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CTRI Number  CTRI/2020/07/026535 [Registered on: 13/07/2020] Trial Registered Prospectively
Last Modified On: 11/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to observe the effects of 8.4% Sodium Bicarbonate impregnated steam inhalation on Covid-19 infected patients 
Scientific Title of Study   A randomized open label parallel group trial to study the safety and efficacy of steam impregnated with 8.4 % Sodium Bicarbonate in patients with Covid-19 infection 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bharat S Mody 
Designation  Director, CEO & Chief Surgeon 
Affiliation  Welcare Hospital 
Address  Welcare Hospital, Near Mercedes Showroom, Atladara-Vadsar Ring Road, Atladara, Vadodara.

Vadodara
GUJARAT
390012
India 
Phone    
Fax    
Email  joints.mody@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bharat S Mody 
Designation  Director, CEO & Chief Surgeon 
Affiliation  Welcare Hospital 
Address  Welcare Hospital, Near Mercedes Showroom, Atladara-Vadsar Ring Road, Atladara, Vadodara.


GUJARAT
390012
India 
Phone    
Fax    
Email  joints.mody@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kshitij B Mody 
Designation   
Affiliation  Welcare Hospital 
Address  Welcare Hospital, Near Mercedes Showroom, Atladara-Vadsar Ring Road, Atladara, Vadodara.

Vadodara
GUJARAT
390012
India 
Phone    
Fax    
Email  drkshitijmody@welcarehospital.co.in  
 
Source of Monetary or Material Support  
Myself Health Check Ltd. Unit-1, Hayes Industrial Estate, Godstone Road, Caterhjam, Surrey CR3 6SF UK 
Welcare Hospital, Near Mercedes Showroom, Atladara-Vadsar Ring Road, Atladara, Vadodara  
 
Primary Sponsor  
Name  Dr Bharat S Mody 
Address  Welcare Hospital, Near Mercedes Showroom, Atladara Vadsar Ring Road, Atladara, Vadodara 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Myself Health Check Ltd  Myself Health Check Ltd. Unit-1, Hayes Industrial Estate, Godstone Road, Caterhjam, Surrey CR3 6SF UK 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharat S Mody  Welcare Hospital  Near Mercedes Showroom, Atladara-Vadsar Ring Road, Atladara
Vadodara
GUJARAT 
9824036065

joints.mody@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee of Centre for Knee Surgery  Approved 
Ethics Committee of Centre for Knee Surgery  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Sodium Bicarbonate 8.4% Impregnated Steam Inhalation  50 ml of 8.4% Sodium Bicarbonate through a naso-oral delivery apparatus attached to an electric steam generating apparatus. Frequency would be twice daily separated by 8 hours for 5 days, 5 minutes per session. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Males and Females of age 18 years or more diagnosed with Covid-19 infection by RT-PCR test method and not on Invasive Ventilatory Support.

Subject willing to give written consent (Volunteer Information Sheet and Informed Consent Form) prior to enrolment in the study.

Subjects must have clinically acceptable results for all the screening parameters. 
 
ExclusionCriteria 
Details  Males and Females not proven to have Covid-19 infection by a positive RT-PCR test result.

Males and Females having proven Covid-19 infection by positive RT-PCR test result but on Invasive Ventilatory Support.

Subject deemed uncooperative or noncompliant. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in laboratory values of the following inflammatory markers: ESR, CRP, Serum Ferritin, Serum Procalcitonin, Serum Lactate Dehydrogenase (LDH), and IL6 and improvement in clinical parameters.

Reduction in laboratory values of the following coagulopathy marker: D Dimer

Improvement in Clinical Parameters. 
5 days 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/07/2020 
Date of Study Completion (India) 31/08/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

INTRODUCTION, BACKGROUND & RATIONALE

Respiratory infections are caused by bacteria, viruses, fungi, and parasites. (Reference-1) Microbes require for their growth a particular range of external pH which affects their many biological actions such as enzyme activity, reaction rates, protein stability and structure of nucleic acids. (Reference-2,3)

The airway surface liquid (ASL) contains a complex mixture of antimicrobial factors that kill inhaled or aspirated organisms and act as a first line of defense. The composition of ASL is critical for antimicrobial effectiveness. Changes in the ASL occur with inflammation or infection as local acidosis. (Reference-4,7)

In respiratory tract infections caused by bacteria, viruses, fungi, and mycobacteria, there will be an expected local acidic medium in the lung secretions. Changing the local pH of lower respiratory tract secretions to alkaline side by adding Sodium Bicarbonate (SB) 8.4% can affect growth and/or may be lethal for the respiratory tract pathogens. (Reference-1)

There is evidence in literature that Viruses belonging to the Corona group need a low PH environment to allow the first connectivity of the Virus to the cell wall. (Reference-5,6,7) The present pandemic of Covid-19 is caused by a novel member of the Corona group of viruses viz SARS-CoV- 2;2019-nCoV.

Sodium Bicarbonate inhalations (4.2% & 8.4%) have been used as a treatment measure in pathological respiratory conditions such as cystic fibrosis and chlorine gas inhalations. Its safety, tolerability and efficacy in improvement in those clinical conditions have been well established. (Reference-8,9)

The aim of this study is to evaluate the effect of SB 8.4% inhaled with steam resulting in the increased pH of the ASL on the Covid-19 infection pathology. The effect was monitored by measuring the surrogate markers of the two processes (intense inflammation and coagulation) which have been identified as the method by which high morbidity and mortality results for these patients. These markers being ESR, CRP, Serum Ferritin, Serum Procalcitonin, IL6 and D Dimer.

If the results indicate a beneficial effect then this could be an extremely useful easy to use and relatively inexpensive method of preventing, aborting and/or mitigating the devastating effects of Covid-19 and result in improved outcomes of the patients infected by this virus.



References

  1. El Badrawy MK, Elela MA, Yousef AM, et al. Effect of sodium bicarbonate 8.4% on respiratory tract pathogens. Chest Lung Res. 2018;1(1):3-7.

  2. Alaiwa AMH, Reznikov LR, Gansemer ND, et al. pH modulates the activity and synergism of the airway surface liquid antimicrobials defensin-3 and LL-37. Proc Natl Acad Sci. 2014;111(52):18703-8.

  3. Slonczewski JL, Fujisawa M, Dopson M, et al. Cytoplasmic pH measurement and homeostasis in bacteria and archaea. Adv Micro Physiol. 2009;55:1-79.

  4. Pezzulo AA, Tang XX, Hoegger MJ, Abou Alaiwa MH, Ramchandran S, Moninger TO, Karp PH, Wohlford-Lenane CL, Haagsman HP, van Ejik M, Banfi B, Horswill AR, Stoltz DA, McCray PB Jr, Welsh MJ, Zabner J. Reduced airway surface pH impairs bacterial killing in the porcine cystic fibrosis lung. Nature. 2012;487(7405):109-13.

5. Yang ZY, Huang Y, Ganesh L, Leung K, Kong wp. et al. pH- Dependent Entry of Severe Acute Respiratory Syndrome Coronavirus Is Mediated by the Spike Glycoprotein and Enhanced by Dendritic Cell Transfer through DC-SIGN. J Virol. 2004; 78: 5642-5650.

PubMed:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC415834/

6. 1. Chu, V. McElroy, L. Chu, V. Bauman, B. Whittaker, G. The Avian Coronavirus Infectious Bronchitis undergoes direct low PH dependent Fusion activation during entry into the host cells. J Virol. 2006; 80:3180-3188.

PubMed:

https://www.ncbi.nlm.nih.gov/pubmed/16537586

7. Mudasir A. Mir 1 *, Sheikh Mansoor 2, Abida Bhat 3 - A review on probable Lysosomotropic properties of Sodium bicarbonate to restrain viral entry of Coronavirus 2 (SARS- CoV-2)

8. Gomez CCS, Parazzi PLF, Clinckspoor KJ, Mauch RM, Pessine FBT, et al, safety, tolerability and effects of sodium bicarbonate inhalation in cystic fi brosis. Clin Drug Investig. 2019; 40: 105-117.

PubMed:

https://www.ncbi.nlm.nih.gov/pubmed/31721070

9. Aslan S, Kandis̀§ H, Akgun M, Cakir Z, Inandi T, et al. The effect of nebulized sodium bicarbonate treatment on RADS patients due to chlorine gas inhalation. Inhal. Tox. 2006; 18: 895-900.

PubMed:

https://www.ncbi.nlm.nih.gov/pubmed/16864407 

 
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