Coronavirus Clinical Trial
Official title:
The CASCADE Study - Measures of Complement Activation and Inflammation in Patients With Coronavirus Disease 2019
NCT number | NCT04453527 |
Other study ID # | PHT/2020/37 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 28, 2020 |
Est. completion date | May 30, 2021 |
Verified date | April 2023 |
Source | Portsmouth Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
COVID-19 is a new disease and therefore it is still not clear exactly how the virus affects the body and why people are affected so differently. It causes infection in the lungs and the virus can then attack blood vessels in the lungs and other organs to spark off an inflammatory process that can make a person very ill. It also can cause damage within tiny blood vessels that makes a person's blood thicken up and stop flow in vital organs. The investigators believe complement (which is a chemical in the body which can be harmful in excess) orchestrates the inflammation and thickening of the blood that can make a person sick. The investigators now need to know which of these complement chemicals are elevated in COVID-19 and compare to healthy volunteers, and assess whether the levels are higher in people with severe lung disease. The investigators believe that if levels are increased there are special treatments that can counteract them and potentially be an effective treatment for COVID-19. In this study the investigators will measure different parts of the inflammation process to better understand what may be causing severe disease and to see if there may be benefits from a new treatment to reduce inflammation
Status | Completed |
Enrollment | 72 |
Est. completion date | May 30, 2021 |
Est. primary completion date | May 30, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 1. Adults =18 years old requiring hospital admission for COVID-19 2. COVID-19 confirmed by either*: - A positive swab (using RT-PCR) - OR based on a high level of clinical probability confirmed by the presence of typical symptoms and compatible radiological findings on imaging with no alternative cause for these findings identified by the treating physician. Exclusion Criteria: - 1. Renal replacement therapy on ITU 2. Significant trauma (including an acute fracture or significant head injury) 3. Massive transfusion of blood products 4. Confirmed bacteraemia with pathogenic organism on blood cultures or other severe bacterial infections (including abscess/empyema) which persist despite broad-spectrum antibiotics and are thought to be significantly contributing to the patient's symptoms and clinical state. Recruitment will not be delayed however pending a negative culture. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Portsmouth Hospitals NHS Trust | Portsmouth |
Lead Sponsor | Collaborator |
---|---|
Portsmouth Hospitals NHS Trust | Akari Therapuetics |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complement Activation | C5a, C5, C3, sC5b9, Bb concentration from serum | 14 days sampling time period | |
Primary | Leukotrienes Measure | LTB4 concentration from plasma | 14 days sampling time period | |
Primary | Coagulation Measure | Level of platelets, INR, APTS, D-Dimer, Fibrinogen, thrombin antithrombin complex (TAT), from citrate plasma | 14 days sampling time period | |
Primary | Hyperinflammation Measure | • CRP, Ferritin, PCT, LDH, Troponin, ALT from plasma | 14 days sampling time period | |
Primary | Cell Count | Total White Blood Cell count (including lymphocytes, monocytes and neutrophils) | 14 days sampling time period | |
Primary | Cytokines and Chemokine Measure | Level of • Pro-inflammatory - IL-1a, IL-1ß, IL-2, IL-5, IL-6, IL-7, IL-8, IL-17, GCSF, GMCSF, IFN ?, IP10, MCP-1, MIP1a, TNFa and anti inflammatory IL-4, IL-10, IL-13, IL-22, TGF-a from plasma | 14 days sampling time period | |
Primary | Endothelial dysfunction measures: | VEGF, tissue factor and PAI-1, from plasma | 14 days sampling time period |
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