FOI release

Freedom of Information request (FOI 22/882)

Published 17 January 2024

© Crown copyright 2024

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.

Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.

This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-29-august-2022/freedom-of-information-request-foi-22882

FOI 22/882

4th September 2022

Dear

Thank you for your email.

Emergency use authorisation does not apply to clinical trials. The submission and approval process for all clinical trial authorisation (CTA) applications involving investigational medicinal products, including COVID-19 clinical trials, is detailed on the MHRA website.

Information on the interventions authorised for investigation in the ‘HEAL-COVID’ and ‘STIMULATE-ICP’ clinical trials is publicly available on the ISRCTN registry:

  1. HEAL-COVID - ISRCTN - ISRCTN15851697: Helping alleviate the longer-term consequences of COVID-19. Atorvastatin and apixaban are authorised for use in the HEAL-COVID clinical trial. No application has been made by the trial sponsor to include metformin in this trial.
  2. STIMULATE-ICP - ISRCTN - ISRCTN10665760: Symptoms, trajectory, inequalities and management: understanding Long COVID to address and transform existing integrated care pathways. Famotidine, loratadine, rivaroxaban and colchicine are all authorised for use in the STIMULATE-ICP clinical trial.

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Experience Centre

Back to top