Inhaled Ibuprofen to Treat COVID-19

NCT ID: NCT04382768

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-01-31

Brief Summary

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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

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Conditions

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Coronavirus Infection Respiratory Disease SARS (Disease)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Luarprofen

Inhaled Hypertonic ibuprofen 50 mg tid

Group Type EXPERIMENTAL

Inhaled Hypertonic ibuprofen

Intervention Type DRUG

Standard of care plus lipid ibuprofen 50mg tid

Interventions

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Inhaled Hypertonic ibuprofen

Standard of care plus lipid ibuprofen 50mg tid

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Council of Scientific and Technical Research, Argentina

OTHER_GOV

Sponsor Role collaborator

Centro de Excelencia en Productos y Procesos Córdoba

UNKNOWN

Sponsor Role collaborator

Química Luar SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Néstor H García

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dante M Beltramo, PhD

Role: STUDY_DIRECTOR

Centro de Excelencia en Productos y Procesos Córdoba

Locations

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Centro de Excelencia en Productos y Procesos Córdoba

Córdoba, , Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Dante M Beltramo, PhD

Role: CONTACT

54 9 351 766-8050

Nestor H García, MD, PhD

Role: CONTACT

5493513539948

Facility Contacts

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German Ambasch, MD

Role: primary

54 9 351 564-2602

Alexis Doreski, MD

Role: backup

54 9 11 5800-5058

References

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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.

Reference Type RESULT
PMID: 29772761 (View on PubMed)

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.

Reference Type RESULT
PMID: 17031779 (View on PubMed)

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.

Reference Type RESULT
PMID: 32419926 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34460083 (View on PubMed)

Other Identifiers

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DNL000004

Identifier Type: -

Identifier Source: org_study_id

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