Status:
WITHDRAWN
CORONA: A Study Using DeltaRex-G Gene Therapy for Symptomatic COVID-19
Lead Sponsor:
Aveni Foundation
Conditions:
COVID-19
Cytokine Storm
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
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 Acu...
Detailed Description
Background and Proposed Research Importance Coronavirus disease 2019 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2. COVID-19 causes life threatening complications...
Eligibility Criteria
Inclusion
- 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
- Patients with severe disease as evidenced by presence of pneumonia, diagnosis of ARDS in hospitalized patients
- 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
- 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
Key Trial Info
Start Date :
December 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04378244
Start Date
December 12 2022
End Date
July 12 2024
Last Update
February 24 2025
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