Randomised Evaluation of COVID-19 Therapy (RECOVERY)
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ClinicalTrials.gov Identifier: NCT04381936 |
Recruitment Status :
Recruiting
First Posted : May 11, 2020
Last Update Posted : February 10, 2021
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Condition or disease | Intervention/treatment | Phase |
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Severe Acute Respiratory Syndrome | Drug: Lopinavir-Ritonavir Drug: Corticosteroid Drug: Hydroxychloroquine Drug: Azithromycin Biological: Convalescent plasma Drug: Tocilizumab Biological: Immunoglobulin Drug: Synthetic neutralising antibodies Drug: Aspirin Drug: Colchicine Drug: Baricitinib Drug: Anakinra | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40000 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Intervention Model Description: | Main randomisation (part A): Simultaneously with part B, C or D (if appropriate), patients are randomly allocated between no additional treatment, colchicine, corticosteroids (children only) or intravenous immunoglobulin (children only). Main randomisation (part B): Simultaneously with part A, C or D (if appropriate), patients are randomly allocated between no additional treatment or synthetic neutralizing antibodies (REGN-COV2) . Main Randomisation (part C): Simultaneously with part A, B or D (if appropriate), patients are randomly allocated between no additional treatment or aspirin Main randomisation (part D): Simultaneously with part A, B or C (if appropriate), patients are randomly allocated between no additional treatment or baricitinib. Subsequent randomisation: Children with PIMS-TS (hyper-inflammatory state associated with COVID-19) can be randomised to no additional treatment vs tocilizumab vs anakinra. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomised Evaluation of COVID-19 Therapy |
Actual Study Start Date : | March 19, 2020 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2031 |

Arm | Intervention/treatment |
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No Intervention: Standard Care
Patient receives usual hospital care
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Active Comparator: Low dose corticosteroids
First (main) randomisation part A [This arm is now closed to adult recruitment] |
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) |
Active Comparator: Hydroxychloroquine
First (main) randomisation part A [This arm is now closed to recruitment] |
Drug: Hydroxychloroquine
Hydroxychloroquine by mouth for a total of 10 days (see Protocol for timing and dosage). |
Active Comparator: Lopinavir-Ritonavir
First (main) randomisation part A [This arm is now closed to recruitment] |
Drug: Lopinavir-Ritonavir
Lopinavir 400mg-Ritonavir 100mg by mouth (or nasogastric tube) every 12 hours for 10 days. |
Active Comparator: Azithromycin
First (main) randomisation part A [This arm is now closed to recruitment] |
Drug: Azithromycin
Azithromycin 500mg by mouth (or nasogastric tube) or intravenously once daily for 10 days. |
Active Comparator: Convalescent plasma
First (main) randomisation part B [This arm is now closed to recruitment] |
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). |
Active Comparator: Tocilizumab
Subsequent randomisation. Participants with progressive COVID-19 (as evidenced by hypoxia and an inflammatory state) may undergo an optional subsequent randomisation between Tocilizumab and no additional treatment. [This arm is now closed to adult recruitment] |
Drug: Tocilizumab
Tocilizumab by intravenous infusion with the dose determined by body weight (see Protocol for dosage) |
Active Comparator: Intravenous Immunoglobulin
First (main) randomisation part A (open to children only)
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Biological: Immunoglobulin
Intravenous immunoglobulin (IVIg) for children >44 weeks gestational age and <18 years with PIMS-TS only (see Protocol for dosage) |
Active Comparator: Synthetic neutralising antibodies
First (main) randomisation part B
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Drug: Synthetic neutralising antibodies
For participants ≥12 years only: 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
Other Name: REGN-COV2 |
Active Comparator: Aspirin
First (main) randomisation part C
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Drug: Aspirin
150 mg by mouth (or nasogastric tube) or per rectum once daily until discharge, for adults ≥18 years old. |
Active Comparator: Colchicine
First (main) randomisation part A
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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 |
Active Comparator: Baricitinib
First (main) randomisation part D
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Drug: Baricitinib
4 mg once daily by mouth or nasogastric tube for 10 days in total |
Active Comparator: Anakinra
Subsequent randomisation for children only with PIMS-TS
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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. |
- All-cause mortality [ Time Frame: Within 28 days after randomisation ]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.
- Duration of hospital stay [ Time Frame: Within 28 days and up to 6 months after the main randomisation ]To assess the effects of study treatment on number of days stay in hospital
- Composite endpoint of death or need for mechanical ventilation or ECMO [ Time Frame: Within 28 days and up to 6 months after the main randomisation ]Among patients not on invasive mechanical ventilation at baseline, the number of patients with a composite endpoint of death or need for invasive mechanical ventilation or ECMO.
- Need for (and duration of) ventilation [ Time Frame: Within 28 days and up to 6 months after the main randomisation ]To assess the effects of study treatment on number of patients who needed any ventilation and (for invasive mechanical ventilation) the number of days it was required
- Need for renal replacement [ Time Frame: Within 28 days and up to 6 months after the main randomisation ]To assess the effects of study treatment on number of patients who needed renal replacement therapy
- Number of patients who had thrombotic events [ Time Frame: Within 28 days and up to 6 months after the main randomisation ]To assess the effects of study treatment on number of patients who had thrombotic events, defined as either (i) acute pulmonary embolism; (ii) deep vein thrombosis; (iii) ischaemic stroke; (iv) myocardial infarction; or (v) systemic arterial embolism.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- (i) Hospitalised
- (ii) SARS-CoV-2 infection (clinically suspected or laboratory confirmed)
- (iii) 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
Exclusion Criteria:
- 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) 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381936
Contact: Richard Haynes | +44 (0)1865 743743 | recoverytrial@ndph.ox.ac.uk |
United Kingdom | |
Nuffield Department of Population Health, University of Oxford | Recruiting |
Oxford, United Kingdom, OX3 7LF | |
Contact: Peter W Horby recoverytrial@ndph.ox.ac.uk | |
Principal Investigator: Peter W Horby |
Principal Investigator: | Peter W Horby | University of Oxford |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Oxford |
ClinicalTrials.gov Identifier: | NCT04381936 |
Other Study ID Numbers: |
NDPHRECOVERY 2020-001113-21 ( EudraCT Number ) ISRCTN50189673 ( Registry Identifier: ISRCTN ) |
First Posted: | May 11, 2020 Key Record Dates |
Last Update Posted: | February 10, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The data-sharing plans for this study have been provided in the Data Sharing Statement in RECOVERY publication: N Engl J Med. 2020 Jul 17;NEJMoa2021436. doi: 10.1056/NEJMoa2021436 |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Access Criteria: | Proposals for substudies must be approved by the Trial Steering Committee. Procedures for accessing the data for this study are available on https://www.ndph.ox.ac.uk/data-access |
URL: | https://www.ndph.ox.ac.uk/data-access |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
COVID-19 SARS-CoV-2 SARS coronavirus 2 SARS |
Severe Acute Respiratory Syndrome Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Aspirin Ritonavir Lopinavir Azithromycin Hydroxychloroquine Colchicine Interleukin 1 Receptor Antagonist Protein |
Antibodies Immunoglobulins Immunoglobulins, Intravenous Immunologic Factors Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |