Larkin: FDA Emergency Use Authorized Treatment Protocol of DeltaRex-G for Severe Covid-19 [IND# 27185]

According to the Center for Disease Control and Prevention, more than 38 million COVID-19 cases have been reported in the United States as of August 31, 2021 [1]. There have been over 2 million (2,674,920) COVID hospitalizations and 631,440 deaths reported [1]. COVID-19 associated ARDS has been shown to be the primary mortality cause among patients hospitalized in the setting of severe COVID-19 infection We propose Del-taRex-G, a disease-targeted replication-incompetent retroviral vector that ultimately works by accumulating in inflamed lung tissue and inhibiting the hyperproliferation of immune cells, as a potential upfront treatment modality in COVID-19 complicated by ARDS. This article is dedicated to the treatment of symp-tomatic COVID-19 disease, explaining the rationale behind Del-taRex-G treatment in COVID-19 induced ARDS, and providing the treatment protocol which has gained US FDA Emergency Use Authorization for an adult patient with severe COVID-19 induced ARDS (IND# 27185). This EUA, granted within 24 hours of application with the FDA, provides a precedent for the treatment of other patients afflicted with severe COVID-19.