Cytokine Storm Among Bangladeshi Patients With COVID-19
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|ClinicalTrials.gov Identifier: NCT04598334|
Recruitment Status : Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : April 13, 2022
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|Condition or disease|
|Cytokine Storm, COVID-19|
- 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.
- 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.
- 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.
To estimate the burden of 'Cytokine Storm' and its correlation with the magnitude of the severity of COVID-19 illness in Bangladeshi adults.
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 Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||Investigating the Inflammatory Cytokines and Cytokine Storm Among Bangladeshi Patients With COVID-19: a Prospective, Observational Study|
|Estimated Study Start Date :||July 15, 2022|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
COVID-19 positive by RT-PCR
specified number of COVID-19 positive patients will be followed up from admission to outcome (discharge/death/referral). Blood samples will be tested at different time points; cytokines and stool microbiota will be tested at the end of the study and we will analyze the study findings.
- COVID-19 positive participants having high cytokines [ Time Frame: Eight months ]The proportion of COVID-19 positive participants having high cytokines during the study period
- High cytokine burden and severe COVID-19 [ Time Frame: Eight months ]The proportion of participants having both high cytokine burden and severe COVID-19 illness.
- Participants outcome as improved and discharged/referred/deteriorated/death [ Time Frame: Six months ]Participants outcome (improved & discharged/referred/deteriorated/death) as percentage
- Coagulation profile [ Time Frame: Six months ]The proportion of participants having abnormal coagulation profile
- Score on chest X-ray [ Time Frame: Six months ]The proportion of participants having a poor score on chest X-ray
- Gut microbiota [ Time Frame: Eight months ]The frequency distribution of different gut microbiota from stool specimen by 16S rRNA sequencing
- Three cytokines (IL-6, IL1β, TNF α) in healthy participants [ Time Frame: Eight months ]The mean value of cytokines (IL-6, IL1β, TNF α) in healthy participants
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Probability Sample|
- Adults aged ≥18 years,
- Informed consent obtained for participation,
- A mild, moderate or severe (±critical cases) RT-PCR confirmed COVID-19 cases,
- RT-PCR negative healthy volunteers.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598334
|Contact: Monira Sarmin, MBBS, MCPS||+8801718596947 ext firstname.lastname@example.org|
|Contact: Mohammod J Chisti, MBBS,PhDemail@example.com|
|Dhaka, Bangladesh, 1000|
|Contact: Monira Sarmin, MBBS, MCPS +8801718596947 ext 2186 firstname.lastname@example.org|
|Contact: Mohammod J Chisti, MBBS, PhD email@example.com|
|Principal Investigator: Monira Sarmin, MBBS|
|Principal Investigator: Tahmeed Ahmed, MBBS, PhD|
|Principal Investigator:||Monira Sarmin||International Centre for Diarrhoeal Disease Research, Bangladesh|
|Responsible Party:||International Centre for Diarrhoeal Disease Research, Bangladesh|
|Other Study ID Numbers:||
|First Posted:||October 22, 2020 Key Record Dates|
|Last Update Posted:||April 13, 2022|
|Last Verified:||March 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Cytokine Release Syndrome
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Systemic Inflammatory Response Syndrome