We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cytokine Storm Among Bangladeshi Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04598334
Recruitment Status : Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : April 13, 2022
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Cytokine Storm, COVID-19

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Participants outcome as improved and discharged/referred/deteriorated/death [ Time Frame: Six months ]
    Participants outcome (improved & discharged/referred/deteriorated/death) as percentage

  2. Coagulation profile [ Time Frame: Six months ]
    The proportion of participants having abnormal coagulation profile

  3. Score on chest X-ray [ Time Frame: Six months ]
    The proportion of participants having a poor score on chest X-ray

  4. Gut microbiota [ Time Frame: Eight months ]
    The frequency distribution of different gut microbiota from stool specimen by 16S rRNA sequencing

  5. 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
Plasma and stool samples will be stored in-80'C following a standard operating procedure for testing stool microbiota and cytokines in blood

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Study Population
The largest diarrheal hospital in the world, the icddr,b Dhaka Hospital admits and treats the general population from Dhaka city with complaints of diarrhea, pneumonia, and malnutrition. For this COVID-19 pandemic, it is also treating its staff and their near relatives in addition to the general patients reporting to the hospital. icddr,b Dhaka hospital manage patients according to clinical condition, and refer patients to appropriate COVID-19 facility if deemed necessary.
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:

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Monira Sarmin, MBBS, MCPS +8801718596947 ext 2186 drmonira@icddrb.org
Contact: Mohammod J Chisti, MBBS,PhD chisti@icddrb.org

Locations
Layout table for location information
Bangladesh
Icddr,B
Dhaka, Bangladesh, 1000
Contact: Monira Sarmin, MBBS, MCPS    +8801718596947 ext 2186    drmonira@icddrb.org   
Contact: Mohammod J Chisti, MBBS, PhD       chisti@icddrb.org   
Principal Investigator: Monira Sarmin, MBBS         
Principal Investigator: Tahmeed Ahmed, MBBS, PhD         
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Layout table for investigator information
Principal Investigator: Monira Sarmin International Centre for Diarrhoeal Disease Research, Bangladesh
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:
Medicine JHU. COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins 2020 [Available from: https://coronavirus.jhu.edu/map.html.
IEDCR. COVID-19: Institute of Epidemiology Disease Control and Research; 2020 [Available from: https://www.iedcr.gov.bd/website/index.php/component/content/article/73-ncov-2019.
National Guidelines on Clinical Management of Coronavirus Disease 2019 (COVID-19). version 7 ed. Government of the People's Republic of Bangladesh: Directorate General of Health Services; 2020.
Organization WH. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected: interim guidance, 13 March 2020. World Health Organization; 2020.
library Phi. COVID-19: Centers for Didease Control and Prevention 2020 [Available from: https://phil.cdc.gov/Details.aspx?pid=23313.
Corona virus: Encyclopædia Britannica, Inc./Patrick O'Neill Riley; 2020 [Available from: https://www.britannica.com/science/coronavirus-virus-group.
Irving K. Acute phase reactants: UpToDate; 2020 [Available from: https://www.uptodate.com/contents/acute-phase-reactants?search=acute%20phase%20reactants&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1.
Tobias Herold M, Arnreich C, Hellmuth JC, Matthias Klein M, Tobias Weinberger M. Level of IL-6 predicts respiratory failure in hospitalized symptomatic COVID-19 patients.
wikipedia. Tumor necrosis factor 2020 [Available from: https://en.wikipedia.org/wiki/Tumor_necrosis_factor.
Wikipedia. Interleukin 1 beta 2020 [Available from: https://en.wikipedia.org/wiki/Interleukin_1_beta.
NIH. COVID-19 treatment guideline, Pharmacologic Interventions [Available from: https://www.covid19treatmentguidelines.nih.gov/critical-care/pharmacologic-interventions/.
Medicine BSo. COVID-19 management guideline-Bangladesh Model. Dhaka, Bangladesh2020
Organization WH. Use of chest imaging in COVID-19 11 June 2020.

Layout table for additonal information
Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT04598334    
Other Study ID Numbers: PR-20084
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Cytokine storm
COVID-19
Bangladesh
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Cytokine Release Syndrome
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock