Dear Dr Tamar,

Thank you for your message and raising these concerns with us. As of yesterday evening, the Executive Group of Solidarity Trial have made the recommendation to resume the treatment arm with HCQ/CQ. Therefore, with immediate effect the randomization software will be reset to allocate newly randomized patients to hydroxychloroquine. You can find more information in the attached Letter from the Executive Committee. This news was also formally announced by WHO.

That being said, in sharing this update with you, I’m not diminishing the importance of ensuring we expedite the shipment of the other trials drugs to Georgia. The team is diligently working through the process to ensure timely provision of Remdesivir, Lopinavir/Ritonavir and/or Lopinavir/Ritonavir plus Interferon β1 as soon as possible.

Please don’t hesitate to get in touch if you have any further questions or concerns.

With best regards,

Patrick

 

 

Resending with attachment. The text is copied in below. My apologies for this inconvenience.  

 

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. Let me assure you that we will do our best to be your worthy partner in this study.

 

The study already obtained clearance from both national ethical committee as well as ethical committees from each participating clinical sites (4 sites in Tbilisi and 2 sites in regions). Necessary training on data entry and randomization was conducted and the study sites are ready to start enrollment of patients. However, we would like to draw your attention to a very important issue, namely:

 

As you are well aware the results of studies published in recent days showed an increased risk of adverse effects of chloroquine/hydroxychloroquine, including cardiac arrhythmias in patients with COVID-19. Accordingly, on 25 May WHO made decision to temporarily remove hydroxychloroquine (Plaquenil) from “Solidarity” study treatment arms. 

 

In line with WHO recommendation we removed the use of hydroxychloroquine (Plaquenil) from our national COVID-19 treatment protocol until WHO makes the final decision. Please be informed that as a standard of care we were using hydroxychloroquine (Plaquenil) for COVID-19 patients with moderate, severe and critical conditions and no serious side effects have been reported so far.  

 

After removing hydroxychloroquine (Plaquenil) from our national COVID-19 treatment protocol at present COVID-19 patients in Georgia are left without any antiviral medications. Therefore provision of other antivirals: Remdesivir, Lopinavir/Ritonavir or Lopinavir/Ritonavir plus Interferon β1a within the “Solidarity” trial is a matter of urgency for us.  

 

We would highly appreciate if you could consider abovementioned serious circumstance and facilitate a timely provision of Remdesivir, Lopinavir/Ritonavir and/or Lopinavir/Ritonavir plus Interferon β1in frame of “Solidariy” trial to us as soon as possible.  

 

Thank you in advance for your kind consideration and we look forward to your response.

 

Best regards,

 

Tengiz Tsertsvadze 

 

 

Dear Dr Dara

 

I hope this e-mail find you doing well. First of all I would like to express our sincere gratitude for all support provided to Georgia for joining the Solidarity trial. Selected clinical sites look forward to getting access to drugs and starting patients enrollment. With this e-mail I am sending the letter from Professor Tengiz Tsertsvadze for your kind review and consideration.

Please find the attached.

Thanks for your attention to my e-mail in advance.

 

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

 

Sincerely,

Tamar Gabunia, MD, MPH

First Deputy Minister

 

 

 

 

 

 

Dear Solidarity Trial P.Is and esteemed colleagues,

 

We are pleased to be sharing with you the new WHO ‘interim’ guidance on COVID-19 clinical management (attached). This is a key documents in our collective objective to: (1) Slow and stop transmission of the virus; (2) Provide optimized care for all patients; and (3) Minimize the impact of the epidemic on health systems, social services and economic activity.

 

This guidance is intended for clinicians involved in the care of patients with suspected or confirmed COVID-19. As all of you copied are involved in the Solidarity Trial, we wanted to make sure you get this document and we encourage you to share this broadly within your networks. Please note that it is not meant to replace clinical judgment or specialist consultation, but rather to strengthen frontline clinical management based on the latest WHO guidance.

 

Furthermore, we wanted to thank you for all your hard work, dedication and time with enrolling patients in Solidarity Trial. To date, 17 countries have started Solidarity Trial in 320 hospitals around the world and where 885 clinicians including yourselves are involved. Patient enrollment has surpassed 3,000 on May 18^th – 8 weeks since the launch of the initiative on March 18 by the Director General of the WHO (Dr. Tedros). By the end of May, we expect another 10-12 countries to start enrolling patients with at least one country representing each WHO region. This is tremendous progress and we owe it to you. You should all be proud to be part of this global mega-trial to help research into an effective COVID-19 treatment and your efforts are not going unnoticed.

 

Of course, the battle against this pandemic is far from over and time is not on our side. The faster we can go, the quicker we can identify solutions. The international community is counting on your help to implement and accelerate all possible efforts for Solidarity Trial and to enroll as many patients as possible.

 

All the very best and keep safe.

Patrick

(on behalf of Dr Soumya (WHO Chief Scientist); the co-leads of Solidarity Trial (Dr Ana Maria, Dr Marie-Pierre and Dr Vasee); and our Regional and Country Office Focal points that have done an incredible job helping)

___________________________________________________________________________
Patrick Lydon

Research & Development Blueprint Unit  – WHO Health Emergencies Preparedness & Response

World Health Organization | 20 Avenue Appia | CH-1211 Geneva 27 Switzerland | Office: M1156
*: lydonp@who.int |(:office +41.22.791.4238 |(:mobile +41.79.475.5550 |(:skype: patricklydon

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