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CORONA: A Study Using DeltaRex-G Gene Therapy for Symptomatic COVID-19 (CORONA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04378244
Recruitment Status : Not yet recruiting
First Posted : May 7, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Aveni Foundation

Brief 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. DeltaRex-G is a safe, non-pathogenic, replication incompetent, RNA virus-based gene vector. DeltaRex-G nanoparticles (~100 nm) can mimic RNA virus SARS-CoV-2 by binding to viral receptors in human cells and may serve as a decoy to prevent SARSCoV-2 cell entry by crowding/neutralizing the SARS-CoV-2 even where the receptors may be different.
  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. The 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.

Condition or disease Intervention/treatment Phase
COVID-19 Cytokine Storm Acute Respiratory Distress Syndrome Drug: DeltaRex-G Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Sequential assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CORONA: A Phase 1/2 Study Using DeltaRex-G Gene Therapy for Symptomatic COVID-19
Estimated Study Start Date : June 12, 2020
Estimated Primary Completion Date : January 12, 2021
Estimated Study Completion Date : March 12, 2021


Arm Intervention/treatment
Experimental: DeltaRex-G

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

Drug: DeltaRex-G

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Survival [ Time Frame: 2 months ]
    Duration of survival

  2. Hospital Stay [ Time Frame: 3 weeks ]
    Time of hospital admission to time of discharge

  3. Ventilator Therapy [ Time Frame: 3 weeks ]
    Time from start of mechanical ventilation to extubation or death

  4. Intensive Care Unit Stay [ Time Frame: 3 weeks ]
    Time from start of intensive care to discarge to regular room

  5. Cytokine Pattern [ Time Frame: 3 weeks ]
    Improvement in serum cytokine IL-6, IL12, TNF alpha



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:

  • Male or female ≥ 18 years of age
  • Confirmed COVID-19 positive by viral RT PCR
  • Symptomatic patients who are admitted to the hospital for medical treatment
  • Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the investigator's IRB/Ethics Committee
  • Willingness to comply with all study procedures and availability for the duration of the study.
  • Adequate hematologic, renal or hepatic function defined by any of the following screening laboratory
  • Values:

    i) Neutrophils >1000/uL ii) Platelets > 75,000/uL iii) Serum creatinine >1.5 x ULN or creatinine clearance < 60 mL/min (using the Cockcroft Gault formula) iv) AST/ALT, alk phos <3 x ULN vi) Total Bilirubin <1.5 x ULN

  • All women of childbearing potential must have a negative pregnancy test and all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 2 months after the last dose.

Exclusion Criteria:

All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation, as follows:

  • Females who are pregnant or breast-feeding
  • Unwillingness or inability to comply with the study protocol for any reason

Information from the National Library of Medicine

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


Contacts
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Contact: Erlinda M Gordon, MD 818-726-3278 egordon@avenifoundation.org
Contact: Victoria Chua-Alcala, MD 310-552-9999 vchua@sarcomaoncology.com

Sponsors and Collaborators
Aveni Foundation
Investigators
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Principal Investigator: Sant P Chawla, MD Mission Community Hospital
Publications:

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Responsible Party: Aveni Foundation
ClinicalTrials.gov Identifier: NCT04378244    
Other Study ID Numbers: AF20-203
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aveni Foundation:
cyclin G1
gene therapy
activated T cells
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury