Coronavirus
Conditions
Keywords
SARS-CoV-2, COVID-19
Brief summary
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).
Detailed description
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.
Interventions
DRUGSilmitasertib
Standard of care / best supportive care in combination with CX-4945 1000 mg administered orally, two times a day.
Sponsors
Senhwa Biosciences, Inc.
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or non-pregnant female adult ≥ 18 years of age 2. Diagnosed/confirmed with COVID-19 by standard RT-PCR assay or equivalent testing within 7 days prior to randomization (Day1). 3. 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% 4. Patient (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 5. Adequate hematopoietic capacity, as defined by the following: 1. Hemoglobin ≥ 9.0 g/dL and not transfusion dependent 2. Platelets ≥ 100,000/mm3 3. Absolute neutrophil count ≥ 1500 cells/mm3 6. Adequate hepatic function, as defined by the following: 1. AST and ALT ≤ 2.5 times upper limit of normal (ULN) 2. Total bilirubin ≤ 1.5 x ULN 3. Albumin ≥ 3.0 g/dL 7. 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). 8. 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
1. Patient showing signs of respiratory failure necessitating mechanical ventilation 2. Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately. 3. Active or uncontrolled infections other than COVID-19 or with serious illnesses or medical conditions which would not permit the patient to receive study treatment 4. Active or planned concomitant treatment with other investigational antivirals or immunomodulators 5. Chronic diarrhea (excess of 2-3 stools/day above normal frequency) 6. Current use or anticipated need for drugs that are known strong inhibitors or inducers of major CYP enzymes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | Through Day 60 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Assessed on Day 14 and Day 28 | Difference in percentage of subjects with clinical recovery compared at Day 14 and Day 28. |
| To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Assessed at Day 1, Day 8, Day 14 and Day 28 | 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. |
| Number of Days Hospitalized | Through Day 28 | Days of hospitalization from randomization through Day 28 |
| To Evaluate Changes in IL-6 Level | Assessed on Days 1, 4, 8, 11, and 14 | IL-6 level |
| To Evaluate Changes in CRP | Assessed on Days 1, 4, 8, 11, and 14 | CRP level |
| To Evaluate Changes in LDH | Assessed on Days 1, 4, 8, 11, and 14 | LDH level |
| To Evaluate Changes in CPK | Assessed on Days 1, 4, 8, 11, and 14 | CPK level |
| To Evaluate Changes in Ferritin | Assessed on Days 1, 4, 8, 11, and 14 | Ferritin level |
| To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm. | Through Day 28 | 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. |
| Number of Days of Supplemental Oxygen Use | Through Day 28 | Days of supplemental oxygen (if applicable) from randomization through day 28 |
| All-cause Mortality Status | Through Day 60 | The number of deaths occurred in each treatment group from randomization through Day 60 |
| Number of Days of On-invasive Ventilation/High Flow Oxygen | Through Day 28 | Days of non-invasive ventilation/high flow oxygen (if applicable) from randomization through day 28 |
| Number of Days of Invasive Mechanical Ventilation/ECMO | Through Day 28 | Days of invasive mechanical ventilation/ECMO (if applicable) from randomization through Day 28. |
| Number of Patients Returned to Room Air | Through Day 28 | Number of patients returned to room air after randomization through Day 14 or Day 28. |
| Change in Pulse Oxygen Saturation | Days 4, 8, 11, 14, and 28 | Change in pulse oxygen saturation (SpO2) from randomization to Day 4, 8, 11, 14 and 28 |
| Number of Thrombosis Events | Through Day 28 | Number of documented venous thromboembolism (VTE), arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events from randomization through Day 28 |
| Changes in EQ-D5-5L | Days randomization, 8, 14 and 28 | 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 |
| To Evaluate Changes in D-dimer | Assessed on Days 1, 4, 8, 11, and 14 | D-dimer level |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Of the 31 enrolled participants, 29 met inclusion criteria and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Standard of Care Standard of care / supportive care
Participants received supportive care/Standard of Care. | 14 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Subject Expired | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
| Overall Study | Withdrawn from study | 0 | 1 |
Baseline characteristics
| Characteristic | Silmitasertib (CX-4945) in Combination With Standard of Care | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 14.72 | 46.4 years STANDARD_DEVIATION 13.91 | 43.9 years STANDARD_DEVIATION 13.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 16 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 13 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 26 Participants | 11 Participants |
| Region of Enrollment United States | 15 participants | 29 participants | 14 participants |
| Sex: Female, Male Female | 5 Participants | 12 Participants | 7 Participants |
| Sex: Female, Male Male | 10 Participants | 17 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 15 | 2 / 14 |
| other Total, other adverse events | 10 / 15 | 7 / 14 |
| serious Total, serious adverse events | 3 / 15 | 2 / 14 |
Outcome results
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.
Time frame: Through Day 60
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | Experienced Incidence of Treatment Emergent Adverse Events | 10 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | Did not experience Incidence of Treatment Emergent Adverse Events | 5 Participants |
| Standard of Care | Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | Experienced Incidence of Treatment Emergent Adverse Events | 7 Participants |
| Standard of Care | Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | Did not experience Incidence of Treatment Emergent Adverse Events | 7 Participants |
Secondary
All-cause Mortality Status
The number of deaths occurred in each treatment group from randomization through Day 60
Time frame: Through Day 60
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | All-cause Mortality Status | Death - No | 13 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | All-cause Mortality Status | Death - Yes | 2 Participants |
| Standard of Care | All-cause Mortality Status | Death - No | 12 Participants |
| Standard of Care | All-cause Mortality Status | Death - Yes | 2 Participants |
Secondary
Change in Pulse Oxygen Saturation
Change in pulse oxygen saturation (SpO2) from randomization to Day 4, 8, 11, 14 and 28
Time frame: Days 4, 8, 11, 14, and 28
Population: Missing data explains the discrepancy in the total analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | Change in Pulse Oxygen Saturation | Day 4 | 0.5 percentage of hemoglobin saturation | Standard Deviation 3.4 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Change in Pulse Oxygen Saturation | Day 14 | -0.5 percentage of hemoglobin saturation | Standard Deviation 3.9 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Change in Pulse Oxygen Saturation | Day 8 | 1.3 percentage of hemoglobin saturation | Standard Deviation 3.3 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Change in Pulse Oxygen Saturation | Day 28 | 1.7 percentage of hemoglobin saturation | Standard Deviation 2.6 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Change in Pulse Oxygen Saturation | Day 11 | -0.4 percentage of hemoglobin saturation | Standard Deviation 4.8 |
| Standard of Care | Change in Pulse Oxygen Saturation | Day 28 | 1.7 percentage of hemoglobin saturation | Standard Deviation 3.7 |
| Standard of Care | Change in Pulse Oxygen Saturation | Day 4 | -1.1 percentage of hemoglobin saturation | Standard Deviation 1.8 |
| Standard of Care | Change in Pulse Oxygen Saturation | Day 11 | -0.5 percentage of hemoglobin saturation | Standard Deviation 5.6 |
| Standard of Care | Change in Pulse Oxygen Saturation | Day 14 | -1.8 percentage of hemoglobin saturation | Standard Deviation 8.8 |
| Standard of Care | Change in Pulse Oxygen Saturation | Day 8 | 0.3 percentage of hemoglobin saturation | Standard Deviation 3.6 |
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
Time frame: Days randomization, 8, 14 and 28
Population: Missing data explains the discrepancy in the total analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 14 Self-care score | -1.1 score on a scale | Standard Deviation 1.8 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 28 Usual activities score | -2.6 score on a scale | Standard Deviation 1.6 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 14 Mobility score | -1.1 score on a scale | Standard Deviation 1.6 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 8 Pain/discomfort score | 0.3 score on a scale | Standard Deviation 1.1 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 28 Self-care score | -1.3 score on a scale | Standard Deviation 1.7 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 14 Pain/discomfort score | -0.2 score on a scale | Standard Deviation 0.4 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 8 Self-care score | -1.2 score on a scale | Standard Deviation 1.6 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 28 Pain/discomfort score | -0.3 score on a scale | Standard Deviation 0.7 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 8 Usual activities score | -2.3 score on a scale | Standard Deviation 1.6 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 8 Anxiety/depression score | 0 score on a scale | Standard Deviation 0.8 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 28 Mobility score | -1.4 score on a scale | Standard Deviation 1.9 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 14 Anxiety/depression score | -0.2 score on a scale | Standard Deviation 0.7 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 14 Usual activities score | -2.3 score on a scale | Standard Deviation 1.6 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 28 Anxiety/depression score | 0 score on a scale | Standard Deviation 0.5 |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Changes in EQ-D5-5L | Day 8 Mobility score | -1 score on a scale | Standard Deviation 1.6 |
| Standard of Care | Changes in EQ-D5-5L | Day 28 Anxiety/depression score | -0.2 score on a scale | Standard Deviation 1.1 |
| Standard of Care | Changes in EQ-D5-5L | Day 8 Mobility score | -1.7 score on a scale | Standard Deviation 1.2 |
| Standard of Care | Changes in EQ-D5-5L | Day 14 Mobility score | -1.7 score on a scale | Standard Deviation 1.5 |
| Standard of Care | Changes in EQ-D5-5L | Day 28 Mobility score | -2.6 score on a scale | Standard Deviation 1.1 |
| Standard of Care | Changes in EQ-D5-5L | Day 8 Self-care score | -2.1 score on a scale | Standard Deviation 2.6 |
| Standard of Care | Changes in EQ-D5-5L | Day 14 Self-care score | -3 score on a scale | Standard Deviation 1.7 |
| Standard of Care | Changes in EQ-D5-5L | Day 28 Self-care score | -2.8 score on a scale | Standard Deviation 1.3 |
| Standard of Care | Changes in EQ-D5-5L | Day 8 Usual activities score | -0.7 score on a scale | Standard Deviation 2.2 |
| Standard of Care | Changes in EQ-D5-5L | Day 14 Usual activities score | -1.4 score on a scale | Standard Deviation 1.4 |
| Standard of Care | Changes in EQ-D5-5L | Day 28 Usual activities score | -1.4 score on a scale | Standard Deviation 1.3 |
| Standard of Care | Changes in EQ-D5-5L | Day 8 Pain/discomfort score | -0.8 score on a scale | Standard Deviation 1 |
| Standard of Care | Changes in EQ-D5-5L | Day 14 Pain/discomfort score | -0.3 score on a scale | Standard Deviation 1.3 |
| Standard of Care | Changes in EQ-D5-5L | Day 28 Pain/discomfort score | -0.2 score on a scale | Standard Deviation 1.3 |
| Standard of Care | Changes in EQ-D5-5L | Day 8 Anxiety/depression score | 0.1 score on a scale | Standard Deviation 0.6 |
| Standard of Care | Changes in EQ-D5-5L | Day 14 Anxiety/depression score | -0.1 score on a scale | Standard Deviation 1.2 |
Secondary
Number of Days Hospitalized
Days of hospitalization from randomization through Day 28
Time frame: Through Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | Number of Days Hospitalized | 10.1 Days | Standard Deviation 8.4 |
| Standard of Care | Number of Days Hospitalized | 11.7 Days | Standard Deviation 19.7 |
Secondary
Number of Days of Invasive Mechanical Ventilation/ECMO
Days of invasive mechanical ventilation/ECMO (if applicable) from randomization through Day 28.
Time frame: Through Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | Number of Days of Invasive Mechanical Ventilation/ECMO | 1.9 Days | Standard Deviation 5.3 |
| Standard of Care | Number of Days of Invasive Mechanical Ventilation/ECMO | 3 Days | Standard Deviation 7.7 |
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
Time frame: Through Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | Number of Days of On-invasive Ventilation/High Flow Oxygen | 2.1 Days | Standard Deviation 4.1 |
| Standard of Care | Number of Days of On-invasive Ventilation/High Flow Oxygen | 1.9 Days | Standard Deviation 2.9 |
Secondary
Number of Days of Supplemental Oxygen Use
Days of supplemental oxygen (if applicable) from randomization through day 28
Time frame: Through Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | Number of Days of Supplemental Oxygen Use | 4.8 Days | Standard Deviation 4.6 |
| Standard of Care | Number of Days of Supplemental Oxygen Use | 4.2 Days | Standard Deviation 3.2 |
Secondary
Number of Patients Returned to Room Air
Number of patients returned to room air after randomization through Day 14 or Day 28.
Time frame: Through Day 28
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | Number of Patients Returned to Room Air | Day 14 | Return to room air: Yes | 12 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Number of Patients Returned to Room Air | Day 14 | Return to room air: No | 3 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Number of Patients Returned to Room Air | Day 28 | Return to room air: Yes | 12 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | Number of Patients Returned to Room Air | Day 28 | Return to room air: No | 3 Participants |
| Standard of Care | Number of Patients Returned to Room Air | Day 28 | Return to room air: No | 4 Participants |
| Standard of Care | Number of Patients Returned to Room Air | Day 14 | Return to room air: Yes | 10 Participants |
| Standard of Care | Number of Patients Returned to Room Air | Day 28 | Return to room air: Yes | 10 Participants |
| Standard of Care | Number of Patients Returned to Room Air | Day 14 | Return to room air: No | 4 Participants |
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
Time frame: Through Day 28
Population: No data collected for this outcome analysis.
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.
Time frame: Assessed on Day 14 and Day 28
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 14 | 13 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 28 | 13 Participants |
| Standard of Care | 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. | Day 14 | 13 Participants |
| Standard of Care | 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. | Day 28 | 13 Participants |
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)
Time frame: Through Day 28
Population: Missing data explains the discrepancy in the total analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 14 | Death | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 14 | Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 14 | Hospitalized, on non-invasive ventilation or high flow oxygen devices | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 14 | Hospitalized, requiring supplemental oxygen | 2 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 14 | Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 14 | Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 14 | Not hospitalized, limitation on activities and/or requiring home oxygen | 5 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 14 | Not hospitalized, no limitations on activities | 2 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 28 | Death | 2 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 28 | Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 28 | Hospitalized, on non-invasive ventilation or high flow oxygen devices | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 28 | Hospitalized, requiring supplemental oxygen | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 28 | Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 28 | Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 28 | Not hospitalized, limitation on activities and/or requiring home oxygen | 4 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | 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. | Day 28 | Not hospitalized, no limitations on activities | 4 Participants |
| Standard of Care | 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. | Day 28 | Not hospitalized, no limitations on activities | 3 Participants |
| Standard of Care | 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. | Day 14 | Death | 0 Participants |
| Standard of Care | 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. | Day 28 | Death | 0 Participants |
| Standard of Care | 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. | Day 14 | Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) | 2 Participants |
| Standard of Care | 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. | Day 28 | Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 0 Participants |
| Standard of Care | 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. | Day 14 | Hospitalized, on non-invasive ventilation or high flow oxygen devices | 1 Participants |
| Standard of Care | 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. | Day 28 | Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) | 2 Participants |
| Standard of Care | 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. | Day 14 | Hospitalized, requiring supplemental oxygen | 0 Participants |
| Standard of Care | 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. | Day 28 | Not hospitalized, limitation on activities and/or requiring home oxygen | 1 Participants |
| Standard of Care | 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. | Day 14 | Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care | 0 Participants |
| Standard of Care | 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. | Day 28 | Hospitalized, on non-invasive ventilation or high flow oxygen devices | 0 Participants |
| Standard of Care | 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. | Day 14 | Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0 Participants |
| Standard of Care | 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. | Day 28 | Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care | 0 Participants |
| Standard of Care | 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. | Day 14 | Not hospitalized, limitation on activities and/or requiring home oxygen | 2 Participants |
| Standard of Care | 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. | Day 28 | Hospitalized, requiring supplemental oxygen | 0 Participants |
| Standard of Care | 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. | Day 14 | Not hospitalized, no limitations on activities | 4 Participants |
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.
Time frame: Through Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm. | 3 Days | Standard Deviation 1.5 |
| Standard of Care | To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm. | 3.4 Days | Standard Deviation 1.3 |
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.
Time frame: Through hospital discharge, an average of 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm. | 6 Days | Standard Deviation 4.1 |
| Standard of Care | To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm. | 5.1 Days | Standard Deviation 2.9 |
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.
Time frame: Through Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm. | 7.3 Days | Standard Deviation 4.6 |
| Standard of Care | To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm. | 6 Days | Standard Deviation 3.3 |
Secondary
To Evaluate Changes in CPK
CPK level
Time frame: Assessed on Days 1, 4, 8, 11, and 14
Population: Missing data explains the discrepancy in the total analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 8 | Abnormal: High | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 8 | Abnormal: Low | 6 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 8 | Normal | 3 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 1 | Abnormal: High | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 1 | Abnormal: Low | 4 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 1 | Normal | 8 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 1 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 4 | Abnormal: High | 2 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 4 | Abnormal: Low | 4 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 4 | Normal | 6 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 4 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 8 | Unable to determine | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 11 | Abnormal: High | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 11 | Abnormal: Low | 2 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 11 | Normal | 7 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 11 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 14 | Abnormal: High | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 14 | Abnormal: Low | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 14 | Normal | 8 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CPK | Day 14 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 14 | Abnormal: Low | 2 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 8 | Abnormal: High | 0 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 4 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 8 | Abnormal: Low | 1 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 11 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 8 | Normal | 5 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 8 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 1 | Abnormal: High | 1 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 14 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 1 | Abnormal: Low | 2 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 11 | Abnormal: High | 0 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 1 | Normal | 10 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 14 | Abnormal: High | 0 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 1 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 11 | Abnormal: Low | 3 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 4 | Abnormal: High | 0 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 14 | Normal | 3 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 4 | Abnormal: Low | 4 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 11 | Normal | 4 Participants |
| Standard of Care | To Evaluate Changes in CPK | Day 4 | Normal | 8 Participants |
Secondary
To Evaluate Changes in CRP
CRP level
Time frame: Assessed on Days 1, 4, 8, 11, and 14
Population: Missing data explains the discrepancy in the total analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 1 | Abnormal: High | 12 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 1 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 1 | Normal | 3 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 1 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 4 | Abnormal: High | 8 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 4 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 4 | Normal | 4 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 4 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 8 | Abnormal: High | 8 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 8 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 8 | Normal | 2 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 8 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 11 | Abnormal: High | 8 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 11 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 11 | Normal | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 11 | Unable to determine | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 14 | Abnormal: High | 6 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 14 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 14 | Normal | 2 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in CRP | Day 14 | Unable to determine | 1 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 14 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 1 | Abnormal: High | 13 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 8 | Normal | 3 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 1 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 11 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 1 | Normal | 0 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 8 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 1 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 14 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 4 | Abnormal: High | 8 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 11 | Abnormal: High | 5 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 4 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 14 | Abnormal: High | 4 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 4 | Normal | 4 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 11 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 4 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 14 | Normal | 1 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 8 | Abnormal: High | 3 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 11 | Normal | 0 Participants |
| Standard of Care | To Evaluate Changes in CRP | Day 8 | Abnormal: Low | 0 Participants |
Secondary
To Evaluate Changes in D-dimer
D-dimer level
Time frame: Assessed on Days 1, 4, 8, 11, and 14
Population: Missing data explains the discrepancy in the total analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 1 | Abnormal: High | 10 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 1 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 1 | Normal | 2 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 1 | Unable to determine | 2 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 4 | Abnormal: High | 10 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 4 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 4 | Normal | 2 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 4 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 8 | Abnormal: High | 9 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 8 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 8 | Normal | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 8 | Unable to determine | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 11 | Abnormal: High | 9 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 11 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 11 | Normal | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 11 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 14 | Abnormal: High | 8 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 14 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 14 | Normal | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in D-dimer | Day 14 | Unable to determine | 2 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 14 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 1 | Abnormal: High | 8 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 8 | Normal | 1 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 1 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 11 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 1 | Normal | 3 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 8 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 1 | Unable to determine | 2 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 14 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 4 | Abnormal: High | 10 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 11 | Abnormal: High | 5 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 4 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 14 | Abnormal: High | 4 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 4 | Normal | 2 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 11 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 4 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 14 | Normal | 1 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 8 | Abnormal: High | 5 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 11 | Normal | 1 Participants |
| Standard of Care | To Evaluate Changes in D-dimer | Day 8 | Abnormal: Low | 0 Participants |
Secondary
To Evaluate Changes in Ferritin
Ferritin level
Time frame: Assessed on Days 1, 4, 8, 11, and 14
Population: Missing data explains the discrepancy in the total analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 1 | Abnormal: High | 13 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 1 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 1 | Normal | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 1 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 4 | Abnormal: High | 11 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 4 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 4 | Normal | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 4 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 8 | Abnormal: High | 9 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 8 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 8 | Normal | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 8 | Unable to determine | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 11 | Abnormal: High | 8 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 11 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 11 | Normal | 2 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 11 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 14 | Abnormal: High | 6 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 14 | Abnormal: Low | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 14 | Normal | 3 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in Ferritin | Day 14 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 14 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 1 | Abnormal: High | 8 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 8 | Normal | 1 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 1 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 11 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 1 | Normal | 5 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 8 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 1 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 14 | Unable to determine | 1 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 4 | Abnormal: High | 7 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 11 | Abnormal: High | 5 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 4 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 14 | Abnormal: High | 3 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 4 | Normal | 3 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 11 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 4 | Unable to determine | 1 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 14 | Normal | 1 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 8 | Abnormal: High | 4 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 11 | Normal | 2 Participants |
| Standard of Care | To Evaluate Changes in Ferritin | Day 8 | Abnormal: Low | 0 Participants |
Secondary
To Evaluate Changes in IL-6 Level
IL-6 level
Time frame: Assessed on Days 1, 4, 8, 11, and 14
Population: Missing data explains the discrepancy in the total analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 1 | Abnormal: High | 5 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 1 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 1 | Normal | 8 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 1 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 4 | Abnormal: High | 4 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 4 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 4 | Normal | 4 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 4 | Unable to determine | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 8 | Abnormal: High | 5 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 8 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 8 | Normal | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 8 | Unable to determine | 2 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 11 | Abnormal: High | 7 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 11 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 11 | Normal | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 11 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 14 | Abnormal: High | 6 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 14 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 14 | Normal | 3 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in IL-6 Level | Day 14 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 14 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 1 | Abnormal: High | 6 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 8 | Normal | 2 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 1 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 11 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 1 | Normal | 5 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 8 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 1 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 14 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 4 | Abnormal: High | 4 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 11 | Abnormal: High | 5 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 4 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 14 | Abnormal: High | 5 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 4 | Normal | 7 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 11 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 4 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 14 | Normal | 0 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 8 | Abnormal: High | 3 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 11 | Normal | 1 Participants |
| Standard of Care | To Evaluate Changes in IL-6 Level | Day 8 | Abnormal: Low | 0 Participants |
Secondary
To Evaluate Changes in LDH
LDH level
Time frame: Assessed on Days 1, 4, 8, 11, and 14
Population: Missing data explains the discrepancy in the total analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 4 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day1 | Abnormal: High | 13 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day1 | Abnormal: Low | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day1 | Normal | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day1 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 4 | Abnormal: High | 12 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 4 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 4 | Normal | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 8 | Abnormal: High | 11 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 8 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 8 | Normal | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 8 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 11 | Abnormal: High | 9 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 11 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 11 | Normal | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 11 | Unable to determine | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 14 | Abnormal: High | 8 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 14 | Abnormal: Low | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 14 | Normal | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Changes in LDH | Day 14 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 14 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 4 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 4 | Normal | 1 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 8 | Normal | 0 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day1 | Abnormal: High | 13 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 11 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day1 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 8 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day1 | Normal | 0 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 14 | Unable to determine | 1 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day1 | Unable to determine | 0 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 11 | Abnormal: High | 6 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 4 | Abnormal: High | 11 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 14 | Abnormal: High | 2 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 4 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 11 | Abnormal: Low | 0 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 14 | Normal | 2 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 8 | Abnormal: High | 4 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 11 | Normal | 0 Participants |
| Standard of Care | To Evaluate Changes in LDH | Day 8 | Abnormal: Low | 1 Participants |
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
Time frame: Through Day 14
Population: No data collected for this outcome analysis.
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.
Time frame: Assessed at Day 1, Day 8, Day 14 and Day 28
Population: Missing data explains the discrepancy in the total analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 1 | Positive | 15 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 1 | Negative | 0 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 8 | Positive | 8 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 8 | Negative | 3 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 14 | Positive | 4 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 14 | Negative | 5 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 28 | Positive | 1 Participants |
| Silmitasertib (CX-4945) in Combination With Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 28 | Negative | 4 Participants |
| Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 28 | Negative | 5 Participants |
| Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 1 | Positive | 12 Participants |
| Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 14 | Positive | 3 Participants |
| Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 1 | Negative | 0 Participants |
| Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 28 | Positive | 0 Participants |
| Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 8 | Positive | 4 Participants |
| Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 14 | Negative | 2 Participants |
| Standard of Care | To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm. | Day 8 | Negative | 2 Participants |