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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04374591
Recruitment Status : Active, not recruiting
First Posted : May 5, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:
To report the possible role of S.B 8.4% in the treatment of COVID-19pneumonia.

Condition or disease Intervention/treatment Phase
Pneumonia Covid19 Drug: Sodium Bicarbonate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Sodium Bicarbonate
Inhalation of Sodium Bicarbonate 8.4% via nebulizer
Drug: Sodium Bicarbonate
Inhalation of Sodium Bicarbonate 8.4% via nebulizer

Placebo Comparator: Control
placebo
Drug: Sodium Bicarbonate
Inhalation of Sodium Bicarbonate 8.4% via nebulizer




Primary Outcome Measures :
  1. Time to clinical recovery [ Time Frame: 7 days ]
    defined as return of body temperature and relief of cough for more than 72 hours measured in days


Secondary Outcome Measures :
  1. Pulmonary recovery status [ Time Frame: 7 days ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374591


Locations
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Egypt
Gomhoria Street
Mansoura, Outside U.S./Canada, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Mohammed K Elbadrawy, PhD Chest department Mansoura University Hospital
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT04374591    
Other Study ID Numbers: Sodium Bicarbonate COVID-19
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mansoura University:
COVID-19
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections