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Lack of financing, lack of COVID19 patients in the ICU.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| BEST AVAILABLE TREATMENT | Active Comparator | Patients will receive best available treatment for COVID-19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality | After 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| PaO2/FiO2 | Ratio calculation | 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 |
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Inclusion Criteria:
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:
Signed informed consent, directly or delegated.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Reina SofÃa | Córdoba | Córdona | 14004 | Spain |
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When study is published.
Send request to access.
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D003333 | Coronaviridae Infections |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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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.
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| BAT | Drug | Patients will receive best available treatment for COVID-19. |
|
Clinical improvement according to WHO scale (World Health Organization) for COVID19 which goes from 1 to 7 points.
| 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) | 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. | 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 | 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% | From randomization until patient doesn't need oxygen to mantain 93% saturation, assessed up to 28 days. |
| Favorable radiological evaluation. | Dictated by 3 radiologists. | From randomization until first documented radiology improvement, assessed up to 28 days. |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |