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Hope Biosciences is conducting a research study of an investigational product called autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.
This is a Phase II, Open Label, Single-Center, Clinical Trial to Assess Efficacy of HB-adMSCs to Provide Immune Support Against Coronavirus Disease. 51 patients were enrolled. All patients have previously banked their own mesenchymal stem cells at Hope Biosciences. Eligible participants are either 65 years of age or older, have preexisting conditions, or are at high exposure risk of contracting COVID-19. The primary objective of this study is to provide immune support against COVID-19, measured by the presence or absence of adverse events and serious adverse events related to the study drug. In addition, participants will be monitored for overall clinical status by standard clinical laboratories and inflammatory markers. Participants will complete Short Form Health Survey (SF-36) and depression module (PHQ-9) questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HB-adMSCs | Experimental | Five IV infusions of autologous, adipose-derived mesenchymal stem cells. Baseline laboratory data will be collected prior to first infusion; follow-up data will be compared against baseline according to the following schedule: safety lab follow ups at weeks 6, 14, 26; inflammatory marker follow ups at weeks 6, 14, 26; SF-36 and PHQ-9 Questionnaires at weeks 2, 6, 10, 14, 18, 22, 26. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB-adMSCs | Biological | Five IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at weeks 6, 14, 26. Inflammatory markers will be assessed at weeks 6, 14, 26. SF-36 and PHQ-9 questionnaires will be assessed at weeks 2, 6, 10, 14, 18, 22, 26. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hospitalization for COVID-19 | Number of subjects that require hospitalization for COVID-19 | Week 0 through Week 26 (End of Study) |
| Incidence of Symptoms for COVID-19 | Number of subjects that develop symptoms associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough | Week 0 through Week 26 (End of Study) |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Upper/Lower Respiratory Infection | Absence of upper/lower respiratory infection (with hospitalization criteria) | Week 0 through Week 26 (End of Study) |
| Change From Baseline in Glucose |
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Inclusion Criteria:
Subjects must meet the criteria for 1,2, OR 3, AND 4-7 to be eligible.
Exclusion Criteria:
Subjects must not have any of the following criteria to be eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Thanh Cheng, MD | Hope Biosciences Stem Cell Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Biosciences Stem Cell Research Foundation | Sugar Land | Texas | 77478 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | HB-adMSCs | Five IV infusions of autologous, adipose-derived mesenchymal stem cells. Baseline laboratory data will be collected prior to first infusion; follow-up data will be compared against baseline according to the following schedule: safety lab follow ups at weeks 6, 14, 26; inflammatory marker follow ups at weeks 6, 14, 26; SF-36 and PHQ-9 Questionnaires at weeks 2, 6, 10, 14, 18, 22, 26. HB-adMSCs: Five IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at weeks 6, 14, 26. Inflammatory markers will be assessed at weeks 6, 14, 26. SF-36 and PHQ-9 questionnaires will be assessed at weeks 2, 6, 10, 14, 18, 22, 26. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | HB-adMSCs | Five IV infusions of autologous, adipose-derived mesenchymal stem cells. Baseline laboratory data will be collected prior to first infusion; follow-up data will be compared against baseline according to the following schedule: safety lab follow ups at weeks 6, 14, 26; inflammatory marker follow ups at weeks 6, 14, 26; SF-36 and PHQ-9 Questionnaires at weeks 2, 6, 10, 14, 18, 22, 26. HB-adMSCs: Five IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at weeks 6, 14, 26. Inflammatory markers will be assessed at weeks 6, 14, 26. SF-36 and PHQ-9 questionnaires will be assessed at weeks 2, 6, 10, 14, 18, 22, 26. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Hospitalization for COVID-19 | Number of subjects that require hospitalization for COVID-19 | There was no incidence of hospitalization for COVID-19 in this study. Therefore, the analyses for this outcome measure were not performed. | Posted | Count of Participants | Participants | Week 0 through Week 26 (End of Study) |
|
Week 0 (Infusion 1) through Week 26 (End of Study)
43 out of 51 total subjects experienced at least one adverse event (AE). A total of 154 AEs were recorded during the entirety of the study, 147 of which were mild, 5 moderate, and 2 severe. There were 3 serious adverse events (SAEs) reported during the study period.
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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 | HB-adMSCs | Five IV infusions of autologous, adipose-derived mesenchymal stem cells. Baseline laboratory data will be collected prior to first infusion; follow-up data will be compared against baseline according to the following schedule: safety lab follow ups at weeks 6, 14, 26; inflammatory marker follow ups at weeks 6, 14, 26; SF-36 and PHQ-9 Questionnaires at weeks 2, 6, 10, 14, 18, 22, 26. HB-adMSCs: Five IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at weeks 6, 14, 26. Inflammatory markers will be assessed at weeks 6, 14, 26. SF-36 and PHQ-9 questionnaires will be assessed at weeks 2, 6, 10, 14, 18, 22, 26. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza like illness | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ridhima Vij, PhD | Hope Biosciences Research Foundation | 346-900-0340 | 102 | ridhima@hopebio.org |
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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 | Apr 20, 2020 | Aug 16, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 20, 2020 | Aug 16, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Change from baseline in level of glucose in the blood (mg/dL)
| Weeks 0, 6, 14, 26 |
| Change From Baseline in Calcium | Change from baseline in level of calcium in the blood (mg/dL) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Albumin | Change from baseline in level of albumin in the blood (g/dL) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Total Protein | Change from baseline in level of total protein in the blood (g/dL) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Sodium | Change from baseline in level of sodium in the blood (mmol/L) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Total Carbon Dioxide | Change from baseline in level of carbon dioxide in the blood (mmol/L) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Potassium | Change from baseline in level of potassium in the blood (mmol/L) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Chloride | Change from baseline in level of chloride in the blood (mmol/L) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Blood Urea Nitrogen (BUN) | Change from baseline in level of blood urea nitrogen (BUN) in the blood (mg/dL) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Creatinine | Change from baseline in level of creatinine in the blood (mg/dL) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Alkaline Phosphatase | Change from baseline in level of alkaline phosphatase in the blood (IU/L) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Alanine Aminotransferase | Change from baseline in level of alanine aminotransferase in the blood (IU/L) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Aspartate Aminotransferase | Change from baseline in level of aspartate aminotransferase in the blood (IU/L) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Total Bilirubin | Change from baseline in level of total bilirubin in the blood (mg/dL) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Leukocytes | Change from baseline in level of leukocytes in the blood (x 10^9/L) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Erythrocytes | Change from baseline in erythrocytes in the blood (10^12/L) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Hemoglobin | Change from baseline in level of hemoglobin in the blood (g/dL) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Hematocrit | Change from baseline in level of hematocrit in the blood (%) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Mean Corpuscular Volume | Change from baseline in mean corpuscular volume in the blood (fL) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Mean Corpuscular Hemoglobin | Change from baseline in mean corpuscular hemoglobin in the blood (pg) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Mean Corpuscular Hemoglobin Concentration | Change from baseline in mean corpuscular hemoglobin in the blood (g/dL) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Erythrocyte Distribution Width | Change from baseline in erythrocyte distribution width in the blood (%) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Neutrophils | Change from baseline in neutrophils in the blood (%) (leukocyte differential) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Lymphocytes | Change from baseline in lymphocytes in the blood (%) (leukocyte differential) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Monocytes | Change from baseline in monocytes in the blood (%) (leukocyte differential) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Eosinophils | Change from baseline in eosinophils in the blood (%) (leukocyte differential) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Basophils | Change from baseline in basophils in the blood (%) (leukocyte differential) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Platelets | Change from baseline in platelets in the blood (x 10^9/L) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Prothrombin Time | Change from baseline in prothrombin time in the blood (seconds) | Weeks 0, 6, 14, 26 |
| Change From Baseline in International Normalized Ratio (INR) | Change from baseline in international normalized ratio in the blood (INR) (ratio) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) | Change from baseline in tumor necrosis factor alpha (TNF-alpha) in the blood (ng/L) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Interleukin-6 | Change from baseline in Interleukin-6 in the blood (ng/L) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Interleukin-10 | Change from baseline in Interleukin-10 in the blood (ng/L) | Weeks 0, 6, 14, 26 |
| Change From Baseline in C-Reactive Protein | Change from baseline in C-Reactive Protein in the blood (mg/dL) | Weeks 0, 6, 14, 26 |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning | Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability. | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health | Short-form (36) Health Survey domain Average Role Limitations due to Physical Health; scored on a scale of 0-100; lower score equals more disability. | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems | Short-form (36) Health Survey domain Average Role Limitations due to Emotional Problems; scored on a scale of 0-100; lower score equals more disability. | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue | Short-form (36) Health Survey domain Average Energy/Fatigue; scored on a scale of 0-100; lower score equals more disability. | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being | Short-form (36) Health Survey domain Average Emotional Well-Being; scored on a scale of 0-100; lower score equals more disability. | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning | Short-form (36) Health Survey domain Average Social Functioning; scored on a scale of 0-100; lower score equals more disability. | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain | Short-form (36) Health Survey domain Average Pain; scored on a scale of 0-100; lower score equals more disability. | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
| Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health | Short-form (36) Health Survey domain Average General Health; scored on a scale of 0-100; lower score equals more disability. | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
| Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score | Depression module; scores DSM-IV criteria to monitor severity of depression through 9 total questions; minimum score of 0, maximum score of 27, each question ranges from scores 0-3; higher scores mean worse outcome | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Age, Customized | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | centimeters |
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| Weight | Mean | Standard Deviation | kilograms |
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| Primary | Incidence of Symptoms for COVID-19 | Number of subjects that develop symptoms associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough | There was no incidence of symptoms for COVID-19 in this study. Therefore, the analyses for this outcome measure were not performed. | Posted | Count of Participants | Participants | Week 0 through Week 26 (End of Study) |
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| Secondary | Absence of Upper/Lower Respiratory Infection | Absence of upper/lower respiratory infection (with hospitalization criteria) | There was no upper/lower respiratory infection due to COVID-19 reported in this study. Therefore, the analyses for this outcome measure were not performed. | Posted | Count of Participants | Participants | Week 0 through Week 26 (End of Study) |
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| Secondary | Change From Baseline in Glucose | Change from baseline in level of glucose in the blood (mg/dL) | At baseline (Week 0), the maximum number analyzed was 50. This was the largest N collected. | Posted | Mean | Standard Deviation | mg/dL | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Calcium | Change from baseline in level of calcium in the blood (mg/dL) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | mg/dL | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Albumin | Change from baseline in level of albumin in the blood (g/dL) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | g/dL | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Total Protein | Change from baseline in level of total protein in the blood (g/dL) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | g/dL | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Sodium | Change from baseline in level of sodium in the blood (mmol/L) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | mmol/L | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Total Carbon Dioxide | Change from baseline in level of carbon dioxide in the blood (mmol/L) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | mmol/L | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Potassium | Change from baseline in level of potassium in the blood (mmol/L) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | mmol/L | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Chloride | Change from baseline in level of chloride in the blood (mmol/L) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | mmol/L | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Blood Urea Nitrogen (BUN) | Change from baseline in level of blood urea nitrogen (BUN) in the blood (mg/dL) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | mg/dL | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Creatinine | Change from baseline in level of creatinine in the blood (mg/dL) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | mg/dL | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Alkaline Phosphatase | Change from baseline in level of alkaline phosphatase in the blood (IU/L) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | IU/L | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Alanine Aminotransferase | Change from baseline in level of alanine aminotransferase in the blood (IU/L) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | IU/L | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Aspartate Aminotransferase | Change from baseline in level of aspartate aminotransferase in the blood (IU/L) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | IU/L | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Total Bilirubin | Change from baseline in level of total bilirubin in the blood (mg/dL) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | mg/dL | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Leukocytes | Change from baseline in level of leukocytes in the blood (x 10^9/L) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | 10^9 cells/L | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Erythrocytes | Change from baseline in erythrocytes in the blood (10^12/L) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | 10^12 cells/L | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Hemoglobin | Change from baseline in level of hemoglobin in the blood (g/dL) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | g/dL | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Hematocrit | Change from baseline in level of hematocrit in the blood (%) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | percentage of erythrocytes | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Mean Corpuscular Volume | Change from baseline in mean corpuscular volume in the blood (fL) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | fL | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Mean Corpuscular Hemoglobin | Change from baseline in mean corpuscular hemoglobin in the blood (pg) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | pg | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Mean Corpuscular Hemoglobin Concentration | Change from baseline in mean corpuscular hemoglobin in the blood (g/dL) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | g/dL | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Erythrocyte Distribution Width | Change from baseline in erythrocyte distribution width in the blood (%) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | % of erythrocytes | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Neutrophils | Change from baseline in neutrophils in the blood (%) (leukocyte differential) | At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected. | Posted | Mean | Standard Deviation | percentage of neutrophils in the blood | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Lymphocytes | Change from baseline in lymphocytes in the blood (%) (leukocyte differential) | At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected. | Posted | Mean | Standard Deviation | percentage of lymphocytes in the blood | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Monocytes | Change from baseline in monocytes in the blood (%) (leukocyte differential) | At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected. | Posted | Mean | Standard Deviation | percentage of monocytes in the blood | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Eosinophils | Change from baseline in eosinophils in the blood (%) (leukocyte differential) | At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected. | Posted | Mean | Standard Deviation | percentage of eosinophils in the blood | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Basophils | Change from baseline in basophils in the blood (%) (leukocyte differential) | At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected. | Posted | Mean | Standard Deviation | percentage of basophils in the blood | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Platelets | Change from baseline in platelets in the blood (x 10^9/L) | At baseline (Week 0), the maximum number analyzed was 51. This was the largest N collected. | Posted | Mean | Standard Deviation | 10^9 cells/L | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Prothrombin Time | Change from baseline in prothrombin time in the blood (seconds) | At baseline (Week 0), the maximum number analyzed was 47. This was the largest N collected. | Posted | Mean | Standard Deviation | seconds | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in International Normalized Ratio (INR) | Change from baseline in international normalized ratio in the blood (INR) (ratio) | At baseline (Week 0), the maximum number analyzed was 47. This was the largest N collected. | Posted | Mean | Standard Deviation | ratio | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) | Change from baseline in tumor necrosis factor alpha (TNF-alpha) in the blood (ng/L) | At baseline (Week 0), the maximum number analyzed was 44. This was the largest N collected. | Posted | Mean | Standard Deviation | ng/L | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Interleukin-6 | Change from baseline in Interleukin-6 in the blood (ng/L) | At baseline (Week 0), the maximum number analyzed was 33. This was the largest N collected. | Posted | Mean | Standard Deviation | ng/L | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Interleukin-10 | Change from baseline in Interleukin-10 in the blood (ng/L) | At baseline (Week 0), the maximum number analyzed was 27. This was the largest N collected. | Posted | Mean | Standard Deviation | ng/L | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in C-Reactive Protein | Change from baseline in C-Reactive Protein in the blood (mg/dL) | At baseline (Week 0), the maximum number analyzed was 24. This was the largest N collected. | Posted | Mean | Standard Deviation | mg/dL | Weeks 0, 6, 14, 26 |
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| Secondary | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Physical Functioning | Short-form (36) Health Survey domain Average Physical Functioning; scored on a scale of 0-100; lower score equals more disability. | At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected. | Posted | Mean | Standard Deviation | score on a scale | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
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| Secondary | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Physical Health | Short-form (36) Health Survey domain Average Role Limitations due to Physical Health; scored on a scale of 0-100; lower score equals more disability. | At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected. | Posted | Mean | Standard Deviation | score on a scale | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
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| Secondary | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Role Limitations Due to Emotional Problems | Short-form (36) Health Survey domain Average Role Limitations due to Emotional Problems; scored on a scale of 0-100; lower score equals more disability. | At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected. | Posted | Mean | Standard Deviation | score on a scale | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
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| Secondary | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Energy/Fatigue | Short-form (36) Health Survey domain Average Energy/Fatigue; scored on a scale of 0-100; lower score equals more disability. | At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected. | Posted | Mean | Standard Deviation | score on a scale | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
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| Secondary | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Emotional Well-being | Short-form (36) Health Survey domain Average Emotional Well-Being; scored on a scale of 0-100; lower score equals more disability. | At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected. | Posted | Mean | Standard Deviation | score on a scale | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
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| Secondary | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Social Functioning | Short-form (36) Health Survey domain Average Social Functioning; scored on a scale of 0-100; lower score equals more disability. | At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected. | Posted | Mean | Standard Deviation | score on a scale | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
|
|
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| Secondary | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average Pain | Short-form (36) Health Survey domain Average Pain; scored on a scale of 0-100; lower score equals more disability. | At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected. | Posted | Mean | Standard Deviation | score on a scale | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
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| Secondary | Change From Baseline in Short Form (36) Health Survey (SF-36) Domain Average General Health | Short-form (36) Health Survey domain Average General Health; scored on a scale of 0-100; lower score equals more disability. | At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected. | Posted | Mean | Standard Deviation | score on a scale | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
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| Secondary | Change From Baseline in Patient Health Questionnaire 9 (PHQ-9) Total Score | Depression module; scores DSM-IV criteria to monitor severity of depression through 9 total questions; minimum score of 0, maximum score of 27, each question ranges from scores 0-3; higher scores mean worse outcome | At baseline (Week 0), the maximum number analyzed was 45. This was the largest N collected. | Posted | Mean | Standard Deviation | score on a scale | Weeks 0, 2, 6, 10, 14, 18, 22, 26 |
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|
|
| 0 |
| 51 |
| 3 |
| 51 |
| 42 |
| 51 |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Embolism | Vascular disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Pyrexia | General disorders | Non-systematic Assessment |
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| Chills | General disorders | Non-systematic Assessment |
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| Chest pain | General disorders | Non-systematic Assessment |
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| Oedema peripheral | General disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Balance disorder | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Migraine with aura | Nervous system disorders | Non-systematic Assessment |
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| Paresthesia | Nervous system disorders | Non-systematic Assessment |
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| Sinus headache | Nervous system disorders | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Crohn's disease | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastric dilatation | Gastrointestinal disorders | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | Non-systematic Assessment |
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| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
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| Vision blurred | Eye disorders | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Blood bicarbonate decreased | Investigations | Systematic Assessment |
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| Colonoscopy | Investigations | Systematic Assessment |
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| SARS-CoV-2 antibody test positive | Investigations | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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Not provided
Not provided
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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