Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-31 @ 1:23 AM
Study NCT ID:
NCT04709835
Status:
COMPLETED
Last Update Posted:
2022-10-26
First Post:
2021-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria', 'Lithuania', 'Poland', 'United States']}, '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': 'C000713067', 'term': 'AT-511'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 33 days', 'description': 'Safety Population consisted of all participants who received any amount of study drug and were grouped according to the treatment that the participants actually received rather than the treatment assigned at randomization.', 'eventGroups': [{'id': 'EG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 1, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 5, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA for AT-527 550 mg and Matched Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matched to AT-527 550 mg', 'description': 'Participants received placebo matched to 550 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'OG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.16', 'spread': '0.203', 'groupId': 'OG000'}, {'value': '-1.26', 'spread': '0.206', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.42', 'spread': '0.230', 'groupId': 'OG000'}, {'value': '-2.11', 'spread': '0.226', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.13', 'spread': '0.220', 'groupId': 'OG000'}, {'value': '-3.38', 'spread': '0.220', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7144', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.11', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.292', 'estimateComment': 'A difference in adjusted means of \\<0 favors RO7496998 (AT-527).', 'groupDescription': 'Day 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3373', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.32', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.327', 'estimateComment': 'A difference in adjusted means of \\<0 favors RO7496998 (AT-527).', 'groupDescription': 'Day 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4260', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.25', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.315', 'estimateComment': 'A difference in adjusted means of \\<0 favors RO7496998 (AT-527).', 'groupDescription': 'Day 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 3, Day 5, Day 7', 'description': 'SARS-CoV-2 virus RNA was measured by reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal (NP) swabs. The change from baseline was estimated from an ANCOVA model with baseline viral load as a covariate. Reported here is the adjusted mean change from baseline. A negative change from baseline indicates an improvement.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified ITT infected (mITTi) population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to Cessation of SARS-CoV-2 Viral Shedding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'OG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}, {'id': 'OG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Not estimable due to low number of participants with event.', 'groupId': 'OG000', 'lowerLimit': '144.2', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to low number of participants with event.', 'groupId': 'OG001', 'lowerLimit': '143.8', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to low number of participants with event.', 'groupId': 'OG002', 'lowerLimit': '141.1', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.96', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.74', 'estimateComment': 'Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.33', 'ciLowerLimit': '0.76', 'ciUpperLimit': '2.32', 'estimateComment': 'Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 7', 'description': 'Time to cessation of viral shedding was defined as the time between the initiation of any study treatment and the first time when a negative or below the limit of detection RT-PCR test result was obtained. RT-PCR was measured from NP swabs. Median, 25th and 75th percentiles were estimated from the Kaplan-Meier curve.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Non-Detectable SARS-CoV-2 Virus RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'OG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}, {'id': 'OG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Not estimable due to low number of participants with event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to low number of participants with event.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to low number of participants with event.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.86', 'ciLowerLimit': '0.44', 'ciUpperLimit': '1.70', 'estimateComment': 'Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.06', 'ciLowerLimit': '0.56', 'ciUpperLimit': '2.03', 'estimateComment': 'Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 7', 'description': 'Time to sustained non-detectable SARS-CoV-2 virus RNA was defined as the time between the initiation of any study treatment and first time when a negative or below the limit of detection test result by RT-PCR is obtained after which no positive test above or equal to the limit of detection was reported. RT-PCR was measured from NP swabs. Median, 25th and 75th percentiles were estimated from the Kaplan-Meier curve.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'OG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}, {'id': 'OG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '96.7', 'groupId': 'OG002'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '93.1', 'groupId': 'OG002'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000'}, {'value': '90.0', 'groupId': 'OG001'}, {'value': '83.3', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000'}, {'value': '79.3', 'groupId': 'OG001'}, {'value': '76.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Positivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '5.00', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '10.16', 'estimateComment': 'Confidence interval estimated with the Farrington-Manning method.', 'groupDescription': 'Day 3', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage of Positivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.90', 'ciLowerLimit': '-9.20', 'ciUpperLimit': '5.41', 'estimateComment': 'Confidence interval estimated with the Farrington-Manning method.', 'groupDescription': 'Day 3', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Positivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '5.79', 'ciLowerLimit': '-4.82', 'ciUpperLimit': '16.40', 'estimateComment': 'Confidence interval estimated with the Farrington-Manning method.', 'groupDescription': 'Day 5', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage of Positivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.88', 'ciLowerLimit': '-12.40', 'ciUpperLimit': '10.65', 'estimateComment': 'Confidence interval estimated with the Farrington-Manning method.', 'groupDescription': 'Day 5', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Positivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.39', 'ciLowerLimit': '-10.64', 'ciUpperLimit': '15.42', 'estimateComment': 'Confidence interval estimated with the Farrington-Manning method.', 'groupDescription': 'Day 7', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage of Positivity', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.26', 'ciLowerLimit': '-13.39', 'ciUpperLimit': '12.88', 'estimateComment': 'Confidence interval estimated with the Farrington-Manning method.', 'groupDescription': 'Day 7', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 3, Day 5, Day 7', 'description': 'Reported here is the percentage of participants with a positive virus RNA by RT-PCR test result above or equal to the limit of quantification (LOQ). RT-PCR was measured from NP swabs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'OG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}, {'id': 'OG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'categories': [{'measurements': [{'value': '651.56', 'spread': '189.10', 'groupId': 'OG000'}, {'value': '733.70', 'spread': '146.63', 'groupId': 'OG001'}, {'value': '618.62', 'spread': '194.88', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 3, Day 5, Day 7', 'description': 'AUC is the amount of SARS-CoV-2 virus RNA from baseline to the last sample timepoint and was calculated using the trapezoidal method. RT-PCR was measured from NP swabs.', 'unitOfMeasure': 'log10 copies/mL*hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 Hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'OG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}, {'id': 'OG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.4', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '104.7'}, {'value': '57.2', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '115.8'}, {'value': '56.4', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '96.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 Days', 'description': 'COVID-19 symptoms were evaluated using the first 12 items in the COVID-19 Symptom Diary, which included the following 12 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, and diarrhea. The symptoms were scored on the 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).Time to alleviation or improvement is defined as the length of time taken from start of treatment to the point at which all of the following three criteria are met and maintained for a concurrent duration of at least 21.5 hours: "new" symptoms with a score of 0 or 1; "pre- existing and worsened due to COVID-19" symptoms with at least a single category improvement from baseline; "pre-existing and not worsened due to COVID-19" symptoms remaining the same or at least a single category improvement from baseline.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to Alleviation or Improvement of COVID-19 Symptoms (43 Hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'OG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}, {'id': 'OG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.4', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '104.7'}, {'value': '57.2', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '141.2'}, {'value': '58.1', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '118.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 Days', 'description': 'COVID-19 symptoms were evaluated using the first 12 items in the COVID-19 Symptom Diary, which included the following 12 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, and diarrhea. The symptoms were scored on the 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). Time to alleviation or improvement is defined as the length of time taken from start of treatment to the point at which all of the following three criteria are met and maintained for a concurrent duration of at least 43 hours: "new" symptoms with a score of 0 or 1; "pre- existing and worsened due to COVID-19" symptoms with at least a single category improvement from baseline; "pre-existing and not worsened due to COVID-19" symptoms remaining the same or at least a single category improvement from baseline.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to Alleviation of COVID-19 Symptoms (21.5 Hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'OG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}, {'id': 'OG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.4', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '104.7'}, {'value': '57.2', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '115.8'}, {'value': '56.4', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '96.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 Days', 'description': 'COVID-19 symptoms were evaluated using the first 12 items in the COVID-19 Symptom Diary, which included the following 12 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, and diarrhea. The symptoms were scored on the 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). Time to alleviation of COVID-19 symptoms is defined as the length of time taken from start of treatment to the point at which the following criterion is met and maintained for at least 21.5 hours: Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary, regardless of if the symptom is pre-existing or new.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to Alleviation of COVID-19 Symptoms (43 Hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'OG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}, {'id': 'OG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.4', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '104.7'}, {'value': '57.2', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '141.2'}, {'value': '58.1', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '118.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 Days', 'description': 'COVID-19 symptoms were evaluated using the first 12 items in the COVID-19 Symptom Diary, which included the following 12 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, and diarrhea. The symptoms were scored on the 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). Time to alleviation of COVID-19 symptoms is defined as the length of time taken from start of treatment to the point at which the following criterion is met and maintained for at least 43 hours: Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary, regardless of if the symptom is pre-existing or new.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.'}, {'type': 'SECONDARY', 'title': 'Duration of Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'OG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}, {'id': 'OG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '11.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 Days', 'description': 'Duration of fever was defined as the time from start of treatment to return to an afebrile state (temperature ≤ 37.5°C) maintained for at least 21.5 hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified ITT infected (mITTi) population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization. Only participants who had a fever (temperature \\> 37.5 degrees Celsius) at baseline are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With COVID-19 Related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'OG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}, {'id': 'OG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 33 Days', 'description': 'COVID-19 related complications include death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis, myocarditis, and cardiac failure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.'}, {'type': 'SECONDARY', 'title': 'Time to Alleviation of an Individual Symptom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'OG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}, {'id': 'OG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'title': 'Nasal Congestion/Runny Nose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '59.9'}, {'value': '34.2', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '82.4'}, {'value': '32.7', 'groupId': 'OG002', 'lowerLimit': '10.0', 'upperLimit': '57.7'}]}]}, {'title': 'Sore Throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '22.7'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '45.0'}, {'value': '111.7', 'groupId': 'OG002', 'lowerLimit': '22.1', 'upperLimit': '201.4'}]}]}, {'title': 'Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '129.3'}, {'value': '90.7', 'groupId': 'OG001', 'lowerLimit': '23.7', 'upperLimit': '140.4'}, {'value': '33.9', 'groupId': 'OG002', 'lowerLimit': '20.5', 'upperLimit': '119.2'}]}]}, {'title': 'Shortness of Breath', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.9', 'comment': 'NA: not estimable due to low number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': 'NA'}, {'value': '68.9', 'groupId': 'OG001', 'lowerLimit': '68.5', 'upperLimit': '69.2'}, {'value': '11.6', 'groupId': 'OG002', 'lowerLimit': '11.6', 'upperLimit': '11.6'}]}]}, {'title': 'Aches and Pains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.1', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '60.4'}, {'value': '22.3', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '62.2'}, {'value': '94.4', 'groupId': 'OG002', 'lowerLimit': '48.1', 'upperLimit': '177.7'}]}]}, {'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000', 'lowerLimit': '22.6', 'upperLimit': '178.1'}, {'value': '44.4', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '94.5'}, {'value': '70.6', 'groupId': 'OG002', 'lowerLimit': '22.6', 'upperLimit': '106.0'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '95.8'}, {'value': '11.7', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '93.6'}, {'value': '34.4', 'groupId': 'OG002', 'lowerLimit': '21.8', 'upperLimit': '105.4'}]}]}, {'title': 'Chills/Sweats', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '24.1'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '35.8'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '17.1', 'upperLimit': '41.4'}]}]}, {'title': 'Feeling Hot or Feverish', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '35.7'}, {'value': '48.0', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '72.0'}, {'value': '40.3', 'groupId': 'OG002', 'lowerLimit': '15.9', 'upperLimit': '63.4'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA: not estimable due to low number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '21.1', 'upperLimit': 'NA'}]}]}, {'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA: not estimable due to low number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': 'NA'}]}]}, {'title': 'Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA: not estimable due to low number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9.8', 'groupId': 'OG002', 'lowerLimit': '9.8', 'upperLimit': '9.8'}]}]}, {'title': 'Sense of Smell', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '261.5', 'comment': 'NA: not estimable due to low number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '164.9', 'upperLimit': 'NA'}, {'value': '290.2', 'comment': 'NA: not estimable due to low number of participants with an event.', 'groupId': 'OG001', 'lowerLimit': '130.7', 'upperLimit': 'NA'}, {'value': '213.1', 'groupId': 'OG002', 'lowerLimit': '129.7', 'upperLimit': '513.7'}]}]}, {'title': 'Sense of Taste', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '221.1', 'groupId': 'OG000', 'lowerLimit': '165.3', 'upperLimit': '297.6'}, {'value': '214.1', 'comment': 'NA: not estimable due to low number of participants with an event.', 'groupId': 'OG001', 'lowerLimit': '94.1', 'upperLimit': 'NA'}, {'value': '178.5', 'groupId': 'OG002', 'lowerLimit': '105.5', 'upperLimit': '391.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 Days', 'description': 'The COVID-19 Symptom Diary included the following 14 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, diarrhea, sense of smell over the past 7 days and sense of taste over the past 7 days. The severity of items 1-12 was recorded on a 4-point Likert scale (none=0, mild=1, moderate=2, severe=3). Items 13-14 were recorded on a 3-point Likert scale (same as usual=0, less than usual=1, no sense=2). Time to alleviation of an individual symptom was defined as the time taken from the start of treatment to the point at which the following criterion was met and maintained (for each individual symptom) for at least 21.5 hours: score of 0 or 1 for Items 1-12 of the COVID-19 Symptom Diary; score of 0 for Items 13 and 14 of the COVID-19 Symptom Diary.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITTi population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization. Only participants with a baseline score of \\> 1 for Items 1 - 12 or \\> 0 for Items 13 - 14 of the COVID-19 Symptom Diary were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'OG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}, {'id': 'OG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 33 Days', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any of the following: any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition not present at baseline or related to a protocol-mandated intervention.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who received any amount of study drug and were grouped according to the treatment that the participants actually received rather than the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of AT-511, AT-551, AT-229 and AT-273 for Participants Treated With 550 mg AT-527', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'title': 'AT-511: Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'AT-511: Day 1, 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1950.5', 'spread': '2365.0', 'groupId': 'OG000'}]}]}, {'title': 'AT-511: Day 1, 3 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '441.4', 'spread': '645.8', 'groupId': 'OG000'}]}]}, {'title': 'AT-511: Day 3, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '254.2', 'spread': '943.1', 'groupId': 'OG000'}]}]}, {'title': 'AT-511: Day 5, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '21.9', 'groupId': 'OG000'}]}]}, {'title': 'AT-511: Day 5, 3 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '415.7', 'spread': '445.5', 'groupId': 'OG000'}]}]}, {'title': 'AT-511: Day 5, 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 1, 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '347.5', 'spread': '334.1', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 1, 3 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '375.8', 'spread': '303.9', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 3, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.9', 'spread': '100.1', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 5, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.6', 'spread': '22.7', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 5, 3 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '323.8', 'spread': '168.3', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 5, 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 1, 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '268.5', 'spread': '318.5', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 1, 3 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '427.4', 'spread': '275.8', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 3, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '290.3', 'spread': '152.3', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 5, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '295.4', 'spread': '145.0', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 5, 3 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '773.9', 'spread': '340.8', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 5, 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.2', 'spread': '87.8', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 1, 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.5', 'spread': '29.0', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 1, 3 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '132.2', 'spread': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 3, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '135.9', 'spread': '47.6', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 5, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '138.1', 'spread': '53.0', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 5, 3 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '236.9', 'spread': '79.9', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 5, 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.9', 'spread': '22.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: pre-dose, 1 hour, 3 hours; Day 3: pre-dose; Day 5: pre-dose, 3 hours, 48 hours', 'description': 'AT-511 is the free base form of AT-527. Its major metabolites are AT-551, AT-229, and AT-273.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic-evaluable population consisted of all participants randomized into the study who had at least one post-dose drug concentration measurement at a scheduled visit timepoint.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of AT-511, AT-551, AT-229 and AT-273 for Participants Treated With 1100 mg AT-527', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'title': 'AT-511: Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'AT-511: Day 1, 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3575.0', 'spread': '2883.6', 'groupId': 'OG000'}]}]}, {'title': 'AT-511: Day 1, 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '852.4', 'spread': '1513.2', 'groupId': 'OG000'}]}]}, {'title': 'AT-511: Day 3, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.6', 'spread': '15.9', 'groupId': 'OG000'}]}]}, {'title': 'AT-511: Day 5, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '316.7', 'spread': '1544.7', 'groupId': 'OG000'}]}]}, {'title': 'AT-511: Day 5, 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3568.9', 'spread': '3352.1', 'groupId': 'OG000'}]}]}, {'title': 'AT-511: Day 5, 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1323.3', 'spread': '2883.5', 'groupId': 'OG000'}]}]}, {'title': 'AT-511: Day 5, 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 1, 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '592.2', 'spread': '576.9', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 1, 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '640.4', 'spread': '446.3', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 3, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.0', 'spread': '72.1', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 5, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.3', 'spread': '61.6', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 5, 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '302.8', 'spread': '222.1', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 5, 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '342.1', 'spread': '254.9', 'groupId': 'OG000'}]}]}, {'title': 'AT-551: Day 5, 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '4.8', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 1, 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '371.9', 'spread': '460.3', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 1, 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '865.4', 'spread': '494.2', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 3, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '682.8', 'spread': '351.7', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 5, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '797.8', 'spread': '459.9', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 5, 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '990.9', 'spread': '505.3', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 5, 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1357.2', 'spread': '825.3', 'groupId': 'OG000'}]}]}, {'title': 'AT-229: Day 5, 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '279.4', 'spread': '285.3', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 1, 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.7', 'spread': '47.4', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 1, 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '231.8', 'spread': '111.4', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 3, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '245.6', 'spread': '122.8', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 5, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '263.6', 'spread': '107.3', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 5, 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '252.1', 'spread': '97.4', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 5, 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '310.6', 'spread': '107.5', 'groupId': 'OG000'}]}]}, {'title': 'AT-273: Day 5, 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.4', 'spread': '45.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: pre-dose, 1 hour, 4 hours; Day 3: pre-dose; Day 5: pre-dose, 1 hour, 4 hours, 48 hours', 'description': 'AT-511 is the free base form of AT-527. Its major metabolites are AT-551, AT-229, and AT-273.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic-evaluable population consisted of all participants randomized into the study who had at least one post-dose drug concentration measurement at a scheduled visit timepoint.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA for AT-527 1100 mg and Pooled Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'OG001', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.08', 'spread': '0.190', 'groupId': 'OG000'}, {'value': '-1.18', 'spread': '0.223', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.21', 'spread': '0.205', 'groupId': 'OG000'}, {'value': '-2.31', 'spread': '0.231', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.70', 'spread': '0.207', 'groupId': 'OG000'}, {'value': '-2.78', 'spread': '0.236', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7351', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.10', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.294', 'estimateComment': 'A difference in adjusted means of \\<0 favors RO7496998 (AT-527).', 'groupDescription': 'Day 3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7524', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.10', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.310', 'estimateComment': 'A difference in adjusted means of \\<0 favors RO7496998 (AT-527).', 'groupDescription': 'Day 5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8083', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.08', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.314', 'estimateComment': 'A difference in adjusted means of \\<0 favors RO7496998 (AT-527).', 'groupDescription': 'Day 7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 3, Day 5, Day 7', 'description': 'SARS-CoV-2 virus RNA was measured by reverse-transcription polymerase chain reaction (RT-PCR) from NP swabs. The change from baseline was estimated from an ANCOVA model with baseline viral load as a covariate. Reported here is the adjusted mean change from baseline. A negative change from baseline indicates an improvement.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified ITT infected (mITTi) population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'FG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}, {'id': 'FG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled in the study at sites in the United Kingdom, Spain, Greece, Latvia, Ireland and Canada.', 'preAssignmentDetails': 'The study enrolled non-hospitalized adult participants with mild or moderate COVID-19. Four enrolled participants were not treated and are not included in the Results.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to 550 mg or 1100 mg AT-527 twice a day (BID) on Days 1-5.'}, {'id': 'BG001', 'title': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants received 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.'}, {'id': 'BG002', 'title': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants received 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '32.7', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '40.3', 'spread': '15.6', 'groupId': 'BG002'}, {'value': '36.6', 'spread': '13.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '6.24', 'spread': '1.40', 'groupId': 'BG000'}, {'value': '6.98', 'spread': '1.10', 'groupId': 'BG001'}, {'value': '5.94', 'spread': '1.46', 'groupId': 'BG002'}, {'value': '6.37', 'spread': '1.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'SARS-CoV-2 virus RNA was measured by reverse-transcription polymerase chain reaction (RT-PCR).', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The modified ITT infected (mITTi) population was defined as all participants randomized in the study who received any amount of study drug and had at least one positive SARS-CoV-2 RT-PCR test result above or equal to the limit of quantification (LOQ) during the study, with participants grouped according to the treatment assignment at randomization.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-17', 'size': 1259089, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-15T09:51', 'hasProtocol': True}, {'date': '2021-09-01', 'size': 5689818, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-15T09:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2021-01-12', 'resultsFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-15', 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA for AT-527 550 mg and Matched Placebo', 'timeFrame': 'Baseline, Day 3, Day 5, Day 7', 'description': 'SARS-CoV-2 virus RNA was measured by reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal (NP) swabs. The change from baseline was estimated from an ANCOVA model with baseline viral load as a covariate. Reported here is the adjusted mean change from baseline. A negative change from baseline indicates an improvement.'}, {'measure': 'Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA for AT-527 1100 mg and Pooled Placebo', 'timeFrame': 'Baseline, Day 3, Day 5, Day 7', 'description': 'SARS-CoV-2 virus RNA was measured by reverse-transcription polymerase chain reaction (RT-PCR) from NP swabs. The change from baseline was estimated from an ANCOVA model with baseline viral load as a covariate. Reported here is the adjusted mean change from baseline. A negative change from baseline indicates an improvement.'}], 'secondaryOutcomes': [{'measure': 'Time to Cessation of SARS-CoV-2 Viral Shedding', 'timeFrame': 'Up to Day 7', 'description': 'Time to cessation of viral shedding was defined as the time between the initiation of any study treatment and the first time when a negative or below the limit of detection RT-PCR test result was obtained. RT-PCR was measured from NP swabs. Median, 25th and 75th percentiles were estimated from the Kaplan-Meier curve.'}, {'measure': 'Time to Sustained Non-Detectable SARS-CoV-2 Virus RNA', 'timeFrame': 'Up to Day 7', 'description': 'Time to sustained non-detectable SARS-CoV-2 virus RNA was defined as the time between the initiation of any study treatment and first time when a negative or below the limit of detection test result by RT-PCR is obtained after which no positive test above or equal to the limit of detection was reported. RT-PCR was measured from NP swabs. Median, 25th and 75th percentiles were estimated from the Kaplan-Meier curve.'}, {'measure': 'Percentage of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints', 'timeFrame': 'Baseline, Day 3, Day 5, Day 7', 'description': 'Reported here is the percentage of participants with a positive virus RNA by RT-PCR test result above or equal to the limit of quantification (LOQ). RT-PCR was measured from NP swabs.'}, {'measure': 'Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA', 'timeFrame': 'Baseline, Day 3, Day 5, Day 7', 'description': 'AUC is the amount of SARS-CoV-2 virus RNA from baseline to the last sample timepoint and was calculated using the trapezoidal method. RT-PCR was measured from NP swabs.'}, {'measure': 'Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 Hours)', 'timeFrame': 'Up to 28 Days', 'description': 'COVID-19 symptoms were evaluated using the first 12 items in the COVID-19 Symptom Diary, which included the following 12 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, and diarrhea. The symptoms were scored on the 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).Time to alleviation or improvement is defined as the length of time taken from start of treatment to the point at which all of the following three criteria are met and maintained for a concurrent duration of at least 21.5 hours: "new" symptoms with a score of 0 or 1; "pre- existing and worsened due to COVID-19" symptoms with at least a single category improvement from baseline; "pre-existing and not worsened due to COVID-19" symptoms remaining the same or at least a single category improvement from baseline.'}, {'measure': 'Time to Alleviation or Improvement of COVID-19 Symptoms (43 Hours)', 'timeFrame': 'Up to 28 Days', 'description': 'COVID-19 symptoms were evaluated using the first 12 items in the COVID-19 Symptom Diary, which included the following 12 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, and diarrhea. The symptoms were scored on the 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). Time to alleviation or improvement is defined as the length of time taken from start of treatment to the point at which all of the following three criteria are met and maintained for a concurrent duration of at least 43 hours: "new" symptoms with a score of 0 or 1; "pre- existing and worsened due to COVID-19" symptoms with at least a single category improvement from baseline; "pre-existing and not worsened due to COVID-19" symptoms remaining the same or at least a single category improvement from baseline.'}, {'measure': 'Time to Alleviation of COVID-19 Symptoms (21.5 Hours)', 'timeFrame': 'Up to 28 Days', 'description': 'COVID-19 symptoms were evaluated using the first 12 items in the COVID-19 Symptom Diary, which included the following 12 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, and diarrhea. The symptoms were scored on the 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). Time to alleviation of COVID-19 symptoms is defined as the length of time taken from start of treatment to the point at which the following criterion is met and maintained for at least 21.5 hours: Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary, regardless of if the symptom is pre-existing or new.'}, {'measure': 'Time to Alleviation of COVID-19 Symptoms (43 Hours)', 'timeFrame': 'Up to 28 Days', 'description': 'COVID-19 symptoms were evaluated using the first 12 items in the COVID-19 Symptom Diary, which included the following 12 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, and diarrhea. The symptoms were scored on the 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). Time to alleviation of COVID-19 symptoms is defined as the length of time taken from start of treatment to the point at which the following criterion is met and maintained for at least 43 hours: Score of 0 or 1 on Items 1-12 of the COVID-19 Symptom Diary, regardless of if the symptom is pre-existing or new.'}, {'measure': 'Duration of Fever', 'timeFrame': 'Up to 28 Days', 'description': 'Duration of fever was defined as the time from start of treatment to return to an afebrile state (temperature ≤ 37.5°C) maintained for at least 21.5 hours.'}, {'measure': 'Percentage of Participants With COVID-19 Related Complications', 'timeFrame': 'Up to 33 Days', 'description': 'COVID-19 related complications include death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis, myocarditis, and cardiac failure.'}, {'measure': 'Time to Alleviation of an Individual Symptom', 'timeFrame': 'Up to 28 Days', 'description': 'The COVID-19 Symptom Diary included the following 14 items: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills/sweats, feeling hot or feverish, nausea, vomiting, diarrhea, sense of smell over the past 7 days and sense of taste over the past 7 days. The severity of items 1-12 was recorded on a 4-point Likert scale (none=0, mild=1, moderate=2, severe=3). Items 13-14 were recorded on a 3-point Likert scale (same as usual=0, less than usual=1, no sense=2). Time to alleviation of an individual symptom was defined as the time taken from the start of treatment to the point at which the following criterion was met and maintained (for each individual symptom) for at least 21.5 hours: score of 0 or 1 for Items 1-12 of the COVID-19 Symptom Diary; score of 0 for Items 13 and 14 of the COVID-19 Symptom Diary.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 33 Days', 'description': 'An AE is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any of the following: any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition not present at baseline or related to a protocol-mandated intervention.'}, {'measure': 'Plasma Concentrations of AT-511, AT-551, AT-229 and AT-273 for Participants Treated With 550 mg AT-527', 'timeFrame': 'Day 1: pre-dose, 1 hour, 3 hours; Day 3: pre-dose; Day 5: pre-dose, 3 hours, 48 hours', 'description': 'AT-511 is the free base form of AT-527. Its major metabolites are AT-551, AT-229, and AT-273.'}, {'measure': 'Plasma Concentrations of AT-511, AT-551, AT-229 and AT-273 for Participants Treated With 1100 mg AT-527', 'timeFrame': 'Day 1: pre-dose, 1 hour, 4 hours; Day 3: pre-dose; Day 5: pre-dose, 1 hour, 4 hours, 48 hours', 'description': 'AT-511 is the free base form of AT-527. Its major metabolites are AT-551, AT-229, and AT-273.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '37338393', 'type': 'DERIVED', 'citation': 'Boffito M, Dolan E, Singh K, Holmes W, Wildum S, Horga A, Pietropaolo K, Zhou XJ, Clinch B, Collinson N, Ukachukwu V. A Phase 2 Randomized Trial Evaluating the Antiviral Activity and Safety of the Direct-Acting Antiviral Bemnifosbuvir in Ambulatory Patients with Mild or Moderate COVID-19 (MOONSONG Study). Microbiol Spectr. 2023 Aug 17;11(4):e0007723. doi: 10.1128/spectrum.00077-23. Epub 2023 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'This randomized study evaluates the antiviral activity, safety, efficacy and pharmacokinetics of AT-527 versus a placebo in participants with mild or moderate coronavirus disease (COVID-19) who are not hospitalized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Positive SARS-CoV-2 diagnostic test (RT-PCR or rapid antigen test)at screening\n* Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset ≤5 days prior to randomization\n\nExclusion Criteria:\n\n* Clinical signs indicative of COVID-19 illness requiring hospitalization, defined as any of the following: shortness of breath at rest, respiratory rate ≥30, heart rate ≥125, peripheral capillary oxygen saturation ≤93% on room air\n* Treatment with a therapeutic agent against SARS-CoV-2 including, but not limited to, other direct acting antivirals, convalescent plasma, monoclonal antibodies against SARS CoV-2, or intravenous immunoglobulin within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to screening\n* Requirement, in the opinion of the investigator, for any of the prohibited medications during the study\n* Use of hydroxychloroquine or amiodarone within 3 months of screening\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of AT-527. Women of childbearing potential must have a negative urine pregnancy test result at screening\n* Abnormal laboratory test results at screening\n* Clinically significant abnormal ECG, as determined by the Investigator, at screening\n* Planned procedure or surgery during the study\n* Known allergy or hypersensitivity to study drug or drug product excipients\n* Substance abuse, as determined by the investigator, within 12 months prior to screening\n* Poor peripheral venous access\n* Malabsorption syndrome or other condition that would interfere with enteral absorption\n* Any clinically significant history of epistaxis within the last 3 months and/or history of being hospitalized due to epistaxis of any previous occasion\n* History of anaphylaxis\n* Any uncontrolled serious medical condition or other clinically significant abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study"}, 'identificationModule': {'nctId': 'NCT04709835', 'briefTitle': 'Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase II Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Antiviral Activity, Safety, Pharmacokinetics, and Efficacy of RO7496998 (AT-527) in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19', 'orgStudyIdInfo': {'id': 'WV43042'}, 'secondaryIdInfos': [{'id': '2020-005366-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive AT-527-matched placebo twice a day (BID) on Days 1-5.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AT-527 550 mg (1x550 mg)', 'description': 'Participants will receive 550 mg AT-527 (1x550 mg) twice a day (BID) on Days 1-5.', 'interventionNames': ['Drug: AT-527']}, {'type': 'EXPERIMENTAL', 'label': 'AT-527 1100 mg (4x275 mg)', 'description': 'Participants will receive 1100 mg AT-527 (4x275 mg) twice a day (BID) on Days 1-5.', 'interventionNames': ['Drug: AT-527']}], 'interventions': [{'name': 'AT-527', 'type': 'DRUG', 'otherNames': ['RO7496998'], 'description': 'Results from Arm AT-527 500 mg determined the dose and regimen to be used for AT-527 1100 mg.', 'armGroupLabels': ['AT-527 1100 mg (4x275 mg)', 'AT-527 550 mg (1x550 mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The dose and regimen of the placebo will match that of the respective AT-527 comparator arm.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8M 1K7', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Medical Research Group', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': '115 28', 'city': 'Athens', 'country': 'Greece', 'facility': 'National and Kapodistrian University of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '184 54', 'city': 'Nikaia Attikis', 'country': 'Greece', 'facility': 'General State Hospital of Nikaia St Panteleimon'}, {'zip': '15', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Connolly Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': 'LV-1011', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Outpatient Clinic Adoria', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-2121', 'city': 'Salaspils', 'country': 'Latvia', 'facility': "The Family Physician's Practice of Dr. Maija Kozlovska", 'geoPoint': {'lat': 56.86014, 'lon': 24.36544}}, {'zip': '280146', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28031', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Infanta Leonor', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'OL6 6EW', 'city': 'Ashton-under-Lyne', 'country': 'United Kingdom', 'facility': 'Chapel Street Medical Centre', 'geoPoint': {'lat': 53.48876, 'lon': -2.0989}}, {'zip': 'BL9 0NJ', 'city': 'Bury', 'country': 'United Kingdom', 'facility': 'Tower Family Healthcare - Moorgate Primary Care Ce', 'geoPoint': {'lat': 53.6, 'lon': -2.3}}, {'zip': 'G20 0XA', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'CPS Research', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'SW3 6JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\\_and\\_development/who\\_we\\_are\\_how\\_we\\_work/clinical\\_trials/our\\_commitment\\_to\\_data\\_sharing.htm)"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Atea Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}