From :	Tamar Gabunia <tgabunia@moh.gov.ge>
To :	LYDON, Patrick <lydonp@who.int>; Alisa Tsuladze <atsuladze@moh.gov.ge>; Ekaterine Adamia <eadamia@moh.gov.ge>; MAMULASHVILI, Nino <mamulashvilin@who.int>
Subject :	RE: IMPT: Solidarity Trial Protocol - Revised version 15 (Georgia)
Cc :	HENAO RESTREPO, Ana Maria <henaorestrepoa@who.int>; PREZIOSI, Marie-pierre <preziosim@who.int>; DARA, Masoud <daram@who.int>
Received On :	18.08.2020 08:11
Attachments :	image001.jpg

Dear Patrick

Many thanks for your e-mail and this update. We will proceed as advised and will let you know once approval is finalized.

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

Sincerely,

Tamar Gabunia, MD, MPH

First Deputy Minister

cid:image001.jpg@01D50033.645805C0

From: LYDON, Patrick [mailto:lydonp@who.int]
Sent: 14 August, 2020 15:19
To: Tamar Gabunia ; Alisa Tsuladze ; Ekaterine Adamia ; MAMULASHVILI, Nino
Cc: HENAO RESTREPO, Ana Maria ; PREZIOSI, Marie-pierre ; DARA, Masoud
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