COVID -19, first reported in Wuhan, China, strikes the world hard as a pandemic byspreading up to 213 countries. Bangladesh is also facing its havoc with the death of 3000among 229,185 cases at its 141st day. Most are mild cases presenting with influenza-likeillness with expected recovery. According to World Health Organization, the overallglobal case fatality rate is currently estimated to be 2.9%. However, patients havingsevere or critical illness presenting with severe respiratory distress, ARDS or shocksuffer most with mortality rates of 49.0-61.5%. Studies suggest that there are mild orsevere cytokine storms in severe patients, which is an important cause of death. Anexaggerated and uncontrolled release of pro-inflammatory mediators by an overly activatedimmune system is known as cytokine storms (CS) or cytokine release syndrome (CRS) whichhas an important role in the hemodynamic insults seen in very ill COVID-19 patients. Thisaberrant release of pro-inflammatory cytokines causes lung damage, myocarditis, acutekidney injury, etc. In this study, the investigators aim to estimate the burden ofcytokines and their correlation with the magnitude of the severity of COVID-19 illness inBangladeshi adults.
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.
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:
Icddr,B
Dhaka, Bangladesh
Investigator: Monira Sarmin, MBBS, MCPS
Contact: +8801718596947
drmonira@icddrb.org
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