Inhaled Ibuprofen to Treat COVID-19 (CórdobaTrail)

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronavirus Infection; Respiratory Disease; SARS (Disease)
• Intervention / Treatment: Drug: Inhaled Hypertonic ibuprofen

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, 5000
    • Recruiting
    • Centro de Excelencia en Productos y Procesos Córdoba
    • Contact: German Ambasch, MD; Phone Number: 54 9 351 564-2602; Email: german.ambasch@yahoo.com.ar
    • Contact: Alexis Doreski, MD; Phone Number: 54 9 11 5800-5058; Email: respiramos@yahoo.com.ar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Luarprofen; Inhaled Hypertonic ibuprofen 50 mg tid	Drug: Inhaled Hypertonic ibuprofen; Standard of care plus lipid ibuprofen 50mg tid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Química Luar SRL
• Collaborators: National Council of Scientific and Technical Research, Argentina; Centro de Excelencia en Productos y Procesos Córdoba
• Investigators: Study Director: Dante M Beltramo, PhD, Centro de Excelencia en Productos y Procesos Córdoba

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections; Respiration Disorders; Respiratory Tract Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: DNL000004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No