NCT04945564

Brief Summary

The study will investigate management of Covid-19 patients in home isolation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

August 16, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

June 28, 2021

Last Update Submit

August 13, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (5)

  • Time for recovery of pH

    Acidity Potential Hydrogen

    24 hours

  • Time for recovery of PaO2

    Partial Pressure of Oxygen

    24 hours

  • Time for recovery of PaCO2

    Partial Pressure of Carbon Dioxide

    24 hours

  • Chest CT scan

    Chest computed tomography scan

    Baseline

  • Chest CT scan

    Chest computed tomography scan

    1 day post-treatment

Secondary Outcomes (5)

  • Time for recovery of Temperature

    24 hours

  • Time for recovery of Respiratory Rate

    24 hours

  • Time for recovery of Oxygen Saturation

    24 hours

  • Time for recovery of Heart Rate

    24 hours

  • Time for recovery of Blood Pressure

    24 hours

Study Arms (2)

Oxygen therapy and physical therapy

EXPERIMENTAL
Procedure: Oxygen therapy and physical therapy

Oxygen therapy

ACTIVE COMPARATOR
Device: Oxygen therapy

Interventions

Oxygen therapy and physical therapyPROCEDURE

Patients receive oxygen therapy and physical therapy

Oxygen therapy and physical therapy
Oxygen therapyDEVICE

Patients receive oxygen therapy

Oxygen therapy

Eligibility Criteria

Age20 Years - 42 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Covid-19 patients American Society of Anesthesiologists (ASA) class I \>= 21 years old \<= 40 years old

You may not qualify if:

  • Not being consistent with home-isolation regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A. Sedky

Cairo, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

OxygenPhysical Therapy ModalitiesOxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesTherapeuticsRehabilitationRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2021

First Posted

June 30, 2021

Study Start

June 30, 2021

Primary Completion

August 30, 2021

Study Completion

August 31, 2021

Last Updated

August 16, 2021

Record last verified: 2021-06

Locations

EG(1)