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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001616-18 | EudraCT Number |
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Randomized, prospective, controlled open label clinical trial aimed at investigating if the addition of inhaled corticosteroids (budesonide) reduces treatment failure (defined as a composite variable by the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation, systemic steroids, use of biologics (anti IL-6 or anti IL-1) and/or death) according to hospital standard of care guidance) at day 15 after initiation of therapeutic intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | patients receiving standard of care to treat their pneumonia | |
| Intervention | Experimental | patients receiving standard of care to treat their pneumonia + inhaled budesonide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled budesonide | Drug | adding budesonide to standard of care for pneumonia in COVID19 positive patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in both arms fulfilling the criteria for treatment failure | composite variable that includes the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation and/or death) at day 15 after initiation of therapeutic intervention | 15 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| ICU admission | Yes/no | baseline, day 3, day 7, day 15, day 30 |
| ICU refusal | yes/no and reason | baseline, day3, day 7, day 15, day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Infecciosas "Francisco Javier Muñiz" | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1282AEN | Argentina | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35144989 | Derived | Agusti A, De Stefano G, Levi A, Munoz X, Romero-Mesones C, Sibila O, Lopez-Giraldo A, Plaza Moral V, Curto E, Echazarreta AL, Marquez SE, Pascual-Guardia S, Santos S, Marin A, Valdes L, Saldarini F, Salgado C, Casanovas G, Varea S, Rios J, Faner R. Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial. Eur Respir J. 2022 Mar 10;59(3):2103036. doi: 10.1183/13993003.03036-2021. Print 2022 Mar. | |
| 33844998 |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Occurrence of complications | infectious cardiovascular and /or metabolic complications as well as variation in the 7 point WHO scale. | baseline, day3, day 7, day 15, day 30 |
| lactate dehydrogenase (LDH) | U/L | at baseline, day 3, day 7, day 15, day 30 |
| C Reactive Protein (CRP) | mg/dL | at baseline, day 3, day 7, day 15, day 30 |
| ferritin | ng/mL | at baseline, day 3, day 7, day 15, day 30 |
| D-dimer | ng/mL | at baseline, day 3, day 7, day 15, day 30 |
| leukocyte counts | x10^9/L | at baseline, day 3, day 7, day 15, day 30 |
| CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno") |
| Ciudad Autonoma de Buenos Aires |
| Buenos Aires |
| C1425DQK |
| Argentina |
| Hospital de Rehabilitación Respiratoria "María Ferrer" | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1272AAA | Argentina |
| Hospital Donación "Francisco Santojanni" | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1408INH | Argentina |
| Clínica Monte Grande | Monte Grande | Buenos Aires | B1842 | Argentina |
| Hospital Centro de Salud Zenón J. Santillán | San Miguel de Tucumán | Tucumán Province | T4000 | Argentina |
| Hospital San Juan de Dios | La Plata | B1900 | Argentina |
| Hospital de Santiago | Santiago de Compostela | A Coruña | 15706 | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic of Barcelona | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Derived |
| Agusti A, Torres F, Faner R. Early treatment with inhaled budesonide to prevent clinical deterioration in patients with COVID-19. Lancet Respir Med. 2021 Jul;9(7):682-683. doi: 10.1016/S2213-2600(21)00171-5. Epub 2021 Apr 9. No abstract available. |
| 33388170 | Derived | Farne H, Singanayagam A. Reply. J Allergy Clin Immunol. 2021 Mar;147(3):1117-1118. doi: 10.1016/j.jaci.2020.11.019. Epub 2020 Dec 30. No abstract available. |
| 32738928 | Derived | Nicolau DV, Bafadhel M. Inhaled corticosteroids in virus pandemics: a treatment for COVID-19? Lancet Respir Med. 2020 Sep;8(9):846-847. doi: 10.1016/S2213-2600(20)30314-3. Epub 2020 Jul 30. No abstract available. |
| D007239 |
| Infections |