| From : | Tamar Gabunia <tgabunia@moh.gov.ge> |
| To : | Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>; Tinatin Khardziani <tkhardziani@moh.gov.ge>; giorgi chavchavadze <gchavchavadze@moh.gov.ge>; Ekaterine Adamia <eadamia@moh.gov.ge> |
| Subject : | Fwd: [EXT] Information on SOLIDARITY trial medications |
| Received On : | 07.10.2020 08:50 |
| Attachments : |
Dear Alisa,
Thank you for your message. If the Investigational Brochure and/or IMPD documents for Acalabrutinib are needed, we will need the national PI / national coordinator of Solidarity Trial to return to us a signed copy of the CDA document attached as a word document. Once we get a signed copy of the attached, we can share these confidential documents under the terms of the CDA.
For Remdesivir, we do not have any to ship to you at the moment, but there is a final allocation pending from Gilead. We are sorry we cannot give you a firm date on when additional supplies might be available for the trial. The best I can do is be transparent with you that this is unknown at the moment while we continue to work on arranging for supply.
If you have access to Remdesivir from any of the manufacturers listed here https://www.gilead.com/purpose/advancing-global-health/covid-19/voluntary-licensing-agreements-for-remdesivir Georgia could use that remdesivir for the trial while documenting it appropriately in a note for the record, and as long as of course your relevant in-country authorities authorize it.
All the best,
Patrick
From: Alisa Tsuladze
Sent: 02 October 2020 14:45
To: LYDON, Patrick
Cc: solidaritytrials
Subject: [EXT] Information on SOLIDARITY trial medications
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:lydonp@who.int]
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 <daram@who.int>
Sent: 14 September 2020 20:00
To: Tengiz Tsertsvadze <tt@aidscenter.ge>
Cc: LYDON, Patrick <lydonp@who.int>; solidaritytrials <solidaritytrials@who.int>; M Georgia <tgabunia@moh.gov.ge>;
Ekaterine Adamia <eadamia@moh.gov.ge>; Alisa Tsuladze <atsuladze@moh.gov.ge>
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: daram@who.int | Website: www.euro.who.int
From: Tengiz Tsertsvadze <tt@aidscenter.ge>
Sent: Monday, September 14, 2020 7:04 PM
To: DARA, Masoud <daram@who.int>
Cc: LYDON, Patrick <lydonp@who.int>; solidaritytrials <solidaritytrials@who.int>;
M Georgia <tgabunia@moh.gov.ge>; Ekaterine Adamia <eadamia@moh.gov.ge>;
Alisa Tsuladze <atsuladze@moh.gov.ge>
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