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

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.

Unknown status
Coronavirus Infection
Respiratory Disease
SARS (Disease)

Drug: Inhaled Hypertonic ibuprofen

Standard of care plus lipid ibuprofen 50mg tid

Eligibility Criteria

Inclusion Criteria:

1. Provision of written informed consent by the patient OR by the patient's Legal
Representative.

2. Confirmed or suspected SARS-CoV-2 infection;

3. Pneumonia without criteria of severity.

4. With some of the following conditions:

- Diabetes.

- Cardiovascular disease.

- Chronic kidney disease.

- Chronic obstructive pulmonary disease.

- Structural diseases of the lung

- Immunocompromise.

5. 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.

6. No unstable bronchial asthma

Exclusion Criteria:

1. 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.

2. Patients with a history of unstable bronchial asthma

3. The patient is allergic to ibuprofen or any of the compounds in the preparation.

4. Hypersensitivity to the drug, nasal polyps syndrome, angioedema or bronchospasm
against aspirin or other NSAIDs.

5. Pregnant or lactating woman, or positive pregnancy test on a pre-dose exam.

6. Patient who is expected to be transferred to another place other than the place where
the Program starts, within 7 days of starting it.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Argentina
Locations

Centro de Excelencia en Productos y Procesos Córdoba
Córdoba, Argentina

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

Contacts

Dante M Beltramo, PhD
54 9 351 766-8050
dantemiguelbeltramo@gmail.com

Nestor H García, MD, PhD
5493513539948
garcia.nestor@conicet.gov.ar

Dante M Beltramo, PhD, Study Director
Centro de Excelencia en Productos y Procesos Córdoba

Química Luar SRL
NCT Number
MeSH Terms
Coronavirus Infections
Respiratory Tract Diseases
Respiration Disorders
Ibuprofen