Extended Compassionate Use Program (UCA) With Inhalational Ibuprofen in Patients With Acute Respiratory Pathology, Mediated by COVID-19.

DesconocidoClinicalTrials.gov

ID: NCT04382768Tipo: INTERVENTIONALInicio: 1 de may de 2020Fin estimado: 1 de ene de 2021

Traducción no disponible, mostrando original

Resumen

The study aims to evaluate the reduction in severity and progression of lung injury with inhaled ibuprofen in patients with severe acute respiratory syndrome due to SARS-CoV-2 virus.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Provision of written informed consent by the patient OR by the patient's Legal Representative.
Confirmed or suspected SARS-CoV-2 infection;
Pneumonia without criteria of severity.
With some of the following conditions:
Diabetes.
Cardiovascular disease.
Chronic kidney disease.
Chronic obstructive pulmonary disease.
Structural diseases of the lung
Immunocompromise.
Patient who presents negative results by rtPCR for SARS CoV-2, in case of being highly suspicious, the patient may receive it empirically until the results are obtained.
No unstable bronchial asthma

Criterios de exclusión

The doctor considers that participation in the Program is not the best for patients or for any condition that prevents the Program from being followed safely.
Patients with a history of unstable bronchial asthma
The patient is allergic to ibuprofen or any of the compounds in the preparation.
Hypersensitivity to the drug, nasal polyps syndrome, angioedema or bronchospasm against aspirin or other NSAIDs.
Pregnant or lactating woman, or positive pregnancy test on a pre-dose exam.
Patient who is expected to be transferred to another place other than the place where the Program starts, within 7 days of starting it.

Intervenciones

drug

Inhaled Hypertonic ibuprofen

Standard of care plus lipid ibuprofen 50mg tid

Ubicaciones

Centro de Excelencia en Productos y Procesos Córdoba

Córdoba, Argentina

German Ambasch, MD · german.ambasch@yahoo.com.ar · 54 9 351 564-2602

RECRUITING

Patrocinadores

PrincipalQuímica Luar SRL

ColaboradorNational Council of Scientific and Technical Research, Argentina

ColaboradorCentro de Excelencia en Productos y Procesos Córdoba

Contactos

Dante M Beltramo, PhD

CONTACT

dantemiguelbeltramo@gmail.com 54 9 351 766-8050

Nestor H García, MD, PhD

CONTACT

garcia.nestor@conicet.gov.ar 5493513539948

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