Subject: RE: [EXT] Solidarity trial
From: "LYDON, Patrick" <[email-masked]>
To: "DARA, Masoud" <[email-masked]>, Tengiz Tsertsvadze <[email-masked]>, "SATHIYAMOORTHY, Vaseeharan" <[email-masked]>
Cc: solidaritytrials <[email-masked]>, M Georgia <[email-masked]>, Ekaterine Adamia <[email-masked]>, Alisa Tsuladze <[email-masked]>
Date: Tue, 15 Sep 2020 09:11:53 +0000

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

Sent: 14 September 2020 20:00

To: Tengiz Tsertsvadze

Cc: LYDON, Patrick ; solidaritytrials ; M Georgia ; Ekaterine Adamia ; Alisa Tsuladze

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