Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 can improve patients' health when they are sick with COVID-19.
This open-label, single arm, phase 1 trial will assess the safety and efficacy of convalescent plasma in severely ill, mechanically ventilated participants with pneumonia due to COVID-19. This study will enroll adults 18 years old and older, including pregnant women. A total of 50 eligible participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19. Participants will receive convalescent plasma on Study Day 1 in addition to standard of care. Participants will be assessed daily while hospitalized and then on Study Days 15, 22, 29, and 60. All participants will undergo a series of safety, efficacy, and laboratory assessments. Blood samples will be collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, 15, 29, and 60. Oropharyngeal or endotracheal samples will be collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, and 15.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Penn COVID-19 convalescent plasma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Convalescent Plasma | Biological | Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Serious Adverse Events. | Cumulative incidence of participants with at least one serious adverse events (SAEs) at Study Day 29. | Up to Study Day 29 |
| Time to Clinical Improvement. | Time to removal from mechanical ventilation. | Up to Study Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Status Assessment, Using 8-point Ordinal Scale, of Convalescent Plasma Administration | Time to improvement by at least 2 category from Day 1 (time to reach WHO8 <=5). WHO8 score:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katharine J. Bar, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19. |
| 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. | Cumulative incidence of participants with at least one serious adverse events (SAEs) at Study Day 29. | Posted | Count of Participants | Participants | Up to Study Day 29 |
|
|
Up to 65 days after receiving investigational product
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute CNS Ischemia | Nervous system disorders | DAIDS 2.1 | Non-systematic Assessment | Cerebral vascular accident (e.g., stroke with neurological deficit) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acidosis | Metabolism and nutrition disorders | DAIDS 2.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Lead | University of Pennsylvania | 512-662-4484 | psom-ind-ide@pobox.upenn.edu |
Not provided
| 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 | Mar 10, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093522 | COVID-19 Serotherapy |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to Study Day 29 |
| Clinical Status Assessment Using the National Early Warning Score (NEWS) of Convalescent Plasma Administration | Time to discharge or to a 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 |
| Incidence of New Oxygenation Use up to Day 29 of Convalescent Plasma Administration | Incidence of new oxygenation use up to Day 29. | From enrollment to Day 29. |
| Duration of New Oxygen Use up to Day 29 of Convalescent Plasma Administration | Days of new oxygen use up to Day 29. | From enrollment to Day 29. |
| Oxygenation | Days of supplemental oxygen while in hospital up to Study Day 29. In hospital supplemental oxygen days counted as days with a WHO8 ordinal score of 5, 6, or 7. | Daily while hospitalized up to Study Day 29. |
| Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 of Convalescent Plasma Administration. | Days of non-invasive ventilation/high flow oxygen while in hospital up to Day 29, defined as having WHO8 ordinal score of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices | Daily while in hospital to Study Day 29. |
| Number of Subjects With at Least One Day of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration. | Number of subjects with at least one day of non-invasive ventilation (WHO8 ordinal score of 6) while in hospital | Daily while in hospital to Study Day 29. |
| Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration. | Days of non-invasive ventilation/high flow oxygen up to Day 29. | Daily while in hospital to Study Day 29. |
| Invasive Ventilation/ Extracorporeal Membrane Oxygenation(ECMO) Days | Days on Invasive Ventilator/ECMO defined as WHO8 ordinal score of 7 = Hospitalized, on invasive mechanical ventilation or ECMO | Daily while in hospital to Study Day 29 |
| Incidence of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration. | Incidence of new mechanical ventilation or ECMO use up to Day 29. | From enrollment to Day 29. |
| Duration of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration. | Days of new mechanical ventilation or ECMO use up to Day 29. | From enrollment to 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 |
| Serious Adverse Events (SAEs) Through Day 29 of Convalescent Plasma Administration. | subjects with Serious Adverse Events (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 of Convalescent Plasma Administration. | Number of subjects with at least one Grade 3 or Grade 4 clinical and/or laboratory adverse events through Day 29. | Through Study Day 29 |
| Changes in WBC With Differential Through Day 29 of Convalescent Plasma Administration. | 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 of Convalescent Plasma Administration. | 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 of Convalescent Plasma Administration. | 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 of Convalescent Plasma Administration. | 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 of Convalescent Plasma Administration. | 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 of Convalescent Plasma Administration. | 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 of Convalescent Plasma Administration. | 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 of Convalescent Plasma Administration. | 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 Through Day 29 of Convalescent Plasma Administration. | 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 |
| 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 |
|
|
| Primary | Time to Clinical Improvement. | Time to removal from mechanical ventilation. | excludes those without improvement (were still on mechanical ventilation or died before removal of invasive mechanical ventilation/ECMO) | Posted | Median | Inter-Quartile Range | Days | Up to Study Day 29 |
|
|
|
| Secondary | Clinical Status Assessment, Using 8-point Ordinal Scale, of Convalescent Plasma Administration | Time to improvement by at least 2 category from Day 1 (time to reach WHO8 <=5). WHO8 score:
| excludes those without improvement (WHO8 score of 6,7,or 8) | Posted | Median | Inter-Quartile Range | days | Up to Study Day 29 |
|
|
|
| Secondary | Clinical Status Assessment Using the National Early Warning Score (NEWS) of Convalescent Plasma Administration | Time to discharge or to a 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. | excludes 20 subjects who have outcome measure of Infinity as they were never discharged or never had NEWS <=2 while in hospital by Study Day 29 | Posted | Median | Inter-Quartile Range | days | Up to Study Day 29 |
|
|
|
| Secondary | Incidence of New Oxygenation Use up to Day 29 of Convalescent Plasma Administration | 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 of Convalescent Plasma Administration | Days of new oxygen use up to Day 29. | this endpoint was not measured due to redundancy | Posted | From enrollment to Day 29. |
|
|
| Secondary | Oxygenation | Days of supplemental oxygen while in hospital up to Study Day 29. In hospital supplemental oxygen days counted as days with a WHO8 ordinal score of 5, 6, or 7. | All 32 enrolled subjects were evaluated for days of oxygenation. | Posted | Median | Inter-Quartile Range | days | Daily while hospitalized up to Study Day 29. |
|
|
|
| Secondary | Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 of Convalescent Plasma Administration. | Days of non-invasive ventilation/high flow oxygen while in hospital up to Day 29, defined as having WHO8 ordinal score of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices | All 32 enrolled subjects were evaluated. Subjects who never had a WHO8 ordinal score of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices have a measured outcome of 0 days. | Posted | Median | Inter-Quartile Range | days | Daily while in hospital to Study Day 29. |
|
|
|
| Secondary | Number of Subjects With at Least One Day of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration. | Number of subjects with at least one day of non-invasive ventilation (WHO8 ordinal score of 6) while in hospital | Posted | Count of Participants | Participants | Daily while in hospital to Study Day 29. |
|
|
|
| Secondary | Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration. | Days of non-invasive ventilation/high flow oxygen up to Day 29. | this endpoint was not measured due to redundancy with other endpoints (#8) | Posted | Daily while in hospital to Study Day 29. |
|
|
| Secondary | Invasive Ventilation/ Extracorporeal Membrane Oxygenation(ECMO) Days | Days on Invasive Ventilator/ECMO defined as WHO8 ordinal score of 7 = Hospitalized, on invasive mechanical ventilation or ECMO | Posted | Median | Inter-Quartile Range | days | Daily while in hospital to Study Day 29 |
|
|
|
| Secondary | Incidence of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration. | Incidence of new mechanical ventilation or ECMO use up to Day 29. | Endpoint was not well defined as all subjects started on mechanical ventilation | Posted | From enrollment to Day 29. |
|
|
| Secondary | Duration of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration. | Days of new mechanical ventilation or ECMO use up to Day 29. | Endpoint was not well defined as all subjects started on mechanical ventilation | Posted | From enrollment to 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 | Serious Adverse Events (SAEs) Through Day 29 of Convalescent Plasma Administration. | subjects with Serious Adverse Events (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 of Convalescent Plasma Administration. | Number of subjects with at least one Grade 3 or Grade 4 clinical and/or laboratory adverse events through Day 29. | Posted | Count of Participants | Participants | Through Study Day 29 |
|
|
|
| Secondary | Changes in WBC With Differential Through Day 29 of Convalescent Plasma Administration. | 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 of Convalescent Plasma Administration. | 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 of Convalescent Plasma Administration. | 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 of Convalescent Plasma Administration. | 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 of Convalescent Plasma Administration. | 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 of Convalescent Plasma Administration. | 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 ALT Measurement Through Day 29 of Convalescent Plasma Administration. | 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 | U/L | Through Day 29. |
|
|
|
| Secondary | Changes in AST Measurement Through Day 29 of Convalescent Plasma Administration. | 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 | U/L | Through Day 29 |
|
|
|
| Secondary | Changes in PT Measurement Through Day 29 of Convalescent Plasma Administration. | 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. analyzed sample size is 30 because 2 subjects did not have PT lab collected. | Posted | Median | Inter-Quartile Range | seconds | Through Day 29 |
|
|
|
| 14 |
| 32 |
| 23 |
| 32 |
| 32 |
| 32 |
|
| Acidosis | Metabolism and nutrition disorders | DAIDS 2.1 | Non-systematic Assessment | Laboratory Value: Chemistries |
|
| Arrhythmia (by ECG or physical examination) | Cardiac disorders | DAIDS 2.1 | Non-systematic Assessment | Life-threatening arrhythmia OR Urgent intervention indicated |
|
| Creatinine Clearance Low | Renal and urinary disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Dyspnea or Respiratory Distress | Respiratory, thoracic and mediastinal disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Hemorrhage (with significant acute blood loss) | Vascular disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Embolism | Vascular disorders | DAIDS 2.1 | Non-systematic Assessment | Life-threatening embolic event (e.g., pulmonary embolism, thrombus) |
|
| Altered mental status | Psychiatric 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 |
|
| ALT, High | Investigations | DAIDS 2.1 | Non-systematic Assessment |
|
| Altered Mental Status | Nervous system disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Arrhythmia | 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 |
|
| Calcium, Low | Metabolism and nutrition disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Creatinine, High | Investigations | DAIDS 2.1 | Non-systematic Assessment |
|
| Fever (non-axillary temperatures only) | General 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 |
|
| Lactate, High | Investigations | DAIDS 2.1 | Non-systematic Assessment |
|
| Platelets, Decreased | Blood and lymphatic system disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Sodium, High | Metabolism and nutrition disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Thrombosis or Embolism | Vascular disorders | DAIDS 2.1 | Non-systematic Assessment |
|
| Hemorrhage (with significant acute blood loss) | Blood and lymphatic system disorders | 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 |
|
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 |