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Trial - NCT04954014


Column Value
Trial registration number NCT04954014
Full text link
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04954014

First author
Last imported at : Sept. 7, 2021, 2 a.m.
Source : ClinicalTrials.gov

Antonio Miguel Luque Pineda

Contact
Last imported at : Sept. 7, 2021, 2 a.m.
Source : ClinicalTrials.gov

uicec@imibic.org

Registration date
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

2021-07-08

Recruitment status
Last imported at : Sept. 7, 2021, 2 a.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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: respiratory distress: tachypnea> 30 breaths / minute partial arterial oxygen pressure (pao2) / fraction of inspiration (fio2) ≤ 300 mmhg signed informed consent, directly or delegated.

Exclusion criteria
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

- 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. - 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.

Number of arms
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Maimónides Biomedical Research Institute of Córdoba

Inclusion age min
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

90

Countries
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Spain

Type of patients
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Severe/critical disease at enrollment

Severity scale
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Sept. 7, 2021, 2 a.m.
Source : ClinicalTrials.gov

21

primary outcome
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Mortality

Notes
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 197, "treatment_name": "Bevacizumab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]