Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT04480632
Status:
UNKNOWN
Last Update Posted:
2020-07-22
First Post:
2020-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Plasmapheresis in Critically Ill Adult Patients With COVID-19 Confirmed Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D016638', 'term': 'Critical Illness'}], '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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Quasi-experimental and open-label intervention study. In this study, the application of convalescent plasma is considered as an intervention, but randomization will not be performed by investigators; one arm will be patients who received ABO compatible convalescent plasma and the comparison group will be those patients with intervention indication but without compatible ABO plasma units within the institution.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2020-07-17', 'studyFirstSubmitQcDate': '2020-07-17', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': '30 days', 'description': 'In-hospital mortality after administration of ABO compatible convalescent plasma or indication (but not plasmapheresis for absence of compatible convalescent plasma) for comparison group'}], 'secondaryOutcomes': [{'measure': 'Incidence of renal replacement therapy', 'timeFrame': '30 days', 'description': 'Number of patients with medical indication of hemodialysis or peritoneal dialysis for acute renal failure'}, {'measure': 'Incidece of adverse events', 'timeFrame': 'During tranfusion until 24 hours after.', 'description': 'Number of patients with Alergic reaction, Anaphylaxis, Severe thrombotic events, Transfusion-related acute lung injury (TRALI)\\], Transfusion-associated circulatory overload (TACO)\\], Antibody-Dependent Enhancement (ADE)\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Convalescent plasma', 'Intensive Care Unit', 'Critical illness'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '15616839', 'type': 'BACKGROUND', 'citation': 'Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.'}, {'pmid': '23977432', 'type': 'BACKGROUND', 'citation': 'Hui DS. Severe acute respiratory syndrome (SARS): lessons learnt in Hong Kong. J Thorac Dis. 2013 Aug;5 Suppl 2(Suppl 2):S122-6. doi: 10.3978/j.issn.2072-1439.2013.06.18.'}, {'pmid': '25030060', 'type': 'BACKGROUND', 'citation': 'Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.'}, {'pmid': '32241301', 'type': 'BACKGROUND', 'citation': 'Keith P, Day M, Perkins L, Moyer L, Hewitt K, Wells A. A novel treatment approach to the novel coronavirus: an argument for the use of therapeutic plasma exchange for fulminant COVID-19. Crit Care. 2020 Apr 2;24(1):128. doi: 10.1186/s13054-020-2836-4. No abstract available.'}, {'pmid': '32219428', 'type': 'BACKGROUND', 'citation': 'Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.'}, {'pmid': '32243945', 'type': 'BACKGROUND', 'citation': 'Zhang B, Liu S, Tan T, Huang W, Dong Y, Chen L, Chen Q, Zhang L, Zhong Q, Zhang X, Zou Y, Zhang S. Treatment With Convalescent Plasma for Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection. Chest. 2020 Jul;158(1):e9-e13. doi: 10.1016/j.chest.2020.03.039. Epub 2020 Mar 31.'}, {'pmid': '32253318', 'type': 'BACKGROUND', 'citation': 'Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.'}, {'pmid': '32281317', 'type': 'BACKGROUND', 'citation': 'Ahn JY, Sohn Y, Lee SH, Cho Y, Hyun JH, Baek YJ, Jeong SJ, Kim JH, Ku NS, Yeom JS, Roh J, Ahn MY, Chin BS, Kim YS, Lee H, Yong D, Kim HO, Kim S, Choi JY. Use of Convalescent Plasma Therapy in Two COVID-19 Patients with Acute Respiratory Distress Syndrome in Korea. J Korean Med Sci. 2020 Apr 13;35(14):e149. doi: 10.3346/jkms.2020.35.e149.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: The SARS-CoV-2 outbreak has left more than two million infected worldwide in the first four months of COVID-19 epidemic. To date, there is no specific treatment for the disease and in critically ill patients there is an additional challenge in controlling the systemic inflammatory response, which is characterized by cytokine storm, alteration in coagulation and endothelial activation in addition to infection. Strategies used in previous viral epidemics, such as convalescent plasma, are therapeutic options to rescue, especially in individuals with a critical presentation of the disease.\n\nAim: To establish clinical response of critically ill patients with COVID-19 who received convalescent plasma from subjects recovered from SARS-CoV-2 during their stay in Intensive Care Unit at Fundación Cardiovascular de Colombia (Hospital Internacional de Colombia).\n\nMethodology: Quasi-experimental study (no randomization will be performed). Adult patients who meet selection criteria will receive 500 ml of ABO compatible convalescent plasma, obtained by apheresis from patients recovered from SARS-CoV-2 infection. The main outcome will be in-hospital mortality at 30 days, while indication for ventilatory support (intubation) and adverse events at thirty days will be evaluated as secondary outcomes, compared to subjects receiving usual treatment for clinical sign and symptoms given the absence of ABO compatible plasma units. A survival analysis will be performed using Kaplan-Meier method and association strength will be reported using HR and 95% CI crude and adjusted for confounding variables.\n\nExpected results: It is expected to know the clinical and paraclinical response of patients receiving convalescent plasma in our institution, as well as to establish their probability of survival and its associated factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range: Over 18 years old\n* Patients with confirmed infection by COVID-19 (positive real-time PCR) in ICU with:\n* Respiratory failure receiving ventilatory support and high parameters\n* Severe pneumonia with rapid progression\n* Ability to sign informed consent\n\nExclusion Criteria:\n\n* Pregnant women\n* Contraindication of plasma administration due to history of anaphylaxis during transfusions'}, 'identificationModule': {'nctId': 'NCT04480632', 'acronym': 'PLASMA', 'briefTitle': 'Therapeutic Plasmapheresis in Critically Ill Adult Patients With COVID-19 Confirmed Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Cardiovascular de Colombia'}, 'officialTitle': 'Therapeutic Plasmapheresis in Critically Ill Adult Patients With COVID-19 Confirmed Diagnosis / Plasmaféresis terapéutica en Pacientes Adultos críticamente Enfermos Con diagnóstico Confirmado de COVID-19', 'orgStudyIdInfo': {'id': 'CEI-2020-01200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABO compatible convalescent plasma', 'description': 'A 500 ml dose of convalescent plasma (from a single donor or two 250 ml units from one or two donations) collected by apheresis will be administered. In case of plasma storage, plasma unit will be thawed following parameters of blood bank. Administration will take place slowly and over the course of four hours. When two 250 ml units are administered, second unit must be administered after the first unit in a period not exceeding 12 hours.', 'interventionNames': ['Biological: Convalescent plasma']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual medical care for critically ill patients at ICU'}], 'interventions': [{'name': 'Convalescent plasma', 'type': 'BIOLOGICAL', 'description': 'ABO compatible convalescent plasma obtained from from recovered COVID-19 patients', 'armGroupLabels': ['ABO compatible convalescent plasma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Piedecuesta', 'state': 'Santander Department', 'country': 'Colombia', 'facility': 'Hospital Internacional de Colombia', 'geoPoint': {'lat': 6.98789, 'lon': -73.04953}}], 'centralContacts': [{'name': 'Norma Serrano, MD', 'role': 'CONTACT', 'email': 'normaserrano@fcv.org', 'phone': '3102740099'}, {'name': 'Claudia Colmenares, MD', 'role': 'CONTACT', 'email': 'claudiacolmenares@fcv.org', 'phone': '3002090822'}], 'overallOfficials': [{'name': 'Norma Serrano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research, development and innovation director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Cardiovascular de Colombia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}