Inhaled Ibuprofen to Treat COVID-19
- Conditions
- SARS (Disease)Coronavirus InfectionRespiratory Disease
- Interventions
- Registration Number
- NCT04382768
- Lead Sponsor
- Química Luar SRL
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Luarprofen Inhaled Hypertonic ibuprofen Inhaled Hypertonic ibuprofen 50 mg tid
- Primary Outcome Measures
Name Time Method Change to Negativization of the swab to the following treatment points on day 7, day 14, 21 and 28 after treatment with inhaled Ibuprofen. 7, 14 and 28 days Negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
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. 7, 14 and 28 days 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
- Secondary Outcome Measures
Name Time Method Time from first dose to conversion to normal or mild pneumonia 28 days Incidence of adverse event 28 days Chage in length of Hospital stay 28 days Average score of National Early Warning (NEWS2) between days 1, 7, 14 and 28. 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.
Glucocorticoids requirement 28 days Chage in duration of ventilation 28 days Chage in length of Critical Care stay 28 days Average change in quick sepsis-related organ failure assessment score (qSOFA) score between day 1, 7, 14 and 28. 1, 7, 14 and 28 days 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.Antibiotic requirement 28 days Incidence of serious adverse event 28 days Number of deaths from any cause at 28 days 28 days Lymphocyte count 28 days
Trial Locations
- Locations (1)
Centro de Excelencia en Productos y Procesos Córdoba
🇦🇷Córdoba, Argentina