Official Title
Investigating the Inflammatory Cytokines and Cytokine Storm Among Bangladeshi Patients With COVID-19: a Prospective, Observational Study
Brief Summary

COVID -19, first reported in Wuhan, China, strikes the world hard as a pandemic by spreading up to 213 countries. Bangladesh is also facing its havoc with the death of 3000 among 229,185 cases at its 141st day. Most are mild cases presenting with influenza-like illness with expected recovery. According to World Health Organization, the overall global case fatality rate is currently estimated to be 2.9%. However, patients having severe or critical illness presenting with severe respiratory distress, ARDS or shock suffer most with mortality rates of 49.0-61.5%. Studies suggest that there are mild or severe cytokine storms in severe patients, which is an important cause of death. An exaggerated and uncontrolled release of pro-inflammatory mediators by an overly activated immune system is known as cytokine storms (CS) or cytokine release syndrome (CRS) which has an important role in the hemodynamic insults seen in very ill COVID-19 patients. This aberrant release of pro-inflammatory cytokines causes lung damage, myocarditis, acute kidney injury, etc. In this study, the investigators aim to estimate the burden of cytokines and their correlation with the magnitude of the severity of COVID-19 illness in Bangladeshi adults.

Detailed Description

Background:

1. Burden: COVID -19, first reported in Wuhan, China, strikes the world hard as a pandemic
by spreading up to 213 countries. Bangladesh is also facing its havoc with the death of
3000 among 229,185 cases at its 141st day. Most are mild cases presenting with
influenza-like illness with expected recovery. According to World Health Organization,
the overall global case fatality rate is currently estimated to be 2.9%. However,
patients having severe or critical illness presenting with severe respiratory distress,
ARDS or shock suffer most with mortality of 49.0-61.5%. Studies suggest that there are
mild or severe cytokine storms in severe patients, which is an important cause of death.
An exaggerated and uncontrolled release of proinflammatory mediators by an overly
activated immune system is termed as cytokine storm (CS). Studies depicting that there
might be an important relationship between SARS-CoV-2 and gut microbiota, as a marker to
predict ARDS, can corroborate with the disease severity and outcomes of COVID-19.

2. Knowledge gap: Cytokine storm (CS) has an important role in the hemodynamic insults seen
in very ill COVID-19 patients. In Bangladesh, no study has been conducted to evaluate
the level of cytokines and the gut microbiota in COVID-19 patients presenting with
different level of severity and their possible correlation with COVID-19.

3. Relevance: It will explore the role of CS and gut microbiota in COVID-19 illness
severity. Thus, the results of the study will improve our knowledge and understanding of
the problem, and thereby finding their solutions.

Objectives:

To estimate the burden of 'Cytokine Storm' and its correlation with the magnitude of the
severity of COVID-19 illness in Bangladeshi adults.

Methods:

This will be a prospective observational study in adults aged ≥18 years old with COVID-19
having mild /moderate/severe/critical symptoms. The investigators will measure their cytokine
(IL 6, TNF-Alpha, and IL1 Beta) levels and investigate gut microbiota in addition to regular
laboratory tests at different time points of illness.

Not yet recruiting
Cytokine Storm, COVID-19
Eligibility Criteria

Inclusion Criteria:

1. Adults aged ≥18 years,

2. Informed consent obtained for participation,

3. A mild, moderate or severe (±critical cases) RT-PCR confirmed COVID-19 cases,

4. RT-PCR negative healthy volunteers.

Exclusion Criteria:

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 90 Years
Countries
Bangladesh
Locations

Icddr,B
Dhaka, Bangladesh

Investigator: Monira Sarmin, MBBS, MCPS
Contact: +8801718596947
drmonira@icddrb.org

Investigator:

Contacts

Monira Sarmin, MBBS, MCPS
+8801718596947 - 2186
drmonira@icddrb.org

Mohammod J Chisti, MBBS,PhD - 2334
chisti@icddrb.org

Monira Sarmin, Principal Investigator
International Centre for Diarrhoeal Disease Research, Bangladesh

International Centre for Diarrhoeal Disease Research, Bangladesh
NCT Number
Keywords
Cytokine storm
Covid-19
Bangladesh
MeSH Terms
COVID-19
Cytokine Release Syndrome