Subject: Solidarity trial
From: Tengiz Tsertsvadze <[email-masked]>
To: "DARA, Masoud" <[email-masked]>
Cc: [email-masked], [email-masked], Tamar Gabunia <[email-masked]>, Ekaterine Adamia <[email-masked]>, Alisa Tsuladze <[email-masked]>
Date: Mon, 14 Sep 2020 17:04:38 +0000

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