused by other pathogens, such as influenza and bacteria, for which therapies are widely used without good evidence of benefit or safety.

ELIGIBILITY AND RANDOMISATION: This protocol (v27.0 as of Dec 2023) describes a randomised trial among patients hospitalised with pneumonia caused by COVID-19, influennza or other organisms. All eligible patients are randomly allocated between several treatment arms, each to be given in addition to the usual standard of care in the participating hospital. The study is subdivided into several parts, according to whether participants are children or adults, and by geographic area. The study is dynamic, and treatments are added and removed as results and suitable treatments become available. The parts in the current version of the protocol are as follows:

Part A (COVID-19): discontinued in Protocol v19.0, (children's recruitment to Part A discontinued in Protocol v17.1)

Part B (COVID-19): discontinued in Protocol v16.0.

Part C (COVID-19): discontinued in Protocol v15.0.

Part D (COVID-19): discontinued in Protocol v20.0

Part E (COVID-19): Adults ≥18 years old with hypoxia only, randomised to high-dose corticosteroids vs no additional treatment.

Part F (COVID-19): discontinued in Protocol v26.0

Part G (Influenza): UK patients ≥12 years old (≥18 years old in other countries), with or without SARS-CoV-2 co-infection, randomised to baloxavir marboxil vrs no additional treatment

Part H (Influenza): UK patients ≥12 years old (≥18 years old in other countries), with or without SARS-CoV-2 co-infection, randomised to oseltamivir vrs no additional treatment

Part I (Influenza): UK patients any age (≥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), randomised to Low-dose corticosteroids: Dexamethasone vrs no additional treatment.

Part J (COVID-19): UK patients ≥12 years old, randomised to sotrovimab vs no additional treatment.

Park K (COVID-19): discontinued in Protocol v26.0

Park L (COVID-19): discontinued in Protocol v26.0

Part M (Community-acquired pneumonia with planned antibiotic treatment and without suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis, or Pneumocystis pneumonia): Patients ≥18 years old randomised to Low-dose corticosteroids: Dexamethasone vs no additional treatment.

Children with PIMS-TS: Tocilizumab vs anakinra vs no additional treatment (UK only) (discontinued in Protocol v23.1).

For patients for whom not all the trial arms are appropriate or at locations where not all are available, randomisation will be between fewer arms.

ADAPTIVE DESIGN: The interim trial results will be monitored by an independent Data Monitoring Committee (DMC). The most important task for the DMC will be to assess whether the randomised comparisons in the study have provided evidence on mortality that is strong enough (with a range of uncertainty around the results that is narrow enough) to affect national and global treatment strategies. In such a circumstance, the DMC will inform the Trial Steering Committee who will make the results available to the public and amend the trial arms accordingly. New trial arms can be added as evidence emerges that other candidate therapeutics should be evaluated.

OUTCOMES: The main outcomes will be death, discharge, need for ventilation and need for renal replacement therapy. For the main analyses, follow-up will be censored at 28 days after randomisation. Additional information on longer term outcomes may be collected through review of medical records or linkage to medical databases where available (such as those managed by NHS Digital and equivalent organisations in the devolved nations).

SIMPLICITY OF PROCEDURES: To facilitate collaboration, even in hospitals that suddenly become overloaded, patient enrolment (via the internet) and all other trial procedures are greatly streamlined. Informed consent is simple and data entry is minimal. Randomisation via the internet is simple and quick, at the end of which the allocated treatment is displayed on the screen and can be printed or downloaded. Key follow-up information is recorded at a single timepoint and may be ascertained by contacting participants in person, by phone or electronically, or by review of medical records and databases.

DATA TO BE RECORDED: At randomisation, information will be collected on the identity of the randomising clinician and of the patient, age, sex, major co-morbidity, pregnancy, COVID-19 onset date and severity, and any contraindications to the study treatments. The main outcomes will be death (with date and probable cause), discharge (with date), need for ventilation (with number of days recorded) and need for renal replacement therapy. Reminders will be sent if outcome data have not been recorded by 28 days after randomisation. Suspected Unexpected Serious Adverse Reactions (SUSARs) to one of the study medication (eg, Stevens-Johnson syndrome, anaphylaxis, aplastic anaemia) will be collected and reported in an expedited fashion. Other adverse events will not be recorded but may be available through linkage to medical databases.

NUMBERS TO BE RANDOMISED: The larger the number randomised the more accurate the results will be, but the numbers that can be randomised will depend critically on how large the epidemic becomes. If substantial numbers are hospitalised in the participating centres then it may be possible to randomise several thousand with mild disease and a few thousand with severe disease, but realistic, appropriate sample sizes could not be estimated at the start of the trial.

HETEROGENEITY BETWEEN POPULATIONS: If sufficient numbers are studied, it may be possible to generate reliable evidence in certain patient groups (e.g. those with major comorbidity or who are older). To this end, data from this study may be combined with data from other trials of treatments for COVID-19, such as those being planned by the WHO.

ADD-ON STUDIES: Particular countries or groups of hospitals, may well want to collaborate in adding further measurements or observations, such as serial virology, serial blood gases or chemistry, serial lung imaging, or serial documentation of other aspects of disease status. While well-organised additional research studies of the natural history of the disease or of the effects of the trial treatments could well be valuable (although the lack of placebo control may bias the assessment of subjective side-effects, such as gastrointestinal problems), they are not core requirements.

Conditions

Severe Acute Respiratory Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Care

Patient receives usual hospital care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Low dose corticosteroids

First (main) randomisation part A

[This arm is now closed to recruitment]

Group Type: ACTIVE_COMPARATOR

Corticosteroid

Intervention Type: 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)

Hydroxychloroquine

First (main) randomisation part A

[This arm is now closed to recruitment]

Group Type: ACTIVE_COMPARATOR

Hydroxychloroquine

Intervention Type: DRUG

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

Lopinavir-Ritonavir

First (main) randomisation part A

[This arm is now closed to recruitment]

Group Type: ACTIVE_COMPARATOR

Lopinavir-Ritonavir

Intervention Type: DRUG

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

Azithromycin

First (main) randomisation part A

[This arm is now closed to recruitment]

Group Type: ACTIVE_COMPARATOR

Azithromycin

Intervention Type: DRUG

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

Convalescent plasma

First (main) randomisation part B

[This arm is now closed to recruitment]

Group Type: ACTIVE_COMPARATOR

Convalescent plasma

Intervention Type: 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).

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]

Group Type: ACTIVE_COMPARATOR

Tocilizumab

Intervention Type: DRUG

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

Intravenous Immunoglobulin

First (main) randomisation part A (children only)

[This arm is now closed to recruitment]

Group Type: ACTIVE_COMPARATOR

Immunoglobulin

Intervention Type: BIOLOGICAL

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

Synthetic neutralising antibodies

First (main) randomisation part B.

[This arm is now closed to recruitment]

Group Type: ACTIVE_COMPARATOR

Synthetic neutralising antibodies

Intervention Type: 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

Aspirin

First (main) randomisation part C

[This arm is now closed to recruitment]

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: DRUG

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

Colchicine

First (main) randomisation part A

[This arm is now closed to recruitment]

Group Type: ACTIVE_COMPARATOR

Colchicine

Intervention Type: 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

Baricitinib

First (main) randomisation part D

[This arm is now closed to recruitment]

Group Type: ACTIVE_COMPARATOR

Baricitinib

Intervention Type: 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.

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]

Group Type: ACTIVE_COMPARATOR

Anakinra

Intervention Type: 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.

Dimethyl fumarate

First (main) randomisation part A (UK adults only; early phase assessment)

[This arm is now closed to recruitment]

Group Type: ACTIVE_COMPARATOR

Dimethyl fumarate

Intervention Type: 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).

High Dose Corticosteroids

First (main) randomisation part E

Group Type: ACTIVE_COMPARATOR

High Dose Corticosteroid

Intervention Type: 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.

Empagliflozin

First (main) randomisation part F

[This arm is now closed to recruitment]

Group Type: ACTIVE_COMPARATOR

Empagliflozin

Intervention Type: DRUG

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

Sotrovimab

First (main) randomisation part J

Group Type: ACTIVE_COMPARATOR

Sotrovimab

Intervention Type: 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.

Molnupiravir

First (main) randomisation part K

[This arm is now closed to recruitment]

Group Type: ACTIVE_COMPARATOR

Molnupiravir

Intervention Type: DRUG

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

Paxlovid

First (main) randomisation part L

[This arm is now closed to recruitment]

Group Type: ACTIVE_COMPARATOR

Paxlovid

Intervention Type: DRUG

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

Baloxavir marboxil

Randomisation part G (influenza)

Group Type: ACTIVE_COMPARATOR

Baloxavir Marboxil

Intervention Type: 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.

Oseltamivir

Randomisation part H (influenza)

Group Type: ACTIVE_COMPARATOR

Oseltamivir

Intervention Type: 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)

Low-dose corticosteroids: Dexamethasone (influenza arm)

Randomisation part I (influenza)

Group Type: ACTIVE_COMPARATOR

Low-dose corticosteroids: Dexamethasone

Intervention Type: 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)

Low-dose corticosteroids: Dexamethasone (pneumonia arm)

Randomisation part M (community-acquired pneumonia)

Group Type: ACTIVE_COMPARATOR

Low-dose corticosteroids: Dexamethasone

Intervention Type: DRUG

≥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)

Interventions

Lopinavir-Ritonavir

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

Intervention Type: 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)

Intervention Type: DRUG

Hydroxychloroquine

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

Intervention Type: DRUG

Azithromycin

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

Intervention Type: DRUG

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).

Intervention Type: BIOLOGICAL

Tocilizumab

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

Intervention Type: DRUG

Immunoglobulin

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

Intervention Type: BIOLOGICAL

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

Intervention Type: DRUG

Aspirin

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

Intervention Type: 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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: DRUG

Empagliflozin

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

Intervention Type: 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.

Intervention Type: DRUG

Molnupiravir

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

Intervention Type: DRUG

Paxlovid

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

Intervention Type: 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.

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

REGEN-COV; casirivimab and imdevimab; nirmatrelvir/ritonavir; Xofluza; Tamiflu

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UK Research and Innovation

OTHER

Sponsor Role: collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Wellcome Trust

OTHER

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Department for International Development, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Health Data Research UK

UNKNOWN

Sponsor Role: collaborator

Medical Research Council Population Health Research Unit

UNKNOWN

Sponsor Role: collaborator

NIHR Health Protection Research Unit in Emerging and Zoonotic Infections

UNKNOWN

Sponsor Role: collaborator

Flu Lab

UNKNOWN

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter W Horby

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Kumasi Center for Collaborative Research in Tropical Medicine KNUST

Kumasi, , Ghana

Site Status: RECRUITING

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

New Delhi, , India

Site Status: RECRUITING

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

Jakarta, , Indonesia

Site Status: RECRUITING

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

Kathmandu, , Nepal

Site Status: RECRUITING

Wits Health Consortium

Johannesburg, , South Africa

Site Status: RECRUITING

Nuffield Department of Population Health, University of Oxford

Oxford, , United Kingdom

Site Status: RECRUITING

Oxford University Clinical Research Unit, Centre for Tropical Medicine

Ho Chi Minh City, , Vietnam

Site Status: RECRUITING

Countries

Ghana; India; Indonesia; Nepal; South Africa; United Kingdom; Vietnam

Central Contacts

Richard Haynes

Role: CONTACT

recoverytrial@ndph.ox.ac.uk

+44 (0)1865 743743

Facility Contacts

Role: primary

+233 278 364 389

Role: primary

+91 996 840 8999

Role: primary

+27 11 274 9200

Peter W Horby

Role: primary

recoverytrial@ndph.ox.ac.uk

Role: primary

recoverytrial@oucru.org

+84 8 39241983

References

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.

Reference Type: RESULT

PMID: 32678530 (View on PubMed)

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.

Reference Type: RESULT

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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.

Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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RECOVERY Collaborative Group. Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. medRxiv. 25 September 2022. doi.org/10.1101/2022.09.23.22280285

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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.

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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.

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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. 2025 Aug 28:S1473-3099(25)00361-5. doi: 10.1016/S1473-3099(25)00361-5. Online ahead of print.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Related Links

https://www.recoverytrial.net/

RECOVERY Trial website (preliminary results, the Protocol, the Statistical Analysis Plan, and other trial documents can be downloaded from this website)

Other Identifiers

2020-001113-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ISRCTN50189673

Identifier Type: REGISTRY

Identifier Source: secondary_id

NDPHRECOVERY

Identifier Type: -

Identifier Source: org_study_id