Not provided
Not provided
Not provided
Not provided
Because of the decrease in COVID cases, enrollment is extremely low. Given the current study design, it is not possible to gather data necessary to answer the question about whether study treatment reduces mortality
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Ideal new treatments for Novel Coronavirus-19 (COVID-19) would help halt the progression disease in patients with mild disease prior to the need for artificial respiration (ventilators), and also provide a rescue treatment for patients with severe disease, while also being affordable and available in quantities sufficient to treat large numbers of infected people. Low doses of Naltrexone, a drug approved for treating alcoholism and opiate addiction, as well as Ketamine, a drug approved as an anesthetic, may be able to interrupt the inflammation that causes the worst COVID-19 symptoms and prove an effective new treatment. This study will investigate their effectiveness in a randomized, blinded trial versus standard treatment plus placebo.
There is an urgent need to develop new treatments for Novel Coronavirus-19 (COVID-19) infection using easily available and affordable medications. We need to develop a treatment protocol which prevents progression of the disease and a treatment protocol to rescue those with advanced disease. In addition to anti-viral therapeutics currently under investigation in other trials, the addition of immunomodulators to the treatment regimen appears have to potential to act as agents which can reduce the pathogenicity of this disease by reducing the dysregulation of autoimmunity which is destructive of normal tissue and when unchecked rapidly leads to mortality.
COVID-19 infection has three stages and 80% of infected people stay in stage 1 or stage 2A (viral response and early pulmonary effects), however 20% of patients progress to stage 2B (late pulmonary effects), and of those about 20% progress to stage 3 (hyper-inflammation). An ideal treatment for COVID-19 would have a two-pronged strategy: a treatment that would slow or interrupt the progression of the disease from mild/moderate (stage 1-2A) to severe (stage 2B-3), and a treatment to rescue patients who have become severe. Promising data using tocilizumab, an monoclonal antibody targeting the cytokine Interleukin-6 (IL-6), suggests that interrupting IL-6 is one of the potential pathways to accomplish this.
Low-dose naltrexone has been used off-label for treatment of pain and inflammation in multiple sclerosis, Crohn's disease, fibromyalgia and other pain conditions. Lower than standard doses of naltrexone inhibit cellular proliferation of T- and B- cells and block Toll-like receptor 4 (TLR4), providing pain relief and anti-inflammatory benefit. Naltrexone at doses below the normal therapeutic dose appears to reduce production of multiple cytokines including IL-6 in a steady pace and is available as an oral preparation. As such it is ideal to use to attempt to modify progression to stage 2B as it can easily be given to both hospitalized patients and patients in the community.
Ketamine at low doses, below the normal anesthetic dose, appears to rapidly reduce the production of pro-inflammatory cytokines, especially IL-6 and tumor necrosis factor alpha (TNFα), for hours after an event which would induce the inflammatory response. This drug is given intravenously (IV), either by drip or push, and is easily given in a hospital environment. This could not easily be used in the community but could act as a rescue drug with lower cost and easier availability than tocilizumab, a monoclonal antibody targeting IL-6. Ketamine has been extensively studied in a variety of settings and indications with a well-established side-effect and dosing profile. Ketamine is generally well tolerated and remains inexpensive and widely available on the U.S. market and available for immediate use.
The trial will measure the ability of low dose naltrexone to reduce the progression of participants with COVID-19. In this study, naltrexone or placebo will be given to participants in early stages of COVID-19 infection in a randomized, double blinded manner, whereas the use of ketamine will be unblinded and given as a rescue agent should a participant progress. Additionally, should a participant be ineligible for the randomized portion of the study due to already being in a more advanced stage of the disease, they will be given the opportunity to enter the trial to receive ketamine without being randomized to naltrexone vs placebo.
Participants will continue to receive any standard of care COVID-19 treatment during their participation in this study. Laboratory blood tests such as IL-6 concentration, blood counts, liver and renal function panels as well as close physician supervision will be used to monitor participant condition during hospitalization. Participants will be contacted 1 month post discharge to evaluate outcomes and potential side effects.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19 |
|
| Naltrexone | Experimental | Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19. |
|
| Ketamine | Experimental | Ketamine IV infusion (0.15 mg/kg based on total body weight for maximum 20 mg every 6 hours) for patients with stage 2B or stage 3 COVID-19; may be increased to 0.3 mg/kg based on total body weight for a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug | Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue.. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression of Oxygenation Needs | Count of participants initially presenting with mild/moderate disease who progress to requiring advanced oxygenation (high flow nasal canula, non-rebreather, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation) | up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Failure | Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew Sims, MD PhD | Beaumont Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19 Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm. |
| FG001 | Naltrexone | Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19. Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue.. |
| FG002 | Ketamine | Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well. Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation . Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19 Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm. |
| 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 | Progression of Oxygenation Needs | Count of participants initially presenting with mild/moderate disease who progress to requiring advanced oxygenation (high flow nasal canula, non-rebreather, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation) | Posted | Count of Participants | Participants | up to 1 month |
|
1 month
Systematic assessment of adverse events by review of medical records
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 | Placebo | Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19 Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE ANEMIA | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AGITATION | Psychiatric disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Sims, MD | William Beaumont Hospitals | 248 551-0027 | matthew.sims@beaumont.org |
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 | Sep 2, 2021 | Dec 15, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012128 | Respiratory Distress Syndrome |
| D045169 | Severe Acute Respiratory Syndrome |
| D018352 | Coronavirus Infections |
| D000080424 | Cytokine Release Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D009271 | Naltrexone |
| C000624616 | vivitrol |
| D007649 | Ketamine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
Not provided
Not provided
Prospective, single center, randomized, double blinded study of naltrexone with an open label extension using ketamine as a rescue drug for patients who progress in their disease
Not provided
Not provided
No other parties blinded
|
|
| Ketamine | Drug | Low dose ketamine hydrochloride given intravenously at a dosage of 0.15 mg/kg body weight for maximum 20 mg every 6 hours, to inpatient participants with advanced oxygenation requirements from either time of admission or time of progression of mild/moderate disease until time participant is stable for discharge, as a rescue treatment. If patient is transferred from the naltrexone or placebo arm, they will continue to receive naltrexone/placebo. Dosage of ketamine may be increased to 0.3 mg/kg body weight, maximum 30 mg every 6 hours, if participant does not respond at the lower dosage. Ketamine can be reduced back to 0.15 mg/kg at the clinical decision of the investigator and when patient has hypertensive emergency, the dose can be held until hypertensive emergency is controlled. |
|
|
| Placebo | Other | Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm. |
|
|
| up to 1 month |
| Liver Failure | Count of participants who develop or experience worsened liver failure as defined by serum transaminases five times normal limits | up to 1 month |
| Cytokine Storm | Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting) | up to 1 month |
| COVID Mortality | Count of participants who die from COVID-19 | up to 1 month post hospital discharge |
| Length of Hospital Stay | Length of hospital stay in days | up to 1 month |
| Intensive Care Unit (ICU) Admission | Count of patients admitted to the ICU at any time during index hospitalization | up to 1 month |
| Intensive Care Unit (ICU) Duration | Length of ICU stay in days | up to 1 month |
| Intubation | Count of participants requiring intubation | up to 1 month |
| Intubation Duration | Length of intubation, measured in days | up to 1 month |
| Time Until Recovery | Time measured in days from hospital admission to determination patient is stable for discharge | up to 1 month |
| BG001 | Naltrexone | Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19. Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue.. |
| BG002 | Ketamine | Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well. Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation . Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm. |
| BG003 | 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 |
|
| Region of Enrollment | Number | participants |
|
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19. Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue.. |
| OG002 | Ketamine | Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well. Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation . Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm. |
|
|
| Secondary | Renal Failure | Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported. | Missing data for 4 patients in Ketamine group | Posted | Count of Participants | Participants | up to 1 month |
|
|
|
| Secondary | Liver Failure | Count of participants who develop or experience worsened liver failure as defined by serum transaminases five times normal limits | Missing data for 4 patients in Ketamine group | Posted | Count of Participants | Participants | up to 1 month |
|
|
|
| Secondary | Cytokine Storm | Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting) | Missing data for 4 patients in Ketamine group | Posted | Count of Participants | Participants | up to 1 month |
|
|
|
| Secondary | COVID Mortality | Count of participants who die from COVID-19 | Posted | Count of Participants | Participants | up to 1 month post hospital discharge |
|
|
|
| Secondary | Length of Hospital Stay | Length of hospital stay in days | Admission data not collected for Placebo and Naltrexone patients. Missing discharge data for 5 patients in ketamine group. | Posted | Mean | Standard Deviation | days | up to 1 month |
|
|
|
| Secondary | Intensive Care Unit (ICU) Admission | Count of patients admitted to the ICU at any time during index hospitalization | Data not available for 1 patient in Naltrexone group and 5 patients in Ketamine group | Posted | Count of Participants | Participants | up to 1 month |
|
|
|
| Secondary | Intensive Care Unit (ICU) Duration | Length of ICU stay in days | Patient in naltrexone group admitted to ICU had length of stay=0 | Posted | Mean | Standard Deviation | days | up to 1 month |
|
|
|
| Secondary | Intubation | Count of participants requiring intubation | Posted | Count of Participants | Participants | up to 1 month |
|
|
|
| Secondary | Intubation Duration | Length of intubation, measured in days | No patients in Placebo group were intubated. For those intubated, data not available for 4 patients of 29 intubated in the Ketamine group | Posted | Mean | Standard Deviation | days | up to 1 month |
|
|
|
| Secondary | Time Until Recovery | Time measured in days from hospital admission to determination patient is stable for discharge | Patients not included who died during admission. Of 28 patients in ketamine group surviving to discharge, data missing for 5 patients. Of 8 patients in naltrexone group surviving to discharge, data missing for 1 patient. | Posted | Mean | Standard Deviation | days | up to 1 month |
|
|
|
| 0 |
| 9 |
| 4 |
| 9 |
| 9 |
| 9 |
| EG001 | Naltrexone | Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19. Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue.. | 1 | 9 | 9 | 9 | 7 | 9 |
| EG002 | Ketamine | Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well. Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation . Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm. | 24 | 52 | 52 | 52 | 52 | 52 |
| ACUTE CARDIAC ARREST DUE TO ARRYTHMIA | Cardiac disorders | Systematic Assessment |
|
| ACUTE CARDIOPULMONARY ARREST | Cardiac disorders | Systematic Assessment |
|
| ACUTE CEREBRAL EDEMA AND ACUTE ENCEPHALOPATHY RELATED TO SUBACUTE INFARCT | Nervous system disorders | Systematic Assessment |
|
| ACUTE RENAL FAILURE | Renal and urinary disorders | Systematic Assessment |
|
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| ANEMIA | Blood and lymphatic system disorders | Systematic Assessment |
|
| ANEMIA REQUIRING TRANSFUSION | Blood and lymphatic system disorders | Systematic Assessment |
|
| ASPIRATION PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| ASYSTOLE | Cardiac disorders | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
|
| HEMORRHAGE | Blood and lymphatic system disorders | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | Systematic Assessment |
|
| CARDIOGENIC SHOCK SECONDARY TO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE | Cardiac disorders | Systematic Assessment |
|
| CARDIOPULMONARY ARREST | Cardiac disorders | Systematic Assessment |
|
| CARDIOPULMONARY FAILURE | Cardiac disorders | Systematic Assessment |
|
| CRITICAL ILLNESS MYOPATHY | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | Systematic Assessment |
|
| PNEUMONIA, EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) E COLI | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | Systematic Assessment |
|
| GASTROINTESTINAL BLEED | Gastrointestinal disorders | Systematic Assessment |
|
| HEMATOMA | Vascular disorders | Systematic Assessment |
|
| HEMORRHAGIC SHOCK | Blood and lymphatic system disorders | Systematic Assessment |
|
| HYPERKALEMIA | Blood and lymphatic system disorders | Systematic Assessment |
|
| HYPOTENSION | Blood and lymphatic system disorders | Systematic Assessment |
|
| LABILE HYPOTENSION | Blood and lymphatic system disorders | Systematic Assessment |
|
| METHYCILLIN-RESISTANT STAPHLOCOCCUS AUREUS BACTEREMIA | Infections and infestations | Systematic Assessment |
|
| OLIGOURIA | Renal and urinary disorders | Systematic Assessment |
|
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PROGRESSION OF COVID-19 | Infections and infestations | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PULMONARY EDEMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| SEIZURE | Nervous system disorders | Systematic Assessment |
|
| SEPSIS | Infections and infestations | Systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | Systematic Assessment |
|
| SEPTIC SHOCK SECONDARY TO METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS | Infections and infestations | Systematic Assessment |
|
| SEVERE METABOLIC ENCEPHALOPATHY | Nervous system disorders | Systematic Assessment |
|
| SEVERE SEPSIS | Infections and infestations | Systematic Assessment |
|
| SHOCK | Blood and lymphatic system disorders | Systematic Assessment |
|
| SHORTNESS OF BREATH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| BACTEREMIA, STAPHLOCOCCUS EPIDERMIS | Blood and lymphatic system disorders | Systematic Assessment |
|
| TACHYCARDIS | Cardiac disorders | Systematic Assessment |
|
| TOXIC METABOLIC ENCEPHALOPATHY | Nervous system disorders | Systematic Assessment |
|
| TRACHEAL EDEMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| TREMOR | Nervous system disorders | Systematic Assessment |
|
| UNSTABLE ARRYTHMIA | Cardiac disorders | Systematic Assessment |
|
| ALTERED MENTAL STATUS | Psychiatric disorders | Systematic Assessment |
|
| ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE | Cardiac disorders | Systematic Assessment |
|
| BLEEDING | Blood and lymphatic system disorders | Systematic Assessment |
|
| CHEST PAIN | Cardiac disorders | Systematic Assessment |
|
| CRITICAL ILLNESS MYOPATHY | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| CYST, LOWER EXTREMITY | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| DECUBITUS ULCER | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | Systematic Assessment |
|
| ELEVATED HEART RATE/BLOOD PRESSURE | Cardiac disorders | Systematic Assessment |
|
| EMESIS, ONE EPISODE | Gastrointestinal disorders | Systematic Assessment |
|
| EMESIS, FIVE EPISODES | Gastrointestinal disorders | Systematic Assessment |
|
| EPITAXIS | Blood and lymphatic system disorders | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | Systematic Assessment |
|
| FEVER | General disorders | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | Systematic Assessment |
|
| HEMATURIA | Renal and urinary disorders | Systematic Assessment |
|
| HEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| HYPOTENSION | Cardiac disorders | Systematic Assessment |
|
| LETHARGY, INCREASED | General disorders | Systematic Assessment |
|
| MELENA | Gastrointestinal disorders | Systematic Assessment |
|
| PAIN, WRIST | Injury, poisoning and procedural complications | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| SHORTNESS OF BREATH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | Systematic Assessment |
|
| TREMOR | Nervous system disorders | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | Systematic Assessment |
|
| VENTRICULAR TACHYCARDIA | Cardiac disorders | Systematic Assessment |
|
| XEROSTOMIA | General disorders | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |