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Inhaled Ibuprofen to Treat COVID-19 (CórdobaTrail)

Primary Purpose

Coronavirus Infection, Respiratory Disease, SARS (Disease)

Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Inhaled Hypertonic ibuprofen
Sponsored by
Química Luar SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Excelencia en Productos y Procesos CórdobaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Luarprofen

Arm Description

Inhaled Hypertonic ibuprofen 50 mg tid

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
May 6, 2020
Last Updated
June 10, 2020
Sponsor
Química Luar SRL
Collaborators
National Council of Scientific and Technical Research, Argentina, Centro de Excelencia en Productos y Procesos Córdoba
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1. Study Identification

Unique Protocol Identification Number
NCT04382768
Brief Title
Inhaled Ibuprofen to Treat COVID-19
Acronym
CórdobaTrail
Official Title
Extended Compassionate Use Program (UCA) With Inhalational Ibuprofen in Patients With Acute Respiratory Pathology, Mediated by COVID-19.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Química Luar SRL
Collaborators
National Council of Scientific and Technical Research, Argentina, Centro de Excelencia en Productos y Procesos Córdoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, Respiratory Disease, SARS (Disease)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Luarprofen
Arm Type
Experimental
Arm Description
Inhaled Hypertonic ibuprofen 50 mg tid
Intervention Type
Drug
Intervention Name(s)
Inhaled Hypertonic ibuprofen
Intervention Description
Standard of care plus lipid ibuprofen 50mg tid
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
7, 14 and 28 days
Title
Change to Negativization of the swab to the following treatment points on day 7, day 14, 21 and 28 after treatment with inhaled Ibuprofen.
Description
Negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Time Frame
7, 14 and 28 days
Secondary Outcome Measure Information:
Title
Chage in length of Hospital stay
Time Frame
28 days
Title
Chage in duration of ventilation
Time Frame
28 days
Title
Chage in length of Critical Care stay
Time Frame
28 days
Title
Average score of National Early Warning (NEWS2) between days 1, 7, 14 and 28.
Description
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.
Time Frame
1, 7, 14 and 28
Title
Average change in quick sepsis-related organ failure assessment score (qSOFA) score between day 1, 7, 14 and 28.
Description
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 Frame
1, 7, 14 and 28 days
Title
Time from first dose to conversion to normal or mild pneumonia
Time Frame
28 days
Title
Antibiotic requirement
Time Frame
28 days
Title
Glucocorticoids requirement
Time Frame
28 days
Title
Incidence of adverse event
Time Frame
28 days
Title
Incidence of serious adverse event
Time Frame
28 days
Title
Number of deaths from any cause at 28 days
Time Frame
28 days
Title
Lymphocyte count
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Diabetes. Cardiovascular disease. Chronic kidney disease. Chronic obstructive pulmonary disease. Structural diseases of the lung Immunocompromise. 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: 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. Patients with a history of unstable bronchial asthma The patient is allergic to ibuprofen or any of the compounds in the preparation. Hypersensitivity to the drug, nasal polyps syndrome, angioedema or bronchospasm against aspirin or other NSAIDs. Pregnant or lactating woman, or positive pregnancy test on a pre-dose exam. Patient who is expected to be transferred to another place other than the place where the Program starts, within 7 days of starting it.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dante M Beltramo, PhD
Phone
54 9 351 766-8050
Email
dantemiguelbeltramo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nestor H García, MD, PhD
Phone
5493513539948
Email
garcia.nestor@conicet.gov.ar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dante M Beltramo, PhD
Organizational Affiliation
Centro de Excelencia en Productos y Procesos Córdoba
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Excelencia en Productos y Procesos Córdoba
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
German Ambasch, MD
Phone
54 9 351 564-2602
Email
german.ambasch@yahoo.com.ar
First Name & Middle Initial & Last Name & Degree
Alexis Doreski, MD
Phone
54 9 11 5800-5058
Email
respiramos@yahoo.com.ar

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
29772761
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.
Results Reference
result
PubMed Identifier
17031779
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.
Results Reference
result
PubMed Identifier
32419926
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.
Results Reference
result
PubMed Identifier
34460083
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.
Results Reference
derived

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Inhaled Ibuprofen to Treat COVID-19

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