Severe COVID-19Phase 2NCT04733833
A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19
A Phase 2 study of Severe COVID-19, run by Vascular Biogenics Ltd. operating as VBL Therapeutics at 1 site in Israel.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe COVID-19
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Jan 2021to 25 Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19
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
- Being tested
- VB-201 + Standard of care, Standard of care
- Keywords
- COVID-19, Severe
- Medical subject headings
- COVID-19, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB-201 + Standard of careDrug
Daily oral administration of VB-201- 160 mg (80 mg BID) with standard of care
Standard of careDrug
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | VB-201 + standard of care Receives: Drug: VB-201 + Standard of care |
| Arm 2 | Active comparator | Standard of care Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start26 Jan 2021
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Biogenics Ltd. operating as VBL Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733833
- Sponsor's protocol ID
- VB-201-019
- Status last verified
- Jan 2021
- First submitted
- 27 Jan 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04733833
- Acronym / sponsor ID
- VB-201-019
- Conditions
- Severe COVID-19
- Keywords
- COVID-19, Severe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Vascular Biogenics Ltd. operating as VBL TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: VB-201 + Standard of careVB-201 + standard of care |
| Arm 2 | Active comparator | Drug: Standard of careStandard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (20 listed)
- Evidence of critical COVID-19 based on any of the following
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VB-201 + Standard of careDaily oral administration of VB-201- 160 mg (80 mg BID) with standard of care | Drug | Arm 1 |
| Standard of careStandard of care | Drug | Arm 2 |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Severe COVID-19, run by Vascular Biogenics Ltd. operating as VBL Therapeutics at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.