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The trial was terminated early due to the limited number of new COVID-19 hospitalizations.
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| Name | Class |
|---|---|
| Northwestern University | OTHER |
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This is a single-blind study of Auxora in patients with critical COVID-19 pneumonia, consisting of up to 3 cohorts of escalating dose. The main goal was to assess pharmacodynamic parameters of immune response, while also assessing safety and tolerability of the drug in this patient population.
The primary objective of this study was to assess the pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets and chemokine release to various doses of Auxora in patients with critical COVID-19 pneumonia. Other objectives included assessment of safety and tolerability of Auxora in patients with critical COVID-19 pneumonia, as well as pharmacokinetic profile of Auxora in these patients. Efficacy was also to be examined based on all-cause mortality at day 60, number of days on mechanical ventilation after randomization, number of days in the hospital after randomization, and number of days in the ICU after randomization.
Patients were randomized 3:1 to Auxora or Placebo. The first 4 patients were enrolled in Cohort 1 (3 Auxora, 1 Placebo). If dose escalation occurred, the next 4 patients were to be enrolled in Cohort 2. If dose escalation occurred again, the next 8 patients were to be enrolled in Cohort 3. The decision to escalate dosing was made by CalciMedica in consultation with the PI and after the review of safety events in Cohorts 1 and 2.
(Note: Trial terminated early after the first patient was enrolled in Cohort 3 due to lack of new Covid-19 hospitalizations.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auxora | Experimental | Auxora will be given as a continuous infusion: Day 1: All 3 cohorts will receive 1.25 mL/kg over 4 hours; After initial infusion is complete, Cohort 3 will receive a continuous infusion of 1.0 mL/kg/24 hours for 96 hours Day 2: Cohort 1 will receive 1.0 mL/kg over 4 hours; Cohort 2 will receive 1.25mL/kg over 4 hours Day 3: Cohort 1 and 2 will receive 1.0 mL/kg over 4 hours Day 4: Cohort 2 will receive 1.0 mL/kg over 4 hours |
|
| Placebo | Placebo Comparator | Placebo will be given as a continuous infusion: Day 1: All 3 cohorts will receive 1.25 mL/kg over 4 hours. After initial infusion is complete, Cohort 3 will receive a continuous infusion of 1.0 mL/kg/24 hours for 96 hours Day 2: Cohort 1 will receive 1.0 mL/kg over 4 hours; Cohort 2 will receive 1.25mL/kg over 4 hours Day 3: Cohort 1 and 2 will receive 1.0 mL/kg over 4 hours Day 4: Cohort 2 will receive 1.0 mL/kg over 4 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM4620-IE (Injectable Emulsion) | Drug | Auxora is an injectable emulsion containing 1.6mg/ML of the active pharmaceutical ingredient CM4620. Auxora will be administered intravenously as a continuous infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Combined CD4, CD8, and Monocyte Cell Population in BAL Fluid, as a Percent of Total WBC Population. | Pharmacodynamic endpoint: Assessment of pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets to Auxora treatment. Flow cytometry was performed on fluid collected from the BAL performed prior to the SFISD (-12 hours) and 24 (±12) hours after completing the last infusion of study drug in Cohorts 1 and 2 and during the final 24 hours of the continuous infusion in Cohort 3. The percentage of total WBC population was assessed for the combined CD4, CD8, and monocyte cell population, and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported. | Baseline Assessment up to 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percent of Immune Cells in BAL Fluid | Pharmacodynamic endpoint: Assessment of pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets to Auxora treatment. Flow cytometry was performed on fluid collected from the BAL performed prior to the SFISD (-12 hours) and 24 (±12) hours after completing the last infusion of study drug in Cohorts 1 and 2 and during the final 24 hours of the continuous infusion in Cohort 3. The percentage of total WBC population was assessed for immune cell types and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Experiencing an AE Considered Possibly Related to Study Drug | Safety endpoint. Examines the relatedness of AEs to study drug by assessing the number of patients experiencing any AE (serious or non-serious) considered possibly related to Study Drug. | Randomization through Day 30 |
| Number of Patients Experiencing an SAE (at Least 1) |
Inclusion Criteria:
Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen;
Moderate ARDS characterized by the following criteria:
The patient is ≥18 years of age at the time of consent;
QTcF interval ≤ 440 milliseconds;
A female patient of childbearing potential must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug;
A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug. A male patient must not donate sperm for 39 months;
The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.
Exclusion Criteria:
Expected survival or time to withdrawal of life-sustaining treatments expected to be <7 days.
ECMO;
Suspected septic shock;
The patient has a history of:
Current treatment with:
The patient is known to be pregnant or is nursing;
Currently participating in another study of an investigational drug or therapeutic medical device at the time of consent;
Allergy to eggs or any of the excipients in study drug.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
10 patients were screened, 1 of which did not meet all inclusion/exclusion criteria, resulting in 9 patients randomized. All 9 completed study treatment, and 0 patients withdrew from the study.
Patients were randomized 3:1 to Auxora or Placebo. The first 4 patients were enrolled in Cohort 1, and the next 4 in Cohort 2. The next 8 patients were to be enrolled in Cohort 3, but trial terminated early after the first patient was enrolled in Cohort 3, due to lack of new Covid-19 hospitalizations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Auxora Cohort 1 | Auxora will be given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours |
| FG001 | Auxora Cohort 2 | Auxora will be given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours |
| FG002 | Auxora Cohort 3 | Auxora will be given as a continuous infusion: Day 1: Patients will initially receive 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients will start a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion). |
| FG003 | Placebo | Placebo will be given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo will receive 1.25 mL/kg over 4 hours. After initial infusion is complete, patients enrolled during period 3 will then receive a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo will receive 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 will receive 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 will receive 1.0 mL/kg over 4 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Cohort 1) |
| |||||||||||||
| Period 2 (Cohort 2) |
| |||||||||||||
| Period 3 (Cohort 3) |
|
Due to low enrollment trial was terminated early, and Auxora-treated patients from all Cohorts were combined into one arm for analysis. All placebo-treated patients were combined into one control arm as planned.
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| ID | Title | Description |
|---|---|---|
| BG000 | Auxora Cohort 1 | Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours |
| BG001 | Auxora Cohort 2 |
| 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 | Change From Baseline in Combined CD4, CD8, and Monocyte Cell Population in BAL Fluid, as a Percent of Total WBC Population. | Pharmacodynamic endpoint: Assessment of pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets to Auxora treatment. Flow cytometry was performed on fluid collected from the BAL performed prior to the SFISD (-12 hours) and 24 (±12) hours after completing the last infusion of study drug in Cohorts 1 and 2 and during the final 24 hours of the continuous infusion in Cohort 3. The percentage of total WBC population was assessed for the combined CD4, CD8, and monocyte cell population, and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported. | Posted | Mean | Standard Deviation | Percent of total WBC population | Baseline Assessment up to 120 hours |
|
Adverse Events were collected from randomization through Day 30. All-Cause Mortality was assessed from randomization through Day 60.
Per the protocol, adverse events were assessed from randomization through Day 30 only. An additional mortality assessment was performed at Day 60 for efficacy purposes only. (Note: 3 deaths had occurred in the Auxora-treated group and 1 death in the placebo group by Day 30. 1 additional death had occurred in the Auxora-treated group at the Day 60 mortality assessment.)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Auxora (ALL) | Combined Total data for Auxora-treated patients from all 3 Cohorts. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulseless electrical activity | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
This trial was terminated early due to the limited number of new COVID-19 hospitalizations, leading to small numbers of subjects analyzed (7 randomized to Auxora and 2 randomized to placebo). Hence, no formal hypothesis testing was performed. All performed analyses were based on descriptive summaries.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sudarshan Hebbar, MD (Chief Medical Officer) | CalciMedica | (816) 838-7105 | sudarshan@calcimedica.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 18, 2021 | Jul 27, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 14, 2022 | Jul 27, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 11, 2021 | Jul 28, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000721808 | zegocractin |
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|
| Placebo | Drug | Matching placebo is an injectable emulsion containing no active pharmaceutical ingredient. Placebo will be administered intravenously as a continuous infusion |
|
| Baseline Assessment up to 120 hours |
| Number of Patients Alive at Day 60 | Efficacy endpoint: All-cause Mortality at Day 60 | Randomization through Day 60 |
| Number of Days Alive and Out of the Intensive Care Unit (ICU) | Efficacy Endpoint: Days in ICU (after randomization) | From randomization until discharge from ICU, assessed up to 60 days |
| Number of Days Alive and Out of the Hospital | Efficacy endpoint: Days hospitalized (after randomization) | From randomization until discharge from the hospital, assessed up to 60 days |
| Number of Days Alive and Off Mechanical Ventilation | Efficacy endpoint: Ventilator-free days (after randomization) | From randomization until patient is extubated, assessed up to 60 days |
Safety Endpoint: Incidence of treatment emergent Serious Adverse Events (SAEs) |
| Randomization through day 30 |
| Intensity of AEs | Safety endpoint: Count of the number of AEs for each level of intensity: mild, moderate, or severe | Randomization through Day 30 |
| Number of Patients Experiencing Pre-defined Changes in Cardiac Conduction Assessed by ECG | Safety endpoint: Patients experiencing Changes in cardiac conduction, defined as: QTcF interval of ≥ 500 msec; QTcF prolongation of ≥ 60 msec as compared to baseline; Mobitz Type II second degree atrioventricular (AV) block; Third degree or high grade AV block; or Polymorphic Ventricular Tachycardia | From randomization up to 144 hours after SFISD (start of first infusion of study drug) |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Auxora was given as a continuous infusion:
Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours
| BG002 | Auxora Cohort 3 | Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion). |
| BG003 | Placebo | Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours. |
| BG004 | 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 |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Number of Participants with Additional Prior Positive Covid Test | Count of Participants | Participants |
|
| Number of Participants with Upper Respiratory Co-detection of Sars-CoV-2 | Count of Participants | Participants |
|
| Number of Participants with Bacterial Superinfection at Intubation | Count of Participants | Participants |
|
| OG001 | Auxora Cohort 2 | Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours |
| OG002 | Auxora Cohort 3 | Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion). |
| OG003 | Placebo | Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours. |
|
|
| Secondary | Change From Baseline in Percent of Immune Cells in BAL Fluid | Pharmacodynamic endpoint: Assessment of pharmacodynamic response of bronchoalveolar lavage (BAL) T cell/monocyte subsets to Auxora treatment. Flow cytometry was performed on fluid collected from the BAL performed prior to the SFISD (-12 hours) and 24 (±12) hours after completing the last infusion of study drug in Cohorts 1 and 2 and during the final 24 hours of the continuous infusion in Cohort 3. The percentage of total WBC population was assessed for immune cell types and the change between Pre- and Post-Infusion samples (Post value minus Pre value) was reported. | Posted | Mean | Standard Deviation | Percent of total WBC population | Baseline Assessment up to 120 hours |
|
|
|
| Secondary | Number of Patients Alive at Day 60 | Efficacy endpoint: All-cause Mortality at Day 60 | Posted | Count of Participants | Participants | Randomization through Day 60 |
|
|
|
| Secondary | Number of Days Alive and Out of the Intensive Care Unit (ICU) | Efficacy Endpoint: Days in ICU (after randomization) | Posted | Mean | Standard Deviation | days | From randomization until discharge from ICU, assessed up to 60 days |
|
|
|
| Secondary | Number of Days Alive and Out of the Hospital | Efficacy endpoint: Days hospitalized (after randomization) | Posted | Mean | Standard Deviation | days | From randomization until discharge from the hospital, assessed up to 60 days |
|
|
|
| Secondary | Number of Days Alive and Off Mechanical Ventilation | Efficacy endpoint: Ventilator-free days (after randomization) | Posted | Mean | Standard Deviation | days | From randomization until patient is extubated, assessed up to 60 days |
|
|
|
| Other Pre-specified | Number of Patients Experiencing an AE Considered Possibly Related to Study Drug | Safety endpoint. Examines the relatedness of AEs to study drug by assessing the number of patients experiencing any AE (serious or non-serious) considered possibly related to Study Drug. | Posted | Count of Participants | Participants | Randomization through Day 30 |
|
|
|
| Other Pre-specified | Number of Patients Experiencing an SAE (at Least 1) | Safety Endpoint: Incidence of treatment emergent Serious Adverse Events (SAEs) | Posted | Count of Participants | Participants | Randomization through day 30 |
|
|
|
| Other Pre-specified | Intensity of AEs | Safety endpoint: Count of the number of AEs for each level of intensity: mild, moderate, or severe | Posted | Number | Adverse Events | Randomization through Day 30 |
|
|
|
| Other Pre-specified | Number of Patients Experiencing Pre-defined Changes in Cardiac Conduction Assessed by ECG | Safety endpoint: Patients experiencing Changes in cardiac conduction, defined as: QTcF interval of ≥ 500 msec; QTcF prolongation of ≥ 60 msec as compared to baseline; Mobitz Type II second degree atrioventricular (AV) block; Third degree or high grade AV block; or Polymorphic Ventricular Tachycardia | Posted | Count of Participants | Participants | From randomization up to 144 hours after SFISD (start of first infusion of study drug) |
|
|
|
| 4 |
| 7 |
| 4 |
| 7 |
| 7 |
| 7 |
| EG001 | Auxora Cohort 1 | Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours; Day 2: 1.0 mL/kg (1.6 mg/kg) over 4 hours; Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours | 2 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Auxora Cohort 2 | Auxora was given as a continuous infusion: Day 1: 1.25 mL/kg (2.0 mg/kg) over 4 hours Day 2: 1.25mL/kg (2.0 mg/kg) over 4 hours Day 3: 1.0 mL/kg (1.6 mg/kg) over 4 hours Day 4: 1.0 mL/kg (1.6 mg/kg) over 4 hours | 2 | 3 | 3 | 3 | 3 | 3 |
| EG003 | Auxora Cohort 3 | Auxora was given as a continuous infusion: Day 1: Patients initially received 1.25 mL/kg (2.0 mg/kg) over 4 hours; After initial infusion is complete, patients started a continuous infusion of 1.0 mL/kg/24hours for 96 hours (1.6mg/kg/24hours, ending 4 days and 4 hours after the start of first infusion). | 0 | 1 | 0 | 1 | 1 | 1 |
| EG004 | Placebo | Placebo was given as a continuous infusion, with infusion volume and times matching those of the Auxora Cohort for each respective period. Day 1: All patients randomized to placebo received 1.25 mL/kg over 4 hours. After initial infusion was complete, patients enrolled during period 3 then received a continuous infusion of 1.0 mL/kg/24 hours for 96 hours. Day 2: Patients randomized to placebo received 1.0 mL/kg over 4 hours if enrolled during Period 1, or 1.25mL/kg over 4 hours if enrolled during Period 2. Day 3: Patients randomized to placebo during Periods 1 and 2 received 1.0 mL/kg over 4 hours. Day 4: Patients randomized to placebo during Period 2 received 1.0 mL/kg over 4 hours. | 1 | 2 | 2 | 2 | 2 | 2 |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Septic shock | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Distributive shock | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hypertransaminasemia | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Systemic candida | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Enterococcal infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Staphylococcal bacteremia | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Cystitis escherichia | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Bronchopulmonary aspergillosis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Enterobacter pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Lung abscess | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pneumonia pseudomonal | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pneumonia staphylococcal | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pneumonia streptococcal | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Superficial vein thrombosis | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
The PI shall submit copies of the proposed results communications to the Sponsor at least 30 days in advance of the submission of any proposed publication to a journal, editor, or other third party. Sponsor may request that Confidential Information (other than Study Data) be removed from communications, or that the PI refrain from publication for an additional 60 days in order for patent application(s) directed to the patentable subject matter to be filed with the appropriate patent office(s).
| D011024 |
| Pneumonia, Viral |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| CD8 T Cells |
|
| Neutrophils |
|
| NK cells |
|
| Monocytes |
|
| B cells |
|
| Macrophages |
|
| Possibly related non-serious AEs |
|
| Moderate |
|
| Severe |
|