Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
Study NCT ID:
NCT04528368
Status:
UNKNOWN
Last Update Posted:
2021-08-06
First Post:
2020-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-04', 'studyFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2020-08-25', 'lastUpdatePostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve of SARS-COV-2 viral load obtained from nasopharyngeal and /or oropharyngeal swabs.', 'timeFrame': '0, 3, 6, 9, 12, 15, 18 and 21 days', 'description': 'To evaluate the area under the curve of SARSCoV-2 viral load in nasopharyngeal and or oropharyngeal samples on days 0, 3, 6, 9, 12, 15, 18 and 15 after randomization.'}], 'secondaryOutcomes': [{'measure': 'Assessment of clinical improvement using an Ordinal Severity Scale', 'timeFrame': '0, 7, 10, 14, 21 and 28 days', 'description': 'The seven-point scale is as follows:\n\n* Death 7 points;\n* Hospital admission for mechanical ventilation plus additional organ support (eg, pressors, RRT, ECMO) = 6 points;\n* Hospital admission for mechanical ventilation = 5 points;\n* Hospital admission for non-invasive ventilation or high-flow oxygen therapy = 4 points;\n* Hospital admission for oxygen therapy (but not requiring high-flow or non-invasive ventilation) = 3 points;\n* Hospital admission but not requiring oxygen therapy = 2 points;\n* Discharged with limitations of activities = 1 point;\n* Discharged with no limitations of activities = 0 point;'}, {'measure': 'Evaluate oxygen saturation', 'timeFrame': '0, 3, 6, 9, 12, 15, 18 and 21 days'}, {'measure': 'Evaluate oxygen supplementation', 'timeFrame': '0, 3, 6, 9, 12, 15, 18 and 21 days'}, {'measure': 'Assess respiratory rate', 'timeFrame': '0, 3, 6, 9, 12, 15, 18 and 21 days'}, {'measure': 'Evaluate the PaO2 / FiO2 ratio (for patients on mechanical mechanisms)', 'timeFrame': '0, 3, 6, 9, 12, 15, 18 and 21 days'}, {'measure': 'Length of hospital stay', 'timeFrame': '21 days'}, {'measure': 'Length of stay in intensive care', 'timeFrame': '21 days'}, {'measure': 'Assess the rate of orotracheal intubation', 'timeFrame': '21 days'}, {'measure': 'Change in the profile of cytokines/chemokines in both groups', 'timeFrame': '0, 3, 6, 9, 12, 15, 18 and 21 days', 'description': 'Quantification by ELISA the levels of 36 molecules determined simultaneously using the Human Cytokine Array Kit da R\\&D Systems (C5a, IL-4, IL-32 alpha, CD40 ligand, IL-5, CXCL10 / IP-10, G-CSF, IL-6, CXCL11 / I-TAC, GM-CSF, IL-8, CCL2 / MCP-1, CXCL1 / GRO alpha, IL-10, MIF, CCL1 / I-309, IL-12 p70, CCL3 / MIP-1 alpha, ICAM-1, IL-13, CCL4 / MIP-1 beta, IFN -gamma, IL-16, CCL5 / RANTES, IL-1 alpha, IL-17, CXCL12 / SDF-1, IL-1 beta, IL-17E, Serpin E1 / PAI-1, IL-1ra, IL-23, TNF-alpha, IL-2, IL-27 and TREM-1)'}, {'measure': 'Presence of antibodies against SARS-CoV-2 in serum after convalescent plasma administration', 'timeFrame': '0, 3, 6, 9, 12, 15, 18 and 21 days'}, {'measure': 'Death rate', 'timeFrame': '7, 10, 14, 21 and 28 days'}, {'measure': 'Rate of transfusion reactions to convalescent plasma infusion', 'timeFrame': '21 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Convalescent plasma', 'SARS-CoV-2'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The COVID-19 pandemic has been spreading continuously, and in Brazil, until August 18, 2020, there have been more than 3,359,000 cases with more than 108,536 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of using convalescent plasma for treating patients with COVID-19 pneumonia without indication of ventilatory support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Recipient Inclusion Criteria:\n\n* Confirmed diagnosis of COVID-19 by RT-PCR;\n* Time between symptom onset and inclusion ≤ 7 days;\n* Chest tomography with \\<50% involvement of the lung parenchyma;\n* No indication of ventilatory support at the time of randomization;\n* Sign the consent form.\n\nRecipient Exclusion Criteria:\n\n* Contraindication to transfusion or history of previous reactions to blood products for transfusion;\n* Pregnant women;\n* Limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator.\n\nDonor Inclusion Criteria for Plasmapheresis:\n\n* Convalescent plasma donation will be eligible for patients ≥ 18 years old who had previously confirmed COVID-19 by RT-PCR, which met the criteria adopted by technical notes n13 and 21/2020-CGSH/DAET/SAES/MS;\n* SARS-COV-2 negative RT-PCR;\n* Asymptomatic for at least 14 days;\n* SARS-CoV-2 anti-peak titre with dilution ≥ 1: 320;\n* Sign the consent form.\n\nDonor Exclusion Criteria:\n\n* Female gender with previous pregnancy;\n* Absence of peripheral venous network compatible with the apheresis procedure;\n* Positive or indeterminate result in any of the infectious screening tests;\n* Presence of intellectual incapacity to understand the guidelines regarding the risks and benefits of participating in the study.'}, 'identificationModule': {'nctId': 'NCT04528368', 'briefTitle': 'Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support', 'organization': {'class': 'OTHER', 'fullName': "D'Or Institute for Research and Education"}, 'officialTitle': 'Efficacy and Safety of Using Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support', 'orgStudyIdInfo': {'id': '34651120.8.0000.5249'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Convalescent Plasma + Standard treatment', 'description': 'Participants will receive the standard treatment and convalescent plasma', 'interventionNames': ['Biological: Convalescent plasma']}, {'type': 'NO_INTERVENTION', 'label': 'Standard treatment', 'description': 'Participants will receive the standard treatment'}], 'interventions': [{'name': 'Convalescent plasma', 'type': 'BIOLOGICAL', 'description': 'The intervention group will receive 400 mL of convalescent plasma with a SARS-CoV-2 antispike antibody titer with a dilution ≥ 1: 320.', 'armGroupLabels': ['Convalescent Plasma + Standard treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rio de Janeiro', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Eduardo M Rego, MD, PhD', 'role': 'CONTACT'}, {'name': 'Eduardo M Rego, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "D'Or Institute for Research and Education", 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'centralContacts': [{'name': 'Eduardo M Rego, MD, PhD', 'role': 'CONTACT', 'email': 'edumrego@hotmail.com', 'phone': '55 16 981110090'}, {'name': 'Abel Costa Neto, MD', 'role': 'CONTACT', 'email': 'abel.neto@oncologiador.com.br', 'phone': '55 11 964999091'}], 'overallOfficials': [{'name': 'Eduardo M Rego, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "D'Or Institute for Research and Education"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "D'Or Institute for Research and Education", 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital do Coracao', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}