Subject: Information on SOLIDARITY trial medications
From: Alisa Tsuladze <[email-masked]>
To: Patrick <[email-masked]>, Vaseeharan <[email-masked]>
Cc: solidaritytrials <[email-masked]>, Tamar Gabunia <[email-masked]>, Ekaterine Adamia <[email-masked]>, Alisa Tsuladze <[email-masked]>
Date: Fri, 02 Oct 2020 12:45:08 +0000

Dear Patrick, dear Dr. Vasee,
hope this email finds you well!

I wanted to double check if you
have any updates on Remdesivir shipment and also kindly ask to provide the
information on the manufacturer of Acalabrutinib as our NRA needs this to add
this medication to the list of registered drugs.

We will hopefully have the
requested documents by the end of next week.

I apologize for using my non-work email for technical reasons and I'm copying the previous correspondence in the email.

Thank you for your kind support!

Respectfully,

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
[mailto:[email-masked]]

Sent: Tuesday, September 15, 2020 1:10 PM

To: DARA, Masoud; Tengiz Tsertsvadze; SATHIYAMOORTHY, Vaseeharan

Cc: solidaritytrials; Tamar Gabunia; Ekaterine Adamia; Alisa Tsuladze

Subject: RE: [EXT] Solidarity trial

Dear Prof
Tsertsvadze,

Thank you
for your message. I’m including Dr Vasee on this exchange in order to clarify
the situation on Remdesivir for Georgia.

For
Acalabrutinib, we need to have the assurance that you have gotten both ethics
and regulatory approvals of the revised protocol (V.15). Can you share these
documents with us?

All the very best

Patrick

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

Sent: 14 September 2020 20:00

To: Tengiz Tsertsvadze <[email-masked]>

Cc: LYDON, Patrick <[email-masked]>; solidaritytrials
<[email-masked]>; M Georgia <[email-masked]>;
Ekaterine Adamia <[email-masked]>; Alisa Tsuladze
<[email-masked]>

Subject: RE: [EXT] Solidarity trial

Dear professor Tsertsvadze,

Thank you for you message. I am doing fine. I hope you and
colleagues in Georgia are also doing fine in these trying times. Supply of
medicines under Solidarity trial is led by our headquarters colleagues. Mr
Lydon copied here can kindly add.

Thanks and regards,

Masoud

Dr Masoud Dara

Coordinator, Communicable Diseases

Division of Country Health Programmes

World Health Organization Regional Office for Europe

UN City, Marmorvej 51, 2100 Copenhagen, Denmark

Email: [email-masked] | Website: www.euro.who.int

From: Tengiz Tsertsvadze <[email-masked]>

Sent: Monday, September 14, 2020 7:04 PM

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

Cc: LYDON, Patrick <[email-masked]>;
solidaritytrials <[email-masked]>;
M Georgia <[email-masked]>;
Ekaterine Adamia <[email-masked]>;
Alisa Tsuladze <[email-masked]>

Subject: [EXT] Solidarity trial

Dear
Dr. Dara,

I
hope this email finds you well. Once again we would like to express our sincere
gratitude for selecting Georgia to participate in WHO sponsored “Solidarity”
trial.

As
you are well aware the initial protocol of the “Solidarity” trial
envisioned to study efficacy of Remdesivir, hydroxychloroquine and
Lopinavir/Ritonavir ± Interferon β1a in hospitalized patients with moderate
or severe COVID-19.

On
June 17, 2020, WHO removed hydroxychloroquine from the
above-mentioned trial, and on July 4, 2020, Lopinavir/Ritonavir was also
removed. On August 6, 2020, the “Solidarity” research executive broad
issued a recommendation to evaluate the clinical efficacy of the
additional drug Acalabrutinib as part of this study. Currently,
“Solidarity” trial includes following medications: Remdisivir, Acalabrutinib
and β interferon.

In
line with WHO recommendation we removed the use of hydroxychloroquine
and Lopinavir/Ritonavir outside of clinical trials in our national
COVID-19 treatment protocol. As a result Interferon β1a is the only
medication in the country which we can use for COVID-19 patients at
present. Therefore provision of Remdesivir and Acalabrutinib
within the “Solidarity” trial is a matter of urgency for us.

We
would highly appreciate it if you could consider the above mentioned serious
circumstance and facilitate a timely provision of Remdesivir and Acalabrutinib
to Georgia as soon as possible.

Thank
you in advance for your kind consideration and we look forward to your
response.

Best
regards,

Tengiz
Tsertsvadze