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| Name | Class |
|---|---|
| National Council of Scientific and Technical Research, Argentina | OTHER_GOV |
| Centro de Excelencia en Productos y Procesos Córdoba | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luarprofen | Experimental | Inhaled Hypertonic ibuprofen 50 mg tid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Hypertonic ibuprofen | Drug | Standard of care plus lipid ibuprofen 50mg tid |
|
| 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 |
| 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 |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dante M Beltramo, PhD | Contact | 54 9 351 766-8050 | dantemiguelbeltramo@gmail.com | |
| Nestor H GarcÃa, MD, PhD | Contact | 5493513539948 | garcia.nestor@conicet.gov.ar |
| Name | Affiliation | Role |
|---|---|---|
| Dante M Beltramo, PhD | Centro de Excelencia en Productos y Procesos Córdoba | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Excelencia en Productos y Procesos Córdoba | Recruiting | Córdoba | 5000 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29772761 | Result | Munoz AJ, Alasino RV, Garro AG, Heredia V, Garcia NH, Cremonezzi DC, Beltramo DM. High Concentrations of Sodium Chloride Improve Microbicidal Activity of Ibuprofen against Common Cystic Fibrosis Pathogens. Pharmaceuticals (Basel). 2018 May 17;11(2):47. doi: 10.3390/ph11020047. | |
| 17031779 | Result | He L, Ding Y, Zhang Q, Che X, He Y, Shen H, Wang H, Li Z, Zhao L, Geng J, Deng Y, Yang L, Li J, Cai J, Qiu L, Wen K, Xu X, Jiang S. Expression of elevated levels of pro-inflammatory cytokines in SARS-CoV-infected ACE2+ cells in SARS patients: relation to the acute lung injury and pathogenesis of SARS. J Pathol. 2006 Nov;210(3):288-97. doi: 10.1002/path.2067. |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D012120 | Respiration Disorders |
| D045169 | Severe Acute Respiratory Syndrome |
| D004194 | Disease |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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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.
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| 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 |
| 32419926 | Result | Veljkovic V, Vergara-Alert J, Segales J, Paessler S. Use of the informational spectrum methodology for rapid biological analysis of the novel coronavirus 2019-nCoV: prediction of potential receptor, natural reservoir, tropism and therapeutic/vaccine target. F1000Res. 2020 Jan 27;9:52. doi: 10.12688/f1000research.22149.4. eCollection 2020. |
| 34460083 | Derived | Salva O, Doreski PA, Giler CS, Quinodoz DC, Guzman LG, Munoz SE, Carrillo MN, Porta DJ, Ambasch G, Coscia E, Diaz JLT, Bueno GD, Fandi JO, Maldonado MA, Pena Chiappero LE, Fournier F, Perez HA, Quiroga MA, Sala Mercado JA, Martinez Picco C, Beltran MA, Arganaras LA, Rios NM, Kalayan GI, Beltramo DM, Garcia NH. Reversal of SARS-CoV2-Induced Hypoxia by Nebulized Sodium Ibuprofenate in a Compassionate Use Program. Infect Dis Ther. 2021 Dec;10(4):2511-2524. doi: 10.1007/s40121-021-00527-2. Epub 2021 Aug 30. |
| D007239 |
| Infections |
| D012140 | Respiratory Tract Diseases |
| D012141 | Respiratory Tract Infections |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |