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

October 2, 2020 updated by: Mansoura University

The Role of Sodium Bicarbonate as Adjuvant Treatment of Computed Tomography Identified COVID-19 Pneumonia: A Preliminary Report of Short Term Follow up

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Outside U.S./Canada
      • Mansoura, Outside U.S./Canada, Egypt, 35516
        • Gomhoria Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Mohammed K Elbadrawy, PhD, Chest department Mansoura University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

May 2, 2020

First Submitted That Met QC Criteria

May 2, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sodium Bicarbonate COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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