Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT04453527
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2020-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The CASCADE Study - Measures of Complement Activation and Inflammation in Patients With Covid-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2020-06-30', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complement Activation', 'timeFrame': '14 days sampling time period', 'description': 'C5a, C5, C3, sC5b9, Bb concentration from serum'}, {'measure': 'Leukotrienes Measure', 'timeFrame': '14 days sampling time period', 'description': 'LTB4 concentration from plasma'}, {'measure': 'Coagulation Measure', 'timeFrame': '14 days sampling time period', 'description': 'Level of platelets, INR, APTS, D-Dimer, Fibrinogen, thrombin antithrombin complex (TAT), from citrate plasma'}, {'measure': 'Hyperinflammation Measure', 'timeFrame': '14 days sampling time period', 'description': '• CRP, Ferritin, PCT, LDH, Troponin, ALT from plasma'}, {'measure': 'Cell Count', 'timeFrame': '14 days sampling time period', 'description': 'Total White Blood Cell count (including lymphocytes, monocytes and neutrophils)'}, {'measure': 'Cytokines and Chemokine Measure', 'timeFrame': '14 days sampling time period', 'description': 'Level of • Pro-inflammatory - IL-1α, IL-1β, IL-2, IL-5, IL-6, IL-7, IL-8, IL-17, GCSF, GMCSF, IFN γ, IP10, MCP-1, MIP1α, TNFα and anti inflammatory IL-4, IL-10, IL-13, IL-22, TGF-α from plasma'}, {'measure': 'Endothelial dysfunction measures:', 'timeFrame': '14 days sampling time period', 'description': 'VEGF, tissue factor and PAI-1, from plasma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus']}, 'referencesModule': {'references': [{'pmid': '37731491', 'type': 'DERIVED', 'citation': "Wiffen L, D'Cruz LG, Brown T, Higenbottam TW, Bernstein JA, Campbell C, Moellman J, Ghosh D, Richardson C, Weston-Davies W, Chauhan AJ. Clinical severity classes in COVID-19 pneumonia have distinct immunological profiles, facilitating risk stratification by machine learning. Front Immunol. 2023 Sep 5;14:1192765. doi: 10.3389/fimmu.2023.1192765. eCollection 2023."}]}, 'descriptionModule': {'briefSummary': "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.\n\nIn 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", 'detailedDescription': 'This study is an observational cross-sectional and cohort study to assess whether there is evidence of increased complement activation and/or LTB4 levels and other parameters of inflammation and a pro-coagulative state in adult patients hospitalised with COVID-19 compared to healthy controls and also whether these measures differ with increasing severity of respiratory failure.\n\nBlood samples (serum and plasma) will be obtained from each participant at the time of recruitment into the trial, to assess the profile of complement activation, cytokines/ chemokines, leukotrienes (specifically leukotriene B4) and markers of coagulation and inflammation in patients with COVID-19.\n\nParticipants within the cohort study will be recruited at the point of admission or as close to it as possible. Baseline sampling will be performed at time of recruitment. There will be up to 2 additional sampling points (with not more than one sample per day) if there is any worsening of the participants respiratory failure (i.e. deteriorating from mild to moderate or moderate to severe disease).\n\nPatients just admitted to hospital will be asked to consent for both the case control and the cohort study\n\nData will be collected at baseline for all participants and then again at each further sampling point for the participants within the cohort study.\n\nPatient status will be measured at 14 days from the last point of sampling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with Covid 19 and Healthy Volunteers', 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- 1. Adults ≥18 years old requiring hospital admission for COVID-19\n\n2\\. COVID-19 confirmed by either\\*:\n\n* A positive swab (using RT-PCR)\n* 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.\n\nExclusion Criteria:\n\n* 1\\. Renal replacement therapy on ITU\n\n 2\\. Significant trauma (including an acute fracture or significant head injury)\n\n 3\\. Massive transfusion of blood products\n\n 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."}, 'identificationModule': {'nctId': 'NCT04453527', 'briefTitle': 'The CASCADE Study - Measures of Complement Activation and Inflammation in Patients With Covid-19', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Portsmouth Hospitals NHS Trust'}, 'officialTitle': 'The CASCADE Study - Measures of Complement Activation and Inflammation in Patients With Coronavirus Disease 2019', 'orgStudyIdInfo': {'id': 'PHT/2020/37'}}, 'contactsLocationsModule': {'locations': [{'zip': 'PO6 3LY', 'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Portsmouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portsmouth Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Akari Therapuetics', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}