Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04326114
Other study ID # Covid_ISCIII 20/265-E_BS
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 26, 2020
Est. completion date December 20, 2020

Study information

Verified date June 2020
Source Universidad Complutense de Madrid
Contact César Calvo Lobo, PhD
Phone 91 394 1544
Email cescalvo@ucm.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 240
Est. completion date December 20, 2020
Est. primary completion date December 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy subjects

Exclusion Criteria:

- Drugs

- Surgery

- Neurology diseases

- Rheumatic diseases

- Systemic diseases

- Smokers

Study Design


Intervention

Device:
Inspiratory training device
Inspiratory training by a Power-breath device
Expiratory training device
Expiratory training a Winner-flow device

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad Complutense de Madrid

Outcome

Type Measure Description Time frame Safety issue
Primary COVID-19 disease diagnosis Dichotomous categorical variable measured by "yes" or "no" responses Change from Baseline COVID-19 disease diagnosis at 8 weeks
Secondary COVID-19 disease symptoms severity Dichotomous categorical variable measured by "slight" or "severe" responses Change from Baseline COVID-19 disease symptoms severity at 8 weeks
Secondary Adverse effects Polytomous categorical variable measured by adverse effects responses Change from Baseline adverse effects at 8 weeks
See also
  Status Clinical Trial Phase
Completed NCT04485481 - Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers Phase 1
Completed NCT03473236 - Phase 1A Safety Trial of Inhaled PK10571 (GB002) Phase 1
Not yet recruiting NCT03683953 - The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells Phase 1
Recruiting NCT05546567 - NOPARK Open Label Extension Study N/A
Recruiting NCT05413226 - Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility N/A
Recruiting NCT05112159 - Study of IPG1094 in Healthy Participants Phase 1
Completed NCT04689035 - A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144 Phase 1
Completed NCT04335045 - Phase I Study of PH100 (Ecklonia Cava Phlorotannins) Phase 1
Completed NCT05037227 - Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
Recruiting NCT05517291 - DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease N/A
Enrolling by invitation NCT06446778 - Haemodynamic Mechanisms and Multicentre Prospective Cohort Study of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms. Evaluation of the Safety and Efficacy of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms
Recruiting NCT04573049 - The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement Phase 4
Completed NCT05585463 - Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
Completed NCT04188821 - Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander N/A
Completed NCT03667430 - Safety Evaluation of Porous Silica in Men N/A
Completed NCT04499482 - Safety and Tolerability of Soy Fiber N/A
Completed NCT03141905 - Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease N/A
Completed NCT05244161 - A Quasi-experimental Evaluation of the Malezi Program in Tanzania N/A
Recruiting NCT03791372 - Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy Phase 1
Withdrawn NCT04759066 - The HEALiX™ Intubated Patient (IP) Pilot Study N/A