Management of Covid-19 Patients During Home Isolation | NCT04368923

Studies
Management of Covid-19 Patients During Home Isolation

NCT04368923

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jun 23, 2020Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Covid 19

Interventions

Oxygen Therapy
Physical Therapy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2020Actual

Primary Completion Date

Jun 21, 2020Estimated

Completion Date

Jun 23, 2020Estimated

First Submitted Date

Apr 24, 2020

First Submission Date that Met QC Criteria

Apr 28, 2020

First Posted Date

Apr 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2020

Last Update Posted Date

Jun 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxygen Therapy Group	Experimental		Device: Oxygen Therapy
Physical Therapy Group	Experimental		Procedure: Physical Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxygen Therapy	Device	Patients receive oxygen therapy	Oxygen Therapy Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Vital Signs (Temprature)		24 hours
Vital Signs (Respiratory Rate)		24 hours
Vital Signs (Oxygen Saturation)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33819166	Derived	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.

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

ID	Term
D010102	Oxygen Inhalation Therapy
D026741	Physical Therapy Modalities

ID	Term
D012138	Respiratory Therapy
D013812	Therapeutics
D012046	Rehabilitation