Name (Synonyms) | Correlation | |
---|---|---|
drug1278 | blood sample Wiki | 0.38 |
drug1246 | Whole Genome Analysis Wiki | 0.33 |
drug5 | 0.9% sodium chloride (normal saline) Wiki | 0.33 |
drug1114 | T-cell receptor (TCR) repertoire Wiki | 0.33 |
drug787 | Octagam 10% Wiki | 0.33 |
drug125 | BIOVITALS Wiki | 0.33 |
drug1088 | Stannous Protoporphyrin (90 mg) Wiki | 0.33 |
drug992 | SARS-CoV-2 viral composition Wiki | 0.33 |
drug820 | PUL-042 Inhalation Solution Wiki | 0.24 |
drug208 | COVID-19 Convalescent Plasma Wiki | 0.17 |
drug697 | Methylprednisolone Wiki | 0.11 |
drug1168 | Tocilizumab Wiki | 0.08 |
drug850 | Placebo Wiki | 0.06 |
Name (Synonyms) | Correlation | |
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D007239 | Infection NIH | 0.02 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
D018352 | Coronavirus Infections NIH | 0.02 |
Name (Synonyms) | Correlation |
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There are 9 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 28 days from the start of experimental therapy.
Measure: Severity of COVID-19 Time: 28 daysDescription: Positive test for SARS-CoV-2 infection 28 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: 28 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 14 days from the start of experimental therapy.
Measure: Severity of COVID-19 Time: 14 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 coronavirus disease 2019 (COVID-19) infection in non-critically ill adults who are at high risk of progression.
Description: Determining severity of COVID-19 in patients measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale which 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 monthsOlder age is an independent poor outcome predictor among COVID-19 hospitalized patients . Among 72,314 COVID-19 cases, case fatality rate (CFR) was 2.3% in total population, 8% in people aged 70 to 79, and 14.8% in those aged 80 and older. In the whole population, CFR was higher in people with comorbidities, ranging from 5-6% in persons with hypertension, chronic respiratory disease, diabetes or cancer, up to 10% in those with cardiovascular diseases. Sars-CoV-2 seems to be able to induce a functional exhaustion of specified T and NK lymphocyte subpopulations, breaking down antiviral immunity. One possible explanation is that the immune system of elderly people, might be exhausted by chronic stimulation associated with comorbidities and more susceptible to this Sars-CoV-2 effect. As a result, in these patients, the activation of the innate immune system might fail to produce an adequate adaptive response (i.e., virus-specific CD8+ T-cells). This results in persistent self-induced inflammation that eventually causes mortality. The investigators hypothesize that transfusing convalescent plasma (containing neutralizing antibodies) at an early phase of COVID-19 infection could prevent or switch off the persistent inflammatory response elicited by the virus. The objective of this study are: - To demonstrate the superiority of COVID-19 convalescent plasma (CCP) plus standard therapy (ST) over ST alone - To prevent progression of pneumonia in COVID-19 patients aged ≥65 with chronic comorbidities - To decrease viral load - To raise anti-SARS-CoV-2 antibody titer in recipients
Description: Proportion of patients without progression in severity of pulmonary disease defined as worsening of 2 points in the ordinal scale of WHO within day 14
Measure: Rate of COVID-19 progression Time: days 1 to 14.This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in patients with severe Coronavirus disease
Description: The primary endpoint is stabilization or improvement in clinical status defined as maintenance or improvement by one category on a 6-category clinical status scale on Day 7. Clinical status categories will be defined as: Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief). Hospitalization, not requiring supplemental oxygen. Hospitalization, requiring supplemental oxygen (but not NIV/HFNC). ICU/hospitalization, requiring NIV/HFNC therapy. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. Death.
Measure: Stabilization or Improvement in Clinical Status Time: 7 daysDescription: Change from baseline in oxygen saturation
Measure: Oxygen saturation Time: Up to 33 daysDescription: Change from baseline in Modified Borg Dyspnea scale
Measure: Modified Borg Dyspnea scale Time: Up to 33 daysDescription: Change from baseline in Quality of Life
Measure: Quality of Life (McGill Quality of Life Single-Item Scale) Time: Up to 33 dayaDescription: Time to intubation
Measure: Time to intubation Time: Up to 33 daysDescription: Time to extubation
Measure: Time to extubation Time: Up to 33 daysDescription: Time to mechanical ventilation
Measure: Time to mechanical ventilation Time: Up to 33 daysDescription: Time to cessation of mechanical ventilation
Measure: Time to cessation of mechanical ventilation Time: Up to 33 daysDescription: Time to change of modality for oxygenation
Measure: Time to change of modality for oxygenation Time: Up to 33 daysDescription: Time to death
Measure: Time to death Time: Up to 33 daysDescription: Imaging findings (chest CT/chest X-ray)
Measure: Imaging findings (chest CT/chest X-ray) Time: Up to 7 daysDescription: Change from baseline in blood glucose
Measure: Blood glucose Time: Up to 33 dayaDescription: Change from baseline in blood calcium
Measure: Blood calcium Time: Up to 33 daysDescription: Change from baseline in sodium
Measure: Sodium Time: Up to 33 daysDescription: Change from baseline in potassium
Measure: Potassium Time: Up to 33 daysDescription: Change from baseline in carbon dioxide
Measure: Carbon dioxide Time: Up to 33 daysDescription: Change from baseline in chloride
Measure: Chloride Time: Up to 33 daysDescription: Change from baseline in albumin
Measure: Albumin Time: Up to 33 daysDescription: Change from baseline in total protein
Measure: Total protein Time: Up to 33 daysDescription: Change from baseline in alkaline phosphatase
Measure: Alkaline phosphatase Time: Up to 33 daysDescription: Change from baseline in alanine transaminase
Measure: Alanine transaminase Time: Up to 33 daysDescription: Change from baseline in aspartate aminotransferase
Measure: Aspartate aminotransferase Time: Up to 33 daysDescription: Change from baseline in bilirubin
Measure: Bilirubin Time: Up to 33 daysDescription: Change from baseline in blood urea nitrogen
Measure: Blood urea nitrogen Time: Up to 33 daysDescription: Change from baseline in D-dimer
Measure: D-dimer Time: Up to 33 daysDescription: Change from baseline in fibrinogen
Measure: Fibrinogen Time: Up to 33 daysDescription: Change from baseline in PT
Measure: PT Time: Up to 33 daysDescription: Change from baseline in PTT
Measure: PTT Time: Up to 33 daysDescription: Change from baseline in INR
Measure: INR Time: Up to 33 daysDescription: Change from baseline in hsCRP
Measure: hsCRP Time: Up to 33 daysDescription: Change from baseline in ferritin
Measure: Ferritin Time: Up to 33 daysDescription: Change from baseline in LDH
Measure: LDH Time: Up to 33 daysDescription: Change from baseline in IgG
Measure: IgG Time: Up to 33 daysDescription: Change from baseline in IgM
Measure: IgM Time: Up to 33 daysDescription: Change from baseline in IgA
Measure: IgA Time: Up to 33 daysDescription: Change from baseline in IFE
Measure: IFE Time: Up to 33 daysDescription: Change from baseline in troponin
Measure: Troponin Time: Up to 33 daysDescription: Change from baseline in red blood cell count
Measure: Red blood cell count Time: Up to 33 daysDescription: Change from baseline in hemoglobjn
Measure: Hemoglobin Time: Up to 33 daysDescription: Change from baseline in hematocrit
Measure: Hematocrit Time: Up to 33 daysDescription: Change from baseline in mean corpuscular volume
Measure: Mean corpuscular volume Time: Up to 33 daysDescription: Change from baseline in mean corpuscular hemoglobin
Measure: Mean corpuscular hemoglobin Time: Up to 33 daysDescription: Change from baseline in mean corpuscular hemoglobin concentration
Measure: Mean corpuscular hemoglobin concentration Time: Up to 33 daysDescription: Change from baseline in red cell distribution width
Measure: Red cell distribution width Time: Up to 33 daysDescription: Change from baseline in white blood cell count
Measure: White blood cell count Time: Up to 33 daysDescription: Change from baseline in white blood cell differential
Measure: White blood cell differential Time: Up to 33 daysDescription: Change from baseline in platelet count
Measure: Platelet count Time: Up to 33 daysDescription: Change from baseline in mean platelet volume
Measure: Mean platelet volume Time: Up to 33 daysDescription: Change from baseline in platelet distribution width
Measure: Platelet distribution width Time: Up to 33 daysDescription: Frequency of adverse events
Measure: Frequency of adverse events Time: 33 daysDescription: Frequency of serious adverse events
Measure: Frequency of serious adverse events Time: 33 days