Cytokine Storm, COVID-19 Clinical Trial
Official title:
Investigating the Inflammatory Cytokines and Cytokine Storm Among Bangladeshi Patients With COVID-19: a Prospective, Observational Study
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.
| Status | Not yet recruiting |
| Enrollment | 75 |
| Est. completion date | December 2022 |
| Est. primary completion date | December 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility | 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: |
| Country | Name | City | State |
|---|---|---|---|
| Bangladesh | Icddr,B | Dhaka |
| Lead Sponsor | Collaborator |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh |
Bangladesh,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Participants outcome as improved and discharged/referred/deteriorated/death | Participants outcome (improved & discharged/referred/deteriorated/death) as percentage | Six months | |
| Other | Coagulation profile | The proportion of participants having abnormal coagulation profile | Six months | |
| Other | Score on chest X-ray | The proportion of participants having a poor score on chest X-ray | Six months | |
| Other | Gut microbiota | The frequency distribution of different gut microbiota from stool specimen by 16S rRNA sequencing | Eight months | |
| Other | Three cytokines (IL-6, IL1ß, TNF a) in healthy participants | The mean value of cytokines (IL-6, IL1ß, TNF a) in healthy participants | Eight months | |
| Primary | COVID-19 positive participants having high cytokines | The proportion of COVID-19 positive participants having high cytokines during the study period | Eight months | |
| Secondary | High cytokine burden and severe COVID-19 | The proportion of participants having both high cytokine burden and severe COVID-19 illness. | Eight months |