Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-01-05 @ 6:05 AM
Study NCT ID:
NCT05398718
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2022-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Sotrovimab and Its Impact on the Immune Response to COVID-19 Infection in Real-life in the UAE and Bahrain
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711967', 'term': 'sotrovimab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-30', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-05-30', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To evaluate the impact of sotrovimab on incidence and duration of time for supplemental oxygen, length of stay (LOS) in the intensive care unit (ICU), and total hospital LOS.', 'timeFrame': '6 months', 'description': 'Defined as:\n\nProportion of COVID-19 patients who had ER visits for management of illness, for requirement of supplemental oxygen and/or ICU admission through Day 29 after sotrovimab administration.'}, {'measure': 'Quality of life of patients infused with Sotrovimab', 'timeFrame': '6 months', 'description': 'Defined as Change from baseline in health-related quality of life at Day 29 after sotrovimab administration according to the 20-item short form (SF-20) questionnaire (where available / in a selected fraction of patients only in the prospective arm).\n\nThe questionnaire contains items on physical functioning, role functioning, social functioning, mental health, health perception and pain, the score of all measures is transformed linearly to 0-100 scales, with 0 and 100 assigned to the lowest and highest possible scores, respectively. a high score indicates better health'}, {'measure': 'To evaluate the clinical impact of sotrovimab in preventing mortality.', 'timeFrame': '6 months', 'description': 'Defined as All-cause mortality during 29 days after sotrovimab administration'}], 'primaryOutcomes': [{'measure': '• Proportion of patients with COVID-19 progression through Day 29 after sotrovimab administration:', 'timeFrame': '6 months', 'description': '* Proportion of patients with COVID-19 progression through Day 29 after sotrovimab administration:\n\n * Requiring supplemental oxygen\n * Requiring ICU and/or general ward admission\n * Death\n* Time to first PCR negative status after the COVID-19 symptom onset\n* Time to first PCR negative status after date of sotrovimab administration'}, {'measure': 'To assess the impact of sotrovimab on the strength and duration of the immune response to natural SARS-CoV-2 infection in real-life setting in the UAE and Bahrain.', 'timeFrame': '6 months', 'description': 'Defined as\n\n• Change from baseline in mean levels of elevated SARS-CoV-2 functional neutralising antibodies at Day 29, Day 60 and Day 180 after sotrovimab administration, these will be presented as proportion of patients with that response'}], 'secondaryOutcomes': [{'measure': 'To evaluate the impact of sotrovimab on the duration and the severity of COVID-19 clinical symptoms', 'timeFrame': '6 months', 'description': 'Time to key clinical symptoms alleviation from symptom onset and sotrovimab administration at baseline, Day 29 after sotrovimab administration and Day of symptoms free (for all 350 patients in the interventional phase and part of the patients in the observational phase). Key clinical symptoms alleviation is defined as the clinical resolution of shortness of breath, fever, and body ache'}, {'measure': 'To evaluate the impact of sotrovimab in reducing SARS-CoV-2 viral load and in preventing COVID-19 respiratory disease progression.', 'timeFrame': '6 months'}, {'measure': 'To assess the safety of sotrovimab in real-life setting in the UAE and Bahrain', 'timeFrame': '6 months', 'description': 'Defined as:\n\n* Occurrence of adverse events (AEs) and serious adverse events (SAEs) through Day 29 after sotrovimab administration\n* . Proportion of patients with AEs and SAEs through Day 29 after sotrovimab administration.'}, {'measure': 'To assess the impact of sotrovimab on the strength and duration of the immune response to natural SARS-CoV-2 infection in real-life setting in the UAE and Bahrain.', 'timeFrame': '6 months', 'description': 'Defined as:\n\n• Change from baseline in mean levels of elevated SARS-CoV-2 functional neutralising antibodies at Day 29, Day 60 and Day 180 after sotrovimab administration in patients, who received their complete or incomplete vaccination course within 3 months prior to COVID-19 symptom onset, these will be presented as proportion of patients with that response.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sotrovimab'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': "The United Arab Emirates (UAE), the Kingdom of Bahrain, Kuwait, Oman, and Qatar have authorised sotrovimab for emergency use. Local experience among physicians include recent successful COVID-19 vaccine pivotal studies supported by the authorities' willingness to expedite understanding of the role of monoclonal antibodies such as sotrovimab in the management of COVID-19 and expertise to integrate the latest knowledge into the local or regional COVID-19 management guidelines. The aim of this study is to collect local clinical evidence for sotrovimab effect in the real-life setting in the UAE and the Kingdom of Bahrain. Overall study population is 20,000 and the duration of the study will be approximately six months from recruitment date."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with mild-to-moderate COVID-19 as confirmed by approved local laboratory tests', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults and paediatric patients (≥ 12 years of age weighing at least 40 kg)\n* Mild-to-moderate COVID-19\n* Positive results of direct SARS-CoV-2 viral testing\n* High risk for progression to severe COVID-19\n\nExclusion Criteria:\n\n* Patients who are hospitalised due to COVID-19 before sotrovimab administration\n* Patients who require oxygen therapy due to COVID-19 before sotrovimab administration oPatients who received pharmacological treatment including monoclonal antibodies to any components of SARS-CoV-2 virus within 6 months prior to enrolment into the study in retrospective and prospective arms.'}, 'identificationModule': {'nctId': 'NCT05398718', 'briefTitle': 'Study on Sotrovimab and Its Impact on the Immune Response to COVID-19 Infection in Real-life in the UAE and Bahrain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Abu Dhabi Health Services Company'}, 'officialTitle': 'Bi-directional Real-world Cohort Study on Sotrovimab and Its Impact on the Strength and Duration of the Immune Response to Natural SARS-CoV-2 Infection in Real-life Setting in the UAE and the Kingdom of Bahrain', 'orgStudyIdInfo': {'id': 'Abu Dhabi Health Services'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sotrovimab Arm', 'interventionNames': ['Drug: Sotrovimab']}, {'label': 'Control'}], 'interventions': [{'name': 'Sotrovimab', 'type': 'DRUG', 'description': 'collect local clinical evidence for sotrovimab effect in the real-life setting', 'armGroupLabels': ['Sotrovimab Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manama', 'status': 'RECRUITING', 'country': 'Bahrain', 'contacts': [{'name': 'Manaf Al Qahtani, MD', 'role': 'CONTACT'}], 'facility': 'The National Taskforce for combating COVID-19, Royal Medical Services.', 'geoPoint': {'lat': 26.22787, 'lon': 50.58565}}], 'centralContacts': [{'name': 'Nawal Al Kaabi, MD', 'role': 'CONTACT', 'email': 'research@seha.ae', 'phone': '+97124102985'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abu Dhabi Health Services Company', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}