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Home-based Treatment of Computed Tomography and Clinically Suspected Novel COVID-19 With Adjuvant Inhalable Sodium Bicarbonate: A Preliminary Case Series

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04374591
Recruitment Status : Active, not recruiting
First Posted : May 5, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:
in our practice we faced with 3 cases with clinical and ct pictures as well as laboratory findings suggestive of COVID-19 pneumonia. We treated them with antibiotics, oseltamivir as well as inhalation of sodium bicarbonate. They showed marked clinical, laboratory and radiological improvements.

Condition or disease Intervention/treatment Phase
Pneumonia Covid19 Drug: Sodium Bicarbonate Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home-based Treatment of Computed Tomography and Clinically Suspected Novel COVID-19 With Adjuvant Inhalable Sodium Bicarbonate: A Preliminary Case Series
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Sodium Bicarbonate
Inhalation of Sodium Bicarbonate 8.4% via nebulizer
Drug: Sodium Bicarbonate
Inhalation of Sodium Bicarbonate 8.4% via nebulizer




Primary Outcome Measures :
  1. Time to clinical recovery [ Time Frame: 7 days ]
    defined as return of body temperature and relief of cough for more than 72h measured in days


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 year
  • All patients refused to do RT-PCR test, refused admission to a governmental hospital, and preferred private home treatment
  • Chest CT with pneumonia characteristic of COVID- 19 pattern.
  • SaO2/SPO2 ratio > 93% or PaO2/FIO2 ratio > 300 mmHg under the condition in the hospital room (mid illness).
  • Welling to participate and able to give 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374591


Locations
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Egypt
Gomhoria Street
Mansoura, Outside U.S./Canada, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Mohammed K Elbadrawy, PhD Chest department Mansoura University Hospital
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT04374591    
Other Study ID Numbers: Sodium Bicarbonate COVID-19
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mansoura University:
COVID-19
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections