A Randomized, Controlled Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19
Overview
- Phase
- Phase 2
- Intervention
- VB-201 + Standard of care
- Conditions
- Severe COVID-19
- Sponsor
- Vascular Biogenics Ltd. operating as VBL Therapeutics
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Assess the safety and tolerability of VB-201
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
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:
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
- •Acute Cardiac Failure
- •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
Arms & Interventions
Arm 1
VB-201 + standard of care
Intervention: VB-201 + Standard of care
Arm 2
Standard of care
Intervention: Standard of care
Outcomes
Primary Outcomes
Assess the safety and tolerability of VB-201
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.
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).