Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-29 @ 10:19 PM
Study NCT ID:
NCT04321993
Status:
UNKNOWN
Last Update Posted:
2023-09-18
First Post:
2020-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], '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': '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': 'C000596027', 'term': 'baricitinib'}, {'id': 'D000075242', 'term': 'Janus Kinase Inhibitors'}, {'id': 'C000606551', 'term': 'remdesivir'}, {'id': 'D000998', 'term': 'Antiviral Agents'}, {'id': 'C502936', 'term': 'tocilizumab'}], 'ancestors': [{'id': 'D047428', 'term': 'Protein Kinase Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 363}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2020-03-24', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Global and SARS-CoV-2-specific immune responses before, during and after intervention and in standard of care treatment arm', 'timeFrame': 'Up to 180 days'}], 'primaryOutcomes': [{'measure': 'Clinical status of subject at day 15 (on a 7 point ordinal scale).', 'timeFrame': 'Up to 15 days', 'description': '1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities;\n3. Hospitalized, not requiring supplemental oxygen;\n4. Hospitalized, requiring supplemental oxygen;\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;\n6. Hospitalized, on invasive mechanical ventilation or ECMO;\n7. Death.'}], 'secondaryOutcomes': [{'measure': 'Status on an ordinal scale assessed daily while hospitalized and on days 15 and 29 and 180.', 'timeFrame': 'Up to 180 days', 'description': '1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities;\n3. Hospitalized, not requiring supplemental oxygen;\n4. Hospitalized, requiring supplemental oxygen;\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;\n6. Hospitalized, on invasive mechanical ventilation or ECMO;\n7. Death.'}, {'measure': 'Length of time to clinical improvement', 'timeFrame': 'Up to 29 days', 'description': 'Time to clinical improvement is defined as the time to normalization of respiratory rate, fever, and oxygen saturation, and alleviation of cough within 72 hours.'}, {'measure': 'Number of participants with normal pulmonary function and normal O2 saturation on days 11, 15 and 29', 'timeFrame': 'Up to 29 days'}, {'measure': 'Number of participants that developed Acute Respiratory Distress Syndrome (ARDS) after treatment', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Length of time to clinical progression', 'timeFrame': 'Up to 29 days', 'description': 'Time to clinical progression, defined as the time to death, mechanical ventilation, or ICU admission'}, {'measure': 'Cause of death (if applicable)', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized and on days 15 and 29. (Initial, highest, deltas and mean)', 'timeFrame': 'Up to 29 days'}, {'measure': 'Length of time to normalization of fever', 'timeFrame': 'Up to 29 days', 'description': 'Fever normalization as defined by: Temperature \\< 36.6 °C armpit, \\< 37.2 °C oral, or \\< 37.8 °C rectal sustained for minimum 24 hours'}, {'measure': 'Length of time to normalization of oxygen saturation', 'timeFrame': 'Up to 29 days', 'description': 'Oxygen normalization as defined by: peripheral capillary oxygen saturation (Sp02) \\> 94% sustained minimum 24 hours.'}, {'measure': 'Duration of supplemental oxygen (if applicable)', 'timeFrame': 'Up to 29 days'}, {'measure': 'Duration of mechanical ventilation (if applicable)', 'timeFrame': 'Up to 29 days'}, {'measure': 'Duration of hospitalization', 'timeFrame': 'Up to 29 days'}, {'measure': 'Adverse events', 'timeFrame': 'Up to 180 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID', 'coronavirus', 'SARS-CoV-2'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'Investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate to severe COVID-19 disease that meet eligibility criteria will be offered participation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Moderate to severe COVID-19 associated disease as defined by the WHO\n* Willing and able to provide informed consent prior to performing study procedures\n* Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay\n* Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, or Require mechanical ventilation and/or supplemental oxygen.\n* Normal potassium, magnesium, and calcium levels pre-therapy when used in agents at risk of QT prolongation\n\nPatients will be further distinguished based on their disease severity into one of two categories:\n\n* Moderate and severe, not critical disease: patients with SpO2 ≤ 94% on room air, and those who require supplemental oxygen\n* Severe, critical disease: patients with critical illness requiring ICU-level care including requiring mechanical ventilation or ECMO, and/or end organ dysfunction as seen in sepsis/septic shock.\n\nExclusion Criteria:\n\n* Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 X upper limit of normal (ULN)\n* Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment Medication specific Exclusion\n\nBaricitinib:\n\n1. Contraindicated for patients with known hypersensitivity to baricitinib or to any of the excipients.\n2. Prior untreated latent tuberculosis\n3. Any individuals with TB risk factors will not be enrolled in the baricitinib arm of the study.\n4. Presence of active viral hepatitis C or B\n5. People with a clinical history of invasive or active fungal infection\n6. People with a clinical history of active CMV disease in the last year\n7. Patients who are pregnant or breastfeeding\n8. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \\<15)\n\nTocilizumab:\n\n1. Known hypersensitivity to tocilizumab or any of its components\n2. Prior untreated latent tuberculosis\n3. Any individuals with TB risk factors will not be enrolled in the tocilizumab arm of the study.\n4. Presence of active viral hepatitis C or B\n5. People with a clinical history of invasive or active fungal infection\n6. People with a clinical history of active CMV disease in the last year\n7. CRP\\<75 mg/L\n8. SpO2 ≥ 92% on room air\n\nRemdesivir:\n\n1. Known hypersensitivity to remdesivir or any of its components\n2. Weight below 40 kg\n3. SpO2 ≥ 94% on room air\n4. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \\<30)'}, 'identificationModule': {'nctId': 'NCT04321993', 'briefTitle': 'Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients', 'orgStudyIdInfo': {'id': 'SAIL-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baricitinib', 'description': 'Moderate and severe, not critical disease', 'interventionNames': ['Drug: Baricitinib (janus kinase inhibitor)']}, {'type': 'EXPERIMENTAL', 'label': 'Remdesivir', 'description': 'Moderate and severe, not critical disease', 'interventionNames': ['Drug: Remdesivir (antiviral)']}, {'type': 'EXPERIMENTAL', 'label': 'Remdesivir + baricitinib', 'description': 'Moderate and severe, not critical disease', 'interventionNames': ['Drug: Remdesivir (antiviral) + barictinib (janus kinase inhibitor)']}, {'type': 'EXPERIMENTAL', 'label': 'Tocilizumab', 'description': 'Severe, critical disease', 'interventionNames': ['Drug: Tocilizumab (interleukin 6 inhibitor)']}, {'type': 'NO_INTERVENTION', 'label': 'Clinical standard of care', 'description': 'Moderate and severe, not critical disease AND severe, critical disease as applicable'}], 'interventions': [{'name': 'Baricitinib (janus kinase inhibitor)', 'type': 'DRUG', 'description': 'Baricitinib will be administered as 4 mg po daily for 14 days or until hospital discharge, whichever is sooner.', 'armGroupLabels': ['Baricitinib']}, {'name': 'Remdesivir (antiviral) + barictinib (janus kinase inhibitor)', 'type': 'DRUG', 'description': 'Remdesivir will be administered as a loading dose of 200 mg IV over one hour on day 1 followed by 100 mg IV daily over one hour on days 2-5 (with a possibility to extend to up to 10 days total).\n\nBaricitinib will be administered as 4 mg po daily for 14 days or until hospital discharge, whichever is sooner.', 'armGroupLabels': ['Remdesivir + baricitinib']}, {'name': 'Remdesivir (antiviral)', 'type': 'DRUG', 'description': 'Remdesivir will be administered as a loading dose of 200 mg IV over one hour on day 1 followed by 100 mg IV daily over one hour on days 2-5 (with a possibility to extend to up to 10 days total).', 'armGroupLabels': ['Remdesivir']}, {'name': 'Tocilizumab (interleukin 6 inhibitor)', 'type': 'DRUG', 'description': 'Tocilizumab will be administered as a single IV infusion over one hour. Dosage will be 8 mg/kg total bodyweight up to a maximum of 800 mg.', 'armGroupLabels': ['Tocilizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Nova Scotia Health Authority', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lisa Barrett', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, {'name': 'Dalhousie University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinician Scientist', 'investigatorFullName': 'Lisa Barrett', 'investigatorAffiliation': 'Nova Scotia Health Authority'}}}}