Subject: Re: Questions related to country inclusion in Solidarity Trial
From: Tamar Gabunia </O=EXCHORGANIZATION/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=E6CA04F38EC94D0CADAB9CBDF90FCDDE-TAMAR G>
To: MAMULASHVILI, Nino <[email-masked]>; Anzor tchavtchavadze </o=ExchOrganization/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=0e03f3df18104f3b8b06b0400c558fbf-Anzor t>; [email-masked]
Cc: Ekaterine Adamia </o=ExchOrganization/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=89b4d31758d34f2cbdcfe688199f6941-Ekateri>; DOMENTE, Silviu <[email-masked]>
Date: Tue, 07 Apr 2020 03:47:08 +0000

​Dear Nino

Many thanks for facilitating this process. It is really important for us to join the Solidarity trial initiative. Hopefully inclusion process will go smoothly.

Best

Tamar

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

Sent: Monday, April 6, 2020 9:29 PM

To: Anzor tchavtchavadze; [email-masked]'

Cc: Tamar Gabunia; Ekaterine Adamia; DOMENTE, Silviu

Subject: FW: Questions related to country inclusion in Solidarity Trial

Dear Colleagues,

Please find enclosed some clarifications provided from Masoud Dara on response to two questions raised during today
Clinical Advisory Group meeting at the MoH.

Kind regards, Nino

From: DARA, Masoud

Sent: Monday, April 6, 2020 21:16

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

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

Subject: RE: Questions related to country inclusion in Solidarity Trial

Dear Nino,

Thank you for discussing Solidarity with MoH and the national experts. We are planning to organize an additional session for EURO countries, which we could also  discuss the details with them.

Please find response below:

Thanks and regards,

Masoud

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

Sent: Monday, April 6, 2020 4:58 PM

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

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

Subject: Questions related to country inclusion in Solidarity Trial

Importance: High

Dear Masoud,

Please be informed that today I was asked by the Deputy Minister, Tamar Gabunia, to join the video call during the Clinical Advisory Group meeting that took place at the Ministry.

I have provided information on Solidarity Trial details, followed by questions from the Group members.

I am forwarding you two questions we would like to have WHO clarification on:

If country will be allowed in the process of trial to choose medications for hospitalized patients, or it is purely done randomly and the clinician can’t control the process. Or any modification could be possible in
this regard. Is it obligatory to participate in all four arms of the trial?

MD: As elaborated in the study protocol, it will be 1:1:1:1:1 randomization, this is to increase the credibility of the findings (randomized Clinical Trial). The randomization will happen automatically for all eligible
patients based on the mentioned criteria. We propose to have all four arms compared to the standard of care, however should there be concerns or suggestions, we could discuss them with the MoH and appointed principal investigator(s).

What about providing by WHO medications- is it upon country request, for example Remdesivir seems to be the best option for Georgia, or all medications will be provided, regardless their availability in the country.

MD: Medicine will be provided based on the country needs. If Kaletra or other medicines with quality assurance would be available in the country, we would not need to arrange their shipment to Georgia.

Looking forward to hearing soon from you.

Kind regards, Nino

__________________________________

Dr. Nino Mamulashvili

Program Coordinator

WHO Country Office Georgia

Office location: 81 Vasil Barnov Street, 0179 Tbilisi, Georgia

Mailing address: UN House, 9 Rapiel Eristavi Street, 0179 Tbilisi, Georgia

Mobile: +995 599 567 244

E-mail:
[email-masked]

GPN: 74212