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

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