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Investigator decision
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| Name | Class |
|---|---|
| State University of New York - Downstate Medical Center | OTHER |
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Treatments for COVID-19 are urgently needed. Hydroxychloroquine (HCQ) is an antimalarial and immunomodulatory agent being repurposed for COVID-19 therapy based off in vitro data suggesting a possible antiviral effect. However, HCQ's effect on COVID-19 in human infection remains unknown. To fill this knowledge gap, we will enroll 626 adult patients hospitalized with laboratory-confirmed COVID-19 and randomize them 1:1 to a five-day course of HCQ or placebo. Notable exclusion criteria include ICU admission or ventilation on enrollment, prior therapy with HCQ, and baseline prolonged qTC. Our primary endpoint is a severe disease progression composite outcome (death, ICU admission, mechanical ventilation, ECMO, , and/or vasopressor requirement) at the 14-day post-treatment evaluation. Notable secondary clinical outcomes include 30-day mortality, hospital length of stay, noninvasive ventilator support, and cytokine release syndrome (CRS) grading scale. Secondary exploratory objectives will examine SARS-CoV-2 viral eradication at the EOT, changes in COVID-19 putative prognostic markers and cytokine levels, and titers of anti-SARS-CoV-2 antibodies. This randomized trial will determine if HCQ is effective as treatment in hospitalized non-ICU patients with COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine (HCQ) | Drug | HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With SAE Through Day 30 | The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100) | 30 days |
| Percent of Participants With Grade 3 or 4 AEs Through Day 30 | The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100) | 30 days |
| Percent of Participants With Discontinuation of Therapy (for Any Reason) | The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100) | 30 days |
| Percent of Participants Showing a Severe Disease Progression Composite Outcome | Including any of the following: mortality, ICU admission, invasive mechanical ventilation, ECMO, and/or hypotension requiring vasopressor support by the 14-day post-treatment evaluation (PTE). The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100). | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | LOS is defined as the interval (in days) that the patient was admitted to a non-rehabilitation floor, categorized as short (<7 days), moderate (7-10 days), or extended (>10 days) | 30 days |
| Days of Fever |
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Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Hospitalized adult (≥18 years old) with symptoms consistent with COVID-19 including but not limited to any of the following: fever (documented or subjective), cough, dyspnea, diarrhea, nausea, diffuse myalgias, and/or anosmia
Informed consent signed by patient
Positive SARS-CoV-2 RT-PCR testing (nasopharyngeal, oropharyngeal, sputum and/or bronchoalveolar lavage) o The testing may:
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Mulligan, MD, FIDSA | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of New York (SUNY) Downstate Medical Center | Brooklyn | New York | 11203 | United States | ||
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Requests should be directed to mark.mulligan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydroxychloroquine | Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5) |
| FG001 | Placebo | Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydroxychloroquine | Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5) |
| BG001 | Placebo | Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5 |
| 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 | Percent of Participants With SAE Through Day 30 | The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100) | Posted | Number | percentage of participants | 30 days |
|
30 days
Regular investigator assessment (monitoring for unsolicited adverse events days 1-5, recording of solicited adverse events at days 6, 14, and 30)
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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 | Hydroxychloroquine | Hydroxychloroquine (HCQ): HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Mulligan, MD | NYU Langone Health | (212) 263-5182 | Mark.mulligan@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2020 | Mar 31, 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 |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Placebo-controlled, Randomized
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Double-blind
| Placebo: Calcium citrate | Drug | Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5 |
|
Defined as number of days with temperature >100.4 degrees Fahrenheit.
| 14 days |
| Days of Non-invasive Ventilator Use | Defined as days the patient is placed on non-invasive ventilator support (CPAP or BiPAP), excluding routine CPAP use for sleep apnea. | 14 days |
| Days of Non-rebreather Mask Oxygen Supplementation | Defined as the number of days the subject was on a non-rebreather mask. | 14 days |
| Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale | Grade 1 (mild) = able to be managed with nonparenteral supportive care, Grade 2 (moderate) = at least one of the following present (hospitalization needed for management of CRS-related symptoms, parenteral nutrition or supportive care required, signs of moderate/severe organ dysfunction), Grade 3 (severe) = hospitalization needed for management of at least one of the following (hypotension, hypoxia, organ dysfunction, coagulopathy), Grade 4 (life-threatening) = at least one of the following present (hypotension requiring high-dose vasopressors, hypoxia requiring mechanical ventilation). | Day 1 |
| Percent of Subjects With Q-T Interval, Corrected (qTC) Prolongation at End of Treatment (EOT) | (≥470 milliseconds in men; ≥480 milliseconds in women) on electrocardiogram at EOT (Day 6) | 6 Days |
| Percent of Patients Who Resulted in Mortality | Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100). | 30 days |
| Percent of Participants Who Required ICU Admission | Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100). | 30 Days |
| Percent of Participants Who Required Invasive Mechanical Ventilation | Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100). | 30 Days |
| Percent of Participants Who Required Extracorporeal Membrane Oxygenation (ECMO) | Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100). | 30 Days |
| Percent of Participants With Hypotension Requiring Vasopressor Support | Individual component of severe disease progression composite endpoint evaluated. For incidence, the measure value is reported as a percentage (# of patients with outcome/ # of patients * 100) | 30 Days |
| Percent of Participants With SARS-CoV-2 Viral Eradication From Nasopharyngeal Specimens at EOT | Laboratory endpoint, measured by RT-PCR, reported as the percentage of negative results at day 6 | 6 days |
| Change in Alanine Aminotransferase (ALT) Levels | Biochemistry lab-work will be completed to obtain ALT levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Baseline, 6 days |
| Change in Aspartate Aminotransferase (AST) Levels | Biochemistry lab-work will be completed to obtain AST levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Baseline, 6 days |
| Change in Creatinine Levels | Biochemistry lab-work will be completed to obtain Creatinine levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Baseline, 6 days |
| Change in Glucose Levels | Biochemistry lab-work will be completed to obtain Glucose levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Baseline, 6 days |
| Change in White Blood Cell (WBC) Count | Hematology lab-work will be completed to obtain WBC count (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Baseline, 6 days |
| Change in Hemoglobin Levels | Hematology lab-work will be completed to obtain hemoglobin levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Baseline, 6 days |
| Change in Platelet Count | Hematology lab-work will be completed to obtain platelet count (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Baseline, 6 days |
| Change in Total Bilirubin Levels | Biochemistry lab-work will be completed to obtain bilirubin levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Baseline, 6 days |
| Change in Lactate Dehydrogenase (LDH) Levels | Biochemistry lab-work will be completed to obtain LDH levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Baseline, 6 days |
| Change in C-Reactive Protein (CRP) Levels | Biochemistry lab-work will be completed to obtain CRP levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Baseline, 6 days |
| Change in Interleukin 6 (IL-6) Levels | Biochemistry lab-work will be completed to obtain IL-6 levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Baseline, 6 days |
| NYU Langone Health |
| New York |
| New York |
| 10016 |
| United States |
| 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 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Percent of Participants With Grade 3 or 4 AEs Through Day 30 | The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100) | Posted | Number | percentage of participants | 30 days |
|
|
|
| Primary | Percent of Participants With Discontinuation of Therapy (for Any Reason) | The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100) | Posted | Number | percentage of participants | 30 days |
|
|
|
| Primary | Percent of Participants Showing a Severe Disease Progression Composite Outcome | Including any of the following: mortality, ICU admission, invasive mechanical ventilation, ECMO, and/or hypotension requiring vasopressor support by the 14-day post-treatment evaluation (PTE). The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100). | Posted | Number | percentage of participants | 14 days |
|
|
|
| Secondary | Hospital Length of Stay | LOS is defined as the interval (in days) that the patient was admitted to a non-rehabilitation floor, categorized as short (<7 days), moderate (7-10 days), or extended (>10 days) | Posted | Mean | Standard Deviation | days | 30 days |
|
|
|
| Secondary | Days of Fever | Defined as number of days with temperature >100.4 degrees Fahrenheit. | Posted | Median | Full Range | days | 14 days |
|
|
|
| Secondary | Days of Non-invasive Ventilator Use | Defined as days the patient is placed on non-invasive ventilator support (CPAP or BiPAP), excluding routine CPAP use for sleep apnea. | Posted | Median | Full Range | days | 14 days |
|
|
|
| Secondary | Days of Non-rebreather Mask Oxygen Supplementation | Defined as the number of days the subject was on a non-rebreather mask. | Posted | Median | Full Range | days | 14 days |
|
|
|
| Secondary | Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale | Grade 1 (mild) = able to be managed with nonparenteral supportive care, Grade 2 (moderate) = at least one of the following present (hospitalization needed for management of CRS-related symptoms, parenteral nutrition or supportive care required, signs of moderate/severe organ dysfunction), Grade 3 (severe) = hospitalization needed for management of at least one of the following (hypotension, hypoxia, organ dysfunction, coagulopathy), Grade 4 (life-threatening) = at least one of the following present (hypotension requiring high-dose vasopressors, hypoxia requiring mechanical ventilation). | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Percent of Subjects With Q-T Interval, Corrected (qTC) Prolongation at End of Treatment (EOT) | (≥470 milliseconds in men; ≥480 milliseconds in women) on electrocardiogram at EOT (Day 6) | Posted | Number | percentage of participants | 6 Days |
|
|
|
| Secondary | Percent of Patients Who Resulted in Mortality | Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100). | Posted | Number | percentage of participants | 30 days |
|
|
|
| Secondary | Percent of Participants Who Required ICU Admission | Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100). | Posted | Number | percentage of participants | 30 Days |
|
|
|
| Secondary | Percent of Participants Who Required Invasive Mechanical Ventilation | Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100). | Posted | Number | percentage of participants | 30 Days |
|
|
|
| Secondary | Percent of Participants Who Required Extracorporeal Membrane Oxygenation (ECMO) | Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100). | Posted | Number | percentage of participants | 30 Days |
|
|
|
| Secondary | Percent of Participants With Hypotension Requiring Vasopressor Support | Individual component of severe disease progression composite endpoint evaluated. For incidence, the measure value is reported as a percentage (# of patients with outcome/ # of patients * 100) | Posted | Number | percentage of participants | 30 Days |
|
|
|
| Secondary | Percent of Participants With SARS-CoV-2 Viral Eradication From Nasopharyngeal Specimens at EOT | Laboratory endpoint, measured by RT-PCR, reported as the percentage of negative results at day 6 | Posted | Number | percentage of participants | 6 days |
|
|
|
| Secondary | Change in Alanine Aminotransferase (ALT) Levels | Biochemistry lab-work will be completed to obtain ALT levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Posted | Mean | Standard Deviation | U/L | Baseline, 6 days |
|
|
|
| Secondary | Change in Aspartate Aminotransferase (AST) Levels | Biochemistry lab-work will be completed to obtain AST levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Posted | Mean | Standard Deviation | U/L | Baseline, 6 days |
|
|
|
| Secondary | Change in Creatinine Levels | Biochemistry lab-work will be completed to obtain Creatinine levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Posted | Mean | Standard Deviation | mg/dL | Baseline, 6 days |
|
|
|
| Secondary | Change in Glucose Levels | Biochemistry lab-work will be completed to obtain Glucose levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Posted | Mean | Standard Deviation | mg/dL | Baseline, 6 days |
|
|
|
| Secondary | Change in White Blood Cell (WBC) Count | Hematology lab-work will be completed to obtain WBC count (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Posted | Mean | Standard Deviation | cells per 10^6 L | Baseline, 6 days |
|
|
|
| Secondary | Change in Hemoglobin Levels | Hematology lab-work will be completed to obtain hemoglobin levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Posted | Mean | Standard Deviation | gm/dL | Baseline, 6 days |
|
|
|
| Secondary | Change in Platelet Count | Hematology lab-work will be completed to obtain platelet count (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Posted | Mean | Standard Deviation | platelets per 10^6 L | Baseline, 6 days |
|
|
|
| Secondary | Change in Total Bilirubin Levels | Biochemistry lab-work will be completed to obtain bilirubin levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Posted | Mean | Standard Deviation | mg/dL | Baseline, 6 days |
|
|
|
| Secondary | Change in Lactate Dehydrogenase (LDH) Levels | Biochemistry lab-work will be completed to obtain LDH levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Posted | Mean | Standard Deviation | U/L | Baseline, 6 days |
|
|
|
| Secondary | Change in C-Reactive Protein (CRP) Levels | Biochemistry lab-work will be completed to obtain CRP levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Posted | Mean | Standard Deviation | mg/L | Baseline, 6 days |
|
|
|
| Secondary | Change in Interleukin 6 (IL-6) Levels | Biochemistry lab-work will be completed to obtain IL-6 levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available). | Posted | Mean | Standard Deviation | pg/ml | Baseline, 6 days |
|
|
|
| 7 |
| 67 |
| 10 |
| 67 |
| 32 |
| 67 |
| EG001 | Placebo | Placebo: Calcium citrate: Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5 | 6 | 61 | 10 | 61 | 30 | 61 |
| Alcohol withdrawal syndrome | General disorders | Systematic Assessment |
|
| Cerebral hemorrhage | Nervous system disorders | Systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | Systematic Assessment |
|
| Electrocardiogram QTc interval prolonged | Cardiac disorders | Systematic Assessment |
|
| Hospice care | General disorders | Systematic Assessment |
|
| Hospital acquired hyponatremia | Infections and infestations | Systematic Assessment |
|
| Hospitalization | General disorders | Systematic Assessment |
|
| Hyperkalemia | General disorders | Systematic Assessment |
|
| Intra-abdominal abscess | Infections and infestations | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary embolus | Blood and lymphatic system disorders | Systematic Assessment |
|
| stroke | Nervous system disorders | Systematic Assessment |
|
| Subdural hematoma | Nervous system disorders | Systematic Assessment |
|
| Subdural hemorrhage | Nervous system disorders | Systematic Assessment |
|
| Syncope | General disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Bleeding vaginal | Reproductive system and breast disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Deliria (incl confusion) | General disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Diabetes mellitus (incl subtypes) | Endocrine disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry mouth | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| DVT | Blood and lymphatic system disorders | Systematic Assessment |
|
| Electrocardiogram QTc interval prolonged | Cardiac disorders | Systematic Assessment |
|
| Electrolytes NOS abnormal | General disorders | Systematic Assessment |
|
| Elevated liver enzyme levels | Hepatobiliary disorders | Systematic Assessment |
|
| Epistaxis | General disorders | Systematic Assessment |
|
| Fall | General disorders | Systematic Assessment |
|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hematoma | General disorders | Systematic Assessment |
|
| Hives | Immune system disorders | Systematic Assessment |
|
| Hyperkalemia | General disorders | Systematic Assessment |
|
| Hypokalemia | General disorders | Systematic Assessment |
|
| Hypomagnesemia | General disorders | Systematic Assessment |
|
| Hyponatremia | General disorders | Systematic Assessment |
|
| Hypotension | General disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Increased shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Injection site pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nausea and/or vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Non-sustained ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Staphylococcal pneumonia | Infections and infestations | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Syncope | General disorders | Systematic Assessment |
|
| Vaginal yeast infection | Infections and infestations | 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 |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Severe |
|