Subject: Re: Georgia - Solidarity Trial (Next Steps)
From: Tamar Gabunia </O=EXCHORGANIZATION/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=E6CA04F38EC94D0CADAB9CBDF90FCDDE-TAMAR G>
To: Alisa Tsuladze </o=ExchOrganization/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=6c6cfa06d9a74264a5aa512b6bc62306-Alisa T>
Cc: Ekaterine Adamia </o=ExchOrganization/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=89b4d31758d34f2cbdcfe688199f6941-Ekateri>; Anzor tchavtchavadze </o=ExchOrganization/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=0e03f3df18104f3b8b06b0400c558fbf-Anzor t>
Date: Fri, 15 May 2020 15:51:13 +0000

მადლობაა!

Sent from my Samsung Galaxy smartphone.

-------- Original message --------

From: Alisa Tsuladze <[email-masked]>

Date: 5/15/20 7:49 PM (GMT+04:00)

To: Tamar Gabunia <[email-masked]>

Cc: Ekaterine Adamia <[email-masked]>, Anzor tchavtchavadze <[email-masked]>

Subject: Re: Georgia - Solidarity Trial (Next Steps)

ქალბატონო თამარ, გააგზავნა ეკამ უკვე! მადლობა

Sent from my iPhone

On May 15, 2020, at 19:48, Tamar Gabunia <[email-masked]> wrote:

მადლობა ალისა. კარგია შინაარსი და გაუგზავნე უკვე. მე ჩამსვი ასლში და ეკა და ყველა ვისაც ვსვამთ.

Sent from my Samsung Galaxy smartphone.

-------- Original message --------

From: Alisa Tsuladze <[email-masked]>

Date: 5/15/20 6:36 PM (GMT+04:00)

To: Ekaterine Adamia <[email-masked]>

Cc: Anzor tchavtchavadze <[email-masked]>, Tamar Gabunia <[email-masked]>

Subject: FW: Georgia - Solidarity Trial (Next Steps)

Patrick Lydon-ის იმეილზე პასუხად:

Dear Patrick,

Our actions regarding the next steps are as follows:

1.
Attached is the list of all relevant principle investigators and clinicians involved in the trial; Please, let us know if all the necessary information is provided.  As for the
date for the training - preferably early next week. Any time slot after 12 PM (CET) would be suitable for everyone.

2.
After consultations with the PIs we agreed upon the following medications:

a.
Remdesivir

b.
Lopinavir/Ritonavir (oral, tablets)

c.
Interferon beta-1a (44ug) (subcutaneous)

d.
Hydroxychloroquine sulphate

3.
For the shipment:

a.
The
cosignee:

30008873 - LEPL “SOCIAL SERVICE AGENCY”

#144, TSERETELI AVE.

0159 TBILISI

GEORGIA

b.
Contact person:

Irina Gobejishvili

e-mail:
[email-masked]

სოც. მომსახურებაში საკონტაქტო პირი დასაზუსტებელია, როგორც მივხვდი და ველოდებით მოხსენებით ბარათს?

პატივისცემით,

ალისა წულაძე

From: Ekaterine Adamia

Sent: Wednesday, May 13, 2020 3:03 PM

To: Alisa Tsuladze; Anzor tchavtchavadze

Subject: FW: Georgia - Solidarity Trial (Next Steps)

From: LYDON, Patrick <[email-masked]>

Sent: 13 May, 2020 14:57

To: MAMULASHVILI, Nino <[email-masked]>; DOMENTE, Silviu <[email-masked]>; Tamar Gabunia <[email-masked]>; Ekaterine
Adamia <[email-masked]>; DARA, Masoud <[email-masked]>; HENAO RESTREPO, Ana Maria <[email-masked]>; PREZIOSI, Marie-pierre <[email-masked]>;
SATHIYAMOORTHY, Vaseeharan <[email-masked]>; KONE, Souleymane <[email-masked]>

Subject: Georgia - Solidarity Trial (Next Steps)

Dear Nino,

Congratulations on getting this far. This is great news.

In terms of next steps, we suggest:

First, to organize a web-demo / training with all hospital clinicians and others on the data
and randomization system. It takes about 1 hours. If this is agreeable, we would need to decide on a suitable day/time and to have the names and contact details for all relevant principle investigators to invite. I realize you have sent this already but it
is easiest for us if the information is enter in the attached Excel file also specifying the type of access rights to the randomization and data system. The cells to complete are highlighted in yellow. In addition, we attached other relevant documents related
to the data and randomization system. Everything is web-based / electronic with the exception of the ICF.

Second, we need to plan for shipping the trial drugs to Georgia. Apologies if you have already
sent this to me but could you provide me with the list of the 4 trial drugs you need WHO to provide for the trials. In addition, could you indicated provide us with an address where to send these along with the name and contact details of the consignee? In
the meantime, the second excel file attached has some information on the products and presentations.

Look forward to hearing back from you.

All the best

Patrick

From: MAMULASHVILI, Nino

Sent: 11 May 2020 08:49

To: DARA, Masoud <[email-masked]>; LYDON, Patrick <[email-masked]>

Cc: DOMENTE, Silviu <[email-masked]>;
[email-masked]; Ekaterine Adamia ([email-masked]) <[email-masked]>

Subject: FW: [EXT] SOLIDARITY Protocol signature

Dear Colleagues,

Please find attached English translation of NRA and Bioethics Council clearance documents, along with Georgian original versions.

Kind regards,

Nino

From: Ekaterine Adamia <[email-masked]>

Sent: Friday, May 8, 2020 19:40

To: DARA, Masoud <[email-masked]>

Cc: Tamar Gabunia <[email-masked]>; DOMENTE, Silviu <[email-masked]>;
MAMULASHVILI, Nino <[email-masked]>; Alisa Tsuladze <[email-masked]>;
Anzor tchavtchavadze <[email-masked]>

Subject: RE: [EXT] SOLIDARITY Protocol signature

Dear  Dr.Dara ,

I’m happy to inform you that Georgia has obtained clearance from both national ethical comity and NRA and we are ready to move to next step.

I’m sending both documents attached to this email, they are both in Georgian right now but we can provide translation if necessary.

Thanks and regards,

Eka

From: MAMULASHVILI, Nino <[email-masked]>

Sent: 1 May, 2020 16:01

To: Ekaterine Adamia <[email-masked]>

Cc: Tamar Gabunia <[email-masked]>; DOMENTE, Silviu <[email-masked]>

Subject: FW: [EXT] SOLIDARITY Protocol signature

Dear Eka,

Can you please send to me the NRA and Ethical Committee clearance documents, as per email from Masoud (enclosed).

Kind regards, Nino

From: DARA, Masoud

Sent: Friday, May 1, 2020 15:52

To: MAMULASHVILI, Nino <[email-masked]>

Cc: LYDON, Patrick <[email-masked]>; DOMENTE, Silviu <[email-masked]>

Subject: RE: [EXT] SOLIDARITY Protocol signature

Dear Nino,

Please also send us the NRA and Ethical Committee clearance (fine to be in Georgian) with informal translation for our record.

Thanks and regards,

Masoud

From: MAMULASHVILI, Nino <[email-masked]>

Sent: Thursday, April 30, 2020 9:56 AM

To: DARA, Masoud <[email-masked]>

Cc: LYDON, Patrick <[email-masked]>; DOMENTE, Silviu <[email-masked]>

Subject: FW: [EXT] SOLIDARITY Protocol signature

Dear Masoud,

Please find attached signed from the MoIDP&LHSA of Georgia the Solidarity Trial Protocol page.

Hopefully other requested information from the Ministry will follow shortly.

Kind regards,

Nino

From: Alisa Tsuladze <[email-masked]>

Sent: Thursday, April 30, 2020 11:06

To: MAMULASHVILI, Nino <[email-masked]>

Cc: Ekaterine Adamia <[email-masked]>; DOMENTE, Silviu <[email-masked]>

Subject: [EXT] SOLIDARITY Protocol signature

Hello dear Nino, hope you are doing well!

Please see attached signed protocol (page 2) by Ekaterine Adamia, the representative of the MoH for the trial;

​

Will be waiting for your representative's signature;

Thanks a lot for your kind support!

პატივისცემით,

ალისა წულაძე

Best regards,

Alisa Tsuladze

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