To Dr. Ekaterine Tikaradze, minister for IDPs, Labor, Health and Social Affairs of Georgia, 

We are writing on behalf of the National Institutes of Health and the United States Government's Warp Speed operation dedicated to accelerating the development of COVID-19 therapeutics. As you may know, the very important ACTIV-3/INSIGHT 014 protocol called “Multicenter, Adaptive, Randomized, Blind Controlled Trial of the safety and efficacy of investigational therapy for hospitalized COVID-19 patients” has been submitted for regulatory approval in Georgia. This urgent randomized controlled trial aims to evaluate the safety and efficacy of monoclonal antibodies to SARS-CoV-2 and other COVID-19 therapeutics.

Monoclonal antibodies are among a number of highly prioritized therapeutics being evaluated for the treatment of COVID-19. These monoclonal antibodies have generally demonstrated an acceptable safety profile and promising in vitro activity, but further studies in well-organized and carefully designed randomized trials in combination with the remdesivir treatment standard are needed to establish efficacy, understand the relationship between dose and response, and justify treatment recommendations.

Given that the ongoing COVID-19 pandemic continues to claim many lives, the ACTIV-3 study is now more important than ever and is crucial to improve our understanding of the safety and effectiveness of various monoclonal antibodies in the treatment of COVID-19 in people who have been hospitalized with the infection. The rapid implementation and completion of this trial represents a very high priority for NIH and the rate of deformation of the operation. Therefore, we respectfully request that this protocol receive the support of your ministry and request that this study be prioritized for regulatory review as soon as possible. This would greatly help us in conducting this research in Georgia and in resolving this global pandemic.

Thank you in advance for your willingness to prioritize this important effort. If you have any questions regarding this study, please contact Principal Investigator, Jens Lundgren, MD, (jens.lundgren@regionh.dk). or the lead investigator of this study in Georgia, Tengiz Tsertsvadze, MD, (tt@aidscenter.ge).