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Sections: Correlations,
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Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3669 | Respiratory infections Wiki | 0.21 |
| drug515 | BIOVITALS Wiki | 0.21 |
| drug2658 | Moderate Intensity Aerobic Exercises Wiki | 0.21 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2928 | Octagam 10% Wiki | 0.21 |
| drug4238 | T-cell receptor (TCR) repertoire Wiki | 0.21 |
| drug18 | 0.9% sodium chloride (normal saline) Wiki | 0.21 |
| drug2297 | LYMPHOCYTE MONOCYTE RATIO Wiki | 0.21 |
| drug4749 | Whole Genome Analysis Wiki | 0.21 |
| drug4689 | Vitamin B12 Wiki | 0.21 |
| drug4785 | Zinc Citrate Wiki | 0.21 |
| drug3359 | Predictive factors for clinical response in patients with COVID-19. Wiki | 0.21 |
| drug3790 | SARS-CoV-2 viral composition Wiki | 0.21 |
| drug3735 | Rt PCR Wiki | 0.21 |
| drug2919 | Observational cohort study on the natural history of hospitalized SARS-COV-2 patients. Wiki | 0.21 |
| drug354 | Apilimod Dimesylate Capsule Wiki | 0.21 |
| drug3521 | RBT-9 (90 mg) Wiki | 0.21 |
| drug4372 | The control group will not receive hydroxychloroquine Wiki | 0.21 |
| drug226 | Ad26.COV2.S Wiki | 0.19 |
| drug895 | Camostat Wiki | 0.19 |
| drug3071 | PUL-042 Inhalation Solution Wiki | 0.15 |
| drug4859 | blood sample Wiki | 0.13 |
| drug1830 | HCQ Wiki | 0.11 |
| drug800 | COVID-19 Convalescent Plasma Wiki | 0.10 |
| drug4694 | Vitamin D3 Wiki | 0.09 |
| drug1950 | Hydroxychloroquine Wiki | 0.06 |
| drug3195 | Placebo Wiki | 0.06 |
| drug4690 | Vitamin C Wiki | 0.06 |
| drug2606 | Methylprednisolone Wiki | 0.06 |
| drug4429 | Tocilizumab Wiki | 0.04 |
| drug453 | Azithromycin Wiki | 0.03 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001424 | Bacterial Infections NIH | 0.12 |
| D012327 | RNA Virus Infections NIH | 0.08 |
| D007251 | Influenza, Human NIH | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0011947 | Respiratory tract infection HPO | 0.03 |
Navigate: Correlations HPO
There are 22 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 daysThis is a multi-center, randomized controlled, superiority, open label trial. The objective of this trial is to evaluate the efficacy of HCQ in patients with newly diagnosed COVID-19 who have mild to moderate disease or at risk for complications. We aim to demonstrate decrease in progression to severe pneumonia and hospital related complications among patients who are treated with HCQ compared to patients who are not.
Description: Number patients developing severe infection or death
Measure: Number patients developing severe infection or death Time: within 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 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 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 SpO2/FiO2 ratio
Measure: Oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2) ratio 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 through 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 through 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.COVID-19 is a global pandemic. So far encouraging results have been shown in different parts of the world with the utilisation of hydroxycloroquine, zinc, and azithromycin, and early studies into some of these, plus some with Vitamin C, have also proven beneficial. Vitamin D levels have also been shown to be an important indicator to the severity of symptoms in COVID-19 patients.
Description: Composite measure: Change in severity and duration of symptoms
Measure: Symptoms Time: once daily for 15 days since enrollment/baseline at admission to hospitalDescription: total number of days in hospital since admission
Measure: Length of hospital stay Time: at 15 and 45 days since admission/ enrolmentDescription: need for invasive mechanical ventilation or mortality within 15 days from enrolment
Measure: invasive mechanical ventilation or mortality Time: any time within 15 days from enrolmentDescription: Death
Measure: Mortality Time: 15 and 45 days since enrolmentDescription: need for and number of days of invasive mechanical ventilation, in case of no need for mechanical ventilation: days=0
Measure: mechanical ventilation Time: at 15 and 45 days since enrolmentDescription: need for and number of days for humidified high-flow oxygen
Measure: oxygen Time: 15 and 45 days since enrolmentDescription: admission to ICU (intensive care unit)
Measure: ICU Time: 15 and 45 days since enrolmentDescription: days in hospital
Measure: days in hospital Time: 15 and 45 days since enrolmentDescription: days in ICU
Measure: days in ICU Time: 15 and 45 days since enrolmentDescription: need for and days of renal replacement therapy
Measure: renal replacement therapy Time: 15 and 45 days since enrolmentDescription: need for and days of Extracorporeal support
Measure: Extracorporeal support Time: 15 and 45 days since enrolmentThis 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: Proportion of subjects with stabilized or improved clinical status at Day 7 on at least one category on a 6-point clinical status scale. 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 (Day 1) at Day 7 in terms of the 6-point clinical status scale (descriptive analysis). 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: Descriptive Clinical Status Analysis Time: 7 daysDescription: Proportion of subjects with maintenance or improvement by at least one category on the 6-point clinical status scale on Day 14. (This endpoint will go into formal hypothesis testing procedure) 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: Clinical Status Assessment Time: 14 daysDescription: Time to death
Measure: Time to death Time: Up to 33 daysDescription: Proportion of subjects requiring invasive mechanical ventilation by Day 33.
Measure: Mechanical Ventilation Initiation Time: Up to 33 daysDescription: Duration of invasive mechanical ventilation
Measure: Mechanical Ventilation Duration Time: Up to 33 daysDescription: Results of RT-PCR for SARS-CoV-2 from nares/throat swab and/or sputum and/or lower respiratory tract sample on Day 7.
Measure: SARS-CoV-2 Test Result Time: 7 daysDescription: Incidence of all AEs
Measure: Incidence of all AEs Time: Up to 33 daysDescription: Incidence of AEs considered related to the IMP
Measure: Incidence of AEs considered related to the IMP Time: Up to 33 daysDescription: Incidence of serious adverse events (SAEs)
Measure: Incidence of serious adverse events (SAEs) Time: Up to 33 daysDescription: Radiological findings (chest CT/chest X-ray)
Measure: Radiological 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: Change from baseline in SpO2
Measure: SpO2 Time: Up to 33 daysDescription: Change from baseline in A-a gradient
Measure: A-a gradient Time: Up to 33 daysDescription: Change from baseline in blood pressure
Measure: Blood Pressure Time: Up to 33 daysDescription: Change from baseline in pulse
Measure: Pulse Time: Up to 33 daysDescription: Change from baseline in respiration rate
Measure: Respiration Rate Time: Up to 33 daysDescription: Change from baseline in body temperature
Measure: Body Temperature Time: Up to 33 daysThe study aims to identify environmental factors and genetic (gene mutation and gene expression) changes, which influencing the course of the disease the new type of coronavirus infection COVID-19 in patients nationwide in a multicenter study. At first in the study will be performed 200 patients, selected for a homogeneous groups on the basis of the patient's anamnestic data, genetic testing. Following the interim analysis, based on the results, another 800 people are planned to involve.
Description: Exploring genotype-phenotype connections based on anamnestic data of patients and joint bioinformatics analysis of its genetic variants
Measure: Identification of genetic factors determining the course of the disease in case of COVID-19 Time: 2020. DecemberThe primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
Description: The impact will be evaluated by comparing rates of a composite primary outcome in patients randomized to hydroxychloroquine versus those randomized to placebo. The composite outcome includes progression to severe/critical disease or death (including withdrawal of care/hospice transfer). Progression to severe/critical disease is defined by requiring oxygen delivery via high flow nasal cannula, non-rebreather mask, bipap, or transfer to intensive care (ICU) or intermediate care units (IMCU) due to COVID-19-related complications.
Measure: Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease. Time: 30 DaysDescription: Resolution of symptoms will be assessed using standard medical interview procedures with the subject and review of the medical records.
Measure: Resolution of Symptoms Time: 14 DaysThis is a clinical trial to evaluate the efficacy of LAM-002A compared to placebo treatment in adults with a confirmed SARS-CoV-2 infection who are receiving standards supportive care in an outpatient setting.
Description: The primary efficacy outcome measure evaluates change in SARS-CoV-2 viral load at Day 4 from Day 1, of LAM-002A or placebo-treated participants. SARS-CoV-2 viral load will be measured by a qRT-PCR test of nasopharyngeal samples. Analysis will focus on log10 viral load on Day 4 compared to baseline viral load at Day 1 in participants with baseline viral load >100,000 copies/mL
Measure: Viral Load Change Time: 4 DaysDescription: The proportion of LAM 002A-treated participants who develop TEAEs compared to placebo
Measure: Safety and Tolerability Time: 28 DaysDescription: The proportion of participants treated with LAM-002A compared to placebo, who have disease progression by Day 28 as defined by the occurrence of: Hospitalization Death
Measure: Clinical Efficacy Time: 28 DaysDescription: To evaluate change in COVID-19 clinical status, as defined by the ordinal scale, of participants treated with LAM-002A compared to placebo at Day 28, in participants who become hospitalized and continue LAM-002A/placebo treatment, based on the following scores: Not in the hospital Hospitalized, requiring low flow supplemental oxygen (such as nasal cannula) Hospitalized, not on invasive ventilation (such as 100% non-rebreather, BIPAP), (pre-ICU) Hospitalized, in the ICU, on invasive ventilation or ECMO Dead
Measure: Change in COVID-19 Clinical Status Time: 28 DaysDescription: To compare the proportion of participants at or above 95% oxygen saturation (O2 sat) between LAM-002A versus placebo treatment groups as measured on Days 1, 4, and 11.
Measure: Oxygen Saturation Time: 11 DaysDescription: To potentially evaluate the change from baseline (Day 1, Pre-dose) of SARS-CoV-2 viral load as measured by a qRT-PCR test from saliva samples on Day 4, compared between the LAM-002A arm and the placebo arm in participants with a baseline viral load >100,000 copies/mL
Measure: Viral Clearance Time: 4 DaysDescription: To potentially evaluate the change from baseline (Day 1, Pre-dose) of SARS-CoV-2 viral load as measured by a qRT-PCR test from saliva samples on Day 11, compared between the LAM-002A arm and the placebo arm in participants with a baseline viral load >100,000 copies/mL
Measure: Viral Clearance Time: 11 DaysDescription: To potentially evaluate the change from baseline (Day 1, Pre-dose) of SARS-CoV-2 viral load as measured by a qRT-PCR test from saliva samples on Day 28, compared between the LAM-002A arm and the placebo arm in participants with a baseline viral load >100,000 copies/mL
Measure: Viral Clearance Time: 28 DaysDescription: To potentially evaluate the difference in SARS-CoV-2 viral load as measured by a qRT-PCR test from saliva samples based on AUC(Day1-Day11), between the LAM-002A arm and the placebo arm in participants with a baseline viral load >100,000 copies/mL.
Measure: Viral Clearance AUC Time: 11 DaysDescription: To potentially evaluate the difference in SARS-CoV-2 viral load as measured by a qRT-PCR test from saliva samples based on AUC(Day1-Day28), between the LAM-002A arm and the placebo arm in participants with a baseline viral load >100,000 copies/mL.
Measure: Viral Clearance AUC Time: 28 DaysDescription: To potentially evaluate the difference in proportion of participants with a SARS-CoV-2 viral load less than
This is a phase II/III randomised, multi-centre, prospective, open label, community-based clinical trial. The trial aims to recruit patients who test positive for COVID-19 but who have mild disease and therefore can treat their symptoms in the community. Patients who seek testing and have a confirmed positive test result will be invited to enrol in the trial.
Clinical Picture: Symptomatic COVID-19 presents with a recognizable clinical syndrome that is predictable prior to testing. Clinical judgement remains important, particularly when interpreting negative test results; 2. Biomarkers Associated with COVID-19 Patients: The most common laboratory features reported in patients with COVID-19
Description: Finding the correlation between the results of COVID-19 RT PCR, antibody to PCR COVID-19 IgM & IgG and the severity of the clinical picture
Measure: correlation of COVID-19 antibody to PCR Time: 1 yearDescription: Finding the correlation between the results of the ancillary tests (CRP, ESR, LFT, Ferritin, D dimer) and the severity of the clinical picture
Measure: correlation of ancillaey tests to PCR Time: 1 yearBrief Summary: Purpose of this study is to evaluate efficacy of hydroxychloroquine (HCQ) in reducing progression of Corona Virus Disease 2019 (COVID - 19) and achieving viral clearance. Condition or disease :I COVID-19 ntervention/treatment :Drug: Hydroxychloroquine Sulfate Phase: Phase III
Description: After start of treatment, development of fever > 101 F for > 72 hours, shortness of breath by minimal exertion (10-Step walk test), derangement of basic lab parameters (ALC < 1000 or raised CRP) or appearance of infiltrates on CXR during course of treatment was labeled as progression irrespective of PCR status
Measure: Number of Participants With Progression Time: 5 daysDescription: PCR negativity on day 7 and 14 after admission
Measure: Viral Clearance Time: 14 daysThe study will enroll up to 60,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.
Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus Time: 1 Day post-vaccination (Day 2) to end of study (2.1 Years)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease COVID-19 Regardless of Their Serostatus Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) Time: 1 Day post-vaccination (Day 2) to end of study (2.1 Years)Description: Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO), linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 14 days post vaccination will be reported.
Measure: Number of Participants with First Occurrence of COVID-19 Requiring Medical Intervention Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: The viral load of SARS-CoV-2 will be assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs will be used to detect and/or quantify SARS-CoV-2.
Measure: SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants with Molecularly Confirmed, Moderate to Severe/Critical COVID-19 Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Molecularly confirmed mild COVID-19 is defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Mild COVID-19 includes: Fever, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, or chills, without shortness of breath or dyspnea.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Mild COVID-19 Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Molecularly confirmed moderate and severe/critical COVID-19 defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of this protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized case Definition Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: BOD will be evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
Measure: Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: Serologic conversion between baseline and (Day 1; pre-vaccination), Day 71, 6 Months, 1 year post-vaccination using an ELISA and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 nucleocapsid (N) protein will be reported.
Measure: Serologic Conversion Between Baseline and (Day 1; Pre-vaccination), Day 71, 6 Months and 1- Year Post-vaccination using an Enzyme-linked Immunosorbent Assay (ELISA) Time: Between baseline (Day 1; pre-vaccination) and Day 71, 6 Months, 1-Year post-vaccination (up to 52 Weeks)Description: Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) with onset at least 14 days after vaccination (Day 15) to end of Study (2.1 Years) will be reported.
Measure: Number of Participants with First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) Time: 14 Days post-vaccination (Day 15) to end of study (2.1 Years)Description: SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Measure: Number of Participants with Serious Adverse Events (SAEs) Time: Up to 104 WeeksDescription: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.
Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Time: Up to 6 MonthsDescription: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Leading to Study Discontinuation Time: Up to 104 WeeksDescription: Participants will be asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Measure: Number of Participants with Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination Time: Up to Day 8 (7 Days after first vaccination on Day 1)Description: Participants will be instructed on how to record daily temperature using a thermometer provided for home use. Participants should record the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement is made on any given day, the highest temperature of that day will be recorded in the e-Diary. Fever is defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants will also be instructed on how to note signs and symptoms in the e-Diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
Measure: Number of Participants with Solicited Systemic AEs During 7 Days Following Vaccination Time: Up to Day 8 (7 Days after first vaccination on Day 1)Description: Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measure: Number of Participants with Unsolicited Local Adverse Events (AEs) During 28 Days Post-vaccination Time: Up to Day 29 (28 Days after first vaccination on Day 1)Description: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported
Measure: SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) Time: Up to 104 WeeksDescription: SARS-CoV-2 binding antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response will be reported.
Measure: SARS-CoV-2 Binding Antibodies Assessed by ELISA Time: Up to 104 WeeksCorona virus disease 2019 (COVID 19), first identified in December 2019 in a cluster of population in a Chinese province, soon emerged as a pandemic, causing a huge strain on healthcare system and mortality all over the world. An ideal marker for predicting course of this illness should be easily available and reproducible; as the disease burden has spread to third world countries whose healthcare system is resource limited. Our study is aimed to study the utility of lymphocyte- monocyte ratio in the early stages to predict the progression of COVID 19 pneumonia.
Description: disease progression equal or more than 2 stages
Measure: progression Time: 28 daysDescription: end outcome of the patients diagnosed of COVID-19 infection
Measure: mortality Time: 28 daysParticipants were assigned randomly into two groups, exercise and control groups. All participants in both groups followed the WHO guidelines of quarantine and used standardized medications given by the physician according to the Turkish Ministry of Health guidelines, including the Hydroxyclorocin Sulphate 200 Mg Film Tablet (Plaquenil 200 Mg Film Tablet). The dose was 2 times/ day, 200Mg/time, for 5 days. Besides, the exercise group performed moderate-intensity aerobic exercises for 40 min/ 3 sessions/week, 40 minute/session.
Description: A blood was centrifuged at 3,000 rpm for 15 min at 4◦C. We measured total lymphocytes, leukocytes, and monocytes from total-blood samples utilizing a multichannel hemocyte analysis system (SE-9000; Sysmex Corp, Hyogo, Japan). A saliva sample was collected to measure the salivary IgA-S concentration.
Measure: Immune system markers Time: 4 MonthsDescription: The Wisconsin Upper Respiratory Symptom Survey (WURSS) is an empirically derived patient-oriented illness-specific quality-of-life evaluative outcomes instrument. The development process of this survey was described in detail by Barrett et al. WURSS-24 is designed to evaluate the negative effect of acute upper respiratory infection, presumed viral (the common cold). Its a valid and reliable measurement tool to evaluate the measure items and domains that change over time including influenza-like illness symptoms of headache, body aches, and fever. The participants were asked to fill the survey before starting the study and the 2 times/week.
Measure: Upper respiratory tract infection symptoms severity and progression Time: 4 MonthsThe study will enroll up to 30,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in adult participants.
Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate greater than or equal to (>=) 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of signs and symptoms or severe COVID-19 defined in Food and Drug Administration (FDA) guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline Time: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus Time: 1 day after the 1st vaccination (Day 2) to end of study (2 years and 3 months)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus Time: 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline Time: 1 day after the 1st vaccination (Day 2) to end of study (2 years and 3 months)Description: Moderate defined as one sign or symptom from a list of signs and symptoms, such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms from a list of sign and symptoms or severe COVID-19 defined in FDA guidance.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline Time: 14 days after the 1st vaccination (Day 15) to end of study (2 years and 3 months)Description: Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, intensive care unit (ICU) admission, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO), linked to objective measures such as decreased oxygenation, X-ray, computed tomographic [CT] findings) linked to any molecularly confirmed COVID-19 at least 14 days after the second vaccination will be reported.
Measure: Number of Participants with First Occurrence of COVID-19 Requiring Medical Intervention Time: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: The viral load of SARS-CoV-2 will be assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs will be used to detect and/or quantify SARS-CoV-2.
Measure: SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants with Molecularly Confirmed, Moderate to Severe/Critical COVID-19 Time: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: Molecularly confirmed mild COVID-19 is defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Mild COVID-19 includes: Fever, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, or chills, without shortness of breath or dyspnea.
Measure: Number of Participants with First Occurrence of Molecularly Confirmed Mild COVID-19 Time: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: Molecularly confirmed moderate and severe/critical COVID-19 defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case definition at the time of finalization of this protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
Measure: Number of Participants with First Occurrence of Molecularly confirmed COVID-19 Defined by the US FDA Harmonized Case Definition Time: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: BOD will be evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate, or severe/critical COVID-19 case.
Measure: Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 Time: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: Serologic conversion between baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccination using an ELISA and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 nucleocapsid (N) protein will be reported.
Measure: Serologic Conversion Between Baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccination Using an Enzyme-linked Immunosorbent Assay (ELISA) Time: Between baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccinationDescription: Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) with onset at least 14 days after second vaccination (Day 71) to end of Study (2.3 years) will be reported.
Measure: Number of Participants with First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) Time: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months)Description: SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Measure: Number of Participants with Serious Adverse Events (SAEs) Time: Up to 2 years and 3 monthsDescription: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Time: 6 months after second vaccination (Up to 34 weeks)Description: MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.
Measure: Number of Participants with Medically-Attended Adverse Events (MAAEs) Leading to Study Discontinuation Time: Up to 2 years and 3 monthsDescription: Participants will be asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post each vaccination (day of each vaccination and the subsequent 7 days).
Measure: Number of Participants with Solicited Local Adverse Events (AEs) During 7 Days Following Each Vaccination Time: Up to Day 8 (7 days after first vaccination on Day 1), up to Day 64 (7 days after second vaccination on Day 57)Description: Participants will be instructed on how to record daily temperature using a thermometer provided for home use. Participants should record the temperature in the e-Diary in the evening of the day of each vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement is made on any given day, the highest temperature of that day will be recorded in the e-Diary. Fever is defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants will also be instructed on how to note signs and symptoms in the e-Diary on a daily basis for 7 days post each vaccination (day of each vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
Measure: Number of Participants with Solicited Systemic AEs During 7 Days Following Each Vaccination Time: Up to Day 8 (7 days after first vaccination on Day 1), up to Day 64 (7 days after second vaccination on Day 57)Description: Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measure: Number of Participants with Unsolicited Local Adverse Events (AEs) During 28 Days Post-vaccination Time: Up to Day 29 (28 days after first vaccination on Day 1), up to Day 85 (28 days after second vaccination on Day 57)Description: SARS-CoV-2 binding antibodies as assessed ELISA to measure humoral immune response will be reported.
Measure: SARS-CoV-2 Binding Antibodies Assessed by ELISA Time: Up to 2 years and 3 monthsDescription: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported
Measure: SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) Time: Up to 2 years and 3 monthsRespiratory infections such as colds, flu and pneumonia affect millions of people around the world every year. Most cases are mild, but some people become very unwell. Influenza ('flu') is one of the most common causes of lung infection. Seasonal flu affects between 10% and 46% of the population each year and causes around 12 deaths in every 100,000 people infected. In addition, both influenza and coronaviruses have caused pandemics in recent years, leading to severe disease in many people. Although flu vaccines are available, these need to change every year to overcome rapid changes in the virus and are not completely protective. This study aims to find and develop predictive tests to better understand how and when flu-like illness progresses to more severe disease. This may help to decide which people need to be admitted to hospital, and how their treatment needs to be increased or decreased during infection. The aim is to recruit 100 patients admitted to hospital due to a respiratory infection. It is voluntary to take part and participants can choose to withdraw at any time. The study will involve some blood and nose samples. This will be done on Day 0, Day 2 and Discharge from hospital, and an out-patient follow-up visit on Day 28. The data will be used to develop novel diagnostic tools to assist in rational treatment decisions that will benefit both individual patients and resource allocation. It will also establish research preparedness for upcoming pandemics.
Description: The identity of pathological organisms associated with influenza-like illness (including respiratory viruses and bacteria) will be obtained from the patient's medical record
Measure: Describe the aetiology of influenza-like illness in hospitalised adults Time: Day 0 to Day 28Description: The following data will be collected from the patient's medical record. At enrolment, data will consist of: past medical history, clinical signs and symptoms relating to this admission, vital signs (pulse rate, blood pressure, temperature, oxygen saturation), demographics, drug history, laboratory results including diagnostic microbiological tests and interventions. Data collection on Day 28 will consist of clinical diagnosis at discharge, any febrile illness in the 7 days preceding the visit, mortality and complications between Day 0 and 28.
Measure: Describe the clinical outcomes of influenza-like illness in hospitalised adults Time: Day 0 to Day 28Description: Cytokine levels will be measured in plasma and nasal lining fluid samples by MesoScale Discovery
Measure: Identify changes in cytokine levels during influenza-like illness in hospitalised adults Time: Day 0 to Day 28Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports