CTAG: Antiviral Agents

Download the Position Statement

(v5.0; 15 October 2020)

Key messages

  • Remdesivir (NHS stock) is in limited supply and should only be offered to patients who meet all the ‘eligibility criteria’ and ‘additional criteria’ as outlined in the UK interim Clinical Commissioning Policy for remdesvir
  • Co-administration of dexmathasone or hydrocortisone is recommended for patients with critical or severe COVID-19, or those requiring  supplemental oxygen to maintain target saturation – see CTAG treatment pathway   
  • Hospitals managing COVID-19 cases should make every effort to enrol COVID-19 patients in national priority clinical trials
  • Suspected side effects to medicines used in coronavirus treatment should be reported via the Yellow Card COVID-19 reporting site: https://coronavirus-yellowcard.mhra.gov.uk/

Provenance

CTAG acts as a formal advisory group to the Royal College of Physicians and this position statement is endorsed by:

The CTAG Antivirals subgroup originally involved Infectious Diseases and Virology specialists from the High Consequence Infectious Diseases (HCID) Network, and subsequently expanded to include multidisciplinary representation from non-HCID NHS Providers.


Archives

Date publishedVersionAmendment
23 March 20201.0New document
23 Mar 20201.1Updated Gilead remdesivir Compassionate Use Programme eligibility criteria
27 March 20201.2Added NHS England and NHS Improvement speciality guide for patient management. Added MHRA advice on chloroquine and hydroxychloroquine. Added hydroxychloroquine arm of RECOVERY study; added link to NIHR website.
01 April 20202.0Updated evidence summaries in Appendix 1 (new trials for lopinavir/ritonavir and chloroquine). Merged ‘Position statement’ and ‘Decision Support Tool’ into a single document. Updated Section 3 with new trials. Updated Figure 1 with relationship between RECOVERY and PRINCIPLE/REMAP-CAP.
07 April 20202.1 Updated title to reflect updated scope (antiviral use in hospitals). Updated Section 2, 3 and Figure 1 with new trials and trial status. Included reference to CMO letter. Reformatting throughout. Added BIA and UKCPA-PIN logos (with permission).
08 April 20202.2Updated membership & provenance. Corrected typo (2.5).
18 April 20202.3Updated arms of RECOVERY study. Provided additional information for Gilead remdesivir Compassionate Use Programme. Updated references and web links. Updated evidence summaries in Appendix 1. Added azithromycin and inhaled interferon tables to Appendix 1.
01 May 20202.4Addition of ‘Key messages’ and ‘Abbreviations’. Emphasised importance of avoiding off-label use of investigational antivirals. Added reference to ‘CTAG: Position Statement on the use of investigational immunomodulatory agents for COVID-19 in adults’. Format change to clinical trials tables. Change SNG016 and COPCOV from ‘proposed’ to ‘active’. Added GenOMICC study. Updated evidence summaries in Appendix 1 (remdesivir; nebulised interferon; added EMA statement for chloroquine/hydroxychloroquine).
22 May 20202.5 Included reference to CMO letter and COVID-19 Yellow Card reporting. Updated
evidence summaries in Appendix 1 (interferon). Updated support for patients
diagnosed with COVID-19 whilst receiving investigative prophylactic treatment.
Removed reference to GenOMICC as out of scope. Updated RECOVERY eligibility
criteria to include paediatrics. Changed COPCOV from chloroquine to
hydroxychloroquine. Changed CROWN CORONATION from hydroxychloroquine to
chloroquine. Removed DisCoVeRy from Table 2.
06 June 20203.0Included unlicensed remdesivir EAMS scheme and NHS implementation plan for that scheme; updated Section 2 accordingly and added a new monograph (Section 5). Moved studies ACTT-1, 5773, 5774 and SNG016 into a new ‘Closed to recruitment’ table. Updated evidence summaries in Appendix 1 (remdesivir; chloroquine/hydroxychloroquine).
12 June 20203.1Updated NHS implementation plan for EAMS. Updated evidence summaries in Appendix 1 (remdesivir; chloroquine/hydroxychloroquine).
29 June 20203.2Made reference to RECOVERY dexamethasone results. Added CTAG advice on the use of remdesivir. Updated arms of PRICIPLE study. Updated evidence summaries in Appendix 1 (systemic interferon; convalescent plasma).
03 July 20203.3Moved ACCORD-2 to ‘Active studies’ table. Added discontinued arms of RECOVERY to ‘Closed to recruitment’ table. Updated evidence summaries in Appendix 1 (lopinavir/ritonavir).
10 July 20204.0 Updated with information on conditional marketing authorisation for remdesivir; EAMS programme lapsed so references removed.
18 August 20204.1 Reformatting throughout. Updated evidence summaries in Appendix 1
(chloroquine / hydroxychloroquine, azithromycin, interferon (nebulised),
convalescent plasma).