Subject: RE: [EXT] Solidarity trial
From: "DARA, Masoud" <[email-masked]>
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]>
Date: Mon, 14 Sep 2020 18:00:34 +0000

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

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

To: DARA, Masoud

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

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