Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT04701502
Status:
COMPLETED
Last Update Posted:
2021-10-21
First Post:
2021-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Viusid and Asbrip in Hospitalized Patients With Mild and Moderate COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012120', 'term': 'Respiration Disorders'}], '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': 'C551853', 'term': 'Viusid'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2021-01-04', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in liver function test', 'timeFrame': '21 days', 'description': 'Change in liver function test (AST, ALT and TBIL) by blood biochemical analysis.'}, {'measure': 'Change in kidney function test', 'timeFrame': '21 days', 'description': 'Change in kidney function with creatine clearance rate by blood and urinary biochemical analysis.'}, {'measure': 'Change in routine blood test', 'timeFrame': '21 days', 'description': 'Change in routine blood test red blood cells concentration by blood biochemical analysis.'}, {'measure': 'Change in routine blood test', 'timeFrame': '21 days', 'description': 'Change in routine blood test white blood cell concentration by blood biochemical analysis.'}, {'measure': 'Change in routine blood test', 'timeFrame': '21 days', 'description': 'Change in routine blood test D-dimer level by blood biochemical analysis.'}, {'measure': 'Change in routine blood test', 'timeFrame': '21 days', 'description': 'Change in routine blood test fibrinogen level by blood biochemical analysis at day.'}], 'primaryOutcomes': [{'measure': 'Clinical Improvement', 'timeFrame': '21 days', 'description': 'Clinical Improvement as assessed by change in total symptom score ranging from 0-12.\n\nThe symptom score includes: \\[everyday assessment, up to 21 days\\].\n\n1. Fever (temperature in oC) based on a scale 0-3: 0 \\<36,7; 1 =36,7-37,8; 2 =37,8-38,9; 3 \\> 38,9.\n2. Cough on a scale 0-3: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe.\n3. Shortness of breath based on a scale 0-3: 0 = no shortness of breath, 1 = with moderate intensity exercise, 2 = with walking on flat surface, 3 = short of breath with getting dressed or daily activities.\n4. Fatigue on a 0-3 scale: 0 = no fatigue, 1 = mild fatigue, 2 = moderate fatigue, 3 = severe fatigue.\n\nComposite score is a sum of mentioned four symptom scores, assessed every day up to 21 days. It ranges from 0 to 12.'}, {'measure': 'Time to semirecover', 'timeFrame': '21 days', 'description': 'Efficacy will be determined by the number of days required to reach a 50 percent reduction in the composite score, i.e. "time to semirecovery" (primary outcome measure).'}, {'measure': 'Symptom resolution', 'timeFrame': '21 days', 'description': 'Symptom resolution of COVID-19 disease The number of days required to reach symptom score \\<0,25 for each one of four symptom category mentioned before.'}, {'measure': 'Time to recovery', 'timeFrame': '21 days', 'description': 'Time (days) to recovery from COVID-19 disease The number of days required to reach composite score \\<1.'}], 'secondaryOutcomes': [{'measure': 'Cumulative assessment of disease severity', 'timeFrame': '21 days', 'description': "Disease severity will be measured using a disease severity clinical event scale (assessed until day 21) Change from baseline in the patient's health status on an ordinal scale of 7 categories.\n\n1. Death\n2. Hospitalized, with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)\n3. Hospitalized, with non-invasive ventilation or high-flow oxygen devices\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, which does not require supplemental oxygen\n6. Not hospitalized, limitation of activities.\n7. Not hospitalized, without limitations in activities. Note: lower scores mean a worse result.\n\nNote: lower scores mean a worse outcome"}, {'measure': 'Duration of SARS-CoV-2 PCR positivity', 'timeFrame': '21 days', 'description': 'Daily PCR analysis to measure and compare viral load'}, {'measure': 'Concentration of C-reactive protein in peripheral blood', 'timeFrame': '21 days', 'description': 'Concentration of C-reactive protein in peripheral blood measured by Blood biochemical analysis.'}, {'measure': 'Incidence of hospitalization', 'timeFrame': '21 days', 'description': 'Number of Incidence of hospitalization'}, {'measure': 'Duration (days) of hospitalization', 'timeFrame': '21 days', 'description': 'Number of days of hospitalization'}, {'measure': 'Incidence of mechanical ventilation supply', 'timeFrame': '21 days', 'description': 'Number of incidences of mechanical ventilation supply per patient'}, {'measure': 'Incidence of oxygen use', 'timeFrame': '21 days', 'description': 'Number of incidences of oxygen use'}, {'measure': 'Duration (days) of oxygen use', 'timeFrame': '21 days', 'description': 'Number of days of oxygen use per patient'}, {'measure': 'Mortality rate', 'timeFrame': '21 days', 'description': 'Number of death per group'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Respiratory Disease', 'Immune System', 'Immunomodulator', 'Antiseptic', 'Supportive Care']}, 'descriptionModule': {'briefSummary': 'This is a two-arm, randomized, open label, two-center, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.', 'detailedDescription': 'This is a two-arm, randomized, open label, two-center, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.\n\nA total of 60 subjects will be randomized 2:1 in this study. 40 patients will be assigned to receive daily oral doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours and standard care. Other 20 patients will be assigned to receive only standard care.\n\nTreatment duration: 21 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female adults aged ≥18 years at the time of enrollment.\n2. Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:\n\n Mild (uncomplicated) Illness:\n * Diagnosed with COVID-19 by a standardized RT-PCR assay and\n * Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath and\n * No signs of a more serious lower airway disease and\n * RR\\<20, HR \\<90, oxygen saturation (pulse oximetry) \\> 93% on room air\n\n Moderate Illness:\n * Diagnosed with COVID-19 by a standardized RT-PCR assay and\n * In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) or\n * Signs of moderate pneumonia, including RR ≥ 20 but \\<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \\> 93% on room air and\n * If available, lung infiltrates based on X-ray or CT scan \\< 50% present\n3. Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the Principal Investigator.\n4. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.\n5. Understands and agrees to comply with planned study procedures.\n\nExclusion Criteria:\n\n1. Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening.\n2. History of severe chronic respiratory disease and requirement for long-term oxygen therapy.\n3. Subjects showing signs of clinical jaundice at the time of screening.\n4. History of moderate and severe liver disease (Child-Pugh score \\>12).\n5. Subjects requiring Renal Replacement Therapy (RRT) at the time of screening.\n6. History of uncontrolled diabetes.\n7. History of severe chronic kidney disease or requiring dialysis.\n8. Any uncontrolled active systemic infection requiring admission to an intensive care unit (ICU); Note: Subjects infected with chronic hepatitis B virus or hepatitis C virus will be eligible for the study if they have no signs of hepatic decompensation.\n9. Patients with malignant tumor, or other serious systemic diseases.\n10. Patients who are participating in other clinical trials.\n11. Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Viusid or Asbrip are not eligible.\n\nNote: Empirical antibiotic treatment for secondary bacterial infections is allowed during the study.'}, 'identificationModule': {'nctId': 'NCT04701502', 'briefTitle': 'Efficacy and Safety of Viusid and Asbrip in Hospitalized Patients With Mild and Moderate COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Catalysis SL'}, 'officialTitle': 'Efficacy and Safety of Viusid and Asbrip in Hospitalized Patients With Mild and Moderate COVID-19', 'orgStudyIdInfo': {'id': 'COVID_BULG_2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional', 'description': 'A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip, plus standard care of the hospital.\n\nTreatment duration: 21 days.', 'interventionNames': ['Dietary Supplement: Viusid', 'Dietary Supplement: Asbrip', 'Drug: Standard Care']}, {'type': 'OTHER', 'label': 'Control', 'description': 'A total of 60 subjects will be randomized 2: 1 in this study. 20 control patients will be assigned to standard care of the hospital only.\n\nTreatment duration: 21 days.', 'interventionNames': ['Drug: Standard Care']}], 'interventions': [{'name': 'Viusid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients received daily doses of 30 ml of Viusid every 8 hours plus standard care for COVID-19. Viusid is administered orally.\n\nTreatment duration: 21 days', 'armGroupLabels': ['Interventional']}, {'name': 'Asbrip', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients received daily doses of 10 ml of Asbrip every 8 hours plus standard care for COVID-19. Asbrip is administered orally.\n\nTreatment duration: 21 days', 'armGroupLabels': ['Interventional']}, {'name': 'Standard Care', 'type': 'DRUG', 'description': 'Standard care for COVID-19', 'armGroupLabels': ['Control', 'Interventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'MBAL, Sv. Mina', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '4004', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'MTB Plovdiv', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catalysis SL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}