Coronavirus InfectionCórdobaTrailNCT04382768
Inhaled Ibuprofen to Treat COVID-19
A study testing Inhaled Hypertonic ibuprofen in people with Coronavirus Infection and Respiratory Disease, run by Química Luar SRL at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection, Respiratory Disease, SARS (Disease)
- What is being tested?
- Inhaled Hypertonic ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteArgentina
- Study dates
- 1 May 2020to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Centro de Excelencia en Productos y Procesos Córdoba
Córdoba, 5000
German Ambasch, MD, 54 9 351 564-2602, german.ambasch@yahoo.com.ar
Alexis Doreski, MD, 54 9 11 5800-5058, respiramos@yahoo.com.ar
About this study
Official title: 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.
- Conditions
- Coronavirus Infection, Respiratory Disease, SARS (Disease)
- Being tested
- Inhaled Hypertonic ibuprofen
- Medical subject headings
- Coronavirus Infections, Respiration Disorders, Severe Acute Respiratory Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Hypertonic ibuprofenDrug
Standard of care plus lipid ibuprofen 50mg tid
| Study group | Role | What they receive |
|---|---|---|
| Luarprofen | Experimental | Inhaled Hypertonic ibuprofen 50 mg tid Receives: Drug: Inhaled Hypertonic ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 7, 14 and 28 days
Secondary outcomes (12)
Chage in length of Hospital stay
Measured: 28 days
Chage in duration of ventilation
Measured: 28 days
Chage in length of Critical Care stay
Measured: 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.
Measured: 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.
Measured: 1, 7, 14 and 28 days
Time from first dose to conversion to normal or mild pneumonia
Measured: 28 days
Antibiotic requirement
Measured: 28 days
Glucocorticoids requirement
Measured: 28 days
Incidence of adverse event
Measured: 28 days
Incidence of serious adverse event
Measured: 28 days
Number of deaths from any cause at 28 days
Measured: 28 days
Lymphocyte count
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 May 2020
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Química Luar SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Council of Scientific and Technical Research, Argentina, Centro de Excelencia en Productos y Procesos Córdoba
- Responsible party
- Principal investigator, Néstor H García, National Council of Scientific and Technical Research, Argentina
- Investigators
- Dante M Beltramo, PhD, Study director, Centro de Excelencia en Productos y Procesos Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382768
- Sponsor's protocol ID
- DNL000004
- Acronym
- CórdobaTrail
- Status last verified
- Jun 2020
- First submitted
- 6 May 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 29772761He 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.
PubMed 17031779Veljkovic 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.
PubMed 32419926Salva 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.
PubMed 34460083
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Compassionate Use Program (UCA) With Inhalational Ibuprofen in Patients With Acute Respiratory Pathology, Mediated by COVID-19.
- ClinicalTrials.gov ID
- NCT04382768
- Acronym / sponsor ID
- CórdobaTrail / DNL000004
- Conditions
- Coronavirus Infection, Respiratory Disease, SARS (Disease)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Química Luar SRLIndustry (pharma, biotech, devices)
- Collaborators
- National Council of Scientific and Technical Research, Argentina, Centro de Excelencia en Productos y Procesos Córdoba
- Study start
- 1 May 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Luarprofen | Experimental | Drug: Inhaled Hypertonic ibuprofenInhaled Hypertonic ibuprofen 50 mg tid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled Hypertonic ibuprofenStandard of care plus lipid ibuprofen 50mg tid | Drug | Luarprofen |
Primary outcome
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
12 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Results publication: PubMed 29772761Munoz 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 publication: PubMed 17031779He 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 publication: PubMed 32419926Veljkovic 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.
- Derived from this study: PubMed 34460083Salva 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.
- Individual participant dataSharing planned: Yes
Related trials for Coronavirus Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dante M Beltramo, PhD study director
Centro de Excelencia en Productos y Procesos Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaled Hypertonic ibuprofen in people with Coronavirus Infection and Respiratory Disease, run by Química Luar SRL at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dante M Beltramo, PhD (54 9 351 766-8050, dantemiguelbeltramo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04382768, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.