Randomised Evaluation of COVID-19 Therapy
-
- STATUS
- Recruiting
-
- End date
- Dec 5, 2031
-
- participants needed
- 15000
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- sponsor
- University of Oxford
Summary
RECOVERY is a randomised trial investigating whether treatment with either
Description
The RECOVERY trial has already shown that
BACKGROUND: In early 2020, as this protocol was being developed, there were
ELIGIBILITY AND RANDOMISATION: This protocol describes a randomised trial among patients
hospitalised for
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
OUTCOMES: The main outcomes will be death, discharge, need for ventilation and need for renal
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
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,
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
ADD-ON STUDIES: Particular countries or groups of hospitals, may well want to collaborate in
adding further measurements or
Details
Condition |
Upper respiratory |
---|---|
Age | 100years or below |
Treatment |
|
Clinical Study Identifier | NCT04381936 |
Sponsor | University of Oxford |
Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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