Back to resultsCovid-19 Patients Management During Home Isolation
Primary Purpose
Covid19
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Oxygen therapy and physical therapy
Oxygen therapy
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Covid-19 patients American Society of Anesthesiologists (ASA) class I >= 21 years old <= 40 years old
Exclusion Criteria:
- Not being consistent with home-isolation regimen
Sites / Locations
- A. Sedky
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oxygen therapy and physical therapy
Oxygen therapy
Arm Description
Outcomes
Primary Outcome Measures
Time for recovery of pH
Acidity Potential Hydrogen
Time for recovery of PaO2
Partial Pressure of Oxygen
Time for recovery of PaCO2
Partial Pressure of Carbon Dioxide
Chest CT scan
Chest computed tomography scan
Chest CT scan
Chest computed tomography scan
Secondary Outcome Measures
Time for recovery of Temperature
vital sign
Time for recovery of Respiratory Rate
vital sign
Time for recovery of Oxygen Saturation
vital sign
Time for recovery of Heart Rate
vital sign
Time for recovery of Blood Pressure
vital sign
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04945564
Brief Title
Covid-19 Patients Management During Home Isolation
Official Title
Covid-19 Patients Management During Home Isolation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (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
5. Study Description
Brief Summary
The study will investigate management of Covid-19 patients in home isolation.
Detailed Description
A clinical trial concerned with the treatment of home isolated COVID-19 patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxygen therapy and physical therapy
Arm Type
Experimental
Arm Title
Oxygen therapy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Oxygen therapy and physical therapy
Intervention Description
Patients receive oxygen therapy and physical therapy
Intervention Type
Device
Intervention Name(s)
Oxygen therapy
Intervention Description
Patients receive oxygen therapy
Primary Outcome Measure Information:
Title
Time for recovery of pH
Description
Acidity Potential Hydrogen
Time Frame
24 hours
Title
Time for recovery of PaO2
Description
Partial Pressure of Oxygen
Time Frame
24 hours
Title
Time for recovery of PaCO2
Description
Partial Pressure of Carbon Dioxide
Time Frame
24 hours
Title
Chest CT scan
Description
Chest computed tomography scan
Time Frame
Baseline
Title
Chest CT scan
Description
Chest computed tomography scan
Time Frame
1 day post-treatment
Secondary Outcome Measure Information:
Title
Time for recovery of Temperature
Description
vital sign
Time Frame
24 hours
Title
Time for recovery of Respiratory Rate
Description
vital sign
Time Frame
24 hours
Title
Time for recovery of Oxygen Saturation
Description
vital sign
Time Frame
24 hours
Title
Time for recovery of Heart Rate
Description
vital sign
Time Frame
24 hours
Title
Time for recovery of Blood Pressure
Description
vital sign
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Covid-19 patients American Society of Anesthesiologists (ASA) class I >= 21 years old <= 40 years old
Exclusion Criteria:
Not being consistent with home-isolation regimen
Facility Information:
Facility Name
A. Sedky
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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Covid-19 Patients Management During Home Isolation
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