Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-03-06 @ 4:52 PM
Study NCT ID:
NCT04836260
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2021-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preemptive Use of Convalescent Plasma for High-risk Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000073496', 'term': 'Frailty'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093522', 'term': 'COVID-19 Serotherapy'}], 'ancestors': [{'id': 'D019264', 'term': 'Adoptive Transfer'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open-label non-controlled, non-randomised interventional study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2021-04-06', 'studyFirstSubmitQcDate': '2021-04-06', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of patients that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)', 'timeFrame': '21 days after plasma infusion'}, {'measure': 'Proportion of patients with cleared nasopharyngeal viral load', 'timeFrame': '21 days after plasma infusion', 'description': 'Will be evaluated if CT\\< 30 at 14 days'}], 'primaryOutcomes': [{'measure': 'Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)', 'timeFrame': '7 days after plasma infusion'}, {'measure': 'Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)', 'timeFrame': '14 days after plasma infusion'}, {'measure': 'Proportion of death', 'timeFrame': '28 days after plasma infusion'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with cleared nasopharyngeal viral load', 'timeFrame': '7 days after plasma infusion', 'description': 'Cleared viral load is defined as CT value ≥30'}, {'measure': 'Proportion of patients with cleared nasopharyngeal viral load', 'timeFrame': '14 days after plasma infusion', 'description': 'Cleared viral load is defined as CT value ≥30'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Convalescent plasma'], 'conditions': ['Covid19', 'Immuno-Deficiency', 'Old Age; Debility']}, 'descriptionModule': {'briefSummary': 'Convalescent plasma therapy has been recognized as safe and plasma transfusion is routinely used in clinical practice. A recent study showed that early administration of convalescent plasma can decrease the risk of complications in specific high-risk population.\n\nThe aim of the present study is to offer convalescent plasma therapy to immunocompromised patients and older adults in the early phase of a SARS-Cov-2 infection in order to accelerate viral clearance and prevent complication', 'detailedDescription': 'This is an open-label non-controlled, non-randomised interventional study. Study population consist in immunocompromised patients and older adults with or without co-morbidities.\n\nIncluded patients will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 or equivalent at maximum 3-7 days after diagnosis by RT-PCR or symptom onset or if having mild-moderate disease (WHO scale \\<4).\n\nPatients will be followed-up up to 28 days to assess progression to WHO scale 4 disease, and 28-days mortality and viral load kinetics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Immunocompromised patients defined as\n\n 1. Solid organ transplant ≤1 year before inclusion or treated for acute or chronic rejection episode or\n 2. Allogeneic stem cell transplant recipients ≤2 years before inclusion or treated for acute GvHD ≥grade 2 or chronic moderate-severe GvHD or\n 3. Active solid or haematological oncological disease with curative perspectives or\n 4. HIV infection with CD4\\<350 or\n 5. Hypogammaglobulinemia and other severe genetic immunological defect or\n 6. Auto-immune disease with biological immunosuppressive treatment\\* or\n 7. Other significant immunosuppressive condition such as IgG \\<6, treamtent with Rituximab or other biological lymphopenic treatment AND\n\n * Age ≥ 18 years old and\n * 2 distinct ABO group determination and\n * Positive RT-PCR for SARS-CoV-2 on a respiratory tract sample of ≤ 7 days and days post symptom onset (DPOS) ≤ 7 days at inclusion and/or\n * No oxygen requirement (WHO 8 ordinal scale \\< 4): asymptomatic, mild or moderate disease, or O2 saturation ≥ 90% at room temperature and\n * Compatible ABO donor with neutralizing antibodies (NTAB) ≥1 :160 or equivalent according to predefined antibody commercial assays cut-offs (see Study procedures)\n * RT-PCR on a respiratory tract sample with CT value\\<20 or ascending kinetics at the time of infusion (highly suggested but not necessary)\n2. Older adults defined as Age ≥ 75 years old or ≥ 65 years old with at least one co-existing condition\n\n * Arterial hypertension under pharmacological treatment\n * Diabetes in treatment\n * Obesity (BMI ≥ 30 kg/m2)\n * Chronic obstructive pulmonary disease stade GOLD ≥2\n * Respiratory insufficiency due to any pneumopathy or neurologic disease.\n * Cardiovascular disease as defined by either known coronary heart disease, history of ischemic or hemorrhagic stroke or cardiac insufficiency (ejection fraction \\<40%)\n * Chronic kidney disease (GFR\\<60 ml/min) AND\n * 2 distinct ABO group determination and\n * Positive RT-PCR for SARS-CoV-2 on a respiratory tract sample of ≤ 3 days and days post symptom onset (DPOS) ≤ 3 days at inclusion or RT-PCR on a respiratory tract sample with CT value\\<20 or ascending kinetics at the time of perfusion and\n * No additional oxygen requirement compared to baseline (WHO 8 ordinal scale \\< 4): asymptomatic, mild or moderate disease and\n * Compatible ABO donor with neutralizing antibodies (NTAB) ≥1 :160 or equivalent according to predefined antibody commercial assays cut-offs (see Study procedures)\n\nExclusion criteria:\n\nSeroconversion at the time of inclusion\n\n* Palliative care\n* No signed informed consent\n* History of previous transfusion-related Grade 3 adverse event according to Swissmedic definitions\n* Disseminated intravascular coagulopathy (depending on specialist evaluation)\n* Uncontrolled acute hypervolemia'}, 'identificationModule': {'nctId': 'NCT04836260', 'briefTitle': 'Preemptive Use of Convalescent Plasma for High-risk Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Preemptive Use of Convalescent Plasma for High-risk Patients With SARS-CoV-2 Infection: Phase III-IV Non-controlled Non-randomised Swiss Multicentric Trial', 'orgStudyIdInfo': {'id': '2020-02989'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SARS-CoV-2 convalescent plasma', 'type': 'DRUG', 'description': 'Included patients will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 at maximum 3-7 days after diagnosis by RT-PCR or symptom onset. A second unit of plasma from a different donor can be proposed 24h after the first unit if immunocompromised and/or the patient received less than 3-5ml/kg of plasma volume. Additional units can be exceptionnally infused, at the investigator discretion.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Nina Khanna, MD', 'role': 'CONTACT', 'email': 'nina.khanna@usb.ch', 'phone': '+41613287325'}, {'name': 'Maja Weisser, MD', 'role': 'CONTACT', 'email': 'maja.weisser@usb.ch', 'phone': '+413286742'}, {'name': 'Andreas Buser, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universitätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '1708', 'city': 'Fribourg', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Véronique Erard, MD', 'role': 'CONTACT', 'email': 'Veronique.erard@h-fr.ch', 'phone': '+41 26 3060836'}, {'name': 'Emmanuel Levrat, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'HFR-Fribourg Hôpital Cantonal', 'geoPoint': {'lat': 46.80237, 'lon': 7.15128}}, {'zip': '1205', 'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Diem-Lan Vu Cantero, MD, PhD', 'role': 'CONTACT', 'email': 'diem-lan.vu@hcuge.ch', 'phone': '+41795535512'}, {'name': 'Laurent Kaiser, MD', 'role': 'CONTACT', 'email': 'laurent.kaiser@hcuge.ch', 'phone': '+41795533420'}, {'name': 'Sophie Waldvogel-Abramowski, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Geneva University Hospitals', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '6900', 'city': 'Lugano', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Enos Bernasconi, MD', 'role': 'CONTACT', 'email': 'Enos.Bernasconi@eoc.ch', 'phone': '+41918116022'}, {'name': 'Stefano Fontana, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ospedale Regionale di Lugano', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'centralContacts': [{'name': 'Diem-Lan Vu Cantero, MD, PhD', 'role': 'CONTACT', 'email': 'diem-lan.vu@hcuge.ch', 'phone': '+41795535512'}, {'name': 'Nina Khanna, MD', 'role': 'CONTACT', 'email': 'nina.khanna@usb.ch', 'phone': '+41613287325'}], 'overallOfficials': [{'name': 'Laurent Kaiser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}, {'name': 'Enos Bernasconi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Regionale di Lugano'}, {'name': 'Véronique Erard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HFR-Fribourg Hôpital Cantonal'}, {'name': 'Maja Weisser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik Infektiologie & Spitalhygiene'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, {'name': 'Ospedale Regionale di Lugano', 'class': 'OTHER'}, {'name': 'Hôpital Fribourgeois', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Diem-Lan Vu', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}