CORONA: A Study Using DeltaRex-G Gene Therapy for Symptomatic COVID-19
Status:
Not yet recruiting
Trial end date:
2022-03-12
Target enrollment:
Participant gender:
Summary
COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2.
COVID-19 causes life threatening complications known as Cytokine Release Syndrome or Cytokine
Storm and Acute Respiratory Distress Syndrome. These complications are the main causes of
death in this global pandemic. Over 1000 clinical trials are on-going worldwide to diagnose,
treat, and improve the aggressive clinical course of COVID-19. The investigators propose the
first, and so far, only gene therapy solution that has the potential to address this urgent
unmet medical need.
Rationale
1. There are striking similarities between the damaged lung environment of COVID-19 induced
ARDS and the tumor microenvironment (exposed collagen from tissue destruction by
invading tumor or by the virus-induced immune response, and presence of activated
proliferative cells (cancer cells and tumor associated fibroblasts or activated T cells,
macrophages and pulmonary fibroblasts in COVID-19);
2. DeltaRex-G is a disease-seeking retrovector encoding a cytocidal dominant negative human
cyclin G1 as genetic payload). When injected intravenously, the DeltaRex-G nanoparticles
has a navigational system that targets exposed collagenous proteins (XC proteins) in
injured tissues (e.g. inflamed lung, kidney, etc.), thus increasing the effective drug
concentration at the sites of injury, in the vicinity of activated/proliferative T cells
evoked by COVID-19. Our hypothesis is that DeltaRex-G then enters the rapidly dividing T
cells and kills them by arresting the G1cell division cycle, hence, reducing cytokine
release and ARDS;
3. Intravenous DeltaRex-G has minimal systemic toxicity due to its navigational system
(targeting properties) that limits the biodistribution of DeltaRex-G only to areas of
injury where exposed collagenous (XC) proteins are abnormally found; and
4. DeltaRex-G is currently available in FDA approved "Right to Try" or Expanded Access
Program for Stage 4 cancers for an intermediate size population. To gain this approval,
FDA requires DeltaRex-G to have demonstrated safety and efficacy in early clinical
trials.