Subject: Fw: Questions on the process of countries signing in for Solidarity Trial
From: Tamar Gabunia </O=EXCHORGANIZATION/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=E6CA04F38EC94D0CADAB9CBDF90FCDDE-TAMAR G>
To: "[email-masked]" <[email-masked]>
Cc: amiran gamkrelidze <[email-masked]>, "DOMENTE, Silviu" <[email-masked]>
Date: Sat, 04 Apr 2020 18:02:06 +0000

Dear Nino

Thanks a lot for forwarding these documents. ​Absolutely, we would be delighted with this opportunity. Please kindly advise on next steps.

Tamar

From: MAMULASHVILI, Nino <[email-masked]>

Sent: Saturday, April 4, 2020 10:26 AM

To: Tamar Gabunia

Subject: FW: Questions on the process of countries signing in for Solidarity Trial

Dear Tamar,

The below are follow up communication related to the country participation in COVID-related Solidarity Trial.

According to Masoud, Georgia has a huge research capacity and our inclusion (the sooner the better) will be useful. He asked me to give you his mobile (+4521332063) in case you would like to call him in this regard.

Thank you and kind regards,

Nino

From: DOMENTE, Silviu

Sent: Saturday, April 4, 2020 01:29

To: MAMULASHVILI, Nino <[email-masked]>

Subject: FW: Questions on the process of countries signing in for Solidarity Trial

From: DARA, Masoud

Sent: Saturday, April 4, 2020 01:27

Cc: EURO2019nCoV <[email-masked]>; KOROTYCH, Oleksandr <[email-masked]>; SHARMA, Tarang <[email-masked]>; HUMBERT, Tifenn
Lucile Marie <[email-masked]>; PIRGARI, Dorina <[email-masked]>; EURO Strategic Relations with Countries <[email-masked]>; RUNDSTROEM, Maria <[email-masked]>

Subject: RE: Questions on the process of countries signing in for Solidarity Trial

Respectful WRs/HWOs,

This week together with headquarters, we organized three online briefings with 21 Member States of WHO European Region. Thank you very much for your active role. To recap:

MoH needs to obtain the necessary ethical and regulatory clearances at national level as soon as possible and sign the WHO standardized protocol (coverpage of the Study protocol enclosed for your easy access);

Once the protocol is approved and signed, the names of clinicians and principal investigators together with their emails and phone numbers are to be communicated to WHO (EURO  [email-masked] +
HQ [email-masked] ) with a copy to our WHO Country Office, if there is any;

This will allow to organize a rapid training on how to fill the online data form (taking around 5 minutes to fill in for each patient);

MoH/Clinicians need to clarify what medicines are available or need to be procured locally or supplied by WHO;

The National Drug Regulatory Authority (NRA) will need to issue an emergency authorization so medicines can be imported for those drugs that WHO will supply. If medicines are to be imported, an import permission should be issued
as soon as possible;

WHO will send an official letter to MoH to start the Trial;

Once we know the import permit is available, WHO has agreements with the 5 manufacturers and will instruct them to ship the necessary medicines as soon as possible;

An address of where to send the drugs will be needed and MoH will be responsible for getting the medicines to the different hospitals / clinical trial sites;

For drugs that exist in country, these arms of the trial can move ahead. There is no need to wait for all drugs for all arms to be available;

Once patients come to hospital(s), they will be randomized according to the study protocol and put on standard of care or the trial arms. The data will be entered at admission and then at discharge or in case of death, the death
and conditions which patient was in hospital;

The only paper work involved in the trial centers is the informed consent form (ICF). The rest is all electronic using the WHO system. MoH or WHO Country Office (if there is any) can help with translating the Informed Consent
form to your national/local language (pages 5-8 of the enclosed SOPs and Appendixes);

WHO will process and analyze the data and submit findings to an executive committee. MoH will need to appoint 1 or 2 representatives to join the international steering committee what will have members from all countries conducting
the trials. The steering committee will review the findings from the executive committee before anything is made public. It is through this process that decision will be made to continue or not with certain arms of the trial or add news one. This why it is
called an adaptive RCT.

All the best,

Masoud

From: DARA, Masoud

Sent: Wednesday, April 1, 2020 2:29 PM

Cc: EURO2019nCoV <[email-masked]>; KOROTYCH, Oleksandr <[email-masked]>; SHARMA, Tarang <[email-masked]>; HUMBERT, Tifenn
Lucile Marie <[email-masked]>; PIRGARI, Dorina <[email-masked]>; EURO Strategic Relations with Countries ([email-masked]) <[email-masked]>

Subject: RE: Questions on the process of countries signing in for Solidarity Trial

Dear WRs/HWOs,

Dear colleagues,

Please find enclosed the Russian translation of the Solidarity Protocol, SOPs and Appendixes with thanks to Melita, Saltanat and CO team in Moscow. Please make sure they are kept confidential and shared only with MoH after their confirmation
of their intention to join the Trial and shared only with the experts which MoH confirms it can be shared with. In case of differences, the English version shall be referred to as the original.

Thank you and all the best,

Masoud

From: DARA, Masoud

Sent: Wednesday, April 1, 2020 12:13 PM

To: EU Heads Of COs <[email-masked]>

Cc: EURO2019nCoV <[email-masked]>; KOROTYCH, Oleksandr <[email-masked]>; SHARMA, Tarang <[email-masked]>; HUMBERT, Tifenn
Lucile Marie <[email-masked]>; PIRGARI, Dorina <[email-masked]>; EURO Strategic Relations with Countries ([email-masked]) <[email-masked]>

Subject: Questions on the process of countries signing in for Solidarity Trial

Respectful WRs/HWOs,

As we notice the similar question comes frequently from the countries, please see below headquarters’ response regarding the process of signing in the Solidarity Trial. It is great to see the countries want to move fast, however we shall
make sure NRA and the necessary/ethical clearance are obtained in your countries. We add these questions and answers to the one Alex and the EURO Solidarity Team are compiling.

https://worldhealthorg-my.sharepoint.com/:w:/g/personal/korotycho_who_int/ER4BhLh15zBPrq2x7xwV6RcBUlLzeIii4Fx_dSNU5aUYMg?e=gvp3Az

All the best,

Masoud

From: LYDON, Patrick

Sent: Wednesday, April 1, 2020 12:02 PM

To: GRBIC, Miljana <[email-masked]>; DARA, Masoud <[email-masked]>; ZURLYTE, Ingrida <[email-masked]>

Cc: LAZERI, Ledia <[email-masked]>; KAIC-RAK, Vlasta Antoinette <[email-masked]>; VYSHNEVSKA, Svitlana <[email-masked]>; RUNDSTROEM,
Maria <[email-masked]>; KOROTYCH, Oleksandr <[email-masked]>; SHARMA, Tarang <[email-masked]>; HUMBERT, Tifenn Lucile Marie <[email-masked]>;
PIRGARI, Dorina <[email-masked]>

Subject: RE: 11 AM today Solidarity call

Dear Miljana,

On the WHO side, we cannot move forward until Lithuania and Romania get both regulatory and ethical clearance of the WHO standardized protocol. This is the most important first step. While this is happening, the identification
of hospitals, clinicians, and drugs needed should happen in parallel. Once we know that the protocol has been approved, we can then organize the training with clinicians.

Hope this clarifies.

Best

Patrick

From: GRBIC, Miljana

Sent: 01 April 2020 11:19

To: LYDON, Patrick <[email-masked]>; DARA, Masoud <[email-masked]>; ZURLYTE, Ingrida <[email-masked]>

Cc: LAZERI, Ledia <[email-masked]>; KAIC-RAK, Vlasta Antoinette <[email-masked]>; VYSHNEVSKA, Svitlana <[email-masked]>; RUNDSTROEM,
Maria <[email-masked]>; KOROTYCH, Oleksandr <[email-masked]>; SHARMA, Tarang <[email-masked]>; HUMBERT, Tifenn Lucile Marie <[email-masked]>;
PIRGARI, Dorina <[email-masked]>

Subject: RE: 11 AM today Solidarity call

Dear Patrick,

I am writing on behalf of Romania. Thank you for providing additional information, as it is relevant for Romania as well.

Please consider thought, that requested steps are some short term, and some longer term ones. For countries to be clear on how to proceed, we need a process to be established. For instance, I already have a letter from MOH, announcing Romania’s
engagement in the trial, along with names and contact details of PI and research team.

Would you suggest us, WRs, to ask MOHs to sign the protocol now, and you organize a rapid training immediately after.

The work with NRA is to follow apparently, I am not sure if only having protocol signed is enough, or maybe there will be other requirements-all these have to be clarified in the call with MS-thus I am more comfortable with a guide on the
process.

Hope this clarifies, look forward to receiving further guidance.

Kind regards,

miljana

From: LYDON, Patrick <[email-masked]>

Sent: Wednesday, April 1, 2020 12:05

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

Cc: GRBIC, Miljana <[email-masked]>; LAZERI, Ledia <[email-masked]>; KAIC-RAK, Vlasta Antoinette <[email-masked]>; VYSHNEVSKA, Svitlana
<[email-masked]>; RUNDSTROEM, Maria <[email-masked]>; KOROTYCH, Oleksandr <[email-masked]>; SHARMA, Tarang <[email-masked]>;
HUMBERT, Tifenn Lucile Marie <[email-masked]>; PIRGARI, Dorina <[email-masked]>

Subject: RE: 11 AM today Solidarity call

Dear Ingrid,

Thanks for your patience.

The is no need for a formal letter of agreement at this point. You’re indication to move forward with Solidarity Trials in Lithuania is sufficient. We don’t want to burden the process upfront with too many formalities
that can delay getting started. That said, once things begin, WHO will send a letter to formalize things. If it’s helpful on your end, we can have our DG send an official letter to Lithuania inviting the country to join the solidarity trails. A simple response
from the MOH to this letter would then act as the formal agreement. Does this clarify?

Otherwise, Masoud did an excellent job responding to the other questions which I have bulleted below.

Lithuania needs to take care of the necessary ethics and regulatory clearances at national level and sign the WHO standardized protocol.

Once the protocol is approved and signed, the names of clinicians and principal investigators together with their email and phone numbers are to be communicated to WHO (EURO + HQ)

This will allow to organize a rapid training on how to fill the online data form (taking around 5 min for each patient).

At this point clinicians need to clarify what medicines are available or need to procured locally or need to be supplied by WHO.

The NRA will need to issue an emergency authorization so medicines can be imported for those that WHO will supply. If medicines are to be imported, an import permission should be issued as soon as possible.

Once we know the import permit is available, WHO has agreements with the 5 manufacturers and will instruct them to ship medicines as soon as possible.

An address of where to send the drugs will be needed and Lithuania will be responsible for getting these to the different hospitals / sites

For drugs that exist in country, these arms of the trial can move ahead. There is no need to wait for all drugs for all arms to be available.

Once patients come to hospital, they will be randomized according and put on standard of care or the trial arms. Data will be entered at admission and then at discharge or in case of death, the death and conditions which patient
was in hospital.

The only paper work involved is the informed consent form (ICF). The rest is all electronic using the WHO system

WHO will process and analyze the data and submit findings to an executive committee. Lithuania will need to appoint 1 or 2 people to join the international steering committee what will have members from all countries conducting
the trials. The steering committee will review the findings from the executive committee before anything is made public. It is through this process that decision will be made to continue or not with certain arms of the trial or add news one. This why it is
called an adaptive RCT.

Hope this clarifies some of your questions.

Very best

Patrick

From: DARA, Masoud

Sent: 01 April 2020 08:54

To: ZURLYTE, Ingrida <[email-masked]>

Cc: GRBIC, Miljana <[email-masked]>; LAZERI, Ledia <[email-masked]>; KAIC-RAK, Vlasta Antoinette <[email-masked]>; VYSHNEVSKA, Svitlana
<[email-masked]>; RUNDSTROEM, Maria <[email-masked]>; LYDON, Patrick <[email-masked]>; KOROTYCH, Oleksandr <[email-masked]>;
SHARMA, Tarang <[email-masked]>; HUMBERT, Tifenn Lucile Marie <[email-masked]>; PIRGARI, Dorina <[email-masked]>

Subject: Re: 11 AM today Solidarity call

Dear Ingrida and Miljana,

I refer to Patrick for clarifying the process of official signing in of the countries.

Dear Alex,

Please add this question to FAQ and upon headquarters réponse we add the answer which is useful for all countries.

Thanks and all the best,

Masoud

On 1 Apr 2020, at 06:41, ZURLYTE, Ingrida <[email-masked]> wrote:

 Dear Masoud,

Lithuania has informed through [email-masked] about interest and PI.

Apologies but could you clarify on protocol signature, how, and during TC contract with WHO was mentioned.

Many thanks in advance

Ingrida

Sent from my iPhone

On 1 Apr 2020, at 07:19, GRBIC, Miljana <[email-masked]> wrote:

Dear Masoud,

As Romania yesterday shared the official letter, appointing PI and team, shall we wait for a call with HQ first, then sign the protocol?

Many thanks,

Miljana

Sent from my iPhone

On 1 Apr 2020, at 01:10, DARA, Masoud <[email-masked]> wrote:

Dear colleagues,

I step in and Patrick can correct or add.

The countries shall do all the necessary clearances at national level and sign the protocol. Once the protocol is signed, the names of clinicians and principal investigators together with their email and phone numbers
are to be communicated to headquarters, a session on show them how to fill the online data form (taking around 5 min for each patient) will be arranged. In the meantime it shall be clarified if some medicines are available in the country or need to procured
locally. NRA should issue emergency authorization so medicines can be used/procured or imported for patients. If medicines are to be imported, an import permission shall be issued as soon as possible. Based on the estimated size of the recruitment, WHO will
facilitate/instruct the producer/distributor to ship medicines as soon as possible. Once patients who are coming to hospital, they will be randomized according and put on standard of care or the trial arms and data will be entered at admission and then at
discharge or in case of death, the death and conditions which patient was in hospital.

All the best,

Masoud

From: GRBIC, Miljana

Sent: Tuesday, March 31, 2020 1:55 PM

To: ZURLYTE, Ingrida <[email-masked]>

Cc: DARA, Masoud <[email-masked]>; LAZERI, Ledia <[email-masked]>; KAIC-RAK,
Vlasta Antoinette <[email-masked]>; VYSHNEVSKA, Svitlana <[email-masked]>;
RUNDSTROEM, Maria <[email-masked]>; LYDON, Patrick <[email-masked]>

Subject: Re: 11 AM today Solidarity call

Dear Masoud,

I have a similar question- I understand that the protocol has to be signed, but what further steps are expected, as MOH confirmed Romania’s engagement in the trial.

With my best,

Miljana

Sent from my iPhone

On 31 Mar 2020, at 14:50, ZURLYTE, Ingrida <[email-masked]> wrote:

Dear Masoud and Patrick,

Today we had a brief follow up teleconference with LTU authorities and trial centers regarding further actions.

It became clear that a contract between WHO and MOH would be an essential step triggering all further steps including getting approvals of bioethical committee etc.

Could you please let us know when we can expect to get a contract for consultations and signatures?

Many thanks in advance,

Kind regards,

Ingrida

Ingrida Zurlytė

Head, WHO Country Office, Lithuania

Tel.: +370 5 212 6743

Mobile: +370 686 43 866

Didzioji str. 22

LT-01128 Vilnius

http://www.who.int;
http://euro.who.int

From: ZURLYTE, Ingrida

Sent: Monday, March 30, 2020 10:45

To: DARA, Masoud <[email-masked]>; LAZERI, Ledia <[email-masked]>; GRBIC,
Miljana <[email-masked]>; KAIC-RAK, Vlasta Antoinette <[email-masked]>

Cc: VYSHNEVSKA, Svitlana <[email-masked]>; RUNDSTROEM, Maria <[email-masked]>;
LYDON, Patrick <[email-masked]>

Subject: RE: 11 AM today Solidarity call

Importance: High

Dear Masoud,

From Lithuania we expect the following participants:

Dr Arunas Vaitkevicius, delegated by the MoH, representing State Medicines Control Agency,
[email-masked]

Prof Laimonas Griskevicius, PI, Vilnius University Hospital “Santaros Clinics”,
[email-masked]

Dr Tomas Lapinskas, Kaunas Clinics, Lithuanian University of Health Science,
[email-masked]

Kind regards,

Ingrida

From: DARA, Masoud

Sent: Monday, March 30, 2020 10:13

To: LAZERI, Ledia <[email-masked]>; GRBIC, Miljana <[email-masked]>; ZURLYTE,
Ingrida <[email-masked]>; KAIC-RAK, Vlasta Antoinette <[email-masked]>

Cc: VYSHNEVSKA, Svitlana <[email-masked]>; RUNDSTROEM, Maria <[email-masked]>;
LYDON, Patrick <[email-masked]>

Subject: 11 AM today Solidarity call

Respectful WRs/HWOs,

This is the status so far from the outlook invite I sent yesterday. I notice you have forwarded the invite along the zoom link. Please make sure your MoH and PIs are informed and attend the Solidarity Trial call today
at 11 AM.

Thanks,

Masoud