Cytokine Storm Among Bangladeshi Patients With COVID-19

• Conditions: Cytokine Storm, COVID-19

• Registration Number: NCT04598334
• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

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.

Study Timeline

• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-22
• Status Verified: 2022-03
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-13
• Study Start: 2022-07-15
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COVID-19 positive participants having high cytokines	Eight months	The proportion of COVID-19 positive participants having high cytokines during the study period

Secondary Outcome Measures

Name	Time	Method
High cytokine burden and severe COVID-19	Eight months	The proportion of participants having both high cytokine burden and severe COVID-19 illness.

Trial Locations

Locations (1)

Icddr,B; 🇧🇩 Dhaka, Bangladesh