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NCT05158842: Adult-bCPAP

Treatment of COVID-19 Positive/Negative Bangladeshi Adults With Severe Respiratory Complaints by a Locally Made bCPAP: Feasibility Study

Completed NA Last updated 25 August 2022
What this trial tests

NA trial testing Adult bubble CPAP oxygen therapy device in Severe Pneumonia in 20 participants. Completed in 17 February 2022.

Timeline
8 October 2021
Primary endpoint
17 February 2022
17 February 2022

Quick facts

Lead sponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposedevice feasibility
Enrollment20
Start date8 October 2021
Primary completion17 February 2022
Estimated completion17 February 2022
Sites2 locations across Bangladesh

Drugs / interventions tested

Conditions studied

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh — full company profile →

Who can join

Adults 18 to 64, any sex, with Severe Pneumonia or Acute Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Low and middle-income countries (LMICs) urgently need cost-effective adaptive technologies to provide CPAP. The lead investigator has designed a device that has already been approved by the Directorate General of Drug Administration (DGDA), Government of the People's Republic of Bangladesh. The design of the nasal seal was comfortable and well tolerated by all the participants. Patients were told about some mild discomfort at higher delivered pressures (14 or 15 cm PEEP), consistent with pressurised nasal delivery by similar devices. The safety phase has been initiated since 1st November 2020 and ended in April 2021. One patient withdrew from the study but none of them developed any adverse events. The feasibility phase started at the end of September 2021. Objectives: 1. To evaluate the barriers and operational challenges related to the introduction of adult bubble CPAP oxygen therapy 2. To evaluate the acceptability of introducing adult bubble CPAP in tertiary level hospitals of Bangladesh

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Severe Pneumonia

Currently open trials in the same condition.

Other International Centre for Diarrhoeal Disease Research, Bangladesh trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT05158842.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing