ARDS, HumanPhase 2BEVACORNCT04954014
Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients
A Phase 2 study testing Bevacizumab and BAT in people with ARDS, Human and Coronavirus Infection, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
Our hypothesis is that treating ARDS caused by COVID-19 with bevacizumab improves mortality. This is a phase II, multi-centered, randomized, open label, two-armed clinical trial to study the safety and efficacy of bevacizumab in COVID-19 positive patients who consequently developed ARDS (acute respiratory distress… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ARDS, Human, Coronavirus Infection
- What is being tested?
- Bevacizumab and BAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 31 Aug 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal or over 18 and under 90 years old.
- Confirmed COVID-19 positive diagnostic through PCR.
- Radiological image compatible with non-cardiogenic bilateral pleuropulmonary exudate.
- Patient has received anti-viral and anti-inflammatory therapy.
- Present any of the following clinical-functional criteria:
- Respiratory distress: Tachypnea> 30 breaths / minute
- Partial arterial oxygen pressure (PaO2) / Fraction of inspiration (FiO2) ≤ 300 mmHg
- Signed informed consent, directly or delegated.
Who cannot join
- Severe liver dysfunction (Child Pugh ≥ 3 or AST> 5 times normal)
- Severe renal dysfunction with glomerular filtration <30 mL / minute or under treatment with hemodialysis or peritoneal dialysis.
- Poorly controlled hypertension (BPs> 160 mmHg or TAd <100 mmHg) or having a history previous hypertensive crisis or hypertensive encephalopathy.
- History of poorly controlled heart disease with a NYHA> 2.
- History of thrombosis in the previous 6 months.
- Signs of active bleeding.
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- Open wounds, gastrointestinal perforation.
- Diagnosis of thrombophilic diseases or hemorrhagic diathesis.
- Active viral hepatitis or HIV not properly treated.
- Intolerance or allergy to bevacizumab or its components.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Our hypothesis is that treating ARDS caused by COVID-19 with bevacizumab improves mortality. This is a phase II, multi-centered, randomized, open label, two-armed clinical trial to study the safety and efficacy of bevacizumab in COVID-19 positive patients who consequently developed ARDS (acute respiratory distress syndrome) and who have previously received anti-viral and anti-inflammatory treatment.
Read the detailed description
The vascular endothelial growth factor (VEGF) improves vascular capillarity, which plays an important role in the uncontrolled inflammatory reaction that happens in ARDS. As opposed to this event, angiogenic therapy (like bevacizumab) is known to contribute to normal vascularization, relevant for regaining vascular permeability. Studies in animal models have shown that treating ARDS with anti-VEGF therapy is effective.
- Conditions
- ARDS, Human, Coronavirus Infection
- Being tested
- Bevacizumab, BAT
- Keywords
- ARDS, SARS-CoV-2, Bevacizumab
- Medical subject headings
- Respiratory Distress Syndrome, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Patients will receive best available treatment (BAT) for COVID-19 plus a single dose of bevacizumab calculated as 7,5 mg/kg diluted in 250cc of saline solution during 90 minutes.
BATDrug
Patients will receive best available treatment for COVID-19.
| Study group | Role | What they receive |
|---|---|---|
| BEVACIZUMAB | Experimental | Patients will receive best available treatment (BAT) for COVID-19 plus single dose bevacizumab calculated as 7,5 mg/kg diluted in 250cc of saline solution during 90 minutes. Receives: Drug: Bevacizumab |
| BEST AVAILABLE TREATMENT | Active comparator | Patients will receive best available treatment for COVID-19. Receives: Drug: BAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality
Measured: After 28 days
Secondary outcomes (7)
PaO2/FiO2
Ratio calculation
Measured: 6 hours before bevacizumab administration and 24 hours,72 hours,7 days,14 days and 28 days after.
Clinical improvement according to scale recommended by WHO for COVID19
Clinical improvement according to WHO scale (World Health Organization) for COVID19 which goes from 1 to 7 points.
Measured: 24 hours, 72 hours, 7 days, 14 days and 28 days after treatment.
Time to clinical improvement as stated in the National Early Warning Score 2 (NEWS)
NEWS assesses clinical risk on a scale of 1 (low) to 8 (high)
Measured: From randomization until improvement of 2 points in the scale or until hospital discharge, whatever happens first, assessed up to 28 days.
Time to improvement of oxygenation
Improvement shown during, at least, 48 hours.
Measured: From randomization until outcome event assessed up to 28 days.
Time to improvement of Sp2/O2 ratio regarding the worst Sp2/O2 ratio obtained before bevacizumab treatment.
Time to improvement of Sp2/O2 ratio regarding the worst Sp2/O2 ratio obtained before bevacizumab treatment
Measured: From randomization until first documented Sp2/O2 ratio improvement, assessed up to 28 days.
Time to absence of oxygen need to maintain a saturation equal or over 93%
Time to absence of oxygen need to maintain a saturation equal or over 93%
Measured: From randomization until patient doesn't need oxygen to mantain 93% saturation, assessed up to 28 days.
Favorable radiological evaluation.
Dictated by 3 radiologists.
Measured: From randomization until first documented radiology improvement, assessed up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Sep 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Why it stopped: Lack of financing, lack of COVID19 patients in the ICU.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies 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
- Model description
- Phase II, multi-centered, randomized, open label, two-armed clinical trial to study the safety and efficacy of bevacizumab in COVID-19 positive patients who consequently developed ARDS (acute respiratory distress syndrome) and who have previously received anti-viral and anti-inflammatory treatment.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954014
- Sponsor's protocol ID
- BEVACOR
- Acronym
- BEVACOR
- Status last verified
- Aug 2021
- First submitted
- 6 Jul 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04954014
- Acronym / sponsor ID
- BEVACOR / BEVACOR
- Conditions
- ARDS, Human, Coronavirus Infection
- Keywords
- ARDS, SARS-CoV-2, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of financing, lack of COVID19 patients in the ICU.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 8 Jul 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.
Our hypothesis is that treating ARDS caused by COVID-19 with bevacizumab improves mortality. This is a phase II, multi-centered, randomized, open label, two-armed clinical trial to study the safety and efficacy of bevacizumab in COVID-19 positive patients who consequently developed ARDS (acute respiratory distress syndrome) and who have previously received anti-viral and anti-inflammatory treatment.
Detailed description
The vascular endothelial growth factor (VEGF) improves vascular capillarity, which plays an important role in the uncontrolled inflammatory reaction that happens in ARDS. As opposed to this event, angiogenic therapy (like bevacizumab) is known to contribute to normal vascularization, relevant for regaining vascular permeability. Studies in animal models have shown that treating ARDS with anti-VEGF therapy is effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase II, multi-centered, randomized, open label, two-armed clinical trial to study the safety and efficacy of bevacizumab in COVID-19 positive patients who consequently developed ARDS (acute respiratory distress syndrome) and who have previously received anti-viral and anti-inflammatory treatment.
| Arm | Type | Receives |
|---|---|---|
| BEVACIZUMAB | Experimental | Drug: BevacizumabPatients will receive best available treatment (BAT) for COVID-19 plus single dose bevacizumab calculated as 7,5 mg/kg diluted in 250cc of saline solution during 90 minutes. |
| BEST AVAILABLE TREATMENT | Active comparator | Drug: BATPatients will receive best available treatment for COVID-19. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age equal or over 18 and under 90 years old.
- Confirmed COVID-19 positive diagnostic through PCR.
- Radiological image compatible with non-cardiogenic bilateral pleuropulmonary exudate.
- Patient has received anti-viral and anti-inflammatory therapy.
- Present any of the following clinical-functional criteria:
Key exclusion criteria (11 listed)
- Severe liver dysfunction (Child Pugh ≥ 3 or AST> 5 times normal)
- Severe renal dysfunction with glomerular filtration <30 mL / minute or under treatment with hemodialysis or peritoneal dialysis.
- Poorly controlled hypertension (BPs> 160 mmHg or TAd <100 mmHg) or having a history previous hypertensive crisis or hypertensive encephalopathy.
- History of poorly controlled heart disease with a NYHA> 2.
- History of thrombosis in the previous 6 months.
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 |
|---|---|---|
| BevacizumabPatients will receive best available treatment (BAT) for COVID-19 plus a single dose of bevacizumab calculated as 7,5 mg/kg diluted in 250cc of saline solution during 90 minutes. | Drug | BEVACIZUMAB |
| BATPatients will receive best available treatment for COVID-19. | Drug | BEST AVAILABLE TREATMENT |
Primary outcome
Mortality
Time frame: After 28 days
Mortality
7 secondary outcomes
PaO2/FiO2
Time frame: 6 hours before bevacizumab administration and 24 hours,72 hours,7 days,14 days and 28 days after.
Clinical improvement according to scale recommended by WHO for COVID19
Time frame: 24 hours, 72 hours, 7 days, 14 days and 28 days after treatment.
Time to clinical improvement as stated in the National Early Warning Score 2 (NEWS)
Time frame: From randomization until improvement of 2 points in the scale or until hospital discharge, whatever happens first, assessed up to 28 days.
Time to improvement of oxygenation
Time frame: From randomization until outcome event assessed up to 28 days.
Time to improvement of Sp2/O2 ratio regarding the worst Sp2/O2 ratio obtained before bevacizumab treatment.
Time frame: From randomization until first documented Sp2/O2 ratio improvement, assessed up to 28 days.
Time to absence of oxygen need to maintain a saturation equal or over 93%
Time frame: From randomization until patient doesn't need oxygen to mantain 93% saturation, assessed up to 28 days.
Favorable radiological evaluation.
Time frame: From randomization until first documented radiology improvement, assessed up to 28 days.
Results and safety
The study was stopped early (reason given: Lack of financing, lack of COVID19 patients in the ICU.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Yes
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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 testing Bevacizumab and BAT in people with ARDS, Human and Coronavirus Infection, run by Maimónides Biomedical Research Institute of Córdoba 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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 5 Sep 2021. 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 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 was stopped early (reason given: Lack of financing, lack of COVID19 patients in the ICU.). Results are not available in the source record.
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?
Mortality (time frame: After 28 days). 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 5 Sep 2021.