From : MAMULASHVILI, Nino <mamulashvilin@who.int>
To : Alisa Tsuladze <atsuladze@moh.gov.ge>
Subject : RE: [EXT] Re: IMPT: Solidarity Trial Protocol - Revised version 15 (Georgia)
Cc : Ekaterine Adamia <eadamia@moh.gov.ge>; M Georgia <tgabunia@moh.gov.ge>; Akaki Abutidze (akakiabutidze@yahoo.com) <akakiabutidze@yahoo.com>
Received On : 28.08.2020 17:50
Attachments :

Dear Alisa,

 

Please find attached Georgian translations of the updated Solidarity Trial Protocol -V15 and SOPs-V16 (including Informed Consent Form).

 

Kind regards,

Nino

 

From: Alisa Tsuladze
Sent: Tuesday, August 18, 2020 12:37
To: MAMULASHVILI, Nino
Cc: Ekaterine Adamia ; M Georgia
Subject: [EXT] Re: IMPT: Solidarity Trial Protocol - Revised version 15 (Georgia)

 

​Dear Nino,

 

We would like to ask for a favor once again concerning the Solidarity Trial; Would WHO Georgia office be able to support us in translation of:

 

1. The updated protocol 

2. SoP 

3. The document of changes (v10 vs v15)

 

Please let us know if that is possible so that we proceed with other necessary actions for the ethical and regulatory approval.

 

Thank you in advance!

 

პატივისცემით,

ალისა წულაძე

 

ჯანმრთელობის დაცვის პოლიტიკის სამმართველო

პოლიტიკის დეპარტამენტი

საქართველოს ოკუპირებული ტერიტორიებიდან დევნილთა,

შრომის, ჯანმრთელობისა და სოციალური დაცვის სამინისტრო

 

+995-32-2-51-00-26  ext 1125

 

Best regards,

Alisa Tsuladze, MPH

 

Health Policy Division

Policy Department 

Ministry of Internally Displaced persons from 

Occupied Territories, Labor, Health and Social Affairs of Georgia

 

From: LYDON, Patrick <lydonp@who.int>
Sent: Friday, August 14, 2020 3:19 PM
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)

 

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)

World Health Organization | 20 Avenue Appia | CH-1211 Geneva 27 Switzerland | Office: M1156
*: lydonp@who.int |(:office +41.22.791.4238 |(:mobile +41.79.475.5550 |(:skype: patricklydon

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