Coronavirus Infection, Respiratory Disease, SARS (Disease)
Conditions
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.
Interventions
DRUGInhaled Hypertonic ibuprofen
Standard of care plus lipid ibuprofen 50mg tid
Sponsors
National Council of Scientific and Technical Research, Argentina
Centro de Excelencia en Productos y Procesos Córdoba
Química Luar SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chage in length of Critical Care 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. |
| 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. |
| Time from first dose to conversion to normal or mild pneumonia | 28 days | — |
| Antibiotic requirement | 28 days | — |
| Chage in length of Hospital stay | 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 | — |
| Glucocorticoids requirement | 28 days | — |
| Chage in duration of ventilation | 28 days | — |
Countries
Argentina
Contacts
Primary ContactDante M Beltramo, PhD
Backup ContactNestor H García, MD, PhD
Outcome results
None listed