Inhaled Ibuprofen to Treat COVID-19

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronavirus Infection, Respiratory Disease, SARS (Disease)

Intervention / Treatment
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* Drug: Inhaled Hypertonic ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is an expanded compassionate use program for patients infected with SARS-CoV-2. All patients or their legally authorized representative must provide written informed consent and the patient will be examined to assess their eligibility. Eligible patients will receive inhalation ibuprofen ate three times a day, plus standard care, until the patient became negative, or their physician considers enough or the patient requested to stop.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Luarprofen<br>Inhaled Hypertonic ibuprofen 50 mg tid | Drug: Inhaled Hypertonic ibuprofen<br>* Standard of care plus lipid ibuprofen 50mg tid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the scale of ordinary COVID results at 7, 14 and 28 days in patients with acute respiratory infection, induced by SARS-CoV-2, treated with inhaled Ibuprofen. | Time to clinical improvement: defined as time from inhaled Ibuprofen first dose to an improvement of three points from the status on a seven-category ordinary scale | 7, 14 and 28 days | 
| Change to Negativization of the swab to the following treatment points on day 7, day 14, 21 and 28 after treatment with inhaled Ibuprofen. | Negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart | 7, 14 and 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chage in length of Hospital stay |  | 28 days | 
| Chage in duration of ventilation |  | 28 days | 
| Chage in length of Critical Care stay |  | 28 days | 
| Average score of National Early Warning (NEWS2) between days 1, 7, 14 and 28. | NEWS2 score 20 points is the maximum and indicates that the patient needs emergent assessment by a clinical team or critical care team and usually transfer to higher level of care. | 1, 7, 14 and 28 | 
| Average change in quick sepsis-related organ failure assessment score (qSOFA) score between day 1, 7, 14 and 28. | qSOFA, score for sepsis, a maximum value of 3 indicates high risk qSOFA Scores 2-3 are associated with a 3- to 14-fold increase in in-hospital mortality. Assess for evidence of organ dysfunction with blood testing including serum lactate and calculation of the full SOFA Score. Patients meeting these qSOFA criteria should have infection considered even if it was previously not. | 1, 7, 14 and 28 days | 
| Time from first dose to conversion to normal or mild pneumonia |  | 28 days | 
| Antibiotic requirement |  | 28 days | 
| Glucocorticoids requirement |  | 28 days | 
| Incidence of adverse event |  | 28 days | 
| Incidence of serious adverse event |  | 28 days | 
| Number of deaths from any cause at 28 days |  | 28 days | 
| Lymphocyte count |  | 28 days |