What is the available funding for set-up, per patient and close down?

A combined fee of £279 per patient to cover all costs. If your sites finance requires a more broken-down payment structure, we can make the necessary adjustments.

Is your PANTHER Launch video available to watch?

Yes, please see here.

Will the study be providing the Baricitinib?

No, we will be using ward level stock and managing the costs through the excess treatment costs pathway.

Is there a timeframe that we must randomise the patients?

Yes, within 48hrs of ARDS diagnosis but we encourage you to randomise patients as soon as possible.

Will PANTHER be linked with the API scheme?

Yes

Will we all have access to a “master” eISF, or dependant on amendment? Will we gain access to the updated documents once an amendment goes through at our site?

Your site will have access to a personal eISF once activated. The trial master file will be maintained by the sponsor team. When an amendment is approved, we will have this sent through to your sites eISF inbox for review and you will file it away.

Will there be access to the eISF for the duration of the archiving period please?

Yes

What eISF does PANTHER use?

PANTHER will be using Florence as our electronic ISF, there will be no need to print an eISF.

Which device is being used?

PANTHER will be using the Randox Evidence MultiSTAT device.

What are the dimensions of the device?

585 (H) x 535 (D) x 570 (W) mm

What samples need to be taken?

Only the initial blood sample for the stratification of patients into their subphenotypes is compulsory. The rest are optional, please see the sampling guide for further information.

Will Baricitinib be provided by the sponsor?

No, this will be hospital stock, the costs can be recovered via the excess treatment costs pathway.

How long should Baricitinib be given?

10 Days or until ICU discharge.

Will Simvastatin be provided by the sponsor?

No, this will be hospital stock

How long should Simvastatin be given?

28 Days or until ICU discharge.

Who completes the day 180 follow up calls with the patients?

The central team will complete all follow up calls. Sites are only required to confirm survival status at these time points.

Can ACCPs confirm eligibility?

Yes, they can, but they would need to be listed on the delegation log, as this study is a CTIMP medical oversight is required.

Do clinicians who are confirming eligibility need to be on the delegation log?

Yes, clinicians confirming eligibility should be listed.

Is deferred consent approved for this study?

Yes, if a patient lacks capacity the deferred consent model can be applied. Please speak to next of kin first if possible. Always seek retrospective consent once the patient regains capacity.

Can anyone obtain consent if they are delegated to do so on the delegation log?

Yes, if the PI has delegated the responsibility of taking consent to a doctor or nurse either can obtain consent as long as they are appropriately trained.

Do all pharmacists need GCP or just pharmacists within the clinical trials team set up?

Only those dealing with the drug supply for the trial, the research pharmacist. Other clinical pharmacists in the hospital or ICU do not.

Who can prescribe PANTHER treatments?

Any clinician whose role includes prescribing can prescribe drugs for the trial. They do not need to be listed on the delegation log or GCP trained. However, the study pharmacist, who must be GCP trained and listed on the delegation log will oversee the prescribing for the study.

Do pharmacists need to be GCP trained?

The study (research) pharmacist listed on the delegation log need to be GCP trained. Clinical pharmacists on the wards / ICU do not.