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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Daily oral administration of VB-201- 160 mg (80 mg BID) with standard of care
Standard of care
Chaim Sheba Medical Center
Ramat Gan, Israel
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).
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.
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