Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19
Lead Sponsor:
Vascular Biogenics Ltd. operating as VBL Therapeutics
Conditions:
Severe COVID-19
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04733833
Start Date
January 26 2021
End Date
October 25 2022
Last Update
February 1 2023
Active Locations (1)
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1
Chaim Sheba Medical Center
Ramat Gan, Israel, 5262000