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No need to continue with the availability of the COVID-19 VACCINE
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| Name | Class |
|---|---|
| River Oaks Hospital and Clinics | OTHER |
| United Memorial Medical Center | OTHER |
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Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as treatment for patients suspected to have COVID-19. The study purpose is to evaluate the safety and efficacy of four IV infusions of either placebo or HB-adMSCs in subjects with COVID-19.
This is a Phase II, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial to Assess Efficacy of HB-adMSCs to treat COVID-19 patients. 100 patients will be enrolled. Eligible participants are suspected to have COVID-19 and consent to participate. The primary endpoints of this study are to detect change from baseline in inflammatory markers (IL-6, IL-10, TNF-alpha, C Reactive protein), improving oxygenation, and decreasing time to return to room air (RTRA). In addition, participants will be monitored for overall clinical status by standard clinical laboratories, change from baseline in exploratory markers (D-dimer, myoglobin, troponin, creatinine kinase MB, serum ferritin, CD4:CD8 ratio, CD3-CD56+), time to negative PCR results and clinical improvement according to 7-point ordinal scale, as well as incidence of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HB-adMSCs | Experimental | Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10. |
|
| Placebo | Placebo Comparator | Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB-adMSC | Biological | Hope Biosciences allogeneic adipose-derived mesenchymal stem cells |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Necrosis Factor-Alpha (TNF-alpha) | Change from baseline in Tumor Necrosis Factor-Alpha (TNF-alpha) in the blood (pg/mL) | Day 0, 3, 7, and 10 |
| Interleukin-10 (IL-10) | Change from baseline level of Interleukin-10 (IL-10) in the blood (pg/mL) | Day 0, 3, 7, and 10 |
| Interleukin-6 (IL-6) | Change from baseline in Interleukin-6 (IL-6) in the blood (pg/mL) | Day 0, 3, 7, and 10 |
| C-Reactive Protein (CRP) | Change from baseline in C-Reactive Protein (CRP) in the blood (mg/L) | Day 0, 3, 7, and 10 |
| Oxygenation | Change from baseline Oxygenation (%) in the blood | Day 0, 3, 7, and 10 |
| Return To Room Air (RTRA) | Number of participants who returned to room air | Day 0, 3, 7, and 10 |
| Measure | Description | Time Frame |
|---|---|---|
| D-dimer | Change from baseline in D-dimer in the blood (mg/L) | Day 0, 3, 7, and Day 10 |
| Myoglobin | Clinical lab evaluation of level of Myoglobin in the blood (ng/mL) |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy, lactation and those who are not pregnant but do not take effective contraceptive measures, in women of childbearing age. Absence of pregnancy will be confirmed through urine pregnancy test.
Patients who have participated or are participating in a clinical trial of an experimental vaccine for SARS-CoV-2 or coronavirus during the study or within 30 days.
Inability to provide informed consent or to comply with study requirements.
Patients with the following concomitant or past medical history:
History or evidence of alcohol abuse.
History or evidence of consumption of illicit drugs.
Patients requiring mechanical ventilation.
Patients who are determined by the Principal Investigator to be unsuitable for study enrollment for other reasons.
Any medical disease or condition that, in the opinion of the site Principal Investigator or sub-investigator, precludes study participation. Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
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| Name | Affiliation | Role |
|---|---|---|
| Rajiv Thakur, MD | River Oaks Hospital and Clinics | Principal Investigator |
| Joseph Gathe, MD | United Memorial Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| River Oaks Hospital and Clinics | Houston | Texas | 77027 | United States | ||
| United Memorial Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38188343 | Derived | de Dios C, Vij R, Kim H, Park H, Chang D. Safety of multiple intravenous infusions of adipose-derived mesenchymal stem cells for hospitalized cases of COVID-19: a randomized controlled trial. Front Med (Lausanne). 2023 Dec 22;10:1321303. doi: 10.3389/fmed.2023.1321303. eCollection 2023. |
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A total of 59 subjects were assessed for screening, out of which only 48 were enrolled and 11 failed screening.
A total of 59 subjects were assessed for screening, out of which only 48 were enrolled and 11 failed screening. All 48 were randomized in to the two treatment arms: 100MM HB-adMSCs and placebo. 21 out of 48 randomized subjects discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | HB-adMSCs | Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10. HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells |
| FG001 | Placebo | Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10. Placebo: Saline |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Summary of baseline characteristics for all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | HB-adMSCs | Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10. HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells |
| BG001 | Placebo |
| 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 | Tumor Necrosis Factor-Alpha (TNF-alpha) | Change from baseline in Tumor Necrosis Factor-Alpha (TNF-alpha) in the blood (pg/mL) | Posted | Mean | Standard Deviation | pg/mL | Day 0, 3, 7, and 10 |
|
Screening through Day 28 (End of Study)
Out of 48 total subjects, 39 subjects had reported at least one adverse event (AE). A total of 119 AEs were recorded during the entire course of study, out of which 105 were mild in severity, 2 moderate, 1 severe, 1 life threatening, and 10 fatal (death). There were 12 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 | Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10. HB-adMSC: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiopulmonary Failure | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Body Aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ridhima Vij, PhD | Hope Biosciences Stem Cell 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 | Jun 15, 2020 | Jun 5, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2022 | Jun 5, 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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| Placebo |
| Other |
Saline |
|
| Day 0, 3 7, and 10 |
| Troponin | Clinical lab evaluation of level of Troponin in the blood (ng/mL) | Day 0, 3, 7, and 10 |
| Creatinine Kinase MB (CK-MB) | Clinical lab evaluation of level of Creatinine Kinase (CK-MB) in the blood (ng/mL) | Day 0, 3, 7, and 10 |
| Serum Ferritin | Clinical lab evaluation of level of Serum Ferritin in the blood (ng/mL) | Day 0, 3, 7, and 10 |
| NK Cell Surface Antigen (CD3-CD56+) | Clinical lab evaluation of Percentage of Cells CD3-CD56+ in the blood (%) | Day 0, 3, 7, and 10 |
| CD4+/CD8+ Ratio | Clinical lab evaluation of Ratio of CD4+/CD8+ Cells in the blood | Day 0, 3, 7, and 10 |
| 7-Point Ordinal Scale | Change from baseline in Ordinal scale score. Scale of 1-7. A score of 1 indicates Death and 7 indicates Subject is not Hospitalized and has no Limitations on activities. | Day 0, 3, 7, 10, and 28 (End of Study) |
| Computed Tomography (CT) Score | Change from baseline Computed Tomography (CT) Scan Score. A semi-quantitative CT severity scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, < 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, > 75% involvement. The resulting global CT score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better. | Day 0 and Day 28 |
| Chest X-Ray Score | Change from baseline in Chest X-Ray Score. Scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, < 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, > 75% involvement. The resulting score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better. | Day 0, Day 28 |
| Glucose | Clinical lab evaluation of level of Glucose in the blood (mg/dL) | Screening, Day 0, 3, 7, and 10 |
| Blood Urea Nitrogen (BUN) | Clinical lab evaluation of level of Blood Urea Nitrogen (BUN) (mg/dL) | Screening, Day 0, 3, 7, and 10 |
| Estimated Glomerular Filtration Rate (eGFR) if Non-African American | Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) if Non-African American in the blood (mL/min/1.73) | Screening, Day 0, 3, 7, and 10 |
| Estimated Glomerular Filtration Rate (eGFR) if African American | Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) If African American in the blood (mL/min/1.73) | Screening, Day 0, 3, 7, and 10 |
| BUN/Creatinine Ratio | Clinical lab evaluation of BUN/Creatinine Ratio in the blood | Screening, Day 0, 3, 7, and 10 |
| Sodium | Clinical lab evaluation of level of Sodium in the blood (mmol/L) | Screening, Day 0, 3, 7, and 10 |
| Potassium | Clinical lab evaluation of level of Potassium in the blood (mmol/L) | Screening, Day 0, 3, 7, and 10 |
| Chloride | Clinical lab evaluation of level of Chloride in the blood (mmol/L) | Screening, Day 0, 3, 7, and 10 |
| Carbon Dioxide Total | Clinical lab evaluation of total level of Carbon Dioxide in the blood (mmol/L) | Screening, Day 0, 3, 7, and 10 |
| Calcium | Clinical lab evaluation of level of Calcium in the blood (mg/dL) | Screening, Day 0, 3, 7, and 10 |
| Protein Total | Clinical lab evaluation of total level of Protein in the blood (g/dL) | Screening, Day 0, 3, 7, and 10 |
| Albumin | Clinical lab evaluation of level of Albumin in the blood (g/dL) | Screening, Day 0, 3, 7, and 10 |
| Globulin Total | Clinical lab evaluation of the total level of Globulin in the blood (g/dL) | Screening, Day 0, 3, 7, and 10 |
| Albumin/Globulin (A/G) Ratio | Clinical lab evaluation of Albumin/Globulin (A/G) Ratio in the blood | Screening, Day 0, 3, 7, and 10 |
| Bilirubin Total | Clinical lab evaluation of the total level of Bilirubin in the blood (mg/dL) | Screening, Day 0, 3, 7, and 10 |
| Alkaline Phosphatase | Clinical lab evaluation of level of Alkaline Phosphatase in the blood (IU/L) | Screening, Day 0, 3, 7, and 10 |
| Aspartate Aminotransferase (SGOT) | Clinical lab evaluation of level of Aspartate aminotransferase (SGOT) in the blood (IU/L) | Screening, Day 0, 3, 7, and 10 |
| Alanine Aminotransferase (SGPT) | Clinical lab evaluation of level of Alanine aminotransferase (SGPT) in the blood (IU/L) | Screening, Day 0, 3, 7, and 10 |
| White Blood Count (WBC) | Clinical lab evaluation of count of White Blood Cells (WBCs) in the blood (x10^3/uL) | Screening, Day 0, 3, 7, and 10 |
| Red Blood Cell (RBC) Count | Clinical lab evaluation of Red Blood Cell (RBC) Count in the blood (cells x 10^3/uL) | Screening, Day 0, 3, 7, and 10 |
| Hemoglobin | Clinical lab evaluation of level of Hemoglobin in the blood (g/dL) | Screening, Day 0, 3, 7, and 10 |
| Hematocrit | Clinical lab evaluation of level of Hematocrit in the blood (%) | Screening, Day 0, 3, 7, and 10 |
| Mean Corpuscular Volume (MCV) | Clinical lab evaluation of level of Mean Corpuscular Volume (MCV) in the blood (fL) | Screening, Day 0, 3, 7, and 10 |
| Mean Corpuscular Hemoglobin (MCH) | Clinical lab evaluation of level of Mean Corpuscular Hemoglobin (MCH) in the blood (pg) | Screening, Day 0, 3, 7, and 10 |
| Mean Corpuscular Hemoglobin Concentration (MCHC) | Clinical lab evaluation of Mean Corpuscular Hemoglobin Concentration (MCHC) in the blood (g/dL) | Screening, Day 0, 3, 7, and 10 |
| Red Cell Distribution Width (RDW) | Clinical lab evaluation of Red Cell Distribution Width (RDW) in the blood (%) | Screening, Day 0, 3, 7, and 10 |
| Platelets | Clinical lab evaluation of level of Platelets in the blood (cells x10^3/uL) | Screening, Day 0, 3, 7, and 10 |
| Neutrophils | Clinical lab evaluation of level of Neutrophils in the blood (%) | Screening, Day 0, 3, 7, and 10 |
| Lymphocytes | Clinical lab evaluation of level of Lymphocytes in the blood (%) | Screening, Day 0, 3, 7, and 10 |
| Monocytes | Clinical lab evaluation of level of Monocytes in the blood (%) | Screening, Day 0, 3, 7, and 10 |
| Eosinophils | Clinical lab evaluation of level of Eosinophils n the blood (%) | Screening, Day 0, 3, 7, and 10 |
| Basophils | Clinical lab evaluation of level of Basophils in the blood (%) | Screening, Day 0, 3, 7 and 10 |
| Absolute Neutrophils | Clinical lab evaluation of level of Absolute Neutrophils in the blood (cells x10^3/uL) | Screening, Day 0, 3, 7, and 10 |
| Absolute Lymphocytes | Clinical lab evaluation of level of Absolute Lymphocytes in the blood (cells x10^3/uL) | Screening, Day 0, 3, 7, and 10 |
| Absolute Monocytes | Clinical lab evaluation of level of Absolute Monocytes in the blood (cells x10^3/uL) | Screening, Day 0, 3, 7, and 10 |
| Absolute Eosinophils | Clinical lab evaluation of level of Absolute Eosinophils in the blood (cells x10^3/uL) | Screening, Day 0, 3, 7, and 10 |
| Absolute Basophils | Clinical lab evaluation of level of Absolute Basophils in the blood (cells x10^3/uL) | Screening, Day 0, 3, 7, and 10 |
| Immature Granulocytes | Clinical lab evaluation of level of Immature Granulocytes in the blood (%) | Screening, Day 0, 3, 7, and 10 |
| Absolute Immature Granulocytes | Clinical lab evaluation of level of Absolute Immature Granulocytes in the blood (cells x10^3/uL) | Screening, Day 0, 3, 7, and 10 |
| International Normalized Ratio (INR) | Clinical lab evaluation of International Normalized Ratio (INR) | Screening, Day 0, 3, 7, and 10 |
| Prothrombin Time (PT) | Clinical lab evaluation of Prothrombin Time (seconds) | Screening, Day 0, 3, 7, and 10 |
| Partial Thromboplastin Time (PTT) | Clinical lab evaluation of Partial Thromboplastin Time (PTT) (seconds) | Screening, Day 0, 3, 7, and 10 |
| Houston |
| Texas |
| 77091 |
| United States |
| FDA Clinical Hold |
|
| Discharge or Transfer to other Hospital |
|
| Adverse Event |
|
| Death |
|
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10. Placebo: Saline |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | lbs |
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| Height | Mean | Standard Deviation | in |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
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|
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| Primary | Interleukin-10 (IL-10) | Change from baseline level of Interleukin-10 (IL-10) in the blood (pg/mL) | Posted | Mean | Standard Deviation | pg/mL | Day 0, 3, 7, and 10 |
|
|
|
|
| Primary | Interleukin-6 (IL-6) | Change from baseline in Interleukin-6 (IL-6) in the blood (pg/mL) | Posted | Mean | Standard Deviation | pg/mL | Day 0, 3, 7, and 10 |
|
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|
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| Primary | C-Reactive Protein (CRP) | Change from baseline in C-Reactive Protein (CRP) in the blood (mg/L) | Posted | Mean | Standard Deviation | mg/L | Day 0, 3, 7, and 10 |
|
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| Primary | Oxygenation | Change from baseline Oxygenation (%) in the blood | Posted | Mean | Standard Deviation | % of Oxygen Saturation | Day 0, 3, 7, and 10 |
|
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| Primary | Return To Room Air (RTRA) | Number of participants who returned to room air | Posted | Count of Participants | Participants | Day 0, 3, 7, and 10 |
|
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|
|
| Secondary | D-dimer | Change from baseline in D-dimer in the blood (mg/L) | We had 24 participants in the treatment group and 9 in the placebo who had D-dimer values available. | Posted | Mean | Standard Deviation | mg/L | Day 0, 3, 7, and Day 10 |
|
|
|
| Secondary | Myoglobin | Clinical lab evaluation of level of Myoglobin in the blood (ng/mL) | In the treatment arm, maximum number analyzed was 3 at Day 3 and in Placebo group maximum number analyzed was 1 at Day 3 | Posted | Mean | Standard Deviation | ng/mL | Day 0, 3 7, and 10 |
|
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|
| Secondary | Troponin | Clinical lab evaluation of level of Troponin in the blood (ng/mL) | In the treatment arm, maximum number analyzed was 14 at Day 0 and in Placebo group maximum number analyzed was 5 at Day 0 | Posted | Mean | Standard Deviation | ng/mL | Day 0, 3, 7, and 10 |
|
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|
| Secondary | Creatinine Kinase MB (CK-MB) | Clinical lab evaluation of level of Creatinine Kinase (CK-MB) in the blood (ng/mL) | In the treatment arm, maximum number analyzed was 19 at Day 0 and in Placebo group maximum number analyzed was 8 at Day 0. | Posted | Mean | Standard Deviation | ng/mL | Day 0, 3, 7, and 10 |
|
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|
| Secondary | Serum Ferritin | Clinical lab evaluation of level of Serum Ferritin in the blood (ng/mL) | In the treatment arm, maximum number analyzed was 24 at Day 0 and in Placebo group maximum number analyzed was 7 at Day 0 | Posted | Mean | Standard Deviation | ng/mL | Day 0, 3, 7, and 10 |
|
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|
| Secondary | NK Cell Surface Antigen (CD3-CD56+) | Clinical lab evaluation of Percentage of Cells CD3-CD56+ in the blood (%) | In the treatment arm, maximum number analyzed was 6 at Day 0 and in Placebo group maximum number analyzed was 1 at Day 0 | Posted | Mean | Standard Deviation | % of Cells | Day 0, 3, 7, and 10 |
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| Secondary | CD4+/CD8+ Ratio | Clinical lab evaluation of Ratio of CD4+/CD8+ Cells in the blood | Posted | Mean | Standard Deviation | Ratio | Day 0, 3, 7, and 10 |
|
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|
| Secondary | 7-Point Ordinal Scale | Change from baseline in Ordinal scale score. Scale of 1-7. A score of 1 indicates Death and 7 indicates Subject is not Hospitalized and has no Limitations on activities. | Posted | Count of Participants | Participants | Day 0, 3, 7, 10, and 28 (End of Study) |
|
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|
|
| Secondary | Computed Tomography (CT) Score | Change from baseline Computed Tomography (CT) Scan Score. A semi-quantitative CT severity scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, < 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, > 75% involvement. The resulting global CT score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better. | Posted | Mean | Standard Deviation | Score on a Scale 0-25 | Day 0 and Day 28 |
|
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|
|
| Secondary | Chest X-Ray Score | Change from baseline in Chest X-Ray Score. Scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, < 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, > 75% involvement. The resulting score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better. | Posted | Mean | Standard Deviation | Score on a Scale 0-25 | Day 0, Day 28 |
|
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| Secondary | Glucose | Clinical lab evaluation of level of Glucose in the blood (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | Screening, Day 0, 3, 7, and 10 |
|
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| Secondary | Blood Urea Nitrogen (BUN) | Clinical lab evaluation of level of Blood Urea Nitrogen (BUN) (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | Screening, Day 0, 3, 7, and 10 |
|
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|
| Secondary | Estimated Glomerular Filtration Rate (eGFR) if Non-African American | Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) if Non-African American in the blood (mL/min/1.73) | Estimated glomerular filtration rate (eGFR) if Non-African American | Posted | Mean | Standard Deviation | mL/min/1.73 | Screening, Day 0, 3, 7, and 10 |
|
|
|
| Secondary | Estimated Glomerular Filtration Rate (eGFR) if African American | Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) If African American in the blood (mL/min/1.73) | In the treatment arm, maximum number analyzed was 7 at Day 0 and in Placebo group maximum number analyzed was 2 at Day 10 | Posted | Mean | Standard Deviation | mL/min/1.73 | Screening, Day 0, 3, 7, and 10 |
|
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| Secondary | BUN/Creatinine Ratio | Clinical lab evaluation of BUN/Creatinine Ratio in the blood | Posted | Mean | Standard Deviation | Ratio | Screening, Day 0, 3, 7, and 10 |
|
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| Secondary | Sodium | Clinical lab evaluation of level of Sodium in the blood (mmol/L) | Posted | Mean | Standard Deviation | mmol/L | Screening, Day 0, 3, 7, and 10 |
|
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| Secondary | Potassium | Clinical lab evaluation of level of Potassium in the blood (mmol/L) | Posted | Mean | Standard Deviation | mmol/L | Screening, Day 0, 3, 7, and 10 |
|
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| Secondary | Chloride | Clinical lab evaluation of level of Chloride in the blood (mmol/L) | Posted | Mean | Standard Deviation | mmol/L | Screening, Day 0, 3, 7, and 10 |
|
|
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| Secondary | Carbon Dioxide Total | Clinical lab evaluation of total level of Carbon Dioxide in the blood (mmol/L) | Posted | Mean | Standard Deviation | mmol/L | Screening, Day 0, 3, 7, and 10 |
|
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|
| Secondary | Calcium | Clinical lab evaluation of level of Calcium in the blood (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | Screening, Day 0, 3, 7, and 10 |
|
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| Secondary | Protein Total | Clinical lab evaluation of total level of Protein in the blood (g/dL) | Posted | Mean | Standard Deviation | g/dL | Screening, Day 0, 3, 7, and 10 |
|
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| Secondary | Albumin | Clinical lab evaluation of level of Albumin in the blood (g/dL) | Posted | Mean | Standard Deviation | g/dL | Screening, Day 0, 3, 7, and 10 |
|
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| Secondary | Globulin Total | Clinical lab evaluation of the total level of Globulin in the blood (g/dL) | Posted | Mean | Standard Deviation | g/dL | Screening, Day 0, 3, 7, and 10 |
|
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|
| Secondary | Albumin/Globulin (A/G) Ratio | Clinical lab evaluation of Albumin/Globulin (A/G) Ratio in the blood | In the treatment arm, maximum number analyzed was 14 (at Day 7) and in Placebo group maximum number analyzed was 8 at (Day 10). These were the largest N collected. | Posted | Mean | Standard Deviation | Ratio | Screening, Day 0, 3, 7, and 10 |
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| Secondary | Bilirubin Total | Clinical lab evaluation of the total level of Bilirubin in the blood (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | Screening, Day 0, 3, 7, and 10 |
|
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| Secondary | Alkaline Phosphatase | Clinical lab evaluation of level of Alkaline Phosphatase in the blood (IU/L) | Posted | Mean | Standard Deviation | IU/L | Screening, Day 0, 3, 7, and 10 |
|
|
|
| Secondary | Aspartate Aminotransferase (SGOT) | Clinical lab evaluation of level of Aspartate aminotransferase (SGOT) in the blood (IU/L) | Posted | Mean | Standard Deviation | IU/L | Screening, Day 0, 3, 7, and 10 |
|
|
|
| Secondary | Alanine Aminotransferase (SGPT) | Clinical lab evaluation of level of Alanine aminotransferase (SGPT) in the blood (IU/L) | Posted | Mean | Standard Deviation | IU/L | Screening, Day 0, 3, 7, and 10 |
|
|
|
| Secondary | White Blood Count (WBC) | Clinical lab evaluation of count of White Blood Cells (WBCs) in the blood (x10^3/uL) | Posted | Mean | Standard Deviation | cells x 10^3/uL | Screening, Day 0, 3, 7, and 10 |
|
|
|
| Secondary | Red Blood Cell (RBC) Count | Clinical lab evaluation of Red Blood Cell (RBC) Count in the blood (cells x 10^3/uL) | Posted | Mean | Standard Deviation | cells x 10^3/uL | Screening, Day 0, 3, 7, and 10 |
|
|
|
| Secondary | Hemoglobin | Clinical lab evaluation of level of Hemoglobin in the blood (g/dL) | Posted | Mean | Standard Deviation | g/dL | Screening, Day 0, 3, 7, and 10 |
|
|
|
| Secondary | Hematocrit | Clinical lab evaluation of level of Hematocrit in the blood (%) | Posted | Mean | Standard Deviation | % of RBCs | Screening, Day 0, 3, 7, and 10 |
|
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|
| Secondary | Mean Corpuscular Volume (MCV) | Clinical lab evaluation of level of Mean Corpuscular Volume (MCV) in the blood (fL) | Posted | Mean | Standard Deviation | fL | Screening, Day 0, 3, 7, and 10 |
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| Secondary | Mean Corpuscular Hemoglobin (MCH) | Clinical lab evaluation of level of Mean Corpuscular Hemoglobin (MCH) in the blood (pg) | Posted | Mean | Standard Deviation | pg | Screening, Day 0, 3, 7, and 10 |
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| Secondary | Mean Corpuscular Hemoglobin Concentration (MCHC) | Clinical lab evaluation of Mean Corpuscular Hemoglobin Concentration (MCHC) in the blood (g/dL) | Posted | Mean | Standard Deviation | g/dL | Screening, Day 0, 3, 7, and 10 |
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| Secondary | Red Cell Distribution Width (RDW) | Clinical lab evaluation of Red Cell Distribution Width (RDW) in the blood (%) | Posted | Mean | Standard Deviation | Red Cell Distribution Width % | Screening, Day 0, 3, 7, and 10 |
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| Secondary | Platelets | Clinical lab evaluation of level of Platelets in the blood (cells x10^3/uL) | Posted | Mean | Standard Deviation | cells x 10^3/uL | Screening, Day 0, 3, 7, and 10 |
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| Secondary | Neutrophils | Clinical lab evaluation of level of Neutrophils in the blood (%) | Posted | Mean | Standard Deviation | % of Neutrophils | Screening, Day 0, 3, 7, and 10 |
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| Secondary | Lymphocytes | Clinical lab evaluation of level of Lymphocytes in the blood (%) | Posted | Mean | Standard Deviation | Percentage of Lymphocytes (%) | Screening, Day 0, 3, 7, and 10 |
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| Secondary | Monocytes | Clinical lab evaluation of level of Monocytes in the blood (%) | Posted | Mean | Standard Deviation | % of Monocytes | Screening, Day 0, 3, 7, and 10 |
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| Secondary | Eosinophils | Clinical lab evaluation of level of Eosinophils n the blood (%) | Posted | Mean | Standard Deviation | % of Eosinophils | Screening, Day 0, 3, 7, and 10 |
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| Secondary | Basophils | Clinical lab evaluation of level of Basophils in the blood (%) | Posted | Mean | Standard Deviation | % of Basophils | Screening, Day 0, 3, 7 and 10 |
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|
|
| Secondary | Absolute Neutrophils | Clinical lab evaluation of level of Absolute Neutrophils in the blood (cells x10^3/uL) | In the treatment arm, maximum number analyzed was 21 at Day screening and in Placebo group maximum number analyzed was 10 at Screening. These were the largest N collected | Posted | Mean | Standard Deviation | cells x 10^3/uL | Screening, Day 0, 3, 7, and 10 |
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|
|
| Secondary | Absolute Lymphocytes | Clinical lab evaluation of level of Absolute Lymphocytes in the blood (cells x10^3/uL) | In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 11 at screening. These were the largest N collected for this outcome. | Posted | Mean | Standard Deviation | cells x10^3/uL | Screening, Day 0, 3, 7, and 10 |
|
|
|
| Secondary | Absolute Monocytes | Clinical lab evaluation of level of Absolute Monocytes in the blood (cells x10^3/uL) | In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 10 at screening.These were the largest N for which data for Absolute Monocytes was collected | Posted | Mean | Standard Deviation | cells x10^3/uL | Screening, Day 0, 3, 7, and 10 |
|
|
|
| Secondary | Absolute Eosinophils | Clinical lab evaluation of level of Absolute Eosinophils in the blood (cells x10^3/uL) | In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 10 at screening.These were the largest N for which data for Absolute Eosinophils was collected | Posted | Mean | Standard Deviation | cells x10^3/uL | Screening, Day 0, 3, 7, and 10 |
|
|
|
| Secondary | Absolute Basophils | Clinical lab evaluation of level of Absolute Basophils in the blood (cells x10^3/uL) | In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 10 at screening.These were the largest N for which data for Absolute Basophils was collected | Posted | Mean | Standard Deviation | cells x10^3/uL | Screening, Day 0, 3, 7, and 10 |
|
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|
| Secondary | Immature Granulocytes | Clinical lab evaluation of level of Immature Granulocytes in the blood (%) | In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 9 at screening. These were the largest N for which data for was collected for Immature granulocytes | Posted | Mean | Standard Deviation | % of Immature Granulocytes | Screening, Day 0, 3, 7, and 10 |
|
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|
| Secondary | Absolute Immature Granulocytes | Clinical lab evaluation of level of Absolute Immature Granulocytes in the blood (cells x10^3/uL) | In the treatment arm, maximum number analyzed was 21 at screening and in Placebo group maximum number analyzed was 9 at screening.These were the largest N for which data was collected for Absolute Immature Granulocytes | Posted | Mean | Standard Deviation | cells x10^3/uL | Screening, Day 0, 3, 7, and 10 |
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| Secondary | International Normalized Ratio (INR) | Clinical lab evaluation of International Normalized Ratio (INR) | Posted | Mean | Standard Deviation | Ratio | Screening, Day 0, 3, 7, and 10 |
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| Secondary | Prothrombin Time (PT) | Clinical lab evaluation of Prothrombin Time (seconds) | Posted | Mean | Standard Deviation | seconds | Screening, Day 0, 3, 7, and 10 |
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| Secondary | Partial Thromboplastin Time (PTT) | Clinical lab evaluation of Partial Thromboplastin Time (PTT) (seconds) | In the treatment arm, maximum number analyzed was 25 at screening and in Placebo group maximum number analyzed was11 at screening. These were the largest N for which data for was collected for Partial Thromboplastin time | Posted | Mean | Standard Deviation | seconds | Screening, Day 0, 3, 7, and 10 |
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|
| 8 |
| 33 |
| 9 |
| 33 |
| 27 |
| 33 |
| EG001 | Placebo | Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10. Placebo: Saline | 2 | 15 | 2 | 15 | 12 | 15 |
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Cardiac Arrhythmia | Cardiac disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Hyperthermia | Nervous system disorders | Non-systematic Assessment |
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| Fatigue | Nervous system disorders | Non-systematic Assessment |
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| Anxiety | Nervous system disorders | Non-systematic Assessment |
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| Hypertension | Cardiac disorders | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Chest Discomfort | Cardiac disorders | Non-systematic Assessment |
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| Chills | Nervous system disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vesicular Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Agitation | Nervous system disorders | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | Non-systematic Assessment |
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| Nausea | Nervous system disorders | Non-systematic Assessment |
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| Painful Respiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Pancreatitis | Endocrine disorders | Non-systematic Assessment |
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| Poor Venous Access | Vascular disorders | Non-systematic Assessment |
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| ESR Raised | Blood and lymphatic system disorders | Systematic Assessment |
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| Myofascial Neck Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Brain Natriuretic Peptide Increased | Nervous system disorders | Systematic Assessment |
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| Carbon Dioxide Abnormal | Blood and lymphatic system disorders | Systematic Assessment |
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| Hyperglycemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Urine Abnormality | Renal and urinary disorders | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Myocardial Necrosis Marker Increased | Cardiac disorders | Systematic Assessment |
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| Abnormal Blood Electrolytes | Blood and lymphatic system disorders | Systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Elevated WBC | Blood and lymphatic system disorders | Systematic Assessment |
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| Dry Throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Confusional State | Nervous system disorders | Non-systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
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| Feeling Abnormal | Nervous system disorders | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Kidney Failure | Renal and urinary disorders | Non-systematic Assessment |
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| Hypotension | Cardiac disorders | Non-systematic Assessment |
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| Puncture Site Bleeding | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Joint Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Day 7 |
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| 1: Not hospitalized, no limitations on activities - Day 7 |
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| 1: Not hospitalized, no limitations on activities - Day 10 |
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| 1: Not hospitalized, no limitations on activities - Day 28 (End of Study) |
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| 2: Not hospitalized, limitation on activities - Day 0 |
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| 2: Not hospitalized, limitation on activities - Day 3 |
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| 2: Not hospitalized, limitation on activities - Day 7 |
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| 2: Not hospitalized, limitation on activities - Day 10 |
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| 2: Not hospitalized, limitation on activities - Day 28 (End of Study) |
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| 3: Hospitalized, not requiring supplemental oxygen - Day 0 |
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| 3: Hospitalized, not requiring supplemental oxygen - Day 3 |
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| 3: Hospitalized, not requiring supplemental oxygen - Day 7 |
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| 3: Hospitalized, not requiring supplemental oxygen - Day 10 |
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| 3: Hospitalized, not requiring supplemental oxygen - Day 28 (End of Study) |
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| 4: Hospitalized, requiring supplemental oxygen - Day 0 |
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| 4: Hospitalized, requiring supplemental oxygen - Day 3 |
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| 4: Hospitalized, requiring supplemental oxygen - Day 7 |
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| 4: Hospitalized, requiring supplemental oxygen - Day 10 |
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| 4: Hospitalized, requiring supplemental oxygen - Day 28 (End of Study) |
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| 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 0 |
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| 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 3 |
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| 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 7 |
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| 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 10 |
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| 5: Hospitalized, on noninvasive ventilation or high flow oxygen devices - Day 28 (End of Study) |
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| 6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 0 |
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| 6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 3 |
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| 6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 7 |
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| 6: Hospitalized, on invasive mechanical ventilation or ECMO - Day 10 |
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| 6: Hospitalized, on invasive mechanical ventilation or - Day 28 (End of Study) |
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| 7: Death - Day 0 |
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| 7: Death - Day 3 |
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| 7: Death - Day 7 |
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| 7: Death - Day 10 |
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| 7: Death - Day 28 (End of Study) |
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