Staff Resources

Information and news for staff working on HEAL-COVID

Information

We will invite patients who have been admitted to hospital with COVID-19 to take part in HEAL-COVID. Patients will be asked if they would like to take part shortly before they are discharged home, and will be randomly allocated to receive:

  • Apixaban, an anti-coagulant or “blood thinner”, twice a day for 2 weeks or
  • Atorvastatin, a statin with anti-inflammatory properties, once a day for 12 months or
  • The usual standard care offered by their hospital, as appropriate to their symptoms and conditions.

HEAL-COVID participants will be invited to complete follow-up surveys. This is optional. Surveys can be completed via an app on a smartphone or tablet, or over the phone with a Research Nurse. The surveys will be sent no more frequently than once a week, and include questions relating to symptoms, quality of life, resource use and experience of participating in research.

While the main objective of the trial is to find out if the treatments used are effective, and help improve care for COVID-19 patients in the future, we will also use data from the study to investigate whether the treatments are cost-effective.

Once your site have confirmed that you would like to be involved in HEAL-COVID, you will be provided with log-in details to access the researcher area, containing training materials and access to the randomisation system.

Before you receive these, please feel free to read through the Frequently Asked Questions below, or to get in touch if you cannot find the information you need.

NHS England and Improvement and the Devolved Nations support all UK approved platform studies. For the HEAL-COVID trial and the provision of apixaban and atorvastatin, use in Secondary Care is considered in tariff and no further reimbursement is required. For ongoing prescribing of atorvastatin, logistics are still to be agreed, but costs will be picked up via normal BAU systems.

Site Set-up

How can I see the study protocol?

The study protocol is publicly available here.

When will I receive the study documents?

You should receive the local document pack after you have expressed interest in participating in HEAL-COVID. This will be sent to the proposed PI and the R&D contact, with other contacts (e.g. co-investigators, research nurses) copied in if we have been given contact details.

If your site have expressed interest but you do not have access to the local document pack, please email us at trial.team@heal-covid.net.

What type of sites can take part in HEAL-COVID?

Any hospital in the UK that treats, or may treat, COVID-19 patients can take part in HEAL-COVID. We are keen to have as many NHS sites participating as possible.

Can we still open HEAL-COVID even if we have few or no COVID-19 patients at the moment?

Yes, we wish to be prepared for any potential future increase in COVID-19 admissions.

What do you need from our hospital in order for us to open?

In order to give you the “Green Light” to open to recruitment we will need you to provide us with:

  • A named PI for each site within the trust
  • A Good Clinical Practice (GCP) certificate for the PI only
  • Site staff to have completed self-directed online study training
  • Signed Organisation Information Document (OID)

Signed Site Agreement (this is the model Non-Commercial Agreement and there is no scope for negotiation of terms)

How will I get my log-in details for the researcher area?

Once we have confirmation that your hospital is very likely to take part in HEAL-COVID we will generate log-in details for your site. These will be sent to the proposed PI, who will change the password and share the log-in details with the team supporting the study so that they can complete the training and view the documentation.

Log-in details are provided per site, not for each individual. PIs are responsible for ensuring that these log-in details are shared only with those who will be working on HEAL-COVID.

Will we have a training or initiation visit?

No, all our training materials are shared on the study website, to be completed at your convenience. You will need to complete the training as is relevant to your role on the study (e.g. if you will be randomising patients you must complete the randomisation training, if you will be taking consent you must complete the consent training). The HEAL-COVID training covers the core principles of GCP, as relevant to the study.

We will not be conducting initiation visits, you will be initiated remotely once the minimum criteria have been met (“Green Light”).

Running HEAL-COVID

Can we co-enrol patients in HEAL-COVID on other studies?

HEAL-COVID patients can be co-enrolled with the following studies:

  • RECOVERY
  • REMAP-CAP
  • PHOSP-C
  • ISARIC CCP-UK

Co-enrolment with other interventional studies requires agreement from both study teams. If you have interventional studies running at your site that might be recruiting the same patient group and you wish to consider co-enrolment, please get in touch.

Can I work on HEAL-COVID at more than one hospital within the same trust?

Yes, if you work across multiple hospitals within one trust you can work on HEAL-COVID at all of these, as long as the local PI at each site is aware. You will need to complete the training record at each site separately, and ensure that you use the correct site log-in details for the site you are working at.

Can we recruit patients to HEAL-COVID who have already been discharged from hospital?

At present we can only recruit patients to HEAL-COVID at the end of their inpatient admission (in the 5 days before they are expected to be discharged). We are exploring the possibility of recruiting patients who have been previously hospitalised later, in the community post-discharge. If this is safe and feasible for future arms of the study, the protocol will be amended and community care teams will be approached for involvement.

How can I get in touch with the HEAL-COVID team?

Please email us at trial.team@heal-covid.net and we will get back to you ASAP. You can also check the study Twitter feed for updates about study progress, @heal_covid.

Documents

PDF files should open in your browser, if your browser supports that. Microsoft Word documents will be downloaded.

012 294861 Pharmacy Assurance Technical Review Form Final 22.02.2021
015 HEAL COVID Website Data Processing Statement V3.0 20210406
294861 Favourable Opinion On Further Information 07042021 Reissued
294861 Letter Of HRA Approval 07042021 Reissued
CTA Acceptance Of Amended Request
HEAL COVID Adult Participant Information Sheet And Consent Form V3.0 20210406
HEAL COVID Irasform Submitted 20210318 (REDACTED FOR WEBSITE)
HEAL COVID Personal Legal Rep Information Sheet And Consent Form V3.0 20210406
HEAL COVID Professional Legal Rep Information Sheet And Consent Form V3.0 20210406
Study Protocol

Help and Support

Getting in contact with us

If you need to contact us for any help or assistance then use the following: trial.team@heal-covid.net