Back to resultsThe Role of Sodium Bicarbonate as Adjuvant Treatment of Computed Tomography Identified COVID-19 Pneumonia
Primary Purpose
Pneumonia, Covid19
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sodium Bicarbonate
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring COVID-19
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.
Sites / Locations
- Gomhoria Street
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Placebo Comparator
Arm Label
Sodium Bicarbonate
Control
Arm Description
Inhalation of Sodium Bicarbonate 8.4% via nebulizer
placebo
Outcomes
Primary Outcome Measures
Time to clinical recovery
defined as return of body temperature and relief of cough for more than 72 hours measured in days
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04374591
Brief Title
The Role of Sodium Bicarbonate as Adjuvant Treatment of Computed Tomography Identified COVID-19 Pneumonia
Official Title
The Role of Sodium Bicarbonate as Adjuvant Treatment of Computed Tomography Identified COVID-19 Pneumonia: A Preliminary Report of Short Term Follow up
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To report the possible role of S.B 8.4% in the treatment of COVID-19pneumonia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Covid19
Keywords
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sodium Bicarbonate
Arm Type
Other
Arm Description
Inhalation of Sodium Bicarbonate 8.4% via nebulizer
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Sodium Bicarbonate
Intervention Description
Inhalation of Sodium Bicarbonate 8.4% via nebulizer
Primary Outcome Measure Information:
Title
Time to clinical recovery
Description
defined as return of body temperature and relief of cough for more than 72 hours measured in days
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Pulmonary recovery status
Description
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).
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed K Elbadrawy, PhD
Organizational Affiliation
Chest department Mansoura University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gomhoria Street
City
Mansoura
State/Province
Outside U.S./Canada
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Role of Sodium Bicarbonate as Adjuvant Treatment of Computed Tomography Identified COVID-19 Pneumonia
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