FAQ

Without good evidence to guide the use of oseltamivir and steroids, clinical practice varies widely between different countries, hospitals, and clinicians, and so RECOVERY eligibility follows the ‘Uncertainty Principle’.

The protocol allows wide range of patients to join, but we know some clinicians may have strong views on which kinds of patient they are willing to recruit (e.g. some might give steroids to all severe CAP patients, or oseltamivir to all flu patients if symptom onset was less than 48 hours ago). 

For each treatment comparison:

• If the responsible clinician is reasonably certain that the treatment should, or should not, be given (or if they feel they must follow local guidelines that specify this) then the patient is not eligible for that treatment comparison
• If the responsible clinician is substantially uncertain about giving the trial treatment (whether or not they would usually give it in their normal practice) and they would be happy to follow a random allocation, the patient is potentially eligible.

This means the kind of patients recruited at each site will vary, but when each comparison ends we will explore which (if any) kinds of patients benefit in prespecified subgroup analyses (e.g. based on severity, symptom duration, immunosuppression).

All specific contraindications are listed in Appendix 2 of the latest protocol version. Outside of these contraindications, the responsible clinical team makes the final decision about treatment appropriateness.

If the responsible clinical team think that a specific treatment should be given, then the patient should receive the treatment, and they are ineligible for that comparison. However, this does not make them ineligible for any other treatment comparisons (e.g. a patient who is given oseltamivir as part of usual care may still be eligible for the dexamethasone comparison).

They can join other studies (including CTIMPs) provided the protocols do not conflict. Please email the trial team if you need clarification about a specific study.

There is no way of correcting this. The patient should continue with usual care and not be given the study drug. The follow-up form captures if the patient received the study drug they were allocated and for how long.

Please inform the trial team of the details of the incorrect data by emailing recovery@ecraid.eu 

Any site staff who the principal investigator is satisfied has the necessary training and experience may receive informed consent as long as they have also completed the trial-specific consent training (available on the training page) and completed a 'confirmation of training' form to that effect. This could include clinical staff as well as research staff.

No. Deferred consent is not possible in RECOVERY.

Use a clinical interpretation service (e.g. telephone interpretation) to provide translation of the SIS & ICF and to help answer any questions. Do not rely on family or friends to act as interpreters. Please document in the medical notes how the consent discussion was conducted.

Treatment will be prescribed and administered by hospital staff in the same way as for non-trial medications. Any suitably qualified member of staff can prescribe the trial treatment(s).

Treatments should ideally be stopped after the duration specified in the protocol. Continuation beyond this would be outside the trial, but the managing doctor is free to do what they think is best for the patient (and if they decided to continue a trial treatment it would not constitute a protocol deviation). 

Please resume study treatment if it is clinically appropriate to do so, but do not extend the original treatment end date (and if this has already passed do not resume treatment).

The treatment the participant received should just be recorded on the follow-up form. It is not a protocol violation. If this happens too often it will seriously harm the trial, so staff should avoid recruiting patients to a treatment comparison if they are likely to receive that treatment regardless of allocation (although this will inevitably happen sometimes). This is monitored centrally, and the coordinating office will investigate if adherence to treatment allocation is consistently poor.

No – the trial protocol was designed to be pragmatic and streamlined, and so any monitoring is at the discretion of the clinical team caring for the patient. We record some blood test results on the follow-up form if they are available, but they do not need to be performed for the purpose of the trial (if they were not performed, tick ‘not done’).

Please clarify which of the following kinds of withdrawal they would like:

• stopping study medication, but willing to continue follow up (including possible phone call)
• no further contact from trial staff, but willing to have follow-up information collected from medical records
• stopping all trial procedures with no further follow up.

Please email recoverytrial@ecraid.eu with their study ID and their final decision.

Participants may be transferred for two reasons

1. Transfers for ongoing medical care in another acute hospital.
2. Transfers for rehabilitation once the acute phase of treatment is over.

Ongoing medical care

This transfer would not be considered a discharge. If possible try to make contact with a clinician at the receiving hospital in order to complete the 28-day follow up form. If this is not possible consider whether you can contact the patient or a relative to obtain the necessary information.

Rehabilitation

For the purposes of RECOVERY, this would be considered discharge from acute care so the study treatment should be stopped on transfer. The 28-day follow-up form can be completed on day 28 as if they had been discharged home.