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