Pulmonary FibrosisPhase 1COVINVACNCT04537130
Vaccination of Ex-acute COVID-19 Patients With Fibrosing Lung Syndrome at Discharge
A Phase 1 study testing IN01 vaccine in people with Pulmonary Fibrosis and Covid19, run by Instituto Oncológico Dr Rosell at 1 site in Spain.
Trial summary
Methodology: This is a controlled, randomized, multicenter open-label Phase Ib clinical exploratory trial in patients with fibrosing interstitial lung disease secondary to SARS-CoV-2 infection. Patients who give informed consent will be screened for enrolment in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis, Covid19
- What is being tested?
- IN01 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2020to Jun 2022
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent approved by the investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the performance of any trial activities.
- Age 18 years or older.
- Patients with positive RT-PCR or IGm/IGG blood test for SARS-CoV-2 prior to the inclusion in the study.
- Patients that have pneumonia associated to SARS-CoV-s infection prior to randomization.
- Patients having respiratory dysfunction after SARS-CoV-2 infection and abnormal CT chest imaging.
- Patients previously under high flow nasal cannula or non-invasive ventilation, or supplementary oxygen, during hospitalization for COVID-19.
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- Increased EGF level (more than 200 picogram/ml).
- Negative serum pregnancy test at screening for women of childbearing potential.
- Highly effective contraception for both male and female subjects throughout the study and for at least 3 months after last IMP treatment administration if the risk of conception exists.
Who cannot join
- Patients with previous IPF, Autoimmune disease or connective tissue diseases (CTD).
- Known of previous clinically significant pulmonary abnormalities that may interfere with the measurement of study variables in the opinion of the investigator as ILD, or chronic respiratory failure.
- Other investigational therapy received within 1 month or 6 half-lives (whichever was greater) in the context of a clinical study.
- Included a physician's decision that involvement in the trial was not in the patient's best interest.
- Presence of any condition that would not allow the protocol to be followed safely.
- Any mental health condition, that may interfere in the normal development of the study according to physician criteria.
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- Known hypersensitivity to the trial medication or its components
- Other disease that may interfere with testing procedures or may put the patient at risk when participating in this trial in the judgment of the Investigator.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Women of childbearing potential not willing or able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly as well as one barrier method for 28 days prior to and 3 months after experimental treatment administration. A list of contraception methods meeting these criteria is provided in the patient information.
- Active alcohol or drug abuse in the opinion of the investigator.
- Any other reason that the investigator deems to be incompatible with the patient'sparticipation in study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital El Pilar
Barcelona, 08006
Investigator Selected by Sponsor, 934344412, investigacion@mfar.net
Investigator Selected by Sponsor
About this study
Official title: Phase Ib Controlled Exploratory Trial for Treatment of Fibrosing Interstitial Lung Disease Patients Secondary to SARS-CoV-2 Infection With IN01 Vaccine (COVINVAC)
Methodology:
This is a controlled, randomized, multicenter open-label Phase Ib clinical exploratory trial in patients with fibrosing interstitial lung disease secondary to SARS-CoV-2 infection.
Read more
Patients who give informed consent will be screened for enrolment in the study. Patients that meet the eligibility criteria will be enrolled and randomly allocated in the control arm (best standard of care) or the experimental arm (best standard of care plus IN01 vaccination).
The patients enrolled in the control arm of the study will receive standard of care.
The primary endpoint is safety, measured by the Frequency and severity of AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria. Biochemical and blood count alterations will be also monitored. Safety will be defined based on the frequency and severity of adverse events (AEs) throughout the patient's participation in the study comparing between control and experimental arms.
Efficacy will be measured as function of the annual rate of decline in the Forced Vital Capacity (FVC) at 1 year after patient inclusion in the study and the blood oxygen saturation levels at days 1, 14 (w2), d 28 (w4), 42 (w6) and 92 (w12); week 24, week 36 and week 52. High-resolution Computed Tomography (CT) scans will be taken at at baseline and weeks, 12, 24, and 52 to evaluate the resolution of the fibrosing interstitial lung disease.
A translational substudy will be included.
Objectives:
Primary Objective
● To evaluate the safety and tolerability of IN01 vaccine in diagnosed ex-COVID-19 patients that develop fibrotic lung syndrome after infection.
Secondary Objectives
- To evaluate the effect of IN01 vaccine on Oxygen saturation, pulmonary function, quality of life and fibrosing status in ex-COVID-19 patients that developed fibrosing lung disease after infection.
- To assess biomarkers and molecular markers related to the IN01 vaccine mechanism of action.
- Conditions
- Pulmonary Fibrosis, Covid19
- Being tested
- IN01 vaccine
- Keywords
- EGF, Fibrosis secondary to Covid19 infection, IN01 vaccine
- Medical subject headings
- Pulmonary Fibrosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN01 vaccineBiological
INO1 vaccine is a biological compound comprising generated and purified from recombinant bacteria culture that contains a protein consisting of EGF-4-EGF portion and the Cholera Toxin B-Subunit Domain G33D sequence (CTB-G33D) separated by 4 amino acids and 14 amino acids respectively glycine/serine-rich linkers.
IN01 is a recombinant growth factor fusion molecule which, once injected into the patient, stimulates the immune system to produce polyclonal anti-Epidermal Growth Factor (anti-EGF) neutralizing antibodies. This vaccine-led active immunisation is a new approach to target the growth factor pathways allowing for combinations with other small molecule inhibitors in order to obtain a sustained efficacy with an acceptable toxicity.
The vaccine inhibits binding of circulating Epidermal Growth Factor (EGF) to its receptor, EGF-R to block downstream activation of cell signaling pathways contributing to tumor growth or other pathophysiologies such as fibrosis.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The investigational medical product, the IN01 vaccine, will be administered in two phases to those patients in the experimental arm: the induction phase and the maintenance phase. During the induction phase IN01 vaccine will be administered on day 1 and will be repeated on Day 14, Day 28, Day 42 and day 56. During the maintenance phase, the vaccination will be administered every 2 months with the same dosage and administration mode as during induction. Receives: Biological: IN01 vaccine |
| Control | No intervention | The patients enrolled in the control arm of the study will receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Frequency/severity of AEs)
Frequency and severity of AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria and hematological alterations that are clinical relevant under physician criteria. Data will be presented as number of AEs classified by severity.
Measured: Through study completion, average 1 year
Secondary outcomes (3)
Oxygen saturation
blood oxygen levels will be measured by a pulse oximeter
Measured: baseline and days 1, 14 (w2), 28 (w4), 42 (w6) and 92 (w12); week 24, week 36 and week 52
Quality of life (QoL)
St George QoL questionnaire: Disease-specific questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: baseline and weeks 2, 12, 24, 36 and 52
Fibrotic pulmonary extension (measured as the size of the lesions)
High-resolution CT to follow fibrotic pattern reviewed by a central radiologist
Measured: baseline and weeks, 12, 24, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Dec 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial will enroll 40 patients to be treated with either standard of care (control arm) or IN01 vaccine (experimental arm). Patients will be randomized in a 5:3 ratio to achieve 25 patients allocated in the experimental vs 15 patients in the control arm.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Oncológico Dr Rosell
- Sponsor type
- University, hospital or other
- Collaborators
- IN3BIO, PANGAEA
- Responsible party
- Sponsor
- Investigators
- Pablo Rubinstein, MD, MSc, PhD, Study chair, Hospital El Pilar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537130
- Sponsor's protocol ID
- PANIN3BIO/IN01_COVID19_01
- Other IDs
- 2020-002874-28
- Acronym
- COVINVAC
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Controlled Exploratory Trial for Treatment of Fibrosing Interstitial Lung Disease Patients Secondary to SARS-CoV-2 Infection With IN01 Vaccine (COVINVAC)
- ClinicalTrials.gov ID
- NCT04537130
- Acronym / sponsor ID
- COVINVAC / PANIN3BIO/IN01_COVID19_01
- Conditions
- Pulmonary Fibrosis, Covid19
- Keywords
- EGF, Fibrosis secondary to Covid19 infection, IN01 vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto Oncológico Dr RosellUniversity, hospital or other
- Collaborators
- IN3BIO, PANGAEA
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 3 Sep 2020 (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.
Methodology:
This is a controlled, randomized, multicenter open-label Phase Ib clinical exploratory trial in patients with fibrosing interstitial lung disease secondary to SARS-CoV-2 infection.
Patients who give informed consent will be screened for enrolment in the study. Patients that meet the eligibility criteria will be enrolled and randomly allocated in the control arm (best standard of care) or the experimental arm (best standard of care plus IN01 vaccination).
The patients enrolled in the control arm of the study will receive standard of care.
The primary endpoint is safety, measured by the Frequency and severity of AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria. Biochemical and blood count alterations will be also monitored. Safety will be defined based on the frequency and severity of adverse events (AEs) throughout the patient's participation in the study comparing between control and experimental arms.
Efficacy will be measured as function of the annual rate of decline in the Forced Vital Capacity (FVC) at 1 year after patient inclusion in the study and the blood oxygen saturation levels at days 1, 14 (w2), d 28 (w4), 42 (w6) and 92 (w12); week 24, week 36 and week 52. High-resolution Computed Tomography (CT) scans will be taken at at baseline and weeks, 12, 24, and 52 to evaluate the resolution of the fibrosing interstitial lung disease.
A translational substudy will be included.
Objectives:
Primary Objective
● To evaluate the safety and tolerability of IN01 vaccine in diagnosed ex-COVID-19 patients that develop fibrotic lung syndrome after infection.
Secondary Objectives
- To evaluate the effect of IN01 vaccine on Oxygen saturation, pulmonary function, quality of life and fibrosing status in ex-COVID-19 patients that developed fibrosing lung disease after infection.
- To assess biomarkers and molecular markers related to the IN01 vaccine mechanism of action.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial will enroll 40 patients to be treated with either standard of care (control arm) or IN01 vaccine (experimental arm). Patients will be randomized in a 5:3 ratio to achieve 25 patients allocated in the experimental vs 15 patients in the control arm.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Biological: IN01 vaccineThe investigational medical product, the IN01 vaccine, will be administered in two phases to those patients in the experimental arm: the induction phase and the maintenance phase. During the induction phase IN01 vaccine will be administered on day 1 and will be repeated on Day 14, Day 28, Day 42 and day 56. During the maintenance phase, the vaccination will be administered every 2 months with the same dosage and administration mode as during induction. |
| Control | No intervention | –The patients enrolled in the control arm of the study will receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent approved by the investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the performance of any trial activities.
- Age 18 years or older.
- Patients with positive RT-PCR or IGm/IGG blood test for SARS-CoV-2 prior to the inclusion in the study.
- Patients that have pneumonia associated to SARS-CoV-s infection prior to randomization.
- Patients having respiratory dysfunction after SARS-CoV-2 infection and abnormal CT chest imaging.
Key exclusion criteria (12 listed)
- Patients with previous IPF, Autoimmune disease or connective tissue diseases (CTD).
- Known of previous clinically significant pulmonary abnormalities that may interfere with the measurement of study variables in the opinion of the investigator as ILD, or chronic respiratory failure.
- Other investigational therapy received within 1 month or 6 half-lives (whichever was greater) in the context of a clinical study.
- Included a physician's decision that involvement in the trial was not in the patient's best interest.
- Presence of any condition that would not allow the protocol to be followed safely.
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 |
|---|---|---|
| IN01 vaccineINO1 vaccine is a biological compound comprising generated and purified from recombinant bacteria culture that contains a protein consisting of EGF-4-EGF portion and the Cholera Toxin B-Subunit Domain G33D sequence (CTB-G33D) separated by 4 amino acids and 14 amino acids respectively glycine/serine-rich linkers. IN01 is a recombinant growth factor fusion molecule which, once injected into the patient, stimulates the immune system to produce polyclonal anti-Epidermal Growth Factor (anti-EGF) neutralizing antibodies. This vaccine-led active immunisation is a new approach to target the growth factor pathways allowing for combinations with other small molecule inhibitors in order to obtain a sustained efficacy with an acceptable toxicity. The vaccine inhibits binding of circulating Epidermal Growth Factor (EGF) to its receptor, EGF-R to block downstream activation of cell signaling pathways contributing to tumor growth or other pathophysiologies such as fibrosis. | Biological | Experimental |
Primary outcome
Safety (Frequency/severity of AEs)
Time frame: Through study completion, average 1 year
Frequency and severity of AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria and hematological alterations that are clinical relevant under physician criteria. Data will be presented as number of AEs classified by severity.
3 secondary outcomes
Oxygen saturation
Time frame: baseline and days 1, 14 (w2), 28 (w4), 42 (w6) and 92 (w12); week 24, week 36 and week 52
Quality of life (QoL)
Time frame: baseline and weeks 2, 12, 24, 36 and 52
Fibrotic pulmonary extension (measured as the size of the lesions)
Time frame: baseline and weeks, 12, 24, and 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Pablo Rubinstein, MD, MSc, PhD study chair
Hospital El Pilar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IN01 vaccine in people with Pulmonary Fibrosis and Covid19, run by Instituto Oncológico Dr Rosell at 1 site in Spain.
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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 24 Sep 2020. 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 Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Nepote (934344412, investigacion@mfar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Frequency/severity of AEs) (time frame: Through study completion, average 1 year). 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 24 Sep 2020.