Randomised Evaluation of COVID-19 Therapy (RECOVERY)

January 2, 2024 updated by: University of Oxford

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ghana
      • Kumasi, Ghana
        • Recruiting
        • Kumasi Center for Collaborative Research in Tropical Medicine KNUST
        • Contact:
          • Phone Number: +233 278 364 389
  • India
      • New Delhi, India, ICMR-110029
        • Recruiting
        • Indian Council of Medical Research, Division of Epidemiology and Communicable Diseases
        • Contact:
          • Phone Number: +91 996 840 8999
  • Indonesia
      • Jakarta, Indonesia
        • Recruiting
        • Eijkman Oxford Clinical Research Unit (EOCRU), Eijkman Institute for Molecular Biology
  • Nepal
      • Kathmandu, Nepal
        • Recruiting
        • Clinical Trial Unit, Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Sciences
  • South Africa
      • Johannesburg, South Africa
        • Recruiting
        • Wits Health Consortium
        • Contact:
          • Phone Number: +27 11 274 9200
  • United Kingdom
      • Oxford, United Kingdom, OX3 7LF
        • Recruiting
        • Nuffield Department of Population Health, University of Oxford
        • Contact:
        • Principal Investigator:
          • Peter W Horby
  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Recruiting
        • Oxford University Clinical Research Unit, Centre for Tropical Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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]
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

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
Tocilizumab by intravenous infusion with the dose determined by body weight (see Protocol for dosage)
Active Comparator: Intravenous Immunoglobulin

First (main) randomisation part A (children only)

[This arm is now closed to recruitment]
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.

[This arm is now closed to recruitment]
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
Other Names:
  • REGEN-COV
  • casirivimab and imdevimab
Active Comparator: Aspirin

First (main) randomisation part C

[This arm is now closed to recruitment]
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

[This arm is now closed to recruitment]
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

[This arm is now closed to recruitment]
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.
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]
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.
Active Comparator: Dimethyl fumarate

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

[This arm is now closed to recruitment]
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).
Active Comparator: High Dose Corticosteroids
First (main) randomisation part E
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.
Active Comparator: Sotrovimab
First (main) randomisation part J
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.
Active Comparator: Empagliflozin

First (main) randomisation part F

[This arm is now closed to recruitment]
Drug: Empagliflozin
Adults ≥18 years old only. 10 mg once daily by mouth for 28 days (or until discharge, if earlier).
Active Comparator: Molnupiravir

First (main) randomisation part K

[This arm is now closed to recruitment]
Drug: Molnupiravir
Patients ≥18 years old. 800 mg twice daily for 5 days by mouth.
Active Comparator: Paxlovid

First (main) randomisation part L

[This arm is now closed to recruitment]
Drug: Paxlovid
UK patients ≥18 years old. 300/100 mg twice daily for 5 days by mouth.
Other Names:
  • nirmatrelvir/ritonavir
Active Comparator: Baloxavir marboxil
Randomisation part G (influenza)
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.

Other Names:
  • Xofluza
Active Comparator: Oseltamivir
Randomisation part H (influenza)
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)

Other Names:
  • Tamiflu
Active Comparator: Low-dose corticosteroids: Dexamethasone (influenza arm)
Randomisation part I (influenza)
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)
Active Comparator: Low-dose corticosteroids: Dexamethasone (pneumonia arm)
Randomisation part M (community-acquired pneumonia)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
Time Frame: Within 28 days after randomisation
Within 28 days after randomisation
Influenza co-primary outcome: Time to discharge alive from hospital
Time Frame: Within the first 28-days
Within the first 28-days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 & community-acquired pneumonia: 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
Within 28 days and up to 6 months after the main randomisation
COVID-19 & community-acquired pneumonia: 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.
Within 28 days and up to 6 months after the main randomisation
Influenza: 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.
Within 28 days and up to 6 months after the main randomisation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 28 days and up to 6 months after the main randomisation
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
Within 28 days and up to 6 months after the main randomisation
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.
Within 28 days and up to 6 months after the main randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Bill and Melinda Gates Foundation
Department for International Development, United Kingdom
National Institute for Health Research, United Kingdom
UK Research and Innovation
Wellcome
Health Data Research UK
Medical Research Council Population Health Research Unit
NIHR Clinical Trials Unit Support Funding
NIHR Health Protection Research Unit in Emerging and Zoonotic Infections
Flu Lab

Investigators

  • Principal Investigator: Peter W Horby, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2020

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2036

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NDPHRECOVERY
  • 2020-001113-21 (EudraCT Number)
  • ISRCTN50189673 (Registry Identifier: ISRCTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

RECOVERY data will be made available via the Infectious Diseases Data Observatory (IDDO). Researchers will be able to apply via the IDDO Data Access process - https://www.iddo.org/covid19/data-sharing/accessing-data

IPD Sharing Time Frame

It is anticipated that some datasets will be available by Q1/2024.

IPD Sharing Access Criteria

RECOVERY data will be made available via the Infectious Diseases Data Observatory (IDDO). Researchers will be able to apply via the IDDO Data Access process.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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