Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT04644120
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2020-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19)
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2020-11-23', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs)', 'timeFrame': 'Up to Day 106', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug.'}, {'measure': 'Number of Participants With Study-Drug Related Grade 3 or Higher Infusion-Related Reactions', 'timeFrame': 'Up to Day 106', 'description': 'Participants will be assessed for the infusion-related reaction considered drug-related by the investigator.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Serum Concentration (Cmax) of ABBV-47D11', 'timeFrame': 'Up to Day 85', 'description': 'Maximum observed serum concentration (Cmax) of ABBV-47D11.'}, {'measure': 'Time to Cmax (Tmax) of ABBV-47D11', 'timeFrame': 'Up to Day 85', 'description': 'Time to maximum serum concentration of ABBV-47D11.'}, {'measure': 'Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11', 'timeFrame': 'Up to Day 29', 'description': 'Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11.'}, {'measure': 'Terminal Phase Elimination Half-Life (t1/2) of ABBV-47D11', 'timeFrame': 'Up to Day 85', 'description': 'Terminal phase elimination half-life (t1/2) of ABBV-47D11.'}, {'measure': 'AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11', 'timeFrame': 'Up to Day 85', 'description': 'AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11.'}, {'measure': 'Detection of Anti-Drug Antibodies (ADA) for ABBV-47D11', 'timeFrame': 'Up to Day 85', 'description': 'Anti-drug antibodies will be detected using a tiered approach for ABBV-47D11.'}, {'measure': 'Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-47D11', 'timeFrame': 'Up to Day 85', 'description': 'Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-47D11.'}, {'measure': 'AUC for Change From Baseline (Day 1) in SARS-CoV-2 Ribose Nucleic Acid (RNA) Reverse Transcription-Polymerase Chain Reaction (RT-PCR)', 'timeFrame': 'Baseline (Day 1) through Day 29', 'description': 'Area Under the Serum Concentration-Time Curve (AUC) of SARS-CoV-2 RNA.'}, {'measure': 'Time to Negative SARS-CoV-2 by RT-PCR', 'timeFrame': 'Up to Day 29', 'description': 'Number of days from Baseline (Day 1) to negative SARS-CoV-2 by RT-PCR.'}, {'measure': 'Negative SARS-CoV-2 RNA by RT-PCR', 'timeFrame': 'Up to Day 15', 'description': 'Number of participants with negative SARS-CoV-2 RNA by RT-PCR.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of ABBV-2B04', 'timeFrame': 'Up to Day 85', 'description': 'Maximum observed serum concentration (Cmax) of ABBV-2B04.'}, {'measure': 'Time to Cmax (Tmax) of ABBV-2B04', 'timeFrame': 'Up to Day 85', 'description': 'Time to maximum serum concentration of ABBV-2B04.'}, {'measure': 'Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-2B04', 'timeFrame': 'Up to Day 29', 'description': 'Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-2B04.'}, {'measure': 'Terminal Phase Elimination Half-Life (t1/2) of ABBV-2B04', 'timeFrame': 'Up to Day 85', 'description': 'Terminal phase elimination half-life (t1/2) of ABBV-2B04.'}, {'measure': 'AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04', 'timeFrame': 'Up to Day 85', 'description': 'AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04.'}, {'measure': 'Detection of Anti-Drug Antibodies (ADA) for ABBV-2B04', 'timeFrame': 'Up to Day 85', 'description': 'Anti-drug antibodies will be detected using a tiered approach for ABBV-2B04.'}, {'measure': 'Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-2B04', 'timeFrame': 'Up to Day 85', 'description': 'Neutralizing anti-drug antibodies will be detected using a tiered approach for ABBV-2B04.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CoronaVirus Disease-2019', 'COVID-19', 'Severe Acute Respiratory Syndrome Coronavirus-2', 'SARS-CoV-2', 'ABBV-47D11', 'ABBV-2B04'], 'conditions': ['CoronaVirus Disease-2019 (COVID-19)']}, 'referencesModule': {'references': [{'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate the safety and tolerability of ABBV-47D11 and ABBV-2B04 given alone and in combination to participants with COVID-19 infection. In addition, this study will evaluate the pharmacokinetics (how the body handles the study drug) and anti-viral activity of the study drug.\n\nABBV-47D11 and ABBV-2B04 are investigational anti-SARS-CoV-2 monoclonal antibodies being developed for the treatment of COVID-19. Study will be conducted in two parts. In part A, participants will receive ABBV-47D11 or placebo. There is a 1 in 4 chance that participants will be assigned to placebo. In part B, participants will receive ABBV-2B04 alone or in combination with ABBV-47D11 or placebo. There is a 1 in 5 chance that participants will be assigned to placebo. Around 54 adult participants with COVID-19 will be enrolled in approximately 10 to 30 sites globally.\n\nIn part A participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo on Day 1. In part B participants will receive single intravenous (into the veins) infusion of ABBV-2B04 alone or in combination with ABBV-47D11 or placebo on Day 1. Participants will be followed up for 106 days.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, nasal swabs and presence of side effects.', 'detailedDescription': 'Part B of this study was not conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed SARS-CoV-2 infection based on initial nucleic acid or antigen testing from respiratory swab, saliva, or other bodily fluid within 7 days prior to randomization.\n* Must have \\>= 1 symptom associated with COVID-19 with an onset of \\<= 8 days prior to randomization.\n* Hospitalized or plans for hospital admission due to COVID-19 at the time of randomization or not currently hospitalized and does not have plans for hospital admission at the time of randomization, but is willing to be confined for ≥ 48 hours post-dose for the purposes of participating in this research study\n\nExclusion Criteria:\n\n* Have an oxygen saturation (SpO2) \\< 88% on room air at rest for 5 minutes OR ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \\<= 200 mmHg at randomization.\n* Requiring high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/extracorporeal membrane oxygenation (ECMO) or anticipated impending need for high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/ECMO.\n* Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma.'}, 'identificationModule': {'nctId': 'NCT04644120', 'briefTitle': 'Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ABBV-47D11 and ABBV-2B04 as Monotherapy or Combination Therapy in Adults With COVID-19', 'orgStudyIdInfo': {'id': 'M20-404'}, 'secondaryIdInfos': [{'id': '2020-005203-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Group 1: ABBV-47D11 Dose A', 'description': 'Participants will receive ABBV-47D11 Dose A on Day 1.', 'interventionNames': ['Drug: ABBV-47D11']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Group 1: Placebo for ABBV-47D11', 'description': 'Participants will receive placebo for ABBV-47D11 on Day 1.', 'interventionNames': ['Drug: Placebo for ABBV-47D11']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Group 2: ABBV-47D11 Dose B', 'description': 'Participants will receive ABBV-47D11 Dose B on Day 1.', 'interventionNames': ['Drug: ABBV-47D11']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Group 2: Placebo for ABBV-47D11', 'description': 'Participants will receive placebo for ABBV-47D11 on Day 1.', 'interventionNames': ['Drug: Placebo for ABBV-47D11']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Group 3: ABBV-47D11 Dose C', 'description': 'Participants will receive ABBV-47D11 Dose C on Day 1.', 'interventionNames': ['Drug: ABBV-47D11']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Group 3: Placebo for ABBV-47D11', 'description': 'Participants will receive placebo for ABBV-47D11 on Day 1.', 'interventionNames': ['Drug: Placebo for ABBV-47D11']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Group 1: ABBV-2B04 Dose A', 'description': 'Participants will receive ABBV-2B04 Dose A on Day 1.', 'interventionNames': ['Drug: ABBV-2B04']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Group 1: ABBV-2B04 Dose A + ABBV-47D11', 'description': 'Participants will receive ABBV-2B04 Dose A in combination with ABBV-47D11 on Day 1.', 'interventionNames': ['Drug: ABBV-47D11', 'Drug: ABBV-2B04']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Group 1: Placebo', 'description': 'Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1.', 'interventionNames': ['Drug: Placebo for ABBV-47D11', 'Drug: Placebo for ABBV-2B04']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Group 2: ABBV-2B04 Dose B', 'description': 'Participants will receive ABBV-2B04 Dose B on Day 1.', 'interventionNames': ['Drug: ABBV-2B04']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Group 2: ABBV-2B04 Dose B + ABBV-47D11', 'description': 'Participants will receive ABBV-2B04 Dose B in combination with ABBV-47D11 on Day 1.', 'interventionNames': ['Drug: ABBV-47D11', 'Drug: ABBV-2B04']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Group 2: Placebo', 'description': 'Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1.', 'interventionNames': ['Drug: Placebo for ABBV-47D11', 'Drug: Placebo for ABBV-2B04']}], 'interventions': [{'name': 'ABBV-47D11', 'type': 'DRUG', 'description': 'Intravenous (IV) infusion.', 'armGroupLabels': ['Part A: Group 1: ABBV-47D11 Dose A', 'Part A: Group 2: ABBV-47D11 Dose B', 'Part A: Group 3: ABBV-47D11 Dose C', 'Part B: Group 1: ABBV-2B04 Dose A + ABBV-47D11', 'Part B: Group 2: ABBV-2B04 Dose B + ABBV-47D11']}, {'name': 'Placebo for ABBV-47D11', 'type': 'DRUG', 'description': 'Intravenous (IV) infusion.', 'armGroupLabels': ['Part A: Group 1: Placebo for ABBV-47D11', 'Part A: Group 2: Placebo for ABBV-47D11', 'Part A: Group 3: Placebo for ABBV-47D11', 'Part B: Group 1: Placebo', 'Part B: Group 2: Placebo']}, {'name': 'ABBV-2B04', 'type': 'DRUG', 'description': 'Intervenous (IV) Infusion', 'armGroupLabels': ['Part B: Group 1: ABBV-2B04 Dose A', 'Part B: Group 1: ABBV-2B04 Dose A + ABBV-47D11', 'Part B: Group 2: ABBV-2B04 Dose B', 'Part B: Group 2: ABBV-2B04 Dose B + ABBV-47D11']}, {'name': 'Placebo for ABBV-2B04', 'type': 'DRUG', 'description': 'Intervenous (IV) Infusion', 'armGroupLabels': ['Part B: Group 1: Placebo', 'Part B: Group 2: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206-4007', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Glendale Adventist Medical Center /ID# 225188', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '33157-6608', 'city': 'Cutler Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'Beautiful Minds Clinical Research Center /ID# 228708', 'geoPoint': {'lat': 25.5783, 'lon': -80.3377}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami /ID# 225038', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33407-3100', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Triple O Research Institute /ID# 228612', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60612-7232', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Hospital and Health Sciences System /ID# 224323', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '41501-1689', 'city': 'Pikeville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pikeville Medical Center /ID# 224539', 'geoPoint': {'lat': 37.47927, 'lon': -82.51876}}, {'zip': '08901-1766', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': "Saint Peter's University Hospital /ID# 225183", 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '07102', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': "Saint Michael's Medical Center /ID# 225258", 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Christ Hospital /ID# 224541', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '29605-4210', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': "Prisma Health Children's Hospital Upstate /ID# 224556", 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '77702-1100', 'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'Gadolin Research, LLC /ID# 229394', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '1023', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 226015', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1085', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis Egyetem /ID# 226016', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center-Hebrew University /ID# 225827', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '52621', 'city': 'Tel Hashomer, Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center /ID# 225857'}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Utrecht /ID# 225919', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '00726', 'city': 'Caguas', 'country': 'Puerto Rico', 'facility': 'San Juan Bautista School of Medicine /ID# 225963', 'geoPoint': {'lat': 18.23412, 'lon': -66.0485}}, {'zip': '00674', 'city': 'Manatí', 'country': 'Puerto Rico', 'facility': 'Manati Medical Center /ID# 225936', 'geoPoint': {'lat': 18.42745, 'lon': -66.49212}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}