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| Name | Class |
|---|---|
| Center for Cell and Gene Therapy, Baylor College of Medicine | OTHER |
| The Methodist Hospital Research Institute | OTHER |
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***At this time, we are only enrolling at Houston Methodist Hospital (HMH)/Baylor College of Medicine (BCM) and are not shipping cells outside of BCM/HMH.***
This is a study for patients who have respiratory infection caused by SARS-CoV-2 that have not gotten better. Because there is no standard treatment for this infection, patients are being asked to volunteer for a gene transfer research study using mesenchymal stem cells (MSCs).
Stem cells are cells that do not yet have a specific function in the body. Mesenchymal stem cells (MSCs) are a type of stem cell that can be grown from bone marrow (the spongy tissue inside of bones). Stem cells can develop into other types of more mature (specific) cells, such as blood and muscle cells.
The purpose of this study is to see if MSCs versus controls can help to treat respiratory infections caused by SARS-CoV-2.
Earlier, a healthy donor provided blood cells to generate MSCs. These cells were grown and frozen for later use.
Before being treated, the patient will receive a series of standard medical tests: These tests are done to assess the patient's eligibility to receive the cells.
The patient will be randomly assigned to a study group. We'll use a computer to put the patient into study group A (study drug) or group B (control) by chance (randomized). Patients randomized to the control group, will receive the standard treatment for their respiratory infection.
On the day that the patient is scheduled to receive the cells they will be pre-medicated with Benadryl and Tylenol. The patient will then receive an intravenous (into the vein) infusion of 1 x 10^8 cells/kg of MSCs. The patient will be monitored closely for two hours after the infusion. The patient will receive a second infusion at the same dose within 3-5 days of the initial infusion (at the discretion of the investigator) if there is no improvement in respiratory parameters or if there is a worsening of Acute respiratory distress syndrome (ARDS).
The patient will receive standard medical tests when getting the infusion(s) and afterwards. As part of the research study, the patient will be evaluated daily for 7 days and then weekly at weeks 2, 3, and 4. The evaluations that will be done at these visits include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Run In | Experimental | The study will first enroll and treat six patients with MSCs for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. |
|
| Mesenchymal stromal cells | Experimental | Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. |
|
| Control Group | Other | Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stromal Cells | Biological | Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10^8 MSCs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Treatment-related Serious Adverse Events (tSAEs) | Treatment-related serious adverse events (tSAE) are those directly related to the investigational infusion product. Adverse event grading will be per NCI Common Terminology Criteria for Adverse Events(CTCAE), vs 5. Rate of tSAEs in patients treated with MSCs will be reported as proportion and its 95% confidence interval. | 28 days post cell infusion |
| Number of Participants With Improvement by at Least Two Categories on a Six Category Ordinal Scale at Day 14 | Change by at least two categories on a six-category ordinal scale as improvement at day 14 post-randomization per protocol defined criteria. The six-category ordinal scale ranges from 6 to 1 with a higher score indicating a worse clinical outcome as follows: 6 ꞊ death; 5 ꞊ hospitalization, requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation (IMV); 4 ꞊ hospitalization, requiring non-invasive mechanical ventilation (NIV) and/or High-flow nasal cannula (HFNC) therapy; 3 = hospitalization, requiring supplemental oxygen (but not NIV/HFNC); 2 = hospitalization, not requiring supplemental oxygen; 1 = hospital discharge. | 14 days post cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Status Determined by 6-point Ordinal Scale at Day 28 | Clinical status at day 28 as determined by 6-point ordinal scale as follows: 6 ꞊ death; 5 ꞊ hospitalization, requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation (IMV); 4 ꞊ hospitalization, requiring non-invasive mechanical ventilation (NIV) and/or High-flow nasal cannula (HFNC) therapy; 3 = hospitalization, requiring supplemental oxygen (but not NIV/HFNC); 2 = hospitalization, not requiring supplemental oxygen; 1 = hospital discharge. The six-category ordinal scale ranges from 6 to 1 with a higher score indicating a worse clinical outcome. |
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Inclusion Criteria:
18 years or older
Confirmed SARS-CoV2 infection real-time reverse transcription polymerase chain reaction (RT-PCR) assay
Moderate OR severe ARDS, based on the degree of impairment of oxygenation as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2):
If on invasive or noninvasive (BiPAP) mechanical ventilator, PEEP ≥5 cm H2O
Bilateral opacities present on chest radiograph or computed tomographic (CT) scan, that are not fully explained by pleural effusions, lung collapse, or lung nodules.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LaQuisa Hill, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Safety Run In | The study will first enroll and treat six patients with mesenchymal stromal cells(MSCs) for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells(MSCs): Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10^8 MSCs. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2022 |
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| Supportive Care | Other | Patients will receive supportive care per their treating physician |
|
| 28 days post cell infusion |
| Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | ARDS is divided into 3 groups based on the degree of hypoxemia: mild (partial pressure of oxygen in the arterial blood(PaO2)/fraction of inspired oxygen(FIO2) 201-300 mm Hg), moderate (PaO2/FIO2: 101-200 mm Hg), and severe (PaO2/FIO2 ≤ 100 mm Hg) and ventilator settings with a positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥5 cm water (H2O). | 14 days post cell infusion |
| Number of Oxygenation Free Days at Day 28 | Number of oxygen support-free days through Day 28 | 28 days post cell infusion |
| Number of Participants With Progression to Mechanical Ventilation or ECMO | Participants not receiving mechanical ventilation at baseline who progress to requiring mechanical ventilation. | 28 days post cell infusion |
| Duration of Mechanical Ventilation and/or ECMO | Number of days requiring invasive mechanical ventilation and/or ECMO (ventilation/ECMO free days at day 28) | 28 days post cell infusion |
| Duration of ICU Stay | The number of days a participant spent in ICU. Duration of ICU stay is calculated from the date of admission or data of on study if the patient was admitted to ICU before enrollment to the time of ICU discharge, death, or last follow-up, whichever occurred first. | from the date of admission or data of on study if the patient was admitted to ICU before enrollment to the time of ICU discharge, death, or last follow-up, whichever occurred first. Up to 35 days. |
| Duration of Hospital Stay | Duration of hospital stay is calculated from the date of on study to the time of hospital discharge, death, or last follow-up, whichever occurred first. It does not reflect the entire hospitalization time. | from the date of on study to the time of hospital discharge, death, or last follow-up, whichever occurred first. Up to 35 days. |
| Overall Survival | Probability of overall survival is calculated using Kaplan-Meier survival curves per protocol. Overall survival time is defined as days from the date of randomization or date of infusion if received MSCs to the date of death or the date of the last follow-up for censoring. | 28 days post cell infusion |
| All-cause Mortality | Number and percentage of deaths (all-cause) until Day 28 | 28 days post cell infusion |
| FG001 | Mesenchymal Stromal Cells (MSCs) | Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or acute respiratory distress syndrome (ARDS) clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells (MSCs): Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10^8 MSCs. |
| FG002 | Control Group | Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Run In | The study will first enroll and treat six patients with mesenchymal stromal cells (MSCs) for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells(MSCs): Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10^8 MSCs. |
| BG001 | Mesenchymal Stromal Cells (MSCs) | Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells(MSCs): Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10^8 MSCs. |
| BG002 | Control Group | Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Proportion of Participants With Treatment-related Serious Adverse Events (tSAEs) | Treatment-related serious adverse events (tSAE) are those directly related to the investigational infusion product. Adverse event grading will be per NCI Common Terminology Criteria for Adverse Events(CTCAE), vs 5. Rate of tSAEs in patients treated with MSCs will be reported as proportion and its 95% confidence interval. | All participants who received MSCs are included in the analysis. | Posted | Number | 95% Confidence Interval | proportion of participant | 28 days post cell infusion |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants With Improvement by at Least Two Categories on a Six Category Ordinal Scale at Day 14 | Change by at least two categories on a six-category ordinal scale as improvement at day 14 post-randomization per protocol defined criteria. The six-category ordinal scale ranges from 6 to 1 with a higher score indicating a worse clinical outcome as follows: 6 ꞊ death; 5 ꞊ hospitalization, requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation (IMV); 4 ꞊ hospitalization, requiring non-invasive mechanical ventilation (NIV) and/or High-flow nasal cannula (HFNC) therapy; 3 = hospitalization, requiring supplemental oxygen (but not NIV/HFNC); 2 = hospitalization, not requiring supplemental oxygen; 1 = hospital discharge. | All study participants are included in the analysis. | Posted | Count of Participants | Participants | 14 days post cell infusion |
| ||||||||||||||||||||||||||||||||||
| Secondary | Clinical Status Determined by 6-point Ordinal Scale at Day 28 | Clinical status at day 28 as determined by 6-point ordinal scale as follows: 6 ꞊ death; 5 ꞊ hospitalization, requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation (IMV); 4 ꞊ hospitalization, requiring non-invasive mechanical ventilation (NIV) and/or High-flow nasal cannula (HFNC) therapy; 3 = hospitalization, requiring supplemental oxygen (but not NIV/HFNC); 2 = hospitalization, not requiring supplemental oxygen; 1 = hospital discharge. The six-category ordinal scale ranges from 6 to 1 with a higher score indicating a worse clinical outcome. | All study participants are included in the analysis. | Posted | Count of Participants | Participants | 28 days post cell infusion |
| ||||||||||||||||||||||||||||||||||
| Secondary | Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 | ARDS is divided into 3 groups based on the degree of hypoxemia: mild (partial pressure of oxygen in the arterial blood(PaO2)/fraction of inspired oxygen(FIO2) 201-300 mm Hg), moderate (PaO2/FIO2: 101-200 mm Hg), and severe (PaO2/FIO2 ≤ 100 mm Hg) and ventilator settings with a positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥5 cm water (H2O). | All study participants are included in the analysis. | Posted | Count of Participants | Participants | 14 days post cell infusion |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Oxygenation Free Days at Day 28 | Number of oxygen support-free days through Day 28 | All study participants are included in the analysis. | Posted | Median | Full Range | days | 28 days post cell infusion |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Progression to Mechanical Ventilation or ECMO | Participants not receiving mechanical ventilation at baseline who progress to requiring mechanical ventilation. | Participants who were not receiving mechanical ventilation at baseline are included in the analysis. | Posted | Count of Participants | Participants | 28 days post cell infusion |
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Mechanical Ventilation and/or ECMO | Number of days requiring invasive mechanical ventilation and/or ECMO (ventilation/ECMO free days at day 28) | All participants are included in the analysis. | Posted | Median | Full Range | days | 28 days post cell infusion |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of ICU Stay | The number of days a participant spent in ICU. Duration of ICU stay is calculated from the date of admission or data of on study if the patient was admitted to ICU before enrollment to the time of ICU discharge, death, or last follow-up, whichever occurred first. | Participants admitted to ICU are included in the analysis. | Posted | Median | Full Range | days | from the date of admission or data of on study if the patient was admitted to ICU before enrollment to the time of ICU discharge, death, or last follow-up, whichever occurred first. Up to 35 days. |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Hospital Stay | Duration of hospital stay is calculated from the date of on study to the time of hospital discharge, death, or last follow-up, whichever occurred first. It does not reflect the entire hospitalization time. | All study participants are included in the analysis. | Posted | Median | Full Range | days | from the date of on study to the time of hospital discharge, death, or last follow-up, whichever occurred first. Up to 35 days. |
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| Secondary | Overall Survival | Probability of overall survival is calculated using Kaplan-Meier survival curves per protocol. Overall survival time is defined as days from the date of randomization or date of infusion if received MSCs to the date of death or the date of the last follow-up for censoring. | All study participants are included in the analysis. | Posted | Number | 95% Confidence Interval | probability of overall survival | 28 days post cell infusion |
| |||||||||||||||||||||||||||||||||
| Secondary | All-cause Mortality | Number and percentage of deaths (all-cause) until Day 28 | All study participants are included in the analysis. | Posted | Count of Participants | Participants | 28 days post cell infusion |
|
28 days after the last dosing of study drug/biologic or until the time of discharge, whichever comes first.
Adverse events are collected as per protocol for participants who received MSCs. All new adverse experiences/toxicities and worsening of baseline toxicities by at least one grade following infusion are collected for 4 weeks after the last dosing of the study drug except for toxicities related to the MSC infusion, which are followed until resolved. Serious Adverse events are collected until 28 days after the last dosing of the study drug or until the time of discharge, whichever comes first.
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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 | Safety Run In | The study will first enroll and treat six patients with mesenchymal stromal cells (MSCs) for safety run in. If no more than 2 treatment-related severe adverse events (tSAEs) are observed, the study will enroll and randomize additional patients in a ratio of 1:1 to receive either MSCs or routine/supportive care. Mesenchymal Stromal Cells(MSCs): Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10^8 MSCs. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG001 | Mesenchymal Stromal Cells (MSCs) | Patients randomized to the MSC arm will be administered an intravenous infusion of MSCs at a dose of 1 x 10^8. A second infusion will be allowed if the patient does not have improvement in respiratory parameters per discretion of the investigator, or ARDS clinically worsens, within 3-5 days following the initial infusion. Mesenchymal Stromal Cells(MSCs): Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10^8 MSCs. | 3 | 10 | 3 | 10 | 10 | 10 |
| EG002 | Control Group | Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician | 2 | 12 | 0 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE(5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE(5.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE(5.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE(5.0) | Systematic Assessment |
| |
| Asystole | Cardiac disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | CTCAE(5.0) | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | CTCAE(5.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE(5.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | CTCAE(5.0) | Systematic Assessment |
| |
| CPK increased | Investigations | CTCAE(5.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Cardiac troponin I increased | Investigations | CTCAE(5.0) | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE(5.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE(5.0) | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE(5.0) | Systematic Assessment |
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| Cytomegalovirus infection reactivation | Infections and infestations | CTCAE(5.0) | Systematic Assessment |
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| Delirium | Psychiatric disorders | CTCAE(5.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE(5.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE(5.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE(5.0) | Systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | CTCAE(5.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE(5.0) | Systematic Assessment |
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| Eosinophilia | Blood and lymphatic system disorders | CTCAE(5.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE(5.0) | Systematic Assessment |
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| Esophagitis | Gastrointestinal disorders | CTCAE(5.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE(5.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE(5.0) | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE(5.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE(5.0) | Systematic Assessment |
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| Folliculitis | Infections and infestations | CTCAE(5.0) | Systematic Assessment |
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| Fungemia | Infections and infestations | CTCAE(5.0) | Systematic Assessment |
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| Glucosuria | Renal and urinary disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE(5.0) | Systematic Assessment |
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| Hematoma | Vascular disorders | CTCAE(5.0) | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
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| Hyperuricemia | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Hypothermia | General disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE(5.0) | Systematic Assessment |
| |
| INR increased | Investigations | CTCAE(5.0) | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | CTCAE(5.0) | Systematic Assessment |
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| Lung infection | Infections and infestations | CTCAE(5.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE(5.0) | Systematic Assessment |
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| Metabolism and nutrition disorders - Other, specify:Mild protein-calorie malnutrition | Metabolism and nutrition disorders | CTCAE(5.0) | Systematic Assessment |
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| Multi-organ failure | General disorders | CTCAE(5.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE(5.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE(5.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE(5.0) | Systematic Assessment |
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| Palpitations | Cardiac disorders | CTCAE(5.0) | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE(5.0) | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE(5.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE(5.0) | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE(5.0) | Systematic Assessment |
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| Rectal hemorrhage | Gastrointestinal disorders | CTCAE(5.0) | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify:Hypercapnia | Respiratory, thoracic and mediastinal disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Retroperitoneal hemorrhage | Gastrointestinal disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE(5.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE(5.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify:rash - unspecified | Skin and subcutaneous tissue disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE(5.0) | Systematic Assessment |
| |
| Vascular disorders - Other, specify:DVT | Vascular disorders | CTCAE(5.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE(5.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE(5.0) | Systematic Assessment |
|
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laquisa Hill | Baylor College of Medicine | 713-441-1450 | LaQuisa.Hill@bcm.edu |
| Jan 10, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 7, 2022 | Feb 23, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000086382 | COVID-19 |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Control Group | Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician |
|
|
| OG002 | Control Group | Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician |
|
|
| OG002 | Control Group | Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician |
|
|
Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians.
Supportive Care: Patients will receive supportive care per their treating physician
|
|
| Control Group |
Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician |
|
|
Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician |
|
|
| OG002 | Control Group | Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician |
|
|
| OG002 | Control Group | Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician |
|
|
| OG002 | Control Group | Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians. Supportive Care: Patients will receive supportive care per their treating physician |
|
|
Patients randomized to the control arm will receive supportive care or treatment designated by their treating physicians.
Supportive Care: Patients will receive supportive care per their treating physician
|
|