Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-03 @ 9:02 PM
Study NCT ID:
NCT04464395
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2020-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], '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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000714109', 'term': 'CPI-006'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19', 'timeFrame': 'Up to 30 days after dose of CPI-006.', 'description': 'Incidence of adverse events (including serious adverse events and dose limiting toxicities).'}, {'measure': 'Immunoglobulin Anti-SARS CoV-2 Levels', 'timeFrame': 'Baseline and Day 28.', 'description': 'Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.'}], 'secondaryOutcomes': [{'measure': 'Negative Nasal Swab Polymerase Chain Reaction (PCR) SARS CoV-2 Viral Tests', 'timeFrame': 'Baseline to two consecutive negative nasal swab PCR SARS CoV-2 viral tests (separated by at least 48 hours).', 'description': 'Time to two consecutive negative nasal swab PCR SARS CoV-2 viral tests.'}, {'measure': 'Duration of symptoms', 'timeFrame': 'Up to 24 weeks after dose of CPI-006.', 'description': 'Duration of COVID-19 related symptoms.'}, {'measure': 'Time to discharge', 'timeFrame': 'Up to 24 weeks after dose of CPI-006.', 'description': 'Time to discharge from hospital.'}, {'measure': 'Rate of medical procedures', 'timeFrame': 'Up to 24 weeks after dose of CPI-006.', 'description': 'Rate of medical procedures during hospitalization.'}, {'measure': 'Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels', 'timeFrame': 'Baseline and visits through Day 28.', 'description': 'Difference between Active Arm and Control Arm patients in terms of changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS CoV-2', 'Coronavirus', 'Covid'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This Phase 1 single-dose, dose-escalation study is an open label trial evaluating the safety of CPI-006, a humanized monoclonal antibody targeting the CD73 cell-surface ectonucleotidase, as immunotherapy for stable hospitalized mild or moderately symptomatic COVID-19 patients with a parallel non-randomized Control Arm for treatment with standard of care only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nasal swab test positive by reverse transcriptase PCR for SARS CoV-2 within past 7 days, and onset of COVID-19 symptoms no more than 10 days prior to the positive test\n* Hospitalized and have stable mild to moderate symptoms of COVID-19\n* Blood oxygen saturation of a minimum of 92% on either no oxygen or up to 5L/min supplemental oxygen\n* Patients with cancer must be in remission or have stable, controlled disease and may be actively receiving drugs or biologics not deemed by the investigator to likely affect immune response.\n* Women must not be of child bearing potential or agree to use contraceptive guidance for 6 weeks\n\nExclusion Criteria:\n\n* Patients receiving previous invasive mechanical ventilation or non-invasive ventilation (CPAP, BiPAP) for COVID-19 illness\n* Patients hospitalized \\>7 days prior to receiving study intervention\n* Other diseases or conditions that are not controlled\n* On drugs or biologics that are immunosuppressive, cytotoxic or immunomodulatory\n* Patients with autoimmune disease must be controlled on non immunosuppressive or immune modifying agents\n* Have received cytotoxic, immunosuppressive or immunomodulatory agents within past 3 months (other than for treatment of COVID-19).\n* Patients receiving experimental therapies that are immunosuppressive\n* Patients receiving non-immuno-suppressive experimental therapies within 7 days prior to receiving CPI-006\n* Patients receiving convalescent plasma within 24 hours prior to receiving CPI-006\n* Patients receiving experimental anti-SARS CoV-2 monoclonal antibodies within past 30 days'}, 'identificationModule': {'nctId': 'NCT04464395', 'briefTitle': 'Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corvus Pharmaceuticals, Inc.'}, 'officialTitle': 'Immunotherapy of COVID-19 With B-Cell Activating CPI-006 Monoclonal Antibody', 'orgStudyIdInfo': {'id': 'CPI-006-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPI-006 Dose Escalation', 'description': 'CPI-006 + Standard of Care', 'interventionNames': ['Drug: CPI-006']}, {'type': 'OTHER', 'label': 'Control Arm', 'description': 'Standard of Care Only', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'CPI-006', 'type': 'DRUG', 'description': 'Participants will receive a single dose of CPI-006 at one of four dose levels (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 5.0 mg/kg) along with standard of care.', 'armGroupLabels': ['CPI-006 Dose Escalation']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Participants will receive standard of care treatment only.', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92243', 'city': 'El Centro', 'state': 'California', 'country': 'United States', 'facility': 'El Centro Regional Medical Center', 'geoPoint': {'lat': 32.792, 'lon': -115.56305}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'S. Mahabhashyam, MD. MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Corvus Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corvus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}