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

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

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

Study Overview

• Status: Completed
• Conditions: Severe COVID-19
• Intervention / Treatment: Drug: Standard of care; Drug: VB-201 + Standard of care

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel, 5262000
    • Chaim Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1; VB-201 + standard of care	Drug: VB-201 + Standard of care; Daily oral administration of VB-201- 160 mg (80 mg BID) with standard of care
ACTIVE_COMPARATOR: Arm 2; Standard of care	Drug: Standard of care; Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.

Collaborators and Investigators

• Sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 26, 2021
• Primary Completion (ACTUAL): October 25, 2022
• Study Completion (ACTUAL): October 25, 2022

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 31, 2021
• First Posted (ACTUAL): February 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Severe
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: VB-201-019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No