Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-30 @ 4:36 PM
Study NCT ID:
NCT04578158
Status:
COMPLETED
Last Update Posted:
2021-04-22
First Post:
2020-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Study the Adjuvant Benefits of Quercetin Phytosome in Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D004417', 'term': 'Dyspnea'}], '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': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-21', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects with COVID-19 disease progression', 'timeFrame': 'From day 1 to day 30', 'description': 'Percentage of subjects who require hospitalisation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19, Quercetin Phytosome, Anti-inflammatory, Immunomodulatory, Respiratory distress'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '32636851', 'type': 'RESULT', 'citation': 'Colunga Biancatelli RML, Berrill M, Catravas JD, Marik PE. Quercetin and Vitamin C: An Experimental, Synergistic Therapy for the Prevention and Treatment of SARS-CoV-2 Related Disease (COVID-19). Front Immunol. 2020 Jun 19;11:1451. doi: 10.3389/fimmu.2020.01451. eCollection 2020.'}, {'pmid': '32745548', 'type': 'RESULT', 'citation': 'Abian O, Ortega-Alarcon D, Jimenez-Alesanco A, Ceballos-Laita L, Vega S, Reyburn HT, Rizzuti B, Velazquez-Campoy A. Structural stability of SARS-CoV-2 3CLpro and identification of quercetin as an inhibitor by experimental screening. Int J Biol Macromol. 2020 Dec 1;164:1693-1703. doi: 10.1016/j.ijbiomac.2020.07.235. Epub 2020 Aug 1.'}, {'pmid': '33179911', 'type': 'RESULT', 'citation': 'Liu X, Raghuvanshi R, Ceylan FD, Bolling BW. Quercetin and Its Metabolites Inhibit Recombinant Human Angiotensin-Converting Enzyme 2 (ACE2) Activity. J Agric Food Chem. 2020 Nov 25;68(47):13982-13989. doi: 10.1021/acs.jafc.0c05064. Epub 2020 Nov 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if Quercetin Phytosome is beneficial for the treatment of COVID-19.', 'detailedDescription': 'This is a randomized, open-labelled and controlled study aimed to investigate the adjuvant benefits of Quercetin Phytosome in community-based subjects with confirmed SARS-CoV-2 infection (by RT-PCR). The study has two arms. In one arm the subjects will receive standard COVID-19 care as per the hospital/physician guidelines, whereas in the other arm the subjects will receive standard COVID-19 care + Quercetin Phytosome. The treatment will continue for 30 days. It is proposed that Quercetin Phytosome will contribute to boosting the natural immunity of the subjects and will help in preventing the COVID-19 disease progression i.e preventing the need of hospitalisation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years of either gender\n* Confirmed SARS-CoV-2 infection by RT-PCR\n* Currently diagnosed with mild-to-moderate symptoms of COVID-19 at home in self-isolation within 3 days of SARS-CoV-2 infection.\n* Displaying typical symptoms of COVID-19 such as a high temperature, a new, continuous cough, a loss or change to sense of smell or taste\n* Patients who have signed informed consent.\n\nExclusion Criteria:\n\n* Patients with proven hypersensitivity or allergic reaction to quercetin\n* Manifest contrary will'}, 'identificationModule': {'nctId': 'NCT04578158', 'briefTitle': 'Trial to Study the Adjuvant Benefits of Quercetin Phytosome in Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Liaquat University of Medical & Health Sciences'}, 'officialTitle': 'A Prospective, Randomized, Open-labelled, Controlled Trial to Study the Adjuvant Benefits of Quercetin Phytosome in Patients With Diagnosis of COVID-19.', 'orgStudyIdInfo': {'id': 'LUMHS/REC/894'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': 'This arm will receive the standard COVID-19 care as per the hospital physician guidelines.', 'interventionNames': ['Drug: Standard COVID-19 care']}, {'type': 'EXPERIMENTAL', 'label': 'Quercetin Phytosome', 'description': 'This arm will receive standard COVID-19 care + Quercetin Phytosome', 'interventionNames': ['Drug: Standard COVID-19 care', 'Dietary Supplement: Quercetin Phytosome']}], 'interventions': [{'name': 'Standard COVID-19 care', 'type': 'DRUG', 'description': 'Patients will receive standard covid-19 care as per the hospital/physician guidelines', 'armGroupLabels': ['Quercetin Phytosome', 'Standard of care']}, {'name': 'Quercetin Phytosome', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will receive a daily dose of 400 mg of oral Quercetin Phytosome', 'armGroupLabels': ['Quercetin Phytosome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76090', 'city': 'Jāmshoro', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Liaquat University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liaquat University of Medical & Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prof. Dr. Ikram Din Ujjan, MBBS, PhD', 'investigatorAffiliation': 'Liaquat University of Medical & Health Sciences'}}}}