Dear Tamar, Alisa, Ekaterine, and Nino,

We recently received additional information on Acalabrutinib from Astra Zeneca relating to nasogastric (NG) administration for patients who cannot be administered the treatment orally. This new information on Acalabrutinib required us to make some minor changes to the SOPs in the sections on administration of treatments. However, no changes to the protocol itself were needed nor the summary changes document. Attached you will find a V.16 of the SOP and appendixes. If you have specific queries related to the documents or technical questions on its content, please address these directly to Vasee (moorthyv@who.int) who will be the point person to respond.

All the very best

Patrick

From: LYDON, Patrick
Sent: 14 August 2020 13:19
To: tgabunia@moh.gov.ge; atsuladze@moh.gov.ge; eadamia@moh.gov.ge; MAMULASHVILI, Nino
Cc: Ana Maria HENAO RESTREPO ; PREZIOSI, Marie-pierre ; Dara Masoud (daram@who.int)
Subject: IMPT: Solidarity Trial Protocol - Revised version 15 (Georgia)
Importance: High

Dear Tamar, Alisa, Ekaterine, and Nino,

We hope you and your teams are doing well; staying safe; yet managing to get some time off during the summer to recharge and spend with family.

You’ve been incredibly patient with us over the past month during which the three co-leads and team have been working intensively on a revised version of the Solidarity Trial therapeutics protocol. Beyond the lengthy process to get approval of the revisions by our WHO Ethics Review Committee (ERC), we wanted to make sure that in addition to dropping the CQ/HCQ and L / R trial arms (to focus on Remdesivir and Interferon) that we also include an additional treatment arm for a immunomodulator (Acalabrutinib).

We are pleased, however, to let you know that this process is now complete and that we can finally share with you the revised Protocol. Attached you will find version 15 and its accompanying SOPs and Appendixes. In addition, the third document provides the detail of the changes made to the protocol between version 10 and the new version 15. This will help you understand specifically what has been revised between both protocol versions.

It is important that in submitting these for national regulatory and ethics approval that you submit all three documents.

Let us know if you have any further questions.

In the meantime, we wish you a nice weekend.

All the very best

Patrick (on behalf of the WHO Secretariat)

_______________________________________________________________________________
Patrick Lydon

Research & Development Blueprint Unit – World Health Emergencies (WHE/HEO)

Promote health, keep the world safe, and serve the vulnerable

From :	LYDON, Patrick <lydonp@who.int>
To :	M Georgia <tgabunia@moh.gov.ge>; atsuladze@moh.gov.ge; eadamia@moh.gov.ge; MAMULASHVILI, Nino <mamulashvilin@who.int>
Subject :	RE: IMPT: Solidarity Trial Protocol - CORRIGENDUM (Georgia)
Received On :	24.08.2020 11:59
Attachments :	smime.p7m