Clinical trial NCT04382768: Inhaled Ibuprofen to Treat COVID-19
Official title: Extended Compassionate Use Program (UCA) With Inhalational Ibuprofen in Patients With Acute Respiratory Pathology, Mediated by COVID-19.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronavirus Infection
Respiratory Disease
SARS (Disease)
Lead sponsor: Química Luar SRL
Sponsor class: INDUSTRY
Collaborators: name: National Council of Scientific and Technical Research, Argentina
name: Centro de Excelencia en Productos y Procesos Córdoba
First posted: 2020-05-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 7, 14 and 28 days
measure: Change to Negativization of the swab to the following treatment points on day 7, day 14, 21 and 28 after treatment with inhaled Ibuprofen.
timeFrame: 7, 14 and 28 days
Secondary outcomes:
measure: Chage in length of Hospital stay
timeFrame: 28 days
measure: Chage in duration of ventilation
timeFrame: 28 days
measure: Chage in length of Critical Care stay
timeFrame: 28 days
measure: Average score of National Early Warning (NEWS2) between days 1, 7, 14 and 28.
timeFrame: 1, 7, 14 and 28
measure: Average change in quick sepsis-related organ failure assessment score (qSOFA) score between day 1, 7, 14 and 28.
timeFrame: 1, 7, 14 and 28 days
measure: Time from first dose to conversion to normal or mild pneumonia
timeFrame: 28 days
measure: Antibiotic requirement
timeFrame: 28 days
measure: Glucocorticoids requirement
timeFrame: 28 days
measure: Incidence of adverse event
timeFrame: 28 days
measure: Incidence of serious adverse event
timeFrame: 28 days
measure: Number of deaths from any cause at 28 days
timeFrame: 28 days
measure: Lymphocyte count
timeFrame: 28 days
Other outcomes:
Locations:
city: Córdoba
country: Argentina
facility: Centro de Excelencia en Productos y Procesos Córdoba
Study officials:
affiliation: Centro de Excelencia en Productos y Procesos Córdoba
name: Dante M Beltramo, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.