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The purpose of this study is to see if this plasma can be safely used in humans with COVID-19 and to see if it improves patients' health as compared to not using it in patients with pneumonia caused by SARS-CoV-2.
This open-label, randomized, controlled, phase 1 trial will assess the safety and efficacy of convalescent plasma in severely ill, hospitalized participants with pneumonia due to COVID-19. This study will enroll adults 18 years old and older, including pregnant women.
A total of 80 eligible participants will be randomized to receive either 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 and standard of care (treatment arm) or standard of care alone (control arm). Participants in the treatment arm will receive 2 units of convalescent plasma on Study Day 1 in addition to standard of care.
Participants will be assessed on study Day 1 (pre-dose), 30 minutes after each unit of plasma, on all Study Days while hospitalized, and Study Days 15, 22, 29, and 60. All participants will undergo a series of safety and efficacy, assessments. Blood samples will be collected on Days 1 (prior to plasma administration), 3, 8, 15, 29, and 60. Oropharyngeal or endotracheal samples will be collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, and 15.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 Convalescent plasma | Experimental | COVID-19 Convalescent plasma on Study Day 1 in addition to standard care |
|
| Standard care | No Intervention | Standard care alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Convalescent Plasma | Biological | 2 units of COVID-19 convalescent plasma compatible with their blood type |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Serious Adverse Events. | Number of participants with at least one serious adverse events (SAEs) up to Study Day 29. | Up to Study Day 29 |
| Clinical Severity Score | Clinical Severity Score (CSC) measured by both survival time, time to recovery (defined by reaching levels 1-3 of the WHO modified 8-Point Ordinal Severity scale), and disease course while hospitalized and is calculated based on a procedure proposed by Shaw and Fay 2016 (https://doi.org/10.1002/sim.6950). CSC ranges from 1 to 57. Higher CSC is worse outcome. Clinical status assessment (WHO modified 8-Point Ordinal Severity scale) includes:
| Up to Study Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Status Assessment, Time to Recovery | Time to recovery, defined by time needed to reach levels 1-3 using the WHO modified 8-Point Ordinal Severity scale assessed daily while hospitalized and on Day 15, 22, and 29:
|
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Inclusion Criteria:
Adult ≥18 years of age
Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other authorized or approved assay in any specimen collected within 72 hours prior to enrollment.
Note - An exception must be requested to the Sponsor if ≥72 hours since positive test.
Hospitalized in participating facility.
Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
Abnormal respiratory status that is judged worse than baseline by the investigator and as documented at any point within 24 hours prior to randomization, consistent with ordinal scale levels 5, 6 or 7, specifically defined as:
Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katharine J. Bar | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36351430 | Derived | Herman JD, Wang C, Burke JS, Zur Y, Compere H, Kang J, Macvicar R, Taylor S, Shin S, Frank I, Siegel D, Tebas P, Choi GH, Shaw PA, Yoon H, Pirofski LA, Julg BD, Bar KJ, Lauffenburger D, Alter G. Nucleocapsid-specific antibody function is associated with therapeutic benefits from COVID-19 convalescent plasma therapy. Cell Rep Med. 2022 Nov 15;3(11):100811. doi: 10.1016/j.xcrm.2022.100811. Epub 2022 Oct 24. | |
| 34788233 |
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| ID | Title | Description |
|---|---|---|
| FG000 | COVID-19 Convalescent Plasma | On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care |
| FG001 | Standard of Care | Standard of care treatment administered only |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One subject (Subject CCP2-043) in treatment plasma arm discontinued/withdrew from study immediately after enrollment before receipt of plasma and was excluded from analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | COVID-19 Convalescent Plasma | COVID-19 Convalescent plasma on Study Day 1 in addition to standard care COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Participants With Serious Adverse Events. | Number of participants with at least one serious adverse events (SAEs) up to Study Day 29. | Posted | Count of Participants | Participants | Up to Study Day 29 |
|
Up to Study Day 60
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
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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 | Treatment | On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute CNS Ischemia | Vascular disorders | DAIDS 2.1 | Non-systematic Assessment | Transient ischemic attack; cerebral vascular accident |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acidosis | Metabolism and nutrition disorders | DAIDS 2.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Lead | University of Pennsylvania | 512-662-4484 | psom-ind-ide@pobox.upenn.edu |
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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 | Aug 28, 2020 | Jan 10, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000093522 | COVID-19 Serotherapy |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
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Participants will be randomized 1:1 to receive either convalescent plasma on Study Day 1 in addition to standard care or standard care alone.
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| Up to Study Day 29 |
| National Early Warning Score (NEWS) Clinical Status Assessment | Time to discharge or to a National Early Warning Score (NEWS) of ≤ 2 and maintained for 24 hours, whichever occurs first. NEWS assessed daily while hospitalized until discharge or death and on Days 15 and 29. Higher NEWS is worse, range from 0 to 20. | Up to Study Day 29 |
| Oxygenation | Days of supplemental oxygen while in hospital. defined as days with WHO8 ordinal score of 5, 6, or 7 | Daily while hospitalized and up to Study Day 29 |
| Incidence of New Oxygenation Use up to Day 29 | Incidence of new oxygenation use up to Day 29. | From enrollment to Day 29. |
| Duration of New Oxygen Use up to Day 29 | Duration (days) of new oxygen use up to Day 29. | From enrollment to Day 29. |
| Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 | Days of non-invasive ventilation/high flow oxygen up to Day 29 Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices | Daily while in hospital to Study Day 29. |
| Number of Participants With at Least One Day on Non-invasive Ventilation/High Flow Oxygen up to Day 29 | number of participants with at least one day on non-invasive ventilation/high flow oxygen Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices | Daily while in hospital until Study Day 29 |
| Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29 | Days of non-invasive ventilation/high flow oxygen up to Day 29 | Daily while in hospital to Study Day 29. |
| Ventilator/ECMO Days to Day 29 | Days of mechanical ventilation or ECMO use (having a WHO8 ordinal score of 7 = Hospitalized, on invasive mechanical ventilation or ECMO) during the study in hospital until study day 29. | Daily while in hospital to Study Day 29 |
| New Mechanical Ventilation or ECMO Use | number of subjects with new mechanical ventilation or ECMO use up to Day 29 since all subjects were not on mechanical ventilation or ECMO at baseline. | From enrollment to Day 29. |
| Duration of New Mechanical Ventilation or ECMO | Days of new mechanical ventilation or ECMO use up to Day 29. | Daily while in hospital to Study Day 29 |
| Duration of Hospitalization | Duration (days) of first hospitalization. Time until death or discharge or Study Day 29 | To Study Day 29 |
| Mortality | 28 day mortality. | 28 days from Study Day 1 |
| Number of Subjects With SAEs Through Day 29 | Number of subjects with SAEs through Day 29. | Through Study Day 29 |
| Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29 | Number of subjects with at least one Grade 3 or Grade 4 clinical and/or laboratory adverse events (AEs) through Day 29. | Through Study Day 29 |
| Changes in WBC With Differential Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Through Day 29 |
| Changes in Hemoglobin Measurement Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Through Day 29 |
| Changes in Platelets Measurement Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Through Day 29. |
| Changes in Creatinine Measurement Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Through Day 29. |
| Changes in Glucose Measurement Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Through Day 29. |
| Changes in Total Bilirubin Measurement Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Through Day 29 |
| Changes in ALT Measurement Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Through Day 29 |
| Changes in AST Measurement Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Through Day 29. |
| Changes in PT Measurement Laboratory Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Through Day 29. |
| Derived |
| Bar KJ, Shaw PA, Choi GH, Aqui N, Fesnak A, Yang JB, Soto-Calderon H, Grajales L, Starr J, Andronov M, Mastellone M, Amonu C, Feret G, DeMarshall M, Buchanan M, Caturla M, Gordon J, Wanicur A, Monroy MA, Mampe F, Lindemuth E, Gouma S, Mullin AM, Barilla H, Pronina A, Irwin L, Thomas R, Eichinger RA, Demuth F, Luning Prak ET, Pascual JL, Short WR, Elovitz MA, Baron J, Meyer NJ, Degnan KO, Frank I, Hensley SE, Siegel DL, Tebas P. A randomized controlled study of convalescent plasma for individuals hospitalized with COVID-19 pneumonia. J Clin Invest. 2021 Dec 15;131(24):e155114. doi: 10.1172/JCI155114. |
| Lost to Follow-up |
|
Standard care alone
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Clinical Severity Score | Clinical Severity Score (CSC) measured by both survival time, time to recovery (defined by reaching levels 1-3 of the WHO modified 8-Point Ordinal Severity scale), and disease course while hospitalized and is calculated based on a procedure proposed by Shaw and Fay 2016 (https://doi.org/10.1002/sim.6950). CSC ranges from 1 to 57. Higher CSC is worse outcome. Clinical status assessment (WHO modified 8-Point Ordinal Severity scale) includes:
| Posted | Median | Inter-Quartile Range | scored on a scale (CSC) | Up to Study Day 29 |
|
|
|
| Secondary | Clinical Status Assessment, Time to Recovery | Time to recovery, defined by time needed to reach levels 1-3 using the WHO modified 8-Point Ordinal Severity scale assessed daily while hospitalized and on Day 15, 22, and 29:
| Population analyzed are only those who recovered. Remaining subjects either died or were still in hospital with WHO8 score > 3 by Study Day 29. | Posted | Median | Inter-Quartile Range | days | Up to Study Day 29 |
|
|
|
| Secondary | National Early Warning Score (NEWS) Clinical Status Assessment | Time to discharge or to a National Early Warning Score (NEWS) of ≤ 2 and maintained for 24 hours, whichever occurs first. NEWS assessed daily while hospitalized until discharge or death and on Days 15 and 29. Higher NEWS is worse, range from 0 to 20. | subjects who never reach National Early Warning Score (NEWS) of ≤ 2 or discharged by Study Day 29 have outcome measure of Infinity | Posted | Median | Inter-Quartile Range | days | Up to Study Day 29 |
|
|
|
| Secondary | Oxygenation | Days of supplemental oxygen while in hospital. defined as days with WHO8 ordinal score of 5, 6, or 7 | All subjects were evaluated. Subjects who never had a day with WHO8 ordinal score of 5, 6, or 7 have outcome measurement of 0 days. | Posted | Median | Inter-Quartile Range | days | Daily while hospitalized and up to Study Day 29 |
|
|
|
| Secondary | Incidence of New Oxygenation Use up to Day 29 | Incidence of new oxygenation use up to Day 29. | this endpoint was not measured due to redundancy | Posted | From enrollment to Day 29. |
|
|
| Secondary | Duration of New Oxygen Use up to Day 29 | Duration (days) of new oxygen use up to Day 29. | This was not measured due to redundancy of endpoints | Posted | From enrollment to Day 29. |
|
|
| Secondary | Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 | Days of non-invasive ventilation/high flow oxygen up to Day 29 Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices | All subjects were evaluated. Subjects who never had a day with WHO8 ordinal score of 6 have outcome measurement of 0 days. | Posted | Median | Inter-Quartile Range | days | Daily while in hospital to Study Day 29. |
|
|
|
| Secondary | Number of Participants With at Least One Day on Non-invasive Ventilation/High Flow Oxygen up to Day 29 | number of participants with at least one day on non-invasive ventilation/high flow oxygen Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices | Posted | Count of Participants | Participants | Daily while in hospital until Study Day 29 |
|
|
|
| Secondary | Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29 | Days of non-invasive ventilation/high flow oxygen up to Day 29 | not measured due to redundancy with other endpoints (#8) | Posted | Daily while in hospital to Study Day 29. |
|
|
| Secondary | Ventilator/ECMO Days to Day 29 | Days of mechanical ventilation or ECMO use (having a WHO8 ordinal score of 7 = Hospitalized, on invasive mechanical ventilation or ECMO) during the study in hospital until study day 29. | All subjects were evaluated. Subjects who never had a day with WHO8 ordinal score of 7 have outcome measurement of 0 days. | Posted | Median | Inter-Quartile Range | days | Daily while in hospital to Study Day 29 |
|
|
|
| Secondary | New Mechanical Ventilation or ECMO Use | number of subjects with new mechanical ventilation or ECMO use up to Day 29 since all subjects were not on mechanical ventilation or ECMO at baseline. | Posted | Count of Participants | Participants | From enrollment to Day 29. |
|
|
|
| Secondary | Duration of New Mechanical Ventilation or ECMO | Days of new mechanical ventilation or ECMO use up to Day 29. | only includes subjects with new mechanical ventilation or ECMO | Posted | Median | Inter-Quartile Range | days | Daily while in hospital to Study Day 29 |
|
|
|
| Secondary | Duration of Hospitalization | Duration (days) of first hospitalization. Time until death or discharge or Study Day 29 | Posted | Median | Inter-Quartile Range | days | To Study Day 29 |
|
|
|
| Secondary | Mortality | 28 day mortality. | Posted | Count of Participants | Participants | 28 days from Study Day 1 |
|
|
|
| Secondary | Number of Subjects With SAEs Through Day 29 | Number of subjects with SAEs through Day 29. | this endpoint is redundant with the primary endpoint | Posted | Through Study Day 29 |
|
|
| Secondary | Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29 | Number of subjects with at least one Grade 3 or Grade 4 clinical and/or laboratory adverse events (AEs) through Day 29. | Posted | Count of Participants | Participants | Through Study Day 29 |
|
|
|
| Secondary | Changes in WBC With Differential Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects. | Posted | Median | Inter-Quartile Range | THO/uL | Through Day 29 |
|
|
|
| Secondary | Changes in Hemoglobin Measurement Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects. | Posted | Median | Inter-Quartile Range | g/dL | Through Day 29 |
|
|
|
| Secondary | Changes in Platelets Measurement Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects. | Posted | Median | Inter-Quartile Range | 10^3 platelets per uL | Through Day 29. |
|
|
|
| Secondary | Changes in Creatinine Measurement Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects. | Posted | Median | Inter-Quartile Range | mg/dL | Through Day 29. |
|
|
|
| Secondary | Changes in Glucose Measurement Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects. | Posted | Median | Inter-Quartile Range | mg/dL | Through Day 29. |
|
|
|
| Secondary | Changes in Total Bilirubin Measurement Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects. Standard of care arm has analyzed sample size of 38 because one subject did not have total bilirubin lab collected | Posted | Median | Inter-Quartile Range | mg/dL | Through Day 29 |
|
|
|
| Secondary | Changes in ALT Measurement Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects. Standard of care arm has analyzed sample size of 38 because one subject did not have ALT lab collected | Posted | Median | Inter-Quartile Range | U/L | Through Day 29 |
|
|
|
| Secondary | Changes in AST Measurement Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects. Standard of care arm has analyzed sample size of 38 because one subject did not have AST lab collected | Posted | Median | Inter-Quartile Range | U/L | Through Day 29. |
|
|
|
| Secondary | Changes in PT Measurement Laboratory Through Day 29 | Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value. | Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects. Plasma arm analyzed sample size is 38 because 2 subjects did not have PT test collected. Standard of care arm analyzed sample size is 37 because 2 subjects did not have PT test collected. | Posted | Median | Inter-Quartile Range | seconds | Through Day 29. |
|
|
|
| 3 |
| 40 |
| 13 |
| 40 |
| 15 |
| 40 |
| EG001 | Control | Standard of care treatment administered only | 11 | 39 | 19 | 39 | 20 | 39 |
|
| Altered Mental Status | Nervous system disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Arrhythmia (by ECG or physical examination) | Cardiac disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Creatinine High | Investigations | DAIDS 2.1 | Non-systematic Assessment | Creatinine greater than 2x baseline |
|
| Glucose low | Endocrine disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Dyspnea or Respiratory Distress | Respiratory, thoracic and mediastinal disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Hemorrhage | Blood and lymphatic system disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Pain | General disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Embolism | Vascular disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Neurosensory alteration | Nervous system disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Thrombosis | Blood and lymphatic system disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Albumin, Low | Metabolism and nutrition disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Alkalosis | Metabolism and nutrition disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Altered Mental Status | Nervous system disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Arrhythmia (by ECG or physical examination) | Cardiac disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| AST, High | Investigations | DAIDS 2.1 | Non-systematic Assessment |
|
| Blood Pressure Abnormalities Hypertension (with the lowest reading taken after repeat testing durin | Vascular disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Creatinine, High | Investigations | DAIDS 2.1 | Non-systematic Assessment |
|
| Dyspnea or Respiratory Distress | Respiratory, thoracic and mediastinal disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Fever (non-axillary temperatures only) | General disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Gastrointestinal Bleeding | Gastrointestinal disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Glucose (mg/dL; mmol/L) Fasting, High | Metabolism and nutrition disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Hemoglobin, Low (g/dL; mmol/L) >= 13 years of age (female only) | Blood and lymphatic system disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Platelets, Decreased | Blood and lymphatic system disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Acute CNS Ischemia | Nervous system disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| ALT High | Investigations | DAIDS 2.1 | Non-systematic Assessment |
|
| Calcium, Low (mg/dL; mmol/L) >= 7 days of age | Investigations | DAIDS 2.1 | Non-systematic Assessment |
|
| Hemoglobin, Low (g/dL; mmol/L) >= 13 years of age (male only) | Blood and lymphatic system disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Pain (not associated with study agent injections and not specified elsewhere) | General disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Pruritus (without skin lesions) | Skin and subcutaneous tissue disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Thrombosis or Embolism Report only one | Blood and lymphatic system disorders | DAIDS 2.1 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |