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

NCT04374591 | Unknown

• 1 other identifier: Sodium Bicarbonate COVID-19
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pneumonia; Covid19

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pulmonary recovery status

  7 days

Study Arms (2)

Sodium Bicarbonate

OTHER

Inhalation of Sodium Bicarbonate 8.4% via nebulizer

Drug: Sodium Bicarbonate

Control

PLACEBO COMPARATOR

placebo

Drug: Sodium Bicarbonate

Interventions

Sodium Bicarbonate DRUG

Inhalation of Sodium Bicarbonate 8.4% via nebulizer

Control; Sodium Bicarbonate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe and critical illness with respiratory failure and/ or hemodynamic instability.
• CT with pleural effusion with or without lung cavitation.
• Other organ failure.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Gomhoria Street

Al Mansurah, Outside U.S./Canada, 35516, Egypt

Location

MeSH Terms

Conditions

Pneumonia; COVID-19

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mohammed K Elbadrawy, PhD

  Chest department Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 5, 2020
• Study Start: August 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)