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NCT05375799: COVID-19
Clinical and Electronic Record for Patients With COVID-19 Treated With the Assisted Breathing Helmet - ELMO in Ceará
trial testing Clinical Observation in COVID-19 in 2,000 participants. Status unknown.
30 August 2022
Quick facts
| Lead sponsor | Escola de Saúde Pública do Ceará |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 2,000 |
| Start date | 1 September 2021 |
| Primary completion | 30 August 2022 |
| Estimated completion | 30 December 2022 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Clinical Observation
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
Escola de Saúde Pública do Ceará
Who can join
18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Continuous positive airway pressure (CPAP) with a helmet-like interface has been described as a safe strategy, with minimal contamination of the environment, improving the oxygenation of patients with acute respiratory failure (ARF) by COVID-19, avoiding intubation in more than half of the cases. ELMOcpap, developed in Ceará, was a great ally in the treatment of these cases during the pandemic in the state. It is estimated that among public and private services, more than 1.400 ELMOs have been applied to patients with COVID-19. However, the determining factors of the success and failure of its use in the different institutions in which it has been applied are still unknown. Therefore, it is necessary to survey all data associated with the use of the device. Objectives: 1. To describe the effects of ELMO in the treatment of patients with hypoxemic respiratory failure due to COVID-19 in a database, in a systematic and standardized way, on clinical history, efficacy, safety, modes, duration of use, the occurrence of adverse events and early predictors of failure. 2. Determine the intubation rate of patients with COVID-19 hypoxemic respiratory failure who used the ELMO. 3. Identify the mortality rate of patients with hypoxemic respiratory failure due to COVID-19 who used the ELMO. Methods: This is a retrospective, multicenter, observational, cohort study of recorded data from patients with COVID-19 hypoxemic respiratory failure who were treated with the ELMO. An online electronic form will be developed with REDCap, where the responsible investigator of each institution will be responsible for filling in the participants' data, ensuring adherence to the protocol and analysis will be carried out of the data of the patients of the participating services of the research that used the ELMO as treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05375799
- Europe PMC full search
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Other Escola de Saúde Pública do Ceará trials
Trials by the same sponsor.
- NCT04470258 — Elmo Respiratory Support Project - COVID-19 · NA · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05375799 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Escola de Saúde Pública do Ceará
- Last refreshed: 14 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05375799.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing