Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 3:28 PM
Study NCT ID:
NCT04452435
Status:
COMPLETED
Last Update Posted:
2021-06-23
First Post:
2020-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of C21 in Subjects With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711730', 'term': 'compound 21'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carl-johan.dalsgaard@vicorepharma.com', 'phone': '+46 70 975 98 63', 'title': 'Carl-Johan Dalsgaard', 'organization': 'Vicore Pharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From signing of informed consent until end-of-trial visit, 14-19 days.', 'description': 'At each visit, the subject was asked about AEs in an objective manner, e.g., "Have you experienced any problems since the last visit?" No AEs were reported from signing of informed consent until randomization except for 2 fatal SAEs.', 'eventGroups': [{'id': 'EG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 30, 'seriousNumAtRisk': 51, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 36, 'seriousNumAtRisk': 55, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'No Treatment (Before Randomization)', 'description': 'Subjects that were enrolled in the trial but not randomized', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 2, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Interleukin level increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Serum ferritin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alpha tumour necrosis factor increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Carbohydrate antigen 125 increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Platelet count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Glycosuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 100}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Cardio-respiratory arrest', 'notes': 'The events had a fatal outcome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'COVID-19 pneumonia', 'notes': 'The events had a fatal outcome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'OG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '0.25'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '0.29'}]}]}], 'analyses': [{'pValue': '=0.4891', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.'}, {'pValue': '=0.0881', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A subgroup analyses was performed in subjects with supplemental oxygen use at baseline. A total of 26 subjects in the C21 group and 27 in the placebo group were included in the analysis of change in CRP from baseline to the mean of the last 2 non-missing scheduled assessments during the treatment period by baseline supplemental oxygen use.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Change in C-reactive protein (CRP) from baseline to the average of the last two assessments in the treatment period', 'unitOfMeasure': 'mg/L', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. A total of 45 subjects in the C21 group and 46 subjects in the placebo group were included in the analysis of the primary endpoint in the FAS. For a number of the excluded subjects, the reason for exclusion from the primary endpoint analysis was that they had no baseline value available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'OG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.02'}, {'value': '-0.34', 'groupId': 'OG001', 'lowerLimit': '-0.47', 'upperLimit': '-0.21'}]}]}], 'analyses': [{'pValue': '=0.0492', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Treatment period of 7 days ((Day 1 to Day 8)', 'description': 'Change in body temperature from baseline to the average of the last two assessments in the treatment period', 'unitOfMeasure': '°C', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with measurements were included in the analysis for the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'OG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.51', 'upperLimit': '1.05'}, {'value': '0.73', 'groupId': 'OG001', 'lowerLimit': '0.51', 'upperLimit': '1.03'}]}]}], 'analyses': [{'pValue': '=0.9923', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Change in IL-6 from baseline to the average of the last two assessments during the treatment period', 'unitOfMeasure': 'pg/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with measurements were included in the analysis for the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IL-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'OG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '0.8'}, {'value': '0.73', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '0.89'}]}]}], 'analyses': [{'pValue': '=0.5355', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Change in IL-10 from baseline to the average of the last two assessments during the treatment period', 'unitOfMeasure': 'pg/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with measurements were included in the analysis for the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in TNF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'OG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '1.07'}, {'value': '1.01', 'groupId': 'OG001', 'lowerLimit': '0.86', 'upperLimit': '1.19'}]}]}], 'analyses': [{'pValue': '=0.4738', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Change in TNF from baseline to the average of the last two assessments during the treatment period.', 'unitOfMeasure': 'pg/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with measurements were included in the analysis for the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CA125', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'OG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1.16', 'groupId': 'OG000', 'lowerLimit': '1.04', 'upperLimit': '1.31'}, {'value': '1.17', 'groupId': 'OG001', 'lowerLimit': '1.05', 'upperLimit': '1.31'}]}]}], 'analyses': [{'pValue': '=0.9418', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Change in CA125 from baseline to the average of the last two assessments in the treatment period', 'unitOfMeasure': 'u/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with measurements were included in the analysis for the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ferritin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'OG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '0.84'}, {'value': '0.74', 'groupId': 'OG001', 'lowerLimit': '0.66', 'upperLimit': '0.84'}]}]}], 'analyses': [{'pValue': '=0.9733', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Change in Ferritin from baseline to the average of the last two assessments during the treatment period.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with measurements were included in the analysis for the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Not in Need of Oxygen Supply', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'OG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.0568', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End-of treatment, Day 7 or 8', 'description': 'Number of subjects not in need of oxygen supply at the end of treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'OG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.6088', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Number of subjects not in need of mechanical invasive or non-invasive ventilation during the treatment period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Time to Need of Mechanical Invasive or Non-invasive Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'OG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '60.0'}, {'value': '77.925', 'groupId': 'OG001', 'lowerLimit': '59.98', 'upperLimit': '95.87'}]}]}], 'analyses': [{'pValue': '=0.5757', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.'}], 'paramType': 'MEAN', 'timeFrame': 'Treatment period of 7 days', 'description': 'Time to need of mechanical invasive or non-invasive ventilation during treatment period', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with measurements were included in the analysis for the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'OG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}], 'analyses': [{'pValue': '=0.8588', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Time on oxygen supply during the treatment period (for those not needing mechanical invasive or non-invasive ventilation)', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'OG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to end-of-trial (Visit 9)', 'description': 'Adverse events were reported from signing of informed consent until end-of-trial visit. No AEs were reported from signing of informed consent until randomization, except for 2 fatal SAEs described under Adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set'}, {'type': 'POST_HOC', 'title': 'Oxygen Supplementation at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'OG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.003', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Follow-up Day 14 (7 days after end-of-treatment)', 'description': 'Number of subjects requiring oxygen supplementation at Day 14', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'FG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}], 'periods': [{'title': 'Screening', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}, {'title': 'Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '96 enrolled subjects were screening failures because inclusion criteria 4 was not met.\n\n2 enrolled subjects decided to withdraw from the trial before randomization. 2 subjects died before randomization (pneumonia). The remaining 106 subjects were randomized to trial treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'C21 Treatment', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days'}, {'id': 'BG001', 'title': 'Placebo Treatment', 'description': 'Oral placebo treatment twice daily for 7 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '68'}, {'value': '51.1', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '68'}, {'value': '52.6', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '68'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'India', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '166.1', 'groupId': 'BG000', 'lowerLimit': '132', 'upperLimit': '198'}, {'value': '166.0', 'groupId': 'BG001', 'lowerLimit': '143', 'upperLimit': '188'}, {'value': '166.1', 'groupId': 'BG002', 'lowerLimit': '132', 'upperLimit': '198'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '70.1', 'groupId': 'BG000', 'lowerLimit': '46', 'upperLimit': '116'}, {'value': '69.2', 'groupId': 'BG001', 'lowerLimit': '47', 'upperLimit': '112'}, {'value': '69.6', 'groupId': 'BG002', 'lowerLimit': '46', 'upperLimit': '116'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '25.4', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '41'}, {'value': '25.1', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '34'}, {'value': '25.2', 'groupId': 'BG002', 'lowerLimit': '15', 'upperLimit': '41'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Supplemental oxygen use at baseline', 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of subjects in use of supplemental oxygen use at baseline', 'unitOfMeasure': 'Participants'}, {'title': 'CRP value ≤ median', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of subjects with baseline CRP value ≤ median', 'unitOfMeasure': 'Participants'}, {'title': 'CRP value > median', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of subjects with baseline CRP value \\> median', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-14', 'size': 1291465, 'label': 'Study Protocol and Statistical Analysis Plan: Study Protocol', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-24T04:55', 'hasProtocol': True}, {'date': '2020-09-10', 'size': 9513792, 'label': 'Statistical Analysis Plan: Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-21T09:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-21', 'studyFirstSubmitDate': '2020-06-29', 'resultsFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-28', 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.)', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Change in C-reactive protein (CRP) from baseline to the average of the last two assessments in the treatment period'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Body Temperature', 'timeFrame': 'Treatment period of 7 days ((Day 1 to Day 8)', 'description': 'Change in body temperature from baseline to the average of the last two assessments in the treatment period'}, {'measure': 'Change From Baseline in IL-6', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Change in IL-6 from baseline to the average of the last two assessments during the treatment period'}, {'measure': 'Change From Baseline in IL-10', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Change in IL-10 from baseline to the average of the last two assessments during the treatment period'}, {'measure': 'Change From Baseline in TNF', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Change in TNF from baseline to the average of the last two assessments during the treatment period.'}, {'measure': 'Change From Baseline in CA125', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Change in CA125 from baseline to the average of the last two assessments in the treatment period'}, {'measure': 'Change From Baseline in Ferritin', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Change in Ferritin from baseline to the average of the last two assessments during the treatment period.'}, {'measure': 'Number of Subjects Not in Need of Oxygen Supply', 'timeFrame': 'End-of treatment, Day 7 or 8', 'description': 'Number of subjects not in need of oxygen supply at the end of treatment'}, {'measure': 'Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Number of subjects not in need of mechanical invasive or non-invasive ventilation during the treatment period'}, {'measure': 'Time to Need of Mechanical Invasive or Non-invasive Ventilation', 'timeFrame': 'Treatment period of 7 days', 'description': 'Time to need of mechanical invasive or non-invasive ventilation during treatment period'}, {'measure': 'Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation)', 'timeFrame': 'Treatment period of 7 days (Day 1 to Day 8)', 'description': 'Time on oxygen supply during the treatment period (for those not needing mechanical invasive or non-invasive ventilation)'}, {'measure': 'Adverse Events', 'timeFrame': 'Day 1 to end-of-trial (Visit 9)', 'description': 'Adverse events were reported from signing of informed consent until end-of-trial visit. No AEs were reported from signing of informed consent until randomization, except for 2 fatal SAEs described under Adverse events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This is a randomised, double-blind, placebo-controlled phase 2 trial investigating the safety and efficacy of C21 in subjects who are hospitalised with COVID-19 infection, but not in need of mechanical invasive or non-invasive ventilation.\n\nIn total, approximately 100 subjects will be enrolled and randomised to receive twice daily oral administration of either standard of care (SoC) + placebo (N=50) or SoC + C21 (N=50). Subjects will be treated for 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure\n2. Diagnosis of coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test \\< 4 days before Visit 1 with signs of an acute respiratory infection\n3. Age \\> 18 and \\< 70 years\n4. CRP \\> 50 and \\< 150 mg/l\n5. Admitted to a hospital or controlled facility (home quarantine is not sufficient)\n6. In the opinion of the Investigator, the subject will be able to comply with the requirements of the protocol\n\nExclusion Criteria:\n\n1. Any previous experimental treatment for COVID-19\n2. Need for mechanical invasive or non-invasive ventilation\n3. Concurrent respiratory disease such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days) prior to COVID-19 diagnosis\n4. Participation in any other interventional trial within 3 months prior to Visit 1\n5. Any of the following findings at Visit 1:\n\n * Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1+2 antigen/antibody (HIV 1+2 Ag/Ab\n * Positive pregnancy test (see Section 8.2.3)\n6. Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the Investigator\n7. Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery), which in the opinion of the Investigator makes the subject inappropriate for this trial\n8. Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I\n9. Treatment with any of the medications listed below within 1 week prior to Visit 1:\n\n 1. Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. John's Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbiturates)\n 2. Warfarin\n10. Pregnant or breast-feeding female subjects\n11. Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1\n12. Male subjects not willing to use contraceptive methods as described in Section 5.3.1\n13. Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)"}, 'identificationModule': {'nctId': 'NCT04452435', 'briefTitle': 'Safety and Efficacy of C21 in Subjects With COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vicore Pharma AB'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled, Phase 2 Trial Investigating the Safety and Efficacy of C21 in Hospitalised Subjects With COVID-19 Infection Not Requiring Mechanical Ventilation', 'orgStudyIdInfo': {'id': 'VP-C21-006'}, 'secondaryIdInfos': [{'id': '2020-001502-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C21 100 mg twice daily', 'description': 'Oral C21 treatment 100 mg twice daily for 7 days', 'interventionNames': ['Drug: C21']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral placebo treatment 100 mg twice daily for 7 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'C21', 'type': 'DRUG', 'description': 'C21', 'armGroupLabels': ['C21 100 mg twice daily']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '380016', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Department of Medicine, Civil Hospital and B J Medical College', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '395001', 'city': 'Surat', 'state': 'Gujarat', 'country': 'India', 'facility': 'Infectious Disease, Metas Adventist Hospital', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '395010', 'city': 'Surat', 'state': 'Gujarat', 'country': 'India', 'facility': 'Clinical Research Department, Basement, Unity Trauma Centre and ICU (Unity Hospital', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '290022', 'city': 'Vadodara', 'state': 'Gujarat', 'country': 'India', 'facility': 'First Floor Clinical Research Department Rhythm Heart Institute', 'geoPoint': {'lat': 22.29941, 'lon': 73.20812}}, {'zip': '400016', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Internal Medicine S.L. Raheja Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '440003', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Department of Medicine, Government Medical College and Hospital', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '411001', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Neuro Critical Care, Grant Medical Foundation Ruby Hall Clinic', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Department of Medicine, Noble Hospitals Pvt. Ltd', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': 'WC1E 6BT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Respiratory Medicine, University College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Joanna Porter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Respiratory Medicine, University College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vicore Pharma AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Orphan Reach Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}