NCT04587921

Brief Summary

The objective of MoxiCov is to monitor the oximetry of patients admitted to the Covid nursery to provide a more detailed assistance expecting to reduce the amount of hypoxia in these patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2021

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

August 18, 2020

Last Update Submit

October 13, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Feasibility of the system: Determination of the number of valid versus not valid or missed measurements

    Determination of the number of valid versus not valid or missed measurements of each participant.

    6 months

  • Hypoxic burden

    Time spent with SpO2\< 93%, 90% and 85%

    6 months

  • Hypoxic alarm

    Number of times the oximeter record 3 consecutive measurements of SpO2\<90%

    6 months

  • Satisfaction of the nursing, medical team and patients with the implemented system

    Measurement of NET PROMOTING SCORE (NPS). This score will show the satisfaction of the healthcare team with the device. This score have a minimum of 0 points and maximum of 32 points.

    6 months

Secondary Outcomes (5)

  • Time of SpO2<90%, SpO2<85% and SpO2<80%

    6 months

  • Number of false alarms caused by malfunctions or bad oximeter positioning

    6 months

  • Total hospital stay

    6 months

  • Time of supplementary oxygen use

    6 months

  • Mortality of participants

    6 months

Study Arms (1)

Patients monitored with oximeter

EXPERIMENTAL

The first 45 patients will be monitored but the results will not be displayed. The second half of the patients the oximeter will have their monitoring data available online in the ward.

Device: Digital oximeter monitoring

Interventions

Digital oximeter and cardiac frequency monitoring.

Patients monitored with oximeter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old
  • COVID 19 positive or suspected COVID19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundação Zerbini - Instituto do Coração (InCor)

São Paulo, São Paulo, 054039000, Brazil

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor/PI

Study Record Dates

First Submitted

August 18, 2020

First Posted

October 14, 2020

Study Start

June 22, 2020

Primary Completion

January 22, 2021

Study Completion

June 22, 2021

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations