Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT04553705
Status:
COMPLETED
Last Update Posted:
2025-09-23
First Post:
2020-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Omega-3, Nigella Sativa, Indian Costus, Quinine, Anise Seed, Deglycyrrhizinated Licorice, Artemisinin, Febrifugine on Immunity of Patients With (COVID-19)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}], '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': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2021-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2020-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical improvement', 'timeFrame': '30 Days', 'description': 'Time to Clinical recovery'}, {'measure': 'Recovery rate from positive to negative swaps', 'timeFrame': '14 Days', 'description': 'Percentage of patients returned to negative swaps of COVID-19'}, {'measure': 'Fever to normal temperature in days', 'timeFrame': '15 Days', 'description': 'Number of days for fever remission T=37.5°C'}, {'measure': 'Remission of lung inflammation in CT or X-ray', 'timeFrame': '30 Days', 'description': 'Number of days to report lungs recovery in chest X ray or CT'}, {'measure': 'Length of hospitalization', 'timeFrame': '10 Days', 'description': 'Number of days for hospitalization'}, {'measure': '(PCR levels) polymerase chain reaction assay levels', 'timeFrame': '10 Days', 'description': 'Change of (PCR levels) \\> 50% in comparison with PCR levels at the admission'}, {'measure': 'Respiratory indexes', 'timeFrame': '10 Days', 'description': "P O2/Fi O2 which reflects patients' oxygen saturation"}, {'measure': 'C-reactive protein mg/L', 'timeFrame': '25 Days', 'description': 'C-reactive protein milligrams per deciliter correlated with inflammation'}, {'measure': 'Serum Ferritin ng/ml', 'timeFrame': '25 Days', 'description': 'Serum Ferritin Nanograms per milliliter correlated with iron overload and illness severity'}, {'measure': 'Lactic acid dehydrogenase U/L', 'timeFrame': '25 Days', 'description': 'Lactic acid dehydrogenase unit per litter correlated with illness severity'}, {'measure': 'leukocytes count μl', 'timeFrame': '30 Days', 'description': 'leukocytes in microliter correlated with mortality'}, {'measure': 'Lipid profile [LDL, HDL, Total cholesterol ]', 'timeFrame': '14 Days', 'description': 'Mg/dl correlated with lipid peroxidation that linked to oxidative stress'}, {'measure': 'total plasma antioxidant capacity', 'timeFrame': '14 Days', 'description': 'Evaluate the antioxidant response against the free radicals produced in COVID-19 infection measured by ELISA'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'omega3', 'thymoquinone'], 'conditions': ['Covid19', 'Immunodeficiency']}, 'descriptionModule': {'briefSummary': 'The first version of this preprint article is registered on the 4th of May 2020 under the digital object identifier of:10.31219/osf.io/u56fc.\n\nCOVID-19 infections virus spread worldwide and impact many countries with sever economical sequences. The effective antiviral medication or vaccination for the virus is unavailable until the present date and it takes months or years to discover the effective treatment or test the efficacy of the discovered treatment.\n\nBased on these facts, the human immune system against the virus may have an effective role to regulate the infection and reduce the mortality rate among the infected patients. This proposed research article aims to explore the available medication/ natural supplementation to boost the immunity system of the patients against COVID-19 infections and reduce the mortality rate among infected patients. Methods: a proposed clinical trial will be carried out to investigate the effect of the different treatment modalities on the human immune system against COVID-19 infection.', 'detailedDescription': 'Natural supplementations have many reported effects on the human health ranged from immunity boosting to effective antiviral effect. Omeg-3 as an example affect the human health by many mechanisms e.g. Anti-oxidant, immunity boosting agent. Moreover, Omega-3 exerts an antiviral effect on Flu virus by inhibiting influenza virus replication 1. On the other hand, black seed supplementation exerts a chelation effect on sickle cell anemia patients and inhibits Human Heme Metabolism 2. Moreover, black seed exerts an antiviral effect on the replication of old coronavirus and the expression of (TRP-genes) family 3. In addition, Omega-3 regulates the human immunity against bacterial and viral infections 4. During the past years, many natural sources exerts an antimalarial effect with perfect reported results 5.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic with respiratory or systemic symptoms\n* Positive nasopharyngeal swab for COVID-19\n* CT imaging showing viral pneumonia\n* Temperature 38°C\n* Respiratory rate \\< 25 /min\n* Oxygen saturation (pulse oximetry) \\>95%\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* Hepatic failure Child-Pugh C\n* Negative swab test of (SARS)-(CoV-2)\n* Expected life is less than 24 hours\n* End-stage lung disease'}, 'identificationModule': {'nctId': 'NCT04553705', 'briefTitle': 'Omega-3, Nigella Sativa, Indian Costus, Quinine, Anise Seed, Deglycyrrhizinated Licorice, Artemisinin, Febrifugine on Immunity of Patients With (COVID-19)', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Impact of Different Treatment Modalities on Immunity Against COVID-19', 'orgStudyIdInfo': {'id': 'TQ/Omega-3 on COVID-19'}, 'secondaryIdInfos': [{'id': 'DOI: 10.31219/osf.io/u56fc', 'type': 'OTHER', 'domain': 'OSFPREPRINTS- MAY-4/2020'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omega-3/thymoquinone supplementation', 'description': '10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA \\& 200-300mg DHA) (3% thymoquinone) per day for one month.\n\nIn addition to the standard care', 'interventionNames': ['Drug: Omega 3/Nigella Sativa Oil']}, {'type': 'EXPERIMENTAL', 'label': 'Omega-3/thymoquinone / Indian Costus supplementation', 'description': '10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA \\& 200-300mg DHA), (3% thymoquinone),(Indian Costus) per day for one month.\n\nIn addition to the standard care', 'interventionNames': ['Drug: Omega 3/Nigella Sativa Oil/Indian Costus']}, {'type': 'EXPERIMENTAL', 'label': 'Omega-3/thymoquinone / Quinine pills', 'description': '10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA \\& 200-300mg DHA), (3% thymoquinone),(1g Quinine) per day for one month.\n\nIn addition to the standard care', 'interventionNames': ['Drug: Omega 3/Nigella Sativa Oil/Quinine pills']}, {'type': 'EXPERIMENTAL', 'label': 'Omega-3/thymoquinone / Anise seed capsule', 'description': '10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA \\& 200-300mg DHA), (3% thymoquinone),(450mg anise seed) per day for one month.\n\nIn addition to the standard care', 'interventionNames': ['Drug: Omega 3/Nigella Sativa Oil/Anise seed capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Omega-3/thymoquinone / Deglycyrrhizinated Licorice', 'description': '10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA \\& 200-300mg DHA), (3% thymoquinone),(Deglycyrrhizinated Licorice 800 mg ) per day for one month.\n\nIn addition to the standard care', 'interventionNames': ['Drug: Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: standard care', 'description': 'The standard protocol care for COVID-19 approved from ministry of health at Saudi arabia', 'interventionNames': ['Drug: Active Comparator']}], 'interventions': [{'name': 'Omega 3/Nigella Sativa Oil', 'type': 'DRUG', 'description': 'Omega-3 supplementation 1000mg contains (300-400mg EPA \\& 200-300mg DHA)\n\nNigella sativa supplementation (1g black seed oil contain 3% thymoquinone', 'armGroupLabels': ['Omega-3/thymoquinone supplementation']}, {'name': 'Omega 3/Nigella Sativa Oil/Indian Costus', 'type': 'DRUG', 'description': 'Omega-3 supplementation 1000mg contains (300-400mg EPA \\& 200-300mg DHA)\n\nNigella sativa supplementation (1g black seed oil contain 3% thymoquinone\n\nIndian Costus supplements', 'armGroupLabels': ['Omega-3/thymoquinone / Indian Costus supplementation']}, {'name': 'Omega 3/Nigella Sativa Oil/Quinine pills', 'type': 'DRUG', 'description': 'Omega-3 supplementation 1000mg contains (300-400mg EPA \\& 200-300mg DHA)\n\nNigella sativa supplementation (1g black seed oil contain 3% thymoquinone\n\nQuinine supplementation (1g Quinine)', 'armGroupLabels': ['Omega-3/thymoquinone / Quinine pills']}, {'name': 'Omega 3/Nigella Sativa Oil/Anise seed capsule', 'type': 'DRUG', 'description': 'Omega-3 supplementation 1000mg contains (300-400mg EPA \\& 200-300mg DHA)\n\nNigella sativa supplementation (1g black seed oil contain 3% thymoquinone\n\nAnise seed supplementation (450mg anise seed)', 'armGroupLabels': ['Omega-3/thymoquinone / Anise seed capsule']}, {'name': 'Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice', 'type': 'DRUG', 'description': 'Omega-3 supplementation 1000mg contains (300-400mg EPA \\& 200-300mg DHA)\n\nNigella sativa supplementation (1g black seed oil contain 3% thymoquinone\n\nDeglycyrrhizinated Licorice 800 mg', 'armGroupLabels': ['Omega-3/thymoquinone / Deglycyrrhizinated Licorice']}, {'name': 'Active Comparator', 'type': 'DRUG', 'description': 'Standard protocol care of COVID-19 infection', 'armGroupLabels': ['Active Comparator: standard care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mecca', 'state': 'Mecca Region', 'country': 'Saudi Arabia', 'facility': 'Maternity and Children hospital', 'geoPoint': {'lat': 21.42664, 'lon': 39.82563}}], 'overallOfficials': [{'name': 'HASSAN Masmali [consultant of Pediatrics], M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Maternity and Children hospital,Mecca, Saudi Arabia'}, {'name': 'MOHAMED M ABDELWAHAB GAMALELDIN, Ph.D Candidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beni-Suef University, Faculty of Pharmacy'}, {'name': 'SHAIMAA M Nashat SAYED ABDELHALIM, Ph.D Candidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beni-Suef University, Faculty of Pharmacy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maternity and Children Hospital, Makkah', 'class': 'OTHER'}, {'name': 'University of Arizona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical researcher', 'investigatorFullName': 'Mohamed Medhat Abdelwahab Gamaleldin', 'investigatorAffiliation': 'Beni-Suef University'}}}}