The Role of Sodium Bicarbonate as Adjuvant Treatment of C... | NCT04374591

Studies
The Role of Sodium Bicarbonate as Adjuvant Treatment of Computed Tomography Identified COVID-19 Pneumonia

NCT04374591

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Oct 6, 2020Actual

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Pneumonia
Covid19

Interventions

Sodium Bicarbonate

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

Jul 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

Aug 1, 2020Actual

Primary Completion Date

Nov 1, 2020Estimated

Completion Date

Nov 1, 2020Estimated

First Submitted Date

May 2, 2020

First Submission Date that Met QC Criteria

May 2, 2020

First Posted Date

May 5, 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

Oct 2, 2020

Last Update Posted Date

Oct 6, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

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

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sodium Bicarbonate	Other	Inhalation of Sodium Bicarbonate 8.4% via nebulizer	Drug: Sodium Bicarbonate
Control	Placebo Comparator	placebo	Drug: Sodium Bicarbonate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sodium Bicarbonate	Drug	Inhalation of Sodium Bicarbonate 8.4% via nebulizer	Control Sodium Bicarbonate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to clinical recovery	defined as return of body temperature and relief of cough for more than 72 hours measured in days	7 days

Secondary Outcomes

Measure	Description	Time Frame
Pulmonary recovery status	assessed by Chest CT defined as exacerbated, unchanged, moderately improved (with less than 50% pneumonia resolved) and significantly improved (with more than 50% pneumonia resolved).	7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18 years.
Fever ≥ 38º C with upper respiratory tract manifestations, generalized bone ache with or without gastrointestinal symptoms as diarrhea.
Chest CT with signs suggestive of COVID-19.
Mild and moderate cases of COVID-19 pneumonia with respiratory and hemodynamic stability. - High C reactive protein (CRP).- With or without history of contact with index case who is isolated in a governmental hospital assigned for treatment of patients proved to have RT-PCR positive test for COVID-19
With or without abnormalities in the total or differential white cell count.
Welling to sign a fully informed consent.

Exclusion Criteria:

Severe and critical illness with respiratory failure and/ or hemodynamic instability.
CT with pleural effusion with or without lung cavitation.
Other organ failure.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohammed K Elbadrawy, PhD	Chest department Mansoura University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gomhoria Street		Al Mansurah	Outside U.S./Canada	35516	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia
D000086382	COVID-19

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017693	Sodium Bicarbonate

Ancestor Terms

ID	Term
D001639	Bicarbonates
D002254	Carbonates
D002255	Carbonic Acid
D017554	Carbon Compounds, Inorganic

Browse Leaves

Not provided

Browse Branches

Not provided