Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-28 @ 4:10 PM
Study NCT ID:
NCT05044650
Status:
UNKNOWN
Last Update Posted:
2022-02-04
First Post:
2021-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of KOVIR Capsule in the Combination Regimen With Background Treatment in COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-09-05', 'releaseDate': '2022-10-25'}], 'estimatedResultsFirstSubmitDate': '2022-10-25'}}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be assigned randomly 7:3 to either KOVIR group or Non-KOVIR group respectively.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-25', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2021-09-13', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean duration of clinical symptoms', 'timeFrame': 'up to 14 days', 'description': 'Mean time from baseline to no clinical symptom of COVID-19'}, {'measure': 'Number of participants with respiratory distress complications requiring treatment', 'timeFrame': 'up to 14 days', 'description': 'Occurrence of symptoms of respiratory distress complications requiring treatment'}, {'measure': 'Change in the severity of daily symptoms', 'timeFrame': 'up to 14 days', 'description': 'Scale: 0 = Asymptomatic, 1 = Mild, 2 = Moderate, 3 = Severe'}, {'measure': 'Number of Participants with Adverse Events as Assessed by CTCAE v5.0', 'timeFrame': 'up to 30 days after last dose', 'description': 'Frequency and severity of Study drug-related adverse events, adverse events leading to study termination, serious adverse events (SAE)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The acute pneumonia pandemic caused by a new strain of corona virus 2019, namely as COVID-19 by the World Health Organization (WHO), is a pandemic caused by SARS-CoV-2 virus. The reported symptoms vary from fever or chills, cough, shortness of breath, to muscle aches, headaches, loss of taste or smell.\n\nThe capsule KOVIR is a product based on the traditional medicine named "Ren shen bai du san" which is used to treat the cold conditions, also known as the initial plague according to the theory of traditional medicine.', 'detailedDescription': 'The acute pneumonia pandemic caused by a new strain of corona virus 2019, namely as COVID-19 by the World Health Organization (WHO), is a pandemic caused by SARS-CoV-2 virus. The reported symptoms have included, but are not limited to fever or chills, cough, shortness of breath, muscle aches, headaches, loss of taste or smell, diarrhea, dizziness, sore throat, abdominal pain, anorexia, and vomiting.\n\nThe capsule KOVIR is a product based on the traditional prescription named "Ren shen bai du san" which is used to treat the cold conditions, also known as the initial plague according to the theory of traditional medicine.\n\nThe study compares between standard dose regimen of KOVIR combined with background treatment in COVID-19 patients and only background treatment in COVID-19 patients. The study will enroll 700 participants to KOVIR group and 300 participant to Non-KOVIR group.\n\nAll participants will be treated and followed up in 14-day period. In case the participant meets the discharge criteria before 14 days, discontinuing the study drug will be done at the discretion of the investigators.\n\nScreening procedures occur at Day 1. Periodic assessments are conducted daily from Day 2-14. Finally, End of study visit is conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, aged from 18-65, Vietnamese nationality\n* Participants diagnosed with Positive result of SARS-CoV-2 using real time RT-PCR test, Ct value \\<30 (equivalent to viral load \\> 3log)\n* Voluntary participation in the study by signing an informed consent\n* Ability to adhere to treatment according to the investigator's assessment\n\nExclusion Criteria:\n\n* Symptoms of severe upper and lower respiratory tract infections such as dyspnea, SpO2\\<93%.\n* Acute reduction of ventilation function of respiratory apparatus and/or respiration function of the lung in any of the following three groups:\n\n * Respiratory distress due to hypoxemia with PaO2 less than 60mmHg when breathing room air.\n * Respiratory distress due to hypercapnia with PaCO2 above 50mmHg\n * Mixed respiratory distress accompanied by both a decrease in PaO2 and an increase in PaCO2\n* Allergy/intolerance to any component of the study drug.\n* Inability to administer medicine.\n* Severe pneumonia as assessed by the investigator.\n* Inability to comply with study procedures or to ensure compliance with study drug administration as assessed by investigators."}, 'identificationModule': {'nctId': 'NCT05044650', 'briefTitle': 'Efficacy of KOVIR Capsule in the Combination Regimen With Background Treatment in COVID-19 Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sao Thai Duong Joint Stock Company'}, 'officialTitle': 'A Study to Evaluate the Efficacy of KOVIR Capsule (TD0069) in the Combination Regimen With Background Treatment in COVID-19 Patients Without Symptoms of Acute Respiratory Distress', 'orgStudyIdInfo': {'id': 'YDHDT-KOVIR-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KOVIR', 'description': 'Standard dose, 3 capsules/time x 3 times/day x 14 days combined with background treatment', 'interventionNames': ['Dietary Supplement: KOVIR capsule combined with background treatment']}, {'type': 'NO_INTERVENTION', 'label': 'NON-KOVIR', 'description': 'Only background treatment'}], 'interventions': [{'name': 'KOVIR capsule combined with background treatment', 'type': 'DIETARY_SUPPLEMENT', 'description': 'KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg', 'armGroupLabels': ['KOVIR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700000', 'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'contacts': [{'name': 'Huong Dinh, SL II., MD.', 'role': 'CONTACT', 'email': 'dinhlanhuonghmu@gmail.com', 'phone': '(+84)983699665'}, {'name': 'Loc Huynh, SL II., MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lan Truong, PhD., MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Traditional Medicine Institute in Ho Chi Minh City', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'centralContacts': [{'name': 'Thi Hong Van Nguyen, MSc', 'role': 'CONTACT', 'email': 'vannh@thaiduong.com.vn', 'phone': '(+84)916451269'}], 'overallOfficials': [{'name': 'Loc Huynh, SL II., MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Traditional Medicine Institute in Ho Chi Minh City'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sao Thai Duong Joint Stock Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Big Leap Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-10-25', 'type': 'RELEASE'}, {'date': '2023-09-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sao Thai Duong Joint Stock Company'}}}}