Inhaled Ibuprofen to Treat COVID-19

Coronavirus Infection Clinical Trial

— CórdobaTrail  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04382768
• Other study ID #: DNL000004
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: January 2021

Study information

• Verified date: June 2020
• Source: Química Luar SRL
• Contact: Dante M Beltramo, PhD
• Phone: 54 9 351 766-8050
• Email: dantemiguelbeltramo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• SARS (Disease)
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Inhaled Hypertonic ibuprofen
Standard of care plus lipid ibuprofen 50mg tid

Locations

Country	Name	City	State
Argentina	Centro de Excelencia en Productos y Procesos Córdoba	Córdoba

Sponsors (3)

Lead Sponsor	Collaborator
Química Luar SRL	Centro de Excelencia en Productos y Procesos Córdoba, National Council of Scientific and Technical Research, Argentina

Country where clinical trial is conducted

Argentina, 

References & Publications (3)

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 — View Citation

Muñoz AJ, Alasino RV, Garro AG, Heredia V, García 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). pii: — View Citation

Veljkovic V, Vergara-Alert J, Segalés 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 targe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Chage in length of Hospital stay		28 days
Secondary	Chage in duration of ventilation		28 days
Secondary	Chage in length of Critical Care stay		28 days
Secondary	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
Secondary	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
Secondary	Time from first dose to conversion to normal or mild pneumonia		28 days
Secondary	Antibiotic requirement		28 days
Secondary	Glucocorticoids requirement		28 days
Secondary	Incidence of adverse event		28 days
Secondary	Incidence of serious adverse event		28 days
Secondary	Number of deaths from any cause at 28 days		28 days
Secondary	Lymphocyte count		28 days