Inhaled Ibuprofen to Treat COVID-19

NCT04382768 | Unknown DMC

• 1 other identifier: DNL000004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection; Respiratory Disease; SARS (Disease)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• 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.

  1, 7, 14 and 28

• Average change in quick sepsis-related organ failure assessment score (qSOFA) score between day 1, 7, 14 and 28.

  1, 7, 14 and 28 days

Study Arms (1)

Luarprofen

EXPERIMENTAL

Inhaled Hypertonic ibuprofen 50 mg tid

Drug: Inhaled Hypertonic ibuprofen

Interventions

Inhaled Hypertonic ibuprofen DRUG

Standard of care plus lipid ibuprofen 50mg tid

Luarprofen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Química Luar SRL: lead
• National Council of Scientific and Technical Research, Argentina: collaborator
• Centro de Excelencia en Productos y Procesos Córdoba: collaborator

Study Sites (1)

Centro de Excelencia en Productos y Procesos Córdoba

Córdoba, 5000, Argentina

RECRUITING

Related Publications (4)

• 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.

  PMID: 29772761 RESULT

• 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.

  PMID: 17031779 RESULT

• 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.

  PMID: 32419926 RESULT

• 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.

  PMID: 34460083 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; Respiration Disorders; Severe Acute Respiratory Syndrome; Disease

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Respiratory Tract Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dante M Beltramo, PhD

  Centro de Excelencia en Productos y Procesos Córdoba

  STUDY DIRECTOR

Central Study Contacts

Dante M Beltramo, PhD

CONTACT

54 9 351 766-8050; dantemiguelbeltramo@gmail.com

Nestor H García, MD, PhD

CONTACT

5493513539948; garcia.nestor@conicet.gov.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: May 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

AR (1)