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Inhaled Ibuprofen to Treat COVID-19 (CórdobaTrail)

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ClinicalTrials.gov Identifier: NCT04382768
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
National Council of Scientific and Technical Research, Argentina
Centro de Excelencia en Productos y Procesos Córdoba
Information provided by (Responsible Party):
Néstor H García, National Council of Scientific and Technical Research, Argentina

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Respiratory Disease SARS (Disease) Drug: Inhaled Hypertonic ibuprofen Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extended Compassionate Use Program (UCA) With Inhalational Ibuprofen in Patients With Acute Respiratory Pathology, Mediated by COVID-19.
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Luarprofen
Inhaled Hypertonic ibuprofen 50 mg tid
 Drug: Inhaled Hypertonic ibuprofen
Standard of care plus lipid ibuprofen 50mg tid


Outcome Measures
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Primary Outcome Measures :
  1. 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 Frame: 7, 14 and 28 days ]
    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

  2. Change to Negativization of the swab to the following treatment points on day 7, day 14, 21 and 28 after treatment with inhaled Ibuprofen. [ Time Frame: 7, 14 and 28 days ]
    Negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart


Secondary Outcome Measures :
  1. Chage in length of Hospital stay [ Time Frame: 28 days ]
  2. Chage in duration of ventilation [ Time Frame: 28 days ]
  3. Chage in length of Critical Care stay [ Time Frame: 28 days ]
  4. Average score of National Early Warning (NEWS2) between days 1, 7, 14 and 28. [ Time Frame: 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.

  5. Average change in quick sepsis-related organ failure assessment score (qSOFA) score between day 1, 7, 14 and 28. [ Time Frame: 1, 7, 14 and 28 days ]

    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.


  6. Time from first dose to conversion to normal or mild pneumonia [ Time Frame: 28 days ]
  7. Antibiotic requirement [ Time Frame: 28 days ]
  8. Glucocorticoids requirement [ Time Frame: 28 days ]
  9. Incidence of adverse event [ Time Frame: 28 days ]
  10. Incidence of serious adverse event [ Time Frame: 28 days ]
  11. Number of deaths from any cause at 28 days [ Time Frame: 28 days ]
  12. Lymphocyte count [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382768


Contacts
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Contact: Dante M Beltramo, PhD 54 9 351 766-8050 dantemiguelbeltramo@gmail.com
Contact: Nestor H García, MD, PhD 5493513539948 garcia.nestor@conicet.gov.ar

Locations
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Argentina
Centro de Excelencia en Productos y Procesos Córdoba Recruiting
Córdoba, Argentina, 5000
Contact: German Ambasch, MD    54 9 351 564-2602    german.ambasch@yahoo.com.ar   
Contact: Alexis Doreski, MD    54 9 11 5800-5058    respiramos@yahoo.com.ar   
Sponsors and Collaborators
Química Luar SRL
National Council of Scientific and Technical Research, Argentina
Centro de Excelencia en Productos y Procesos Córdoba
Investigators
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Study Director: Dante M Beltramo, PhD Centro de Excelencia en Productos y Procesos Córdoba
More Information
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Publications of Results:

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Responsible Party: Néstor H García, Principal Investigator, National Council of Scientific and Technical Research, Argentina
ClinicalTrials.gov Identifier: NCT04382768    
Other Study ID Numbers: DNL000004
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiration Disorders
Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action