Not provided
Not provided
Not provided
Not provided
After 15 months of active enrollment and a lack of qualifying hospitalized COVID-19 patients, the Sponsor-Investigator, Marilyn Csete Glassberg, MD, decided to terminate recruitment before meeting the stated enrollment objectives.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Senhwa Biosciences, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This multi-center, open-label, 2 arm parallel-group, randomized, interventional prospective exploratory study in 40 patients aimed to evaluate safety and explore putative clinical benefits of Silmitasertib 1000 mg BID dose in patients with severe illness caused be SARS-COV-2. This will be a two-arm trial comparing the SOC/best supportive care alone to the SOC/best supportive care with addition of Silmitasertib (allocation ratio 1:1).
This is a phase II multi-center, randomized, open-label, 2 arm parallel-group controlled interventional prospective study of CX-4945 in patients with severe COVID-19. Up to approximately 40 patients will be enrolled into this study. A screening evaluation will occur within 7 days prior to Day 1. All qualified patients will be randomized at Day 1 in a ratio of 1:1 to one of the following two treatment arms:
Arm A: SOC/ best supportive care in combination with CX-4945 1000 mg BID PO or Arm B: SOC/ best supportive care alone The standard of care (SOC) is not pre-specified, may vary among patients, and may include agents with anti-viral activity, such as remdesivir, among others. Investigator discretion is to be applied for any established SOC. Active concomitant treatment with other investigational antivirals or immunomodulators are not permitted Best supportive care is defined as intensive care therapy according to current guidelines, evidence, and best practice, including but not limited to lung protective ventilation, thrombosis prophylaxis, renal replacement therapy when indicated, and access to advanced therapies including extracorporeal membrane oxygenation.
The total duration of the treatment will be 14 days. Patients will be followed up at 28, 45 and 60 days from the start of the treatment. The total duration for each patient in the study (including the screening) will be up to 67 days.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silmitasertib | Active Comparator | Standard of care / supportive care in combination with Silmitasertib (CX-4945) |
|
| Standard of Care | No Intervention | Standard of care / supportive care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silmitasertib | Drug | Standard of care / best supportive care in combination with CX-4945 1000 mg administered orally, two times a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | Adverse Events experienced by the patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy. | Through Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm. | Number of days from randomization to discharge, or to alleviation of cough (defined as mild or absent in a patient reported scale of 0=absent, 1=mild, 2=moderate, and 3=severe). Improvement must be sustained for at least 48 hours. | Through Day 28 |
Not provided
Inclusion Criteria:
Male or non-pregnant female adult ≥ 18 years of age
Diagnosed/confirmed with COVID-19 by standard RT-PCR assay or equivalent testing within 7 days prior to randomization (Day1).
Hospitalized patient with severe illness caused by SARS-CoV-2 (Note: Prior or current use of remdesivir or dexamethasone (SOC) are allowed under the investigator's discretion. Concomitant treatment with other investigational antiviral drugs or immunomodulators are not permitted from Day1 through Day 28)
Symptoms of severe systemic illness/infection with COVID-19:
At least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory infection including dyspnea at rest or respiratory distress AND Clinical signs indicative of severe systemic illness/infection with COVID-19 At least 1 of the following: RR ≥ 30, HR ≥ 125, SaO2 <93% on room air or requires > 2L oxygen by nasal cannula in order to maintain SaO2 ≥93%
Patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
Adequate hematopoietic capacity, as defined by the following:
Adequate hepatic function, as defined by the following:
Adequate renal function, as defined by the following:
a. Renal: calculated creatinine clearance >45 mL/min for patients with abnormal, increased creatinine levels (Cockcroft-Gault formula).
Ability to take oral medication and be willing to adhere to drug administration and premedication requirements (see Section 6.3) throughout study duration.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Phoenix | Phoenix | Arizona | 85006 | United States | ||
| Banner University Medical Center Tucson |
Study results will be published on clinicaltrials.gov.
Not provided
Not provided
Not provided
Not provided
Of the 31 enrolled participants, 29 met inclusion criteria and were randomized.
Participants were recruited from patients hospitalized with diagnosed/confirmed COVID-19 at two academic medical centers between January 2021 and April 2022. The first participant was enrolled on January 21st, 2021, and the last was enrolled in February 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Silmitasertib (CX-4945) in Combination With Standard of Care | Standard of care / supportive care in combination with Silmitasertib (CX-4945) Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator. |
| FG001 | Standard of Care | Participants received supportive care/Standard of Care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Silmitasertib (CX-4945) in Combination With Standard of Care | Standard of care / supportive care in combination with Silmitasertib (CX-4945) Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | Adverse Events experienced by the patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy. | Intent to treat population (all participants assigned to Silmitasertib/Combo, or Standard of Care). The median treatment duration of Silmitasertib was 14 days. The treatment Durations (days) = the last administration date - the first administration. | Posted | Count of Participants | Participants | Through Day 60 |
|
Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Silmitasertib (CX-4945) in Combination With Standard of Care | Standard of care / supportive care in combination with Silmitasertib (CX-4945) Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Systematic Assessment |
After 15 months of active enrollment and a lack of qualifying hospitalized COVID-19 patients, the Sponsor-Investigator, Marilyn Csete Glassberg, MD, decided to terminate recruitment before meeting the stated enrollment objectives.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Winters | University of Arizona | 520-780-1882 | jwinters1@arizona.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2021 | Jun 28, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2021 | Jun 28, 2023 | ICF_003.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555142 | silmitasertib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm. | Number of days from randomization to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), normalization of respiratory rate (< 24 bpm while breathing room air), resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for at least 48 hours. | Through hospital discharge, an average of 28 days |
| To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm. | Number of days from randomization to the first day on which the subject satisfies one of the following three categories from the ordinal NIAID 8- point Clinical Progression Outcomes scale collected daily from randomization through Day 28: Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities. | Through Day 28 |
| To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28. | Difference in percentage of subjects with clinical recovery compared at Day 14 and Day 28. | Assessed on Day 14 and Day 28 |
| To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28. | Percentage of Participants at Each Clinical Status at Day 14 and Day 28 assessed by using the ordinal NIAID 8- point Clinical Progression Outcomes scale (Scale ranges from 1 (Death) to 8 (Not hospitalized, no limitations on activities) | Through Day 28 |
| To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Difference in proportions of patients with conversion of positive RT-PCR to negative RT-PCR as assessed at Day 1, Day 8, Day 14 and Day 28. | Assessed at Day 1, Day 8, Day 14 and Day 28 |
| To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Changes in chest imaging from Screening to Day 5 or 14 | Through Day 14 |
| Number of Days Hospitalized | Days of hospitalization from randomization through Day 28 | Through Day 28 |
| To Evaluate Changes in IL-6 Level | IL-6 level | Assessed on Days 1, 4, 8, 11, and 14 |
| To Evaluate Changes in CRP | CRP level | Assessed on Days 1, 4, 8, 11, and 14 |
| To Evaluate Changes in LDH | LDH level | Assessed on Days 1, 4, 8, 11, and 14 |
| To Evaluate Changes in CPK | CPK level | Assessed on Days 1, 4, 8, 11, and 14 |
| To Evaluate Changes in Ferritin | Ferritin level | Assessed on Days 1, 4, 8, 11, and 14 |
| To Evaluate Changes in D-dimer | D-dimer level | Assessed on Days 1, 4, 8, 11, and 14 |
| Number of Days of Supplemental Oxygen Use | Days of supplemental oxygen (if applicable) from randomization through day 28 | Through Day 28 |
| All-cause Mortality Status | The number of deaths occurred in each treatment group from randomization through Day 60 | Through Day 60 |
| Number of Days of On-invasive Ventilation/High Flow Oxygen | Days of non-invasive ventilation/high flow oxygen (if applicable) from randomization through day 28 | Through Day 28 |
| Number of Days of Invasive Mechanical Ventilation/ECMO | Days of invasive mechanical ventilation/ECMO (if applicable) from randomization through Day 28. | Through Day 28 |
| Number of Patients Returned to Room Air | Number of patients returned to room air after randomization through Day 14 or Day 28. | Through Day 28 |
| Change in Pulse Oxygen Saturation | Change in pulse oxygen saturation (SpO2) from randomization to Day 4, 8, 11, 14 and 28 | Days 4, 8, 11, 14, and 28 |
| Number of Thrombosis Events | Number of documented venous thromboembolism (VTE), arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events from randomization through Day 28 | Through Day 28 |
| Changes in EQ-D5-5L | The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). Higher values indicate worse outcomes, while lower indicate better outcomes. The subscales are combined to compute a total score and averaged to produce the mean and SD. Changes in EQ-D5-5L (used as an indicator of symptom improvement) from randomization to Day 8, 14 and 28 | Days randomization, 8, 14 and 28 |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Subject Expired |
|
| Withdrawn from study |
|
| Adverse Event |
|
| Standard of Care |
Standard of care / supportive care Participants received supportive care/Standard of Care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard of Care | Standard of care / supportive care Participants received supportive care/Standard of Care. |
|
|
| Secondary | To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm. | Number of days from randomization to discharge, or to alleviation of cough (defined as mild or absent in a patient reported scale of 0=absent, 1=mild, 2=moderate, and 3=severe). Improvement must be sustained for at least 48 hours. | Posted | Mean | Standard Deviation | Days | Through Day 28 |
|
|
|
| Secondary | To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm. | Number of days from randomization to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), normalization of respiratory rate (< 24 bpm while breathing room air), resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for at least 48 hours. | Posted | Mean | Standard Deviation | Days | Through hospital discharge, an average of 28 days |
|
|
|
| Secondary | To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm. | Number of days from randomization to the first day on which the subject satisfies one of the following three categories from the ordinal NIAID 8- point Clinical Progression Outcomes scale collected daily from randomization through Day 28: Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities. | Posted | Mean | Standard Deviation | Days | Through Day 28 |
|
|
|
| Secondary | To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28. | Difference in percentage of subjects with clinical recovery compared at Day 14 and Day 28. | Posted | Count of Participants | Participants | Assessed on Day 14 and Day 28 |
|
|
|
| Secondary | To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28. | Percentage of Participants at Each Clinical Status at Day 14 and Day 28 assessed by using the ordinal NIAID 8- point Clinical Progression Outcomes scale (Scale ranges from 1 (Death) to 8 (Not hospitalized, no limitations on activities) | Missing data explains the discrepancy in the total analyzed. | Posted | Count of Participants | Participants | Through Day 28 |
|
|
|
| Secondary | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Difference in proportions of patients with conversion of positive RT-PCR to negative RT-PCR as assessed at Day 1, Day 8, Day 14 and Day 28. | Missing data explains the discrepancy in the total analyzed. | Posted | Count of Participants | Participants | Assessed at Day 1, Day 8, Day 14 and Day 28 |
|
|
|
| Secondary | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Changes in chest imaging from Screening to Day 5 or 14 | No data collected for this outcome analysis. | Posted | Through Day 14 |
|
|
| Secondary | Number of Days Hospitalized | Days of hospitalization from randomization through Day 28 | Posted | Mean | Standard Deviation | Days | Through Day 28 |
|
|
|
| Secondary | To Evaluate Changes in IL-6 Level | IL-6 level | Missing data explains the discrepancy in the total analyzed. | Posted | Count of Participants | Participants | Assessed on Days 1, 4, 8, 11, and 14 |
|
|
|
| Secondary | To Evaluate Changes in CRP | CRP level | Missing data explains the discrepancy in the total analyzed. | Posted | Count of Participants | Participants | Assessed on Days 1, 4, 8, 11, and 14 |
|
|
|
| Secondary | To Evaluate Changes in LDH | LDH level | Missing data explains the discrepancy in the total analyzed. | Posted | Count of Participants | Participants | Assessed on Days 1, 4, 8, 11, and 14 |
|
|
|
| Secondary | To Evaluate Changes in CPK | CPK level | Missing data explains the discrepancy in the total analyzed. | Posted | Count of Participants | Participants | Assessed on Days 1, 4, 8, 11, and 14 |
|
|
|
| Secondary | To Evaluate Changes in Ferritin | Ferritin level | Missing data explains the discrepancy in the total analyzed. | Posted | Count of Participants | Participants | Assessed on Days 1, 4, 8, 11, and 14 |
|
|
|
| Secondary | To Evaluate Changes in D-dimer | D-dimer level | Missing data explains the discrepancy in the total analyzed. | Posted | Count of Participants | Participants | Assessed on Days 1, 4, 8, 11, and 14 |
|
|
|
| Secondary | Number of Days of Supplemental Oxygen Use | Days of supplemental oxygen (if applicable) from randomization through day 28 | Posted | Mean | Standard Deviation | Days | Through Day 28 |
|
|
|
| Secondary | All-cause Mortality Status | The number of deaths occurred in each treatment group from randomization through Day 60 | Posted | Count of Participants | Participants | Through Day 60 |
|
|
|
| Secondary | Number of Days of On-invasive Ventilation/High Flow Oxygen | Days of non-invasive ventilation/high flow oxygen (if applicable) from randomization through day 28 | Posted | Mean | Standard Deviation | Days | Through Day 28 |
|
|
|
| Secondary | Number of Days of Invasive Mechanical Ventilation/ECMO | Days of invasive mechanical ventilation/ECMO (if applicable) from randomization through Day 28. | Posted | Mean | Standard Deviation | Days | Through Day 28 |
|
|
|
| Secondary | Number of Patients Returned to Room Air | Number of patients returned to room air after randomization through Day 14 or Day 28. | Posted | Count of Participants | Participants | Through Day 28 |
|
|
|
| Secondary | Change in Pulse Oxygen Saturation | Change in pulse oxygen saturation (SpO2) from randomization to Day 4, 8, 11, 14 and 28 | Missing data explains the discrepancy in the total analyzed. | Posted | Mean | Standard Deviation | percentage of hemoglobin saturation | Days 4, 8, 11, 14, and 28 |
|
|
|
| Secondary | Number of Thrombosis Events | Number of documented venous thromboembolism (VTE), arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events from randomization through Day 28 | No data collected for this outcome analysis. | Posted | Through Day 28 |
|
|
| Secondary | Changes in EQ-D5-5L | The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). Higher values indicate worse outcomes, while lower indicate better outcomes. The subscales are combined to compute a total score and averaged to produce the mean and SD. Changes in EQ-D5-5L (used as an indicator of symptom improvement) from randomization to Day 8, 14 and 28 | Missing data explains the discrepancy in the total analyzed. | Posted | Mean | Standard Deviation | score on a scale | Days randomization, 8, 14 and 28 |
|
|
|
| 2 |
| 15 |
| 3 |
| 15 |
| 10 |
| 15 |
| EG001 | Standard of Care | Standard of care / supportive care Participants received supportive care/Standard of Care. | 2 | 14 | 2 | 14 | 7 | 14 |
| Tachypnea worsened | Respiratory, thoracic and mediastinal disorders | CTCAE version 5.0 | Systematic Assessment |
|
| Acute hypoxemic respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE version 5.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE version 5.0 | Systematic Assessment |
|
| Premature atrial contractions | Cardiac disorders | CTCAE version 5.0 | Systematic Assessment |
|
| Acute hypoxemic respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE version 5.0 | Systematic Assessment |
|
| Premature atrial contractions | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Bloody diarrhea | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Diarrhea worsened | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Loose stools | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Melena | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Weakness | General disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Pilonidal cyst worsened | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
|
| Weight loss | Investigations | MedDRA version 25.0 | Systematic Assessment |
|
| Decrease appetite | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Leg Pain Bilateral | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Anosmia | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Depression worsened | Psychiatric disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Acute hypoxemic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Tachypnea worsened | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Worsening hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Dermatitis anal | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
|
Not provided
Not provided
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) |
|
| Hospitalized, on non-invasive ventilation or high flow oxygen devices |
|
| Hospitalized, requiring supplemental oxygen |
|
| Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care |
|
| Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care |
|
| Not hospitalized, limitation on activities and/or requiring home oxygen |
|
| Not hospitalized, no limitations on activities |
|
| Day 28 |
|
|
| Negative |
|
| Day 8 |
|
|
| Day 14 |
|
|
| Day 28 |
|
|
| Abnormal: Low |
|
| Normal |
|
| Unable to determine |
|
| Day 4 |
|
|
| Day 8 |
|
|
| Day 11 |
|
|
| Day 14 |
|
|
| Abnormal: Low |
|
| Normal |
|
| Unable to determine |
|
| Day 4 |
|
|
| Day 8 |
|
|
| Day 11 |
|
|
| Day 14 |
|
|
| Abnormal: Low |
|
| Normal |
|
| Unable to determine |
|
| Day 4 |
|
|
| Day 8 |
|
|
| Day 11 |
|
|
| Day 14 |
|
|
| Abnormal: Low |
|
| Normal |
|
| Unable to determine |
|
| Day 4 |
|
|
| Day 8 |
|
|
| Day 11 |
|
|
| Day 14 |
|
|
| Abnormal: Low |
|
| Normal |
|
| Unable to determine |
|
| Day 4 |
|
|
| Day 8 |
|
|
| Day 11 |
|
|
| Day 14 |
|
|
| Abnormal: Low |
|
| Normal |
|
| Unable to determine |
|
| Day 4 |
|
|
| Day 8 |
|
|
| Day 11 |
|
|
| Day 14 |
|
|
| Day 28 |
|
| Day 8 |
|
|
| Day 11 |
|
|
| Day 14 |
|
|
| Day 28 |
|
|
| Day 14 Mobility score |
|
|
| Day 28 Mobility score |
|
|
| Day 8 Self-care score |
|
|
| Day 14 Self-care score |
|
|
| Day 28 Self-care score |
|
|
| Day 8 Usual activities score |
|
|
| Day 14 Usual activities score |
|
|
| Day 28 Usual activities score |
|
|
| Day 8 Pain/discomfort score |
|
|
| Day 14 Pain/discomfort score |
|
|
| Day 28 Pain/discomfort score |
|
|
| Day 8 Anxiety/depression score |
|
|
| Day 14 Anxiety/depression score |
|
|
| Day 28 Anxiety/depression score |
|
|