Back to resultsManagement of Covid-19 Patients During Home Isolation
Primary Purpose
Covid 19
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Oxygen Therapy
Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Covid 19
Eligibility Criteria
Inclusion Criteria:
- Patients with Covid-19
- American Society of Anesthesiologists (ASA) class I
- >= 21 years old
- <= 40 years old
Exclusion Criteria:
- ASA class II, class III or class IV
Sites / Locations
- M. Sedky
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Oxygen Therapy Group
Physical Therapy Group
Arm Description
Outcomes
Primary Outcome Measures
Arterial Blood Gases (ABG): Partial Pressure of Oxygen and Carbon Dioxide
Arterial Blood Gases (ABG): Acidity Potential Hydrogen (pH)
Secondary Outcome Measures
Vital Signs (Temprature)
Vital Signs (Respiratory Rate)
Vital Signs (Oxygen Saturation)
Vital Signs (Heart Rate)
Vital Signs (Blood Pressure)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04368923
Brief Title
Management of Covid-19 Patients During Home Isolation
Official Title
Management of Covid-19 Patients During Home Isolation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
June 21, 2020 (Anticipated)
Study Completion Date
June 23, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will be concerned with managing patients of Covid-19 while being home isolated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid 19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxygen Therapy Group
Arm Type
Experimental
Arm Title
Physical Therapy Group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Oxygen Therapy
Intervention Description
Patients receive oxygen therapy
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Intervention Description
Patients receive physical therapy
Primary Outcome Measure Information:
Title
Arterial Blood Gases (ABG): Partial Pressure of Oxygen and Carbon Dioxide
Time Frame
48 hours
Title
Arterial Blood Gases (ABG): Acidity Potential Hydrogen (pH)
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Vital Signs (Temprature)
Time Frame
24 hours
Title
Vital Signs (Respiratory Rate)
Time Frame
24 hours
Title
Vital Signs (Oxygen Saturation)
Time Frame
24 hours
Title
Vital Signs (Heart Rate)
Time Frame
24 hours
Title
Vital Signs (Blood Pressure)
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Covid-19
American Society of Anesthesiologists (ASA) class I
>= 21 years old
<= 40 years old
Exclusion Criteria:
ASA class II, class III or class IV
Facility Information:
Facility Name
M. Sedky
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
33819166
Citation
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.
Results Reference
derived
Learn more about this trial
Management of Covid-19 Patients During Home Isolation
We'll reach out to this number within 24 hrs