Covid19NCT04945564
Covid-19 Patients Management During Home Isolation
A study testing Oxygen therapy and physical therapy and Oxygen therapy in people with Covid19, run by Cairo University at 1 site in Egypt.
Trial summary
The study will investigate management of Covid-19 patients in home isolation. Read more about this study
- Who is it for?
- Ages 20 to 42 years
- Conditions the study is for
- Covid19
- What is being tested?
- Oxygen therapy and physical therapy and Oxygen therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2021to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 42 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Covid-19 patients American Society of Anesthesiologists (ASA) class I >= 21 years old <= 40 years old
Who cannot join
- Not being consistent with home-isolation regimen
Trial locations and contacts
1 site in 1 country.
About this study
The study will investigate management of Covid-19 patients in home isolation.
Read the detailed description
A clinical trial concerned with the treatment of home isolated COVID-19 patients
- Conditions
- Covid19
- Being tested
- Oxygen therapy and physical therapy, Oxygen therapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen therapy and physical therapyProcedure or surgery
Patients receive oxygen therapy and physical therapy
Oxygen therapyDevice
Patients receive oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| Oxygen therapy and physical therapy | Experimental | Not described Receives: Procedure: Oxygen therapy and physical therapy |
| Oxygen therapy | Active comparator | Not described Receives: Device: Oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for recovery of pH
Acidity Potential Hydrogen
Measured: 24 hours
Time for recovery of PaO2
Partial Pressure of Oxygen
Measured: 24 hours
Time for recovery of PaCO2
Partial Pressure of Carbon Dioxide
Measured: 24 hours
Chest CT scan
Chest computed tomography scan
Measured: Baseline
Chest CT scan
Chest computed tomography scan
Measured: 1 day post-treatment
Secondary outcomes (5)
Time for recovery of Temperature
vital sign
Measured: 24 hours
Time for recovery of Respiratory Rate
vital sign
Measured: 24 hours
Time for recovery of Oxygen Saturation
vital sign
Measured: 24 hours
Time for recovery of Heart Rate
vital sign
Measured: 24 hours
Time for recovery of Blood Pressure
vital sign
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start30 Jun 2021
- Primary completion30 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Sedky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945564
- Sponsor's protocol ID
- REC/036-2021
- Status last verified
- Jun 2021
- First submitted
- 28 Jun 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Patients Management During Home Isolation
- ClinicalTrials.gov ID
- NCT04945564
- Acronym / sponsor ID
- REC/036-2021
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen therapy and physical therapy | Experimental | Procedure: Oxygen therapy and physical therapy |
| Oxygen therapy | Active comparator | Device: Oxygen therapy |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Covid-19 patients American Society of Anesthesiologists (ASA) class I >= 21 years old <= 40 years old
Key exclusion criteria (1 listed)
- Not being consistent with home-isolation regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen therapy and physical therapyPatients receive oxygen therapy and physical therapy | Procedure or surgery | Oxygen therapy and physical therapy |
| Oxygen therapyPatients receive oxygen therapy | Device | Oxygen therapy |
Primary outcome
Time for recovery of pH
Time frame: 24 hours
Acidity Potential Hydrogen
Time for recovery of PaO2
Time frame: 24 hours
Partial Pressure of Oxygen
Time for recovery of PaCO2
Time frame: 24 hours
Partial Pressure of Carbon Dioxide
Chest CT scan
Time frame: Baseline
Chest computed tomography scan
Chest CT scan
Time frame: 1 day post-treatment
Chest computed tomography scan
5 secondary outcomes
Time for recovery of Temperature
Time frame: 24 hours
Time for recovery of Respiratory Rate
Time frame: 24 hours
Time for recovery of Oxygen Saturation
Time frame: 24 hours
Time for recovery of Heart Rate
Time frame: 24 hours
Time for recovery of Blood Pressure
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen therapy and physical therapy and Oxygen therapy in people with Covid19, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for recovery of pH (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.