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

NCT04733833 | Completed Phase 2 DMC

• 1 other identifier: VB-201-019
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Severe COVID-19

Keywords

COVID-19; Severe

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Arm 1

EXPERIMENTAL

VB-201 + standard of care

Drug: VB-201 + Standard of care

Arm 2

ACTIVE COMPARATOR

Standard of care

Drug: Standard of care

Interventions

VB-201 + Standard of care DRUG

Daily oral administration of VB-201- 160 mg (80 mg BID) with standard of care

Arm 1

Standard of care DRUG

Standard of care

Arm 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Vascular Biogenics Ltd. operating as VBL Therapeutics: lead

Study Sites (1)

Chaim Sheba Medical Center

Ramat Gan, 5262000, Israel

Location

MeSH Terms

Conditions

COVID-19; Lymphoma, Follicular

Interventions

1-palmityl-2-(4-carboxybutyl)-sn-glycero-3-phosphocholine; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 2, 2021
• Study Start: January 26, 2021
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: February 1, 2023

Record last verified: 2021-01

Locations

IL (1)