Name (Synonyms) | Correlation | |
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drug934 | blood sample Wiki | 0.44 |
drug718 | SARS-CoV-2 viral composition Wiki | 0.38 |
drug810 | T-cell receptor (TCR) repertoire Wiki | 0.38 |
drug4 | 0.9% sodium chloride (normal saline) Wiki | 0.38 |
drug909 | Whole Genome Analysis Wiki | 0.38 |
drug790 | Stannous protoporphyrin (90mg) Wiki | 0.38 |
drug94 | BIOVITALS Wiki | 0.38 |
drug597 | PUL-042 Inhalation Solution Wiki | 0.27 |
drug507 | Methylprednisolone Wiki | 0.13 |
drug854 | Tocilizumab Wiki | 0.09 |
drug616 | Placebo Wiki | 0.04 |
Name (Synonyms) | Correlation | |
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D007239 | Infection NIH | 0.03 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.03 |
D018352 | Coronavirus Infections NIH | 0.02 |
Name (Synonyms) | Correlation |
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There are 7 clinical trials
Subjects who have documented exposure to SARS-CoV-2 (COVID-19) will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 10 days. Subjects will be followed for the incidence and severity of COVID-19 over 28 days. Subjects will be tested for infection with SARS-CoV-2 at the beginning, middle and end of the study.
Description: To determine the efficacy of PUL-042 Inhalation Solution in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: 1) who have repeated exposure to individuals with SARS-CoV-2 infection and, 2) are asymptomatic at enrollment. The primary endpoint is the severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 14 days from the start of experimental therapy.
Measure: Severity of COVID-19 Time: 14 daysDescription: Positive test for SARS-CoV-2 infection 14 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit
Measure: Incidence of SARS-CoV-2 infection Time: 14 daysDescription: The severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 28 days from the start of experimental therapy.
Measure: Severity of COVID-19 Time: 28 daysDescription: The requirement for ICU admission within 28 days from the start of experimental therapy.
Measure: ICU admission Time: 28 daysDescription: The requirement for mechanical ventilation within 28 days from the start of experimental therapy.
Measure: Mechanical ventilation Time: 28 daysDescription: All cause mortality at 28 days from the start of experimental therapy.
Measure: Mortality Time: 28 daysThe novel coronavirus (COVID-19) emerged in December 2019, and in mere months has spread to more than 104 countries, resulting in an outbreak of viral pneumonia worldwide. Current local quarantine policy in Hong Kong for individuals suspected for COVID-19 requires daily self-reported symptomatology and body temperature, given the intermittent nature and the high dependency of self-discipline undermine the practicality of the approach. To date, the advance in sensor technology has made possible to continuously monitor individual physiological parameters using a simple wearable device. Together with the mobile wearable technology that allowing instantaneous, multi-directional, and massive data transfer, remote continuous physiological monitoring is made possible. The Cardiology division, the Univeristy of Hong Kong has been in collaboration with Biofourmis to implement such technology for remote heart failure management. Similar digital therapeutic system can be applied to remotely monitor physiological parameters of large number of quarantined or suspected COVID-19 at home or in quarantine facility. It is purposed to allow the monitoring team to effectively and remotely monitor COVID-19 quarantined and patients, manage and evaluate the disease progression.
Description: Time from quarantine to diagnosis of COVID-19
Measure: Time to diagnosis of COVID-19 by RT-PCR in subjects Time: within 14 daysDescription: Adherence to device
Measure: Compliance to complete the study Time: within 14 daysDescription: To identify COVID19 subjects
Measure: Sensitivity and specificity of Biovitals® Sentinel Time: within 14 daysDescription: % of family members infection
Measure: Cross infection rate within the family cluster Time: within 14 daysDescription: Length of hospital stay
Measure: Length of hospital stay of positive subjects Time: 1 year at study completionDescription: Length of ICU stay
Measure: Length of ICU stay of positive patients Time: 1 year at study completionDescription: Vital signs of positive patients
Measure: National Early Warning Score 2 rating of positive patients Time: 4 weeks from diagnosisDescription: Virology laboratory result of nasopharyngeal swab
Measure: Viral load of positive patients Time: 4 weeks from diagnosisDescription: Worsening of comorbidities
Measure: Worsening of comorbidities Time: 1 year at study completionDescription: Mortality
Measure: Mortality Time: 1 year at study completionThis study aims to compare the efficacy and safety of Methylprednisolone versus Tocilizumab in improving clinical outcomes and reducing the need for ventilator support in COVID-19 patients with moderate COVID-19 disease at risk for complications of cytokine storm. Approximately 310 participants hospitalized with COVID-19 in UMMC, Hospital Sungai Buloh, Hospital Kuala Lumpur and Hospital Tuanku Jaafar will be enrolled into this study. Eligible participants will be selected based on a set of clinical, laboratory and radiological parameters indicative of early stages of CRS and lung function decline prior to being randomized at a ratio of 1:1 to receive either Tocilizumab or Methylprednisolone. Participants will be monitored daily for clinical and laboratory parameters, and at 48 hours, switched to the alternate study arm should they manifest signs and symptoms indicative of decompensation.
The overall objective is to evaluate the efficacy, tolerability, and safety of a single dose of RBT-9 (Stannous protoporphyrin) versus placebo in preventing the progression of coronavirus disease 2019 (COVID-19) infection in non-critically ill adults who are at high risk due to age or comorbid conditions.
Description: Determining severity of COVID-19 in patients measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale measures the clinical status of a subject at the first assessment of a given day with category 1 most favorable and category 8 least favorable(1. Ambulatory, no limitation of activities; 2. Ambulatory, limitation of activities; 3. Hospitalized, no oxygen therapy; 4. Hospitalized, oxygen by mask or nasal prongs; 5. Hospitalized, non-invasive ventilation or high-flow oxygen; 6. Hospitalized, intubation and mechanical ventilation; 7. Hospitalized, ventilation plus additional organ support - pressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO]; 8. Death)
Measure: Evaluate the effect of RBT-9(stannous protoporphyrin) versus placebo on clinical status of Covid-19 patients as measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale Time: 28 daysDescription: Time to first occurrence of either death from any cause or new/worsened organ dysfunction through Day 28, defined as at least one of the following: 1. Respiratory decompensation; 2. New or worsening congestive heart failure; 3. Requirement of vasopressor therapy and/or inotropic or mechanical circulatory support; 4. Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest; 5. Initiation of renal replacement therapy
Measure: Time to first occurrence of death from any cause or new/worsened organ dysfunction Time: 28 DaysDescription: Percentage of subjects who are alive at Day 28
Measure: All-cause survival Time: 28 DaysDescription: Among subjects who begin oxygen therapy, mean change from initiation to last day on oxygen or Day 28 (whichever happens first) in respiratory distress rate
Measure: Respiratory distress rate Time: 28 DaysDescription: Percentage of subjects with fever through Day 28
Measure: Fever incidence Time: 28 DaysDescription: Percentage of subjects who develop AKI (defined as an increase in serum creatinine by 0.5 mg/dL or more within 48 hours or an increase in serum creatinine to 1.5 × Baseline or more within the last 7 days) through Day 28
Measure: Acute kidney injury (AKI) incidence Time: 28 DaysDescription: Percentage of subjects with new or worsening congestive HF at Day 28
Measure: New or worsening congestive heart failure (HF) Time: 28 DaysDescription: Percentage of subjects who remain hospitalized at Day 28
Measure: Hospitalization status Time: 28 DaysDescription: Percentage of subjects with ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest at Day 28
Measure: Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest Time: 28 DaysDescription: Number of oxygen-free days through Day 28
Measure: Oxygen-free days Time: 28 DaysDescription: Percentage of subjects transferred to the ICU through Day 28
Measure: Intensive care unit (ICU) status Time: 28 DaysDescription: Number of days on mechanical ventilation through Day 28
Measure: Days on ventilator Time: 28 DaysDescription: Time to and duration of vasopressor or inotrope utilization through Day 28
Measure: Time to and duration of vasopressor or inotrope utilization Time: 28 DaysDescription: Percentage of subjects who begin dialysis through Day 28
Measure: Dialysis status Time: 28 DaysIn this study (i) the host genome to identify susceptibility regions of infection, inflammation, and host defense, (ii) host response to Severe Acute Respiratory Syndrome-Corona-Virus-2 (SARS-CoV-2) infection, and (iii) viral sequence composition to define viral sequences which may be correlated with disease severity in addition to the metagenome of the throat swab will be analysed .
Description: The change in the genetic makeup of a virus population (measured in numbers) as the viruses mutate and multiply over time at different time points
Measure: Viral evolution Time: Day 1, Day 3-5, Day 7-9, 48 hours after recoveryDescription: CD4+ and CD8+ T cells from blood (per µl) at different time points measured
Measure: Immune response Time: Day 1, Day 3-5, Day 7-9, 48 hours after recoveryDescription: Clinical classification according to severity: Light and uncomplicated (mild symptoms) Moderate (mild pneumonia) Severe pneumonia Critical (Acute Respiratory Distress Syndrome (ARDS), sepsis, septic shock) Evaluated at several time points
Measure: Disease severity Time: Day 1, Day 3-5, Day 7-9, 48 hours after recoverySARS-CoV-2 induces over-production of inflammatory cytokines, and especially interleukin-6 (IL-6). The apparently strong association between blood levels of inflammaory cytokines and SARS-CoV-2 disease severity has led clinicians to evaluate the administration of steroids or anti-IL-6 antagonists in severely ill patients. As of this day, biomarkers capable of predicting clinical disease progression in Covid-19 patients with mild-to-moderate symptoms have not yet been formally identified. Identifying such markers and evaluating their predictive value may be exploited to guide patient care management, and as such forms the core objective of this proposal. Because of strong inter-individual variations in the ability of innate immune cells to produce cytokines, the hypothesis formulate and intend to test is that innate IL-6 responsiveness varies between recently infected Covid-19 patients and could predict disease outcome. To test this hypothesis, the investigator propose to follow recently infected kidney transplant patients with moderate Covid-19 symptoms. These patients stand a higher risk to progress to severe disease. The staff plan to collect a blood sample in these patients using a system whereby ex vivo cytokine production is initiated in the very same blood collection tube without prior separation and centrifugation, thus reducing labour and operator bias. After incubation with or without known innate immune stimuli, the cell-free phase from each collection-culture tube will be assayed for IL-6 content. Associations between IL-6 content and disease outcome (encephalopathy, transfer to acute care or death) will be determined in 115 Covid-19 kidney transplant patients with moderate symptoms followed in 9 centers.
Description: quantity of IL-6 in of whole blood samples after ex vivo co-stimulation with LPS and ATP in Covid-19 kidney transplant patients.
Measure: Predictive value of IL-6 contents of whole blood samples after ex vivo stimulation Time: 10 monthsSARS-CoV-2 induces over-production of inflammatory cytokines, and especially interleukin-6 (IL-6). The apparently strong association between blood levels of inflammaory cytokines and SARS-CoV-2 disease severity has led clinicians to evaluate the administration of steroids or anti-IL-6 antagonists in severely ill patients. As of this day, biomarkers capable of predicting clinical disease progression in Covid-19 patients with mild-to-moderate symptoms have not yet been formally identified. Identifying such markers and evaluating their predictive value may be exploited to guide patient care management, and as such forms the core objective of this proposal. Because of strong inter-individual variations in the ability of innate immune cells to produce cytokines, the hypothesis the investigators formulate and intend to test is that innate IL-6 responsiveness varies between recently infected Covid-19 patients and could predict disease outcome. To test this hypothesis, the investigators propose to follow recently infected chronic haemodialysis patients with moderate Covid-19 symptoms. These patients stand a higher risk to progress to severe disease. The investigators plan to collect a blood sample in these patients using a system whereby ex vivo cytokine production is initiated in the very same blood collection tube without prior separation and centrifugation, thus reducing labour and operator bias. After incubation with or without known innate immune stimuli, the cell-free phase from each collection-culture tube will be assayed for IL-6 content. Associations between IL-6 content and disease outcome (encephalopathy, transfer to acute care or death) will be determined in 115 Covid-19 chronic haemodialysis patients with moderate symptoms followed in 9 centers.
Description: Quantity of IL-6 in of whole blood samples after ex vivo co-stimulation with LPS and ATP in Covid-19 patients.
Measure: Predictive value of IL-6 contents of whole blood samples after ex vivo stimulation Time: 10 months