Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-02-11 @ 4:16 AM
Study NCT ID:
NCT04715360
Status:
UNKNOWN
Last Update Posted:
2021-01-20
First Post:
2021-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C462182', 'term': 'favipiravir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-12-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-17', 'studyFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2021-01-17', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of aaPRP on pro-inflammatory cytokines plasma level (IL-6, IL-1B, TNFa, IFN gamma, MCP-1) before and after intervention compared to control.', 'timeFrame': '6 days', 'description': 'Patients with positive COVID19 who will improve after receiving aaPRP compared to control.'}, {'measure': 'to evaluate the change of Effect of aaPRP on anti-inflammatory cytokines plasma level (IL-1RA, IL-4, IL-10) before and after intervention compared to control.', 'timeFrame': '6 days', 'description': 'Patients with positive COVID19 who will improve after receiving aaPRP compared to control.'}, {'measure': 'Effect of aaPRP on overall adverse event related to the treatment.', 'timeFrame': '6 days', 'description': 'Patients with positive COVID19 who will improve after receiving aaPRP compared to control.'}, {'measure': 'Effect of aaPRP on CRP level before and after intervention compared to control.', 'timeFrame': '6 days', 'description': 'Patients with positive COVID19 who will improve after receiving aaPRP compared to control.'}], 'secondaryOutcomes': [{'measure': 'Effect of aaPRP on Thorax X-ray image pre and post intervention between control and aaPRP-treated group', 'timeFrame': '6 days', 'description': 'Patients with positive COVID19 who will improve after receiving aaPRP compared to control.'}, {'measure': 'Effect of aaPRP on duration of hospitality of patient compared to control', 'timeFrame': '6 days', 'description': 'Patients with positive COVID19 who will improve after receiving aaPRP compared to control.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aaPRP', 'severe COVID-19', 'platelet-rich plasma', 'SARS-CoV-2', 'autologous'], 'conditions': ['Covid19', 'Sars-CoV-2 Infection', 'ARDS, Human', 'Severe covid19']}, 'descriptionModule': {'briefSummary': 'The positive cases of coronavirus disease-2019 (COVID-19) in Indonesia has been increasing rapidly since the first case found in March 2020 to date. Coronavirus 2 (SARS-CoV-2) virus disrupts human normal immune system resulting in uncontrolled inflammatory response. Based on our research and experience in doing cell therapy for 9 years, activated platelet-rich plasma (PRP) produces anti-inflammatory effects in inflammatory condition that is beneficial for tissue regeneration. In this study, we aimed to evaluate the potential of autologous activated platelet-rich plasma (aaPRP) and the outcomes for treating severe Coronavirus Disease-2019 (COVID-19) patients in Intensive Care Unit (ICU).', 'detailedDescription': 'PRP decreases IL-1β, IL-6, IL-8, and TNFα inflammatory genes expression while also reduces IL-1β and TNFα inflammatory cytokines production. PRP has also been showed to contain interleukin 1 receptor antagonist (IL-1RA), an anti-inflammatory cytokines that suppress IL-6 secretion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe covid-19 patient in ICU\n\nExclusion Criteria:\n\n* CKD on hemodialysis, HIV positive, hepatitis, pregnant, destroyed lung, cancer'}, 'identificationModule': {'nctId': 'NCT04715360', 'briefTitle': 'Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Hayandra Peduli Foundation'}, 'officialTitle': 'Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy', 'orgStudyIdInfo': {'id': '20-12-1526'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'description': 'Only received standard medication (avigan) for severe COVID-19 management', 'interventionNames': ['Drug: Avigan']}, {'type': 'EXPERIMENTAL', 'label': 'PRP Group', 'description': 'received standard medication (avigan) for severe COVID-19 management and autologous activated platelet-rich plasma transfusion', 'interventionNames': ['Combination Product: autologous activated platelet-rich plasma', 'Drug: Avigan']}], 'interventions': [{'name': 'autologous activated platelet-rich plasma', 'type': 'COMBINATION_PRODUCT', 'description': 'Patient received standard medication for COVID-19 management and autologous activated platelet-rich plasma on day 1, 3 and 5 while patient in ICU. On day 0, 4 and 6, hematology analysis, multicytokines measurement and thorax X-ray were done to each patient', 'armGroupLabels': ['PRP Group']}, {'name': 'Avigan', 'type': 'DRUG', 'description': 'Patient received avigan 2x1,600 mg for a day, followed by 2x600 mg for five consecutive days.', 'armGroupLabels': ['Control', 'PRP Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14220', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Louis Martin Christoffel, MD', 'role': 'CONTACT', 'email': 'louischristoffel200@gmail.com', 'phone': '6281340062037'}], 'facility': 'Koja Regional Public Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'centralContacts': [{'name': 'Karina Karina, MD, PhD', 'role': 'CONTACT', 'email': 'karina@hayandra.com', 'phone': '62.21.3909333'}, {'name': 'Imam Rosadi, M.Sc', 'role': 'CONTACT', 'email': 'imam.rosadi@hayandra.com', 'phone': '6285719593848'}], 'overallOfficials': [{'name': 'Louis Martin Christoffel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Koja Regional Public Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hayandra Peduli Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Koja Regional Public Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}