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

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: Pneumonia; Covid19
• Intervention / Treatment: Drug: Sodium Bicarbonate

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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

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

Study record dates

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: COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• 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