NCT04368923

Brief Summary

This study will be concerned with managing patients of Covid-19 while being home isolated.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

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

March 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

April 24, 2020

Last Update Submit

June 19, 2020

Conditions

Covid 19

Outcome Measures

Primary Outcomes (2)

  • Arterial Blood Gases (ABG): Partial Pressure of Oxygen and Carbon Dioxide

    48 hours

  • Arterial Blood Gases (ABG): Acidity Potential Hydrogen (pH)

    48 hours

Secondary Outcomes (5)

  • Vital Signs (Temprature)

    24 hours

  • Vital Signs (Respiratory Rate)

    24 hours

  • Vital Signs (Oxygen Saturation)

    24 hours

  • Vital Signs (Heart Rate)

    24 hours

  • Vital Signs (Blood Pressure)

    24 hours

Study Arms (2)

Oxygen Therapy Group

EXPERIMENTAL
Device: Oxygen Therapy

Physical Therapy Group

EXPERIMENTAL
Procedure: Physical Therapy

Interventions

Oxygen TherapyDEVICE

Patients receive oxygen therapy

Oxygen Therapy Group
Physical TherapyPROCEDURE

Patients receive physical therapy

Physical Therapy Group

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with Covid-19
  • American Society of Anesthesiologists (ASA) class I
  • \>= 21 years old
  • \<= 40 years old

You may not qualify if:

  • ASA class II, class III or class IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M. Sedky

Cairo, Egypt

Location

Related Publications (1)

  • Adly AS, Adly MS, Adly AS. Telemanagement of Home-Isolated COVID-19 Patients Using Oxygen Therapy With Noninvasive Positive Pressure Ventilation and Physical Therapy Techniques: Randomized Clinical Trial. J Med Internet Res. 2021 Apr 28;23(4):e23446. doi: 10.2196/23446.

    PMID: 33819166DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Oxygen Inhalation TherapyPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 30, 2020

Study Start

March 15, 2020

Primary Completion

June 21, 2020

Study Completion

June 23, 2020

Last Updated

June 23, 2020

Record last verified: 2020-06

Locations

EG(1)