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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04374591
• Other study ID #: Sodium Bicarbonate COVID-19
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: July 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Pneumonia

Intervention

Drug:
• Sodium Bicarbonate
Inhalation of Sodium Bicarbonate 8.4% via nebulizer

Locations

Country	Name	City	State
Egypt	Gomhoria Street	Mansoura	Outside U.S./Canada

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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