A Randomized Controlled Trial to Investigate The Role of Adjuvant Inhalable Sodium Bicarbonate Solution 8.4% in Treatment of COVID-19

NCT05035524 | Unknown

• 1 other identifier: SB-COVID
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the role of SB 8.4% as adjuvant therapy in the treatment of COVID- 19 patients proved to be RT-PCR positive (mild, moderate and severe).

Conditions

COVID-19 Pneumonia; Covid19; COVID-19 Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• The time interval to recovery defined as the first day

  assessed by subtracting the day of recovery from the day of infection

  1 months

Study Arms (2)

Sodium Bicarbonate

ACTIVE COMPARATOR

Adjuvant SB treatment Inhalation of SB 8.4% via a jet nebulizer (5 ml every 4 h) starting at 7:00 to 23:00 hours every day for 30 days together with instillation of SB 8.4% drops 4-times daily (three drops for each nostril) were offered to all patients in the study group

Drug: Sodium Bicarbonate Solution

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Sodium Bicarbonate Solution DRUG

Inhalation of SB 8.4% via a jet nebulizer (5 ml every 4 h) starting at 7:00 to 23:00 hours every day for 30 days together with instillation of SB 8.4% drops 4-times daily (three drops for each nostril) were offered to all patients in the study group (El-Badrawy et al., 2019).

Also known as: Sodium Bicarbonate

Sodium Bicarbonate

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• all consecutive patients suspected as COVID-19 presented to the respiratory evaluation zone and outpatient clinic of our university will be subjected to RT-PCR test for COVID.
• Patients proved to be RT-PCR positive will be included in the present study.

You may not qualify if:

• pregnant ladies
• who will refuse enrollment or discontinue follow up.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital - Chest Departement

Al Mansurah, DK, Egypt

Location

Related Publications (1)

• El-Badrawy MK, Elmorsey RA, Elhosiny MM, Shehta M, El-Hadidy TA, Abdelwahab IE, El-Badrawy A, Shokeir AA. Efficacy and Safety of Nebulized Sodium Bicarbonate in Adults with COVID-19 (SODIC): A Randomized, Single-Center, Double-Blinded, Controlled Trial. Curr Ther Res Clin Exp. 2025 May 22;103:100801. doi: 10.1016/j.curtheres.2025.100801. eCollection 2025.

  PMID: 40656233 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Tamer El-Hadidy

  Mansoura University Hospital - Chest Departement

  PRINCIPAL INVESTIGATOR

• Rehab Ahmad Elmorsey

  Mansoura University Hospital - Chest Departement

  PRINCIPAL INVESTIGATOR

• Ibrahim Badr

  Mansoura University Hospital - Chest Departement

  PRINCIPAL INVESTIGATOR

• Mohammed shehta

  Mansoura University Hospital - Chest Departement

  PRINCIPAL INVESTIGATOR

• Adel El-Badrawy

  Mansoura University Hospital - Chest Departement

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 5, 2021
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

EG (1)