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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

Tracking Information
First Submitted Date  ICMJE May 6, 2020
First Posted Date  ICMJE May 11, 2020
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • Chage in length of Hospital stay [ Time Frame: 28 days ]
  • Chage in duration of ventilation [ Time Frame: 28 days ]
  • Chage in length of Critical Care stay [ Time Frame: 28 days ]
  • 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.
  • 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.
  • Time from first dose to conversion to normal or mild pneumonia [ Time Frame: 28 days ]
  • Antibiotic requirement [ Time Frame: 28 days ]
  • Glucocorticoids requirement [ Time Frame: 28 days ]
  • Incidence of adverse event [ Time Frame: 28 days ]
  • Incidence of serious adverse event [ Time Frame: 28 days ]
  • Number of deaths from any cause at 28 days [ Time Frame: 28 days ]
  • Lymphocyte count [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled Ibuprofen to Treat COVID-19
Official Title  ICMJE Extended Compassionate Use Program (UCA) With Inhalational Ibuprofen in Patients With Acute Respiratory Pathology, Mediated by COVID-19.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Coronavirus Infection
  • Respiratory Disease
  • SARS (Disease)
Intervention  ICMJE Drug: Inhaled Hypertonic ibuprofen
Standard of care plus lipid ibuprofen 50mg tid
Study Arms  ICMJE Experimental: Luarprofen
Inhaled Hypertonic ibuprofen 50 mg tid
Intervention: Drug: Inhaled Hypertonic ibuprofen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
40
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04382768
Other Study ID Numbers  ICMJE DNL000004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Néstor H García, National Council of Scientific and Technical Research, Argentina
Study Sponsor  ICMJE Química Luar SRL
Collaborators  ICMJE
  • National Council of Scientific and Technical Research, Argentina
  • Centro de Excelencia en Productos y Procesos Córdoba
Investigators  ICMJE
Study Director: Dante M Beltramo, PhD Centro de Excelencia en Productos y Procesos Córdoba
PRS Account Química Luar SRL
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP