CORONA: A Study Using DeltaRex-G Gene Therapy for Symptomatic COVID-19 (CORONA)
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|ClinicalTrials.gov Identifier: NCT04378244|
Recruitment Status : Not yet recruiting
First Posted : May 7, 2020
Last Update Posted : November 12, 2020
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.
- 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);
- 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;
- 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
- 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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Cytokine Storm Acute Respiratory Distress Syndrome||Drug: DeltaRex-G||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Sequential assignment|
|Masking:||None (Open Label)|
|Official Title:||CORONA: A Phase 1/2 Study Using DeltaRex-G Gene Therapy for Symptomatic COVID-19|
|Estimated Study Start Date :||January 12, 2021|
|Estimated Primary Completion Date :||January 12, 2022|
|Estimated Study Completion Date :||March 12, 2022|
Escalating doses of DeltaRex-G i.v daily for 7 days as follows:
Dose Level I: 3-6 patients will receive 1 x 10e11 cfu/dose Dose Level II: 3-6 patients will receive 2 x 10e11 cfu/ dose Dose Level III: 3-6 patients will receive 3 x 10e11 cfu/dose
This is an open label, dose-seeking phase 1/2 study using escalating doses of DeltaRex-G given intravenously for 7 days in a hospital setting.
The study will employ the standard "Cohort of Three" design (Storer, 1989). Three patients are treated at each dose level with expansion to six patients per cohort if DLT is observed in one of the three initially-enrolled patients at each dose level. If no DLT occurs in 3 patients, escalation to the next dose level will be permitted. The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced DLT, with the next higher dose level having at least two patients who experienced DLT. No intra-patient dose escalation will take place. Patients who do not complete the 7-day treatment will be replaced.
Other Name: DeltaRex-G Retroviral Vector Encoding a Cyclin G1 Inhibitor
- Maximum Tolerated Dose [ Time Frame: 3 weeks ]The study will employ the standard "cohort of three" design (Storer, 1989). Three patients are treated at each dose level with expansion to six patients per cohort if DLT is observed in one of the three initially-enrolled patients at each dose level. The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced DLT, with the next higher dose level having at least two patients who experienced DLT. No intra-patient escalation will take place.
- Survival [ Time Frame: 2 months ]Duration of survival
- Hospital Stay [ Time Frame: 3 weeks ]Time of hospital admission to time of discharge
- Ventilator Therapy [ Time Frame: 3 weeks ]Time from start of mechanical ventilation to extubation or death
- Intensive Care Unit Stay [ Time Frame: 3 weeks ]Time from start of intensive care to discarge to regular room
- Cytokine Pattern [ Time Frame: 3 weeks ]Improvement in serum cytokine IL-6, IL12, TNF alpha
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04378244
|Contact: Erlinda M Gordon, MDemail@example.com|
|Contact: Victoria Chua-Alcala, MDfirstname.lastname@example.org|
|Principal Investigator:||Sant P Chawla, MD||Mission Community Hospital|