Inhaled Ibuprofen to Treat COVID-19 (CórdobaTrail)

Quimica Luar

Status: Unknown

Conditions: Respiratory Disease; SARS (Disease); Coronavirus Infection

Treatments: Drug: Inhaled Hypertonic ibuprofen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04382768

DNL000004

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Luarprofen

Experimental group

Description:

Inhaled Hypertonic ibuprofen 50 mg tid

Treatment:

Drug: Inhaled Hypertonic ibuprofen