Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-01-06 @ 3:06 PM
Study NCT ID:
NCT06489860
Status:
WITHDRAWN
Last Update Posted:
2025-09-04
First Post:
2024-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SARS-CoV-2 Safety Study for the Treatment of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Vietnam']}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Directions: For adults and for Children 1-12 years old. Indication: SARS-CoV-2 Ingredient: Organic Rice 95% and Honey 5% Powder (whole) 1g. Mix one packet with 6.8 fl oz (200 ml) of hot water (220ºF/100ºC) about three minutes until dissolved.\n\nParticipants: Use 4 to 5 packets, use one pack each time after two hours. Humidification: \\<5% Dosage Form: Powder form Dosage Strength: 1.0 G/ 1 Unit, use one pack of 1 g for each time Use within two years from the manufacturing date. Storage normal conditions in dry, cool and temperature from 15 °C to 32 °C Store in a dry environment (75% humidity).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'SARS-CoV-2. Directions: For adults and for Children 1-12 years old. Indication: SARS-CoV-2.\n\nIngredient: Organic Rice 95% and Honey 5% Powder (whole) 1g.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'My record is not overseen by an IRB, I change the Overall Status to Withdrawn.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-02-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-24', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-07-04', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SARS-CoV-2', 'timeFrame': 'From September to October, 2024', 'description': '1. Parameters: Humidification, Unit: %, Result: 4.40, Test Method: ISO 7932: 2004.\n2. Cadmium (Cd), mg/Kg, 0.1, CASE.TN.0018 (Ref. AOAC 999.11).\n3. Hydrargyrum (Hg), mg/Kg, 0.01, CASE.TN.0141 (Ref . EPA Method 7473).\n4. Plumbum (Pb), mg/liter, 0.001, SMEWW3030E 2017: 31258: 2017.\n5. Cadmium (Cd), mg/liter, 0.0001, SMEWW3030E 2017: 31258: 2017. .\n6. Arsen (As), mg/liter, 0.001, SMEWW3030E 2017: 31258: 2017.\n7. Hydrargyrum (Hg), mg/liter, 0.0001, SMEWW3030E 2017: 31258: 2017.\n8. Clostridium perfringents, CFU/g, \\< 10, ISO 7937:2004.\n9. Coliforms, CFU/g, \\< 10, ISO 4832:2006 (\\*).\n10. Escherichia coli, CFU/g, \\< 10, ISO 7937:2006.\n11. Salmonella, /25g, Not detected, ISO 7937:2007.\n12. Staphylococcus aureus, CFU/g, \\< 10, ISO 7937:2008.\n13. Total Yeasts molds, CFU/g, \\< 10, ISO 7937:2009.\n14. Total Aerobic Microbial, CFU/g, 1.0 x 100, ISO 7937:2010.\n15. Vibrio parahaemolyticuc, /25g, Not detected, ISO 7937:2011. .'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV-2']}, 'referencesModule': {'references': [{'pmid': '21366476', 'type': 'RESULT', 'citation': 'Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database--update and key issues. N Engl J Med. 2011 Mar 3;364(9):852-60. doi: 10.1056/NEJMsa1012065.'}], 'seeAlsoLinks': [{'url': 'http://dhacoffee.com', 'label': 'This Website was pause hosting website'}]}, 'descriptionModule': {'briefSummary': 'SARS-CoV-2 produced strong pluripotent stem cells and brain cells to protect Telomere chromosomes to maintain Acid Deoxyribonucleic (ADN) Molecules.', 'detailedDescription': 'SARS-CoV-2 produced strong pluripotent stem cells and brain cells to change and disappear defective cells in virus variants, Covid-19 disease. Pluripotent stem cells produced strong cells serve as a repair system, replacing damaged cells, defective cells and dead cells.\n\nCHEMISTRY:\n\nSARS-CoV-2 does not use any chemicals, no colors and no additives and no preservatives.\n\nToxicology:\n\nSARS-CoV-2 product is not adverse effect, non-toxic and no pharmacal toxicology.\n\nSARS-CoV-2 is not placebo drug'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '1 Year', 'genderBased': True, 'genderDescription': 'Directions: For adults and for Children 1-12 years old.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SARS-CoV-2\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT06489860', 'acronym': 'SARS-CoV-2', 'briefTitle': 'SARS-CoV-2 Safety Study for the Treatment of COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'DHA Coffee Co., Ltd'}, 'officialTitle': 'SARS-CoV-2 Safety Study for the Treatment of COVID-19', 'orgStudyIdInfo': {'id': 'DHACoffee'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SARS-CoV-2 Safety Study for the Treatment of COVID-19', 'description': 'Directions: For adults and for Children 1-12 years old. Indication:SARS-CoV-2 Ingredients: Organic Rice 95% and Honey 5% Powder (whole) 1g. Mix one packet with 6.8 fl oz (200 ml) of hot water (220ºF/100ºC) about three minutes until dissolved.\n\nParticipants: Use 4 to 5 packets, use one pack each time after two hours. Humidification: \\<5% Dosage Form: Powder form Dosage Strength: 1.0 G/ 1 Unit, use one pack of 1 g for each time Use within two years from the manufacturing date. Storage normal conditions in dry, cool and temperature from 15 °C to 32 °C Store in a dry environment (75% humidity).', 'interventionNames': ['Drug: HIV', 'Drug: Malignant Neoplasms Safety Study for the Treatment of Neoplasms']}], 'interventions': [{'name': 'HIV', 'type': 'DRUG', 'otherNames': ['HIV Safety Study for the Treatment of Anti-AIDS Drug'], 'description': 'Directions: For adults and for Children 1-12 years old. Indication: HIV Ingredient: Organic Rice 93% and Honey 7% Powder (whole) 1g. Masking: None (Open Label) Mix one packet with 6.8 fl oz (200 ml) of hot water (220ºF/100ºC) about three minutes until dissolved. Participants: Use 4 to 5 packets, use one pack each time after two hours.\n\nHumidification: \\<5% Dosage Form:\n\nPowder form Dosage Strength: 1.0 G/ 1 Unit, use one pack of 1 g for each time Use within two years from the manufacturing date', 'armGroupLabels': ['SARS-CoV-2 Safety Study for the Treatment of COVID-19']}, {'name': 'Malignant Neoplasms Safety Study for the Treatment of Neoplasms', 'type': 'DRUG', 'otherNames': ['Malignant Neoplasms'], 'description': 'Directions: For adults and for Children 1-12 years old. Indication: Malignant Neoplasms . Ingredient: Organic Rice 92% and Honey 8% Powder (whole) 1g. Mix one packet with 6.8 fl oz (200 ml) of hot water (220ºF/100ºC) about three minutes until dissolved. Participants: Use 4 to 5 packets, use one pack each time after two hours. Humidification: \\<5% Dosage Form: Powder form Dosage Strength: 1.0 G/ 1 Unit, use one pack of 1 g for each time Use within two years from the manufacturing date.', 'armGroupLabels': ['SARS-CoV-2 Safety Study for the Treatment of COVID-19']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'PHUOC T DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DHA Coffee Co., Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '20 -1 g Packets Net Weight 0.70 oz (20 g) Directions: For adults and for Children 1-12 years old. Indication: Treated the SARS-CoV-2 treatment COVID-19 within 20 days Ingredient: Organic Rice 95% and Honey 5% Powder (whole) 1g. Mix one packet with 6.8 fl oz (200 ml) of hot water (220ºF/100ºC) about three minutes until dissolved.\n\nParticipants: Use 4 to 5 packets, use one pack each time after two hours. Use within two years from the manufacturing date. Humidification: \\<5% Dosage Form: Powder form Dosage Strength: 1.0 G/ 1 Unit, use one pack of 1 g for each time Storage normal conditions in dry, cool and temperature from 15 °C to 32 °C Store in a dry environment (75% humidity).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DHA Coffee Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DHA Coffee Co., Ltd', 'investigatorFullName': 'Do Van Tin', 'investigatorAffiliation': 'DHA Coffee Co., Ltd'}}}}