Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-31 @ 9:30 PM
Study NCT ID:
NCT04927169
Status:
TERMINATED
Last Update Posted:
2024-04-12
First Post:
2021-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection (Brazil Cohort)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D008231', 'term': 'Lymphopenia'}], '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': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015851', 'term': 'Interleukin-7'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Unblinded Pharmacist will prepare blinded syringes of colorless drug or placebo'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled of treatment vs placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'POOR ACCRUAL', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety assessment through incidence and scoring of grade 3-4 adverse events', 'timeFrame': '45 days', 'description': 'Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0) to assess safety'}], 'primaryOutcomes': [{'measure': 'Change of the absolute lymphocyte count (ALC) of lymphopenic (ALC≤1000/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever occurs first', 'timeFrame': 'one month', 'description': 'A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or Hospital Discharge'}], 'secondaryOutcomes': [{'measure': 'To obtain "clinical improvement" as defined by an improvement in a 11-points WHO score for Clinical Assessment, through day 30 or HD.', 'timeFrame': 'one month', 'description': 'to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by the 11 points WHO clinical score'}, {'measure': 'a significant change of SARS-CoV-2 viral load through day 30 or HD', 'timeFrame': 'one month', 'description': 'The decrease of SARS-CoV-2 viral load from measurements at baseline and days of treatment dose 4 and dose 5, Day 21 and Day 30 or HD (whichever occurs first)'}, {'measure': 'frequency of secondary infections through day 45 compared to placebo arm', 'timeFrame': '45 days', 'description': 'Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45'}, {'measure': 'length of hospitalization compared to placebo arm', 'timeFrame': '45 days', 'description': 'Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)'}, {'measure': 'Length of stay in ICU compared to placebo arm', 'timeFrame': '45 days', 'description': 'Number of days in ICU during index hospitalization'}, {'measure': 'number of readmissions to ICU compared to placebo arm', 'timeFrame': '45 days', 'description': 'Readmissions to ICU through Day 45'}, {'measure': 'organ support free days compared to placebo arm', 'timeFrame': '45 days', 'description': 'Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days)'}, {'measure': 'Frequency of re-hospitalization through day 45 compared to placebo arm', 'timeFrame': '45 days', 'description': 'Number of readmissions to the hospital through Day 45'}, {'measure': 'All-cause mortality through day 45 compared to placebo arm', 'timeFrame': '45 days', 'description': 'All-cause mortality through Day 45'}, {'measure': 'CD4+ and CD8+ T cell counts compared to placebo arm', 'timeFrame': '30 days', 'description': 'Absolute numbers of CD4+ and CD8+ T-cell counts at time points indicated on the Schedule of Activities (SoA)through Day 30 or HD'}, {'measure': 'level of other known biomarkers of inflammation: Ferritin compared to placebo', 'timeFrame': '30 days', 'description': 'Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30'}, {'measure': 'Level of other known biomarkers of inflammation: C reactive protein level (CRP) compared to placebo arm', 'timeFrame': '30 days', 'description': 'Level of other known biomarkers of inflammation: CRP compared to placebo arm'}, {'measure': 'Level of other known biomarkers of inflammation: D-dimer compared to placebo arm', 'timeFrame': '30 days', 'description': 'Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30'}, {'measure': 'Physiological status through National Early Warning Score (NEWS2) evaluation compared to Placebo arm', 'timeFrame': '30 days', 'description': 'Evaluate chnage of the NEWS2 score value. Score form 0 to 4: NO Risk Score of 7 or more: High risk'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Lymphocytopenia']}, 'referencesModule': {'references': [{'pmid': '32171076', 'type': 'RESULT', 'citation': 'Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.'}, {'pmid': '32031570', 'type': 'RESULT', 'citation': 'Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.'}, {'pmid': '29515037', 'type': 'RESULT', 'citation': 'Francois B, Jeannet R, Daix T, Walton AH, Shotwell MS, Unsinger J, Monneret G, Rimmele T, Blood T, Morre M, Gregoire A, Mayo GA, Blood J, Durum SK, Sherwood ER, Hotchkiss RS. Interleukin-7 restores lymphocytes in septic shock: the IRIS-7 randomized clinical trial. JCI Insight. 2018 Mar 8;3(5):e98960. doi: 10.1172/jci.insight.98960.'}, {'pmid': '18946659', 'type': 'RESULT', 'citation': 'Venet F, Chung CS, Kherouf H, Geeraert A, Malcus C, Poitevin F, Bohe J, Lepape A, Ayala A, Monneret G. Increased circulating regulatory T cells (CD4(+)CD25 (+)CD127 (-)) contribute to lymphocyte anergy in septic shock patients. Intensive Care Med. 2009 Apr;35(4):678-86. doi: 10.1007/s00134-008-1337-8. Epub 2008 Oct 23.'}, {'pmid': '39903535', 'type': 'DERIVED', 'citation': 'Shankar-Hari M, Francois B, Remy KE, Gutierrez C, Pastores S, Daix T, Jeannet R, Blood J, Walton AH, Salomao R, Auzinger G, Striker D, Martin RS, Anand NJ, Bosanquet J, Blood T, Brakenridge S, Moldawer LL, Vachharajani V, Yee C, Dal-Pizzol F, Morre M, Berbille F, van den Brink M, Hotchkiss R. A randomized, double-blind, placebo-controlled trial of IL-7 in critically ill patients with COVID-19. JCI Insight. 2025 Feb 4;10(6):e189150. doi: 10.1172/jci.insight.189150.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of the effects of CYT107 vs Placebo administered by intra-muscular route (IM) at 10μg/kg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients', 'detailedDescription': "Approximately forty-eight (48) participants will be randomized 1:1 to receive\n\n(a) Intramuscular (IM) administration of CYT107 at 10 μg/kg followed, after 72hrs of observation, by 10 μg/kg twice a week for 3 weeks (maximum 7administrations adjusted to patient's length of stay in the hospital) or (b)Intramuscular (IM) placebo (normal saline) at the same frequency. The aim of the study is to test the ability of CYT107 to produce an immune reconstitution of these patients and observe possible association with a clinical improvement.\n\nThis cohort excludes oncology patients on treatment"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. A written, signed informed consent, or emergency oral consent, by the patient or the patient's legally authorized representative, and the anticipated ability for participant to be re-consented in the future for ongoing Study participation\n2. Men and women aged ≥ 25 - 80 (included) years of age\n3. Hospitalized patients with two absolute lymphocyte count (ALC) ≤ 1000 cells/mm3, at two time points at least 24 hours apart, following HOSPITALIZATION:\n4. Hospitalized patients with moderate to severe hypoxemia requiring oxygen therapy at \\>4L per minute nasal cannula or greater to keep saturations \\>90%, non-invasive positive pressure ventilation (e.g., BIPAP), or patients intubated / ventilated for respiratory failure\n5. Confirmed infection with COVID-19 by any acceptable test available / utilized at each site\n6. Willingness and ability to practice contraception regardless of the gender of the patient during 5 months after last drug exposure\n7. Private insurance or government / institution financial support (through CMS or other)\n\nExclusion Criteria:\n\n1. Pregnancy or breast feeding\n2. ALT and/or AST \\> 5 x ULN\n3. Known, active auto-immune disease;\n4. Ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy within last 3 months and/or ongoing\n5. Patients with past history of Solid Organ transplant\n6. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load\n7. Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation \\>85% with maximal available therapy for \\>6 hours\n8. Patients receiving any agent with immune suppressive effects, other than steroids at dosages less than 300 mg/day equivalent hydrocortisone and/or anti-IL-6R treatments like Tocilizumab or Sarilumab or anti-IL-1 treatment like Anakinra which should preferably be minimized\n9. Patients with baseline Rockwood Clinical Frailty Scale ≥ 6 at Hospital admission\n10. Patients showing an increase of the NEWS2 score by more than 6 points during the screening/ baseline period (48 to 72 hrs prior to first administration)\n11. Patients under guardianship"}, 'identificationModule': {'nctId': 'NCT04927169', 'acronym': 'ILIAD-7-BRA', 'briefTitle': 'InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection (Brazil Cohort)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Revimmune'}, 'officialTitle': 'Recombinant Human InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic PAtients With COVID-19 Infection - "ILIAD 7 Trial" Brazil Cohort', 'orgStudyIdInfo': {'id': 'ILIAD-7 BRAZIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CYT107', 'description': 'IM administration of CYT107 / Interleukin-7', 'interventionNames': ['Drug: Interleukin-7']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO', 'description': 'IM administration of Saline at the same volume', 'interventionNames': ['Drug: PLACEBO']}], 'interventions': [{'name': 'Interleukin-7', 'type': 'DRUG', 'otherNames': ['CYT107'], 'description': 'IM administration at 10μg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay', 'armGroupLabels': ['CYT107']}, {'name': 'PLACEBO', 'type': 'DRUG', 'otherNames': ['SALINE'], 'description': 'IM administration of a volume of saline identical to 10μg/kg CYT107, twice a week for three weeks and up to 7 administrations according to Hospital length of stay', 'armGroupLabels': ['PLACEBO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '88103', 'city': 'São José', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Hospital Sao Jose', 'geoPoint': {'lat': -27.61528, 'lon': -48.6275}}, {'zip': '18618', 'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Upeclin-Unesp', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}, {'zip': '14051', 'city': 'Monte Alegre', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Das Clinicas de Ribeirao Preto', 'geoPoint': {'lat': -21.86667, 'lon': -46.78333}}, {'zip': '04021', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Federal de Sao Paolo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04038', 'city': 'Vila Clementino', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Edmundo Vasconcelos', 'geoPoint': {'lat': -23.59818, 'lon': -46.64393}}], 'overallOfficials': [{'name': 'Reinaldo SALOMAO, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Escola Paulista de Medicina Universidade Federal de São Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revimmune', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Resolution Latin America', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}