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A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19

Primary Purpose

Severe COVID-19

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
VB-201 + Standard of care
Standard of care
Sponsored by
Vascular Biogenics Ltd. operating as VBL Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe COVID-19 focused on measuring COVID-19, Severe

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed and approved informed consent before initiation of protocol-specified procedures;
  2. Male or female subjects, ≥18 to ≤80 years of age with COVID-19
  3. SARS-2-CoV-2 infection confirmed by PCR in the last 8 days
  4. Hospitalized

  5. Symptoms of Severe COVID-19 as demonstrated by one of the following:

    • Respiratory frequency >30 breaths per minute
    • SpO2 <94% on room air at sea level
    • Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mmHg
    • lung infiltrates >50%

  6. For a female subject; either:

    • subject is of non-childbearing potential, defined as: menopause with amenorrhea >1 years, hysterectomy, or bilateral oopherectomy or
    • agrees to continue to use highly effective methods of birth control defined as those alone or in combination that result in a low failure rate (<1%) when used consistently and correctly throughout the study and for at least one month following treatment termination and have a negative pregnancy test at screening and before the first dose of study drug; Males must use at least one method of contraception (e.g. condom) throughout the study and for 90 days following the last dose of study drug;
  7. In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.

Exclusion Criteria:

  1. Evidence of critical COVID-19 based on any of the following

    • Admission to ICU
    • Assisted ventilation (invasive or non-invasive)
    • ECMO or hemofiltration required
    • ARDS
    • Shock
    • Acute Cardiac Failure
  2. Dementia
  3. Bacterial co-infection
  4. Co-infection with other common viral pneumonias (e.g. Influenza)
  5. Participation in another interventional clinical trial or intention to participate in another interventional study during the course of this study;
  6. In the opinion of the investigator, unlikely to survive for at least 48 hours from screening or anticipate mechanical ventilation within 48 hours
  7. Unable to take oral medication
  8. History of gastrointestinal illness that may cause nausea and vomiting

  9. Subjects with any laboratory test at screening that common medical practice would deem as significantly abnormal. For example:

    • Alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase >5.0 times the upper limit of normal (ULN) or
    • Creatinine clearance <30 mL/min
  10. The subject has a known allergy or sensitivity to the study treatment or to any of the excipients contained in the study drug formulation (see list of ingredients in the Investigator's Brochure);
  11. Female subject with a positive pregnancy test or nursing, or planning a pregnancy during the course of the study;
  12. Unwilling or unable to comply with study requirements

Sites / Locations

  • Chaim Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

VB-201 + standard of care

Standard of care

Outcomes

Primary Outcome Measures

Assess the safety and tolerability of VB-201
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (Time frame: Adverse events will be collected from the time the informed consent is signed through 28 days after the subject's last dose. All adverse events that are ongoing at the time of completion/discontinuation will be followed until resolution or the event is chronic or stable in the opinion of the investigator).

Secondary Outcome Measures

Full Information

First Posted
January 27, 2021
Last Updated
January 31, 2023
Sponsor
Vascular Biogenics Ltd. operating as VBL Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04733833
Brief Title
A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19
Official Title
A Randomized, Controlled Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
October 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Biogenics Ltd. operating as VBL Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this Phase 2 study is to test safety, efficacy, and tolerability of an oral preparation of VB-201 in patients with severe COVID-19

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe COVID-19
Keywords
COVID-19, Severe

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
VB-201 + standard of care
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Standard of care
Intervention Type
Drug
Intervention Name(s)
VB-201 + Standard of care
Intervention Description
Daily oral administration of VB-201- 160 mg (80 mg BID) with standard of care
Intervention Type
Drug
Intervention Name(s)
Standard of care
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
Assess the safety and tolerability of VB-201
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (Time frame: Adverse events will be collected from the time the informed consent is signed through 28 days after the subject's last dose. All adverse events that are ongoing at the time of completion/discontinuation will be followed until resolution or the event is chronic or stable in the opinion of the investigator).
Time Frame
Subjects will participate in the study for approximately 7 weeks: up to 1 day for screening and establishment of baseline, followed by 14 days of treatment and a follow-up visit 4 weeks after last dose of study medication.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and approved informed consent before initiation of protocol-specified procedures; Male or female subjects, ≥18 to ≤80 years of age with COVID-19 SARS-2-CoV-2 infection confirmed by PCR in the last 8 days Hospitalized Symptoms of Severe COVID-19 as demonstrated by one of the following: Respiratory frequency >30 breaths per minute SpO2 <94% on room air at sea level Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mmHg lung infiltrates >50% For a female subject; either: subject is of non-childbearing potential, defined as: menopause with amenorrhea >1 years, hysterectomy, or bilateral oopherectomy or agrees to continue to use highly effective methods of birth control defined as those alone or in combination that result in a low failure rate (<1%) when used consistently and correctly throughout the study and for at least one month following treatment termination and have a negative pregnancy test at screening and before the first dose of study drug; Males must use at least one method of contraception (e.g. condom) throughout the study and for 90 days following the last dose of study drug; In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures. Exclusion Criteria: Evidence of critical COVID-19 based on any of the following Admission to ICU Assisted ventilation (invasive or non-invasive) ECMO or hemofiltration required ARDS Shock Acute Cardiac Failure Dementia Bacterial co-infection Co-infection with other common viral pneumonias (e.g. Influenza) Participation in another interventional clinical trial or intention to participate in another interventional study during the course of this study; In the opinion of the investigator, unlikely to survive for at least 48 hours from screening or anticipate mechanical ventilation within 48 hours Unable to take oral medication History of gastrointestinal illness that may cause nausea and vomiting Subjects with any laboratory test at screening that common medical practice would deem as significantly abnormal. For example: Alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase >5.0 times the upper limit of normal (ULN) or Creatinine clearance <30 mL/min The subject has a known allergy or sensitivity to the study treatment or to any of the excipients contained in the study drug formulation (see list of ingredients in the Investigator's Brochure); Female subject with a positive pregnancy test or nursing, or planning a pregnancy during the course of the study; Unwilling or unable to comply with study requirements
Facility Information:
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel

12. IPD Sharing Statement

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A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19

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