- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04945564
Covid-19 Patients Management During Home Isolation
August 13, 2021 updated by: A. Sedky, Cairo University
The study will investigate management of Covid-19 patients in home isolation.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
A clinical trial concerned with the treatment of home isolated COVID-19 patients
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- A. Sedky
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 42 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Oxygen therapy and physical therapy
|
Patients receive oxygen therapy and physical therapy
|
|
Active Comparator: Oxygen therapy
|
Patients receive oxygen therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time for recovery of pH
Time Frame: 24 hours
|
Acidity Potential Hydrogen
|
24 hours
|
|
Time for recovery of PaO2
Time Frame: 24 hours
|
Partial Pressure of Oxygen
|
24 hours
|
|
Time for recovery of PaCO2
Time Frame: 24 hours
|
Partial Pressure of Carbon Dioxide
|
24 hours
|
|
Chest CT scan
Time Frame: Baseline
|
Chest computed tomography scan
|
Baseline
|
|
Chest CT scan
Time Frame: 1 day post-treatment
|
Chest computed tomography scan
|
1 day post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time for recovery of Temperature
Time Frame: 24 hours
|
vital sign
|
24 hours
|
|
Time for recovery of Respiratory Rate
Time Frame: 24 hours
|
vital sign
|
24 hours
|
|
Time for recovery of Oxygen Saturation
Time Frame: 24 hours
|
vital sign
|
24 hours
|
|
Time for recovery of Heart Rate
Time Frame: 24 hours
|
vital sign
|
24 hours
|
|
Time for recovery of Blood Pressure
Time Frame: 24 hours
|
vital sign
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2021
Primary Completion (Anticipated)
August 30, 2021
Study Completion (Anticipated)
August 31, 2021
Study Registration Dates
First Submitted
June 28, 2021
First Submitted That Met QC Criteria
June 28, 2021
First Posted (Actual)
June 30, 2021
Study Record Updates
Last Update Posted (Actual)
August 16, 2021
Last Update Submitted That Met QC Criteria
August 13, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/036-2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.