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:

LEPL “SOCIAL SERVICE AGENCY”

#144, TSERETELI AVE.

0159 TBILISI

GEORGIA

b.       Contact person:

Irina Gobejishvili

e-mail: IGobejishvili@ssa.gov.ge

All the best,

Eka

Ekaterine Adamia

Head of Health Care Policy Division

Ministry of IDPs from the Occupied Territories,

Labour, Health and Social Affairs of Georgia

Address: 144, Ak. Tsereteli Ave. Tbilisi 0119

Phone: (032) 5100381110

Mob: (+995) 577282825

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

Dear Colleagues,

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

Kind regards,

Nino

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

Dear Eka,

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

Kind regards, Nino

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

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

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!