Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-11 @ 10:10 PM
Study NCT ID:
NCT04377802
Status:
UNKNOWN
Last Update Posted:
2020-05-06
First Post:
2020-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safe Return to Regular Clinical Operation After COVID-19 Pandemic
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': 'D025202', 'term': 'Molecular Diagnostic Techniques'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-05', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-05', 'lastUpdatePostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health care provider safe return to work', 'timeFrame': 'two weeks from giving serum or swab sample', 'description': 'by confirming that healthcare providers have antibodies against SARS-CoV-2 virus and/or their respiratory samples prove the absence of the virus, they can be considered safe and can report to work. By doing so, we could facilitate going back to normal life and ultimately help improving healthcare functionality as well as overall businesses operation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID 19']}, 'descriptionModule': {'briefSummary': ". Coronavirus (SARS-CoV2) appeared first in China late 2019 and caused an acute respiratory disease referred to as Coronavirus disease 2019 (COVID-19). SARS-CoV2 is considered by the World Health Organization (WHO) as pandemic and affected nations worldwide, leading to close borders and major economical struggle. The ongoing viral threat due to the lack of effective therapies and vaccination might prolonged this economical challenge and many businesses will face huge financial constraints leading to laying off labors, an increase in the unemployment rate, and major companies' bankruptcies. However, returning to normal business operations should be done with a safety focus and not be at the cost of global health and wellbeing. Immunity against COVID-19 is going to be a major determinant for a future safe work environment and will reduce the viral infection risk. Therefore, PI is suggesting that if an employee has antibodies against SARS-CoV-2 confirmed by serological testing, he or she could go back to work safely with taking the necessary precautions.", 'detailedDescription': "Coronavirus (SARS-CoV2) appeared first in China late 2019 and caused an acute respiratory disease referred as Coronavirus disease 2019 (covid-19). SARS-CoV2 is considered by the World Health Organization (WHO) as pandemic and affected nations worldwide, leading to close borders and major economical struggle. The ongoing viral threat due to the lack of effective therapies and vaccination might prolonged this economical challenge and many businesses will face huge financial constrains leading to laying off labors, increase in the unemployment rate and major companies' bankruptcies. However, returning to normal business operation should be done with a safety focus and not be at the cost of the global health and wellbeing. Immunity against COVID-19 is going to be a major determinant for future safe work environment and will reduce the viral infection risk. Therefore, PI is suggesting that if an employee has antibodies against SARS-CoV-2 confirmed by serological testing, he or she could go back to work safely with taking the necessary precautions.\n\nMaterials and Methods: Oncology medical staffs directly involved with patients will be serologically tested using the SARS-CoV-2 IgG assay kit (Abbott Diagnostics, US). If Participants were IgG positive, partcipants will be assumed as immune and therefore, could join the work forces. If partcipants tested negative, partcipants will undergo molecular testing using the RealStar® SARS-CoV-2 RT-PCR Kit RUO (Altona Diagnostics, Germany) to confirm freedom from COVID-19 and then partcipants could join as safe work environment. However, if Positive PCR, partcipants will be quarantined for 14 days or until 2 negative PCR obtained as per the standard Saudi Ministry of Health (MOH) guidelines.\n\nConclusion: by confirming that healthcare providers have antibodies against SARS-CoV-2 virus and/or their respiratory samples prove the absence of the virus, they can be considered safe and can report to work. By doing so, PI could facilitate going back to normal life and ultimately help improving healthcare functionality as well as overall businesses operation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all Health care provider at KFSH D\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT04377802', 'briefTitle': 'Safe Return to Regular Clinical Operation After COVID-19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'King Fahad Specialist Hospital Dammam'}, 'officialTitle': 'Safe Return to Regular Clinical Operation After COVID-19 Pandemic; (Oncology Center, Prospective Cohort)', 'orgStudyIdInfo': {'id': 'KFSH-ONC-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'molecular testing for virus RNA using RT-PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serological testing will be performed using SARS-CoV-2 IgG assay kit (Abbott Diagnostics, US) to check for the immunity. The IgG serology test (200 individuals per run) will be done using ARCHITECT i2000SR system which provides the results within 60 minutes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31444', 'city': 'Dammam', 'state': 'Eastern Province', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Hani Al Hashmi, MD', 'role': 'CONTACT', 'email': 'hashmih@yahoo.com', 'phone': '00966564773377'}, {'name': 'Hani Al Hashmi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fahad Ibnshamsah, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Salem Ghandourah, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'king Fahad specialist hospital', 'geoPoint': {'lat': 26.43442, 'lon': 50.10326}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Fahad Specialist Hospital Dammam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}