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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4335 | Zinc Wiki | 0.47 |
| drug3462 | SBRT Wiki | 0.27 |
| drug4574 | melatonin Wiki | 0.27 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1783 | Hydroxychloroquine + lopinavir/ritonavir Wiki | 0.27 |
| drug1494 | FSD201 Wiki | 0.27 |
| drug4411 | bromelain Wiki | 0.27 |
| drug4248 | Vitamin B12 Wiki | 0.27 |
| drug1489 | FLOW intervention Wiki | 0.27 |
| drug1541 | Five-days oseltamivir Wiki | 0.27 |
| drug3649 | Smartphone-based voice and self-reported symptom collection Wiki | 0.27 |
| drug2271 | Macrolide administered for 3-5 days Wiki | 0.27 |
| drug1544 | Fixed-duration Hydrocortisone Wiki | 0.27 |
| drug2462 | N-acetyl cysteine Wiki | 0.27 |
| drug3952 | Ten-days oseltamivir Wiki | 0.27 |
| drug3056 | Prasugrel Wiki | 0.27 |
| drug3125 | Protocolised mechanical ventilation strategy Wiki | 0.27 |
| drug271 | Amoxicillin-clavulanate Wiki | 0.27 |
| drug4371 | anti-CD40 antibody (CDX-1140) Wiki | 0.27 |
| drug1490 | FLT3 Ligand (CDX-301) Wiki | 0.27 |
| drug1936 | Infrared Energy and Dietary Supplement Wiki | 0.27 |
| drug1968 | Interferon-β1a Wiki | 0.27 |
| drug861 | Ceftaroline Wiki | 0.27 |
| drug2034 | Ivermectin 3mg Tab Wiki | 0.27 |
| drug3842 | Symptom Survey Wiki | 0.27 |
| drug1750 | Home-based exercise Wiki | 0.27 |
| drug4015 | Ticagrelor Wiki | 0.27 |
| drug2913 | Piperacillin-tazobactam Wiki | 0.27 |
| drug2272 | Macrolide administered for up to 14 days Wiki | 0.27 |
| drug2440 | Moxifloxacin or Levofloxacin Wiki | 0.27 |
| drug1266 | Doxycycline Hcl Wiki | 0.27 |
| drug2344 | Mesenchymal Stromal Cells infusion Wiki | 0.27 |
| drug3615 | Shock-dependent hydrocortisone Wiki | 0.27 |
| drug4337 | Zinc Citrate Wiki | 0.27 |
| drug4255 | Vitamin E Wiki | 0.27 |
| drug862 | Ceftriaxone Wiki | 0.27 |
| drug3187 | Quercetin Wiki | 0.27 |
| drug1545 | Fixed-duration higher dose Hydrocortisone Wiki | 0.27 |
| drug1415 | Eritoran Wiki | 0.27 |
| drug4253 | Vitamin D3 Wiki | 0.22 |
| drug1807 | Hydroxychloroquine Sulfate Tablets Wiki | 0.19 |
| drug3628 | Simvastatin Wiki | 0.19 |
| drug3989 | Therapeutic anticoagulation Wiki | 0.19 |
| drug4251 | Vitamin D Wiki | 0.18 |
| drug1775 | Hydroxychloroquine Wiki | 0.16 |
| drug942 | Clopidogrel Wiki | 0.15 |
| drug2859 | Pentoxifylline Wiki | 0.15 |
| drug340 | Apremilast Wiki | 0.15 |
| drug1030 | Control Wiki | 0.15 |
| drug3040 | Povidone-Iodine Wiki | 0.13 |
| drug2325 | Melatonin Wiki | 0.13 |
| drug356 | Aspirin Wiki | 0.13 |
| drug421 | Azithromycin Wiki | 0.13 |
| drug3532 | Sarilumab Wiki | 0.12 |
| drug764 | COVID-19 convalescent plasma Wiki | 0.12 |
| drug274 | Anakinra Wiki | 0.09 |
| drug2174 | Lopinavir/ritonavir Wiki | 0.08 |
| drug2029 | Ivermectin Wiki | 0.06 |
| drug1060 | Convalescent plasma Wiki | 0.06 |
| drug1511 | Favipiravir Wiki | 0.06 |
| drug4025 | Tocilizumab Wiki | 0.04 |
| drug2916 | Placebo Wiki | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung NIH | 0.12 |
| D003141 | Communicable Diseases NIH | 0.10 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.09 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0030358 | Non-small cell lung carcinoma HPO | 0.12 |
| HP:0100526 | Neoplasm of the lung HPO | 0.08 |
| HP:0002090 | Pneumonia HPO | 0.04 |
Navigate: Correlations HPO
There are 14 clinical trials
REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic resulting in critical illness. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19.
Description: Primary end-point for patients with suspected or proven COVID-19 pandemic infection
Measure: Days alive and not receiving organ support in ICU Time: Day 21Description: EQ5D-5L and WHODAS 2.0 (not completed in all regions)
Measure: Health-related Quality of life assessment Time: 6 monthsDescription: Characterised as home, rehabilitation hospital, nursing home or long-term care facility, or another acute hospital
Measure: Destination at time of hospital discharge Time: Free text Day 90Description: Antibiotic Domain specific outcome
Measure: Occurrence of multi-resistant organism colonisation/infection Time: Day 90, censored at hospital dischargeDescription: Antibiotic Domain specific outcome
Measure: Occurrence clostridium difficile Time: Day 90, censored at hospital dischargeDescription: Macrolide Duration domain specific outcome, and COVID-19 Antiviral Domain specific outcome.
Measure: Occurrence of serious ventricular arrhythmia (including ventricular fibrillation) or sudden unexpected death Time: Day 90, censored at hospital dischargeDescription: Antiviral Domain specific outcome. Only required at selected sites.
Measure: Change from baseline influenza virus levels in upper and lower respiratory tract specimens Time: Day 3, up to Day 7Description: COVID-19 Antiviral Domain and COVID-19 Immune Modulation Domain specific endpoint
Measure: Serial detection of SARS-CoV-2 in upper or lower respiratory tract specimens (using only specimens collected for routine clinical testing) Time: Day 90, censored at hospital dischargeLOVIT is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in septic intensive care unit patients. Patients with COVID-19 are considered eligible for this study.
Description: Defined as death or dependency on mechanical ventilation, renal replacement, or vasopressors
Measure: Number of deceased participants or with persistent organ dysfunction Time: Both assessed at 28 daysDescription: Persistent organ dysfunction-free days in intensive care unit
Measure: Number of participants with persistent organ dysfunction-free days in intensive care unit Time: Up to day 28Description: Mortality at 6 months
Measure: Number of participants deceased at 6 months Time: 6 monthsDescription: Assessed by the questionnaire EuroQol-5D (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measure: Score of health related quality of life in 6-month survivors Time: 6 monthsDescription: Assessed by serum lactate concentration
Measure: Global tissue dysoxia Time: Days 1, 3, 7Description: Assessed by the Sequential Organ Failure Assessment (SOFA) score. Used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on 6 different sub-scores, one each for the respiratory (PaO2/FiO2 mmHg), cardiovascular (mean arterial pressure OR administration of vasopressors required), hepatic (liver bilirubin (mg/dl) [μmol/L]), coagulation (platelets×103/µl), renal (kidneys creatinine (mg/dl) [μmol/L] (or urine output)) and neurological (Glasgow coma scale). The sub-score of eah system ranges from 0 (best) to +4 (worst).
Measure: Organ function (including renal function) Time: Days 1, 2, 3, 4, 7, 10, 14, 28Description: Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP)
Measure: Rate of inflammation Time: Days 1, 3, 7Description: Assessed by procalcitonin (PCT)
Measure: Rate of infection Time: Days 1, 3, 7Description: Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)
Measure: Rate of endothelial injury Time: Days 1, 3, 7Description: Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Measure: Occurrence of stage 3 acute kidney injury Time: Up to day 28Description: clinician judgment of hemolysis, as recorded in the chart, OR hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following: reticulocyte count >2 times upper limit of normal at clinical site lab; haptoglobin < lower limit of normal at clinical site lab; indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab; Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab. Severe hemolysis: - hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells
Measure: Acute hemolysis Time: Up to day 28Description: Core lab-validated glucose level of less than 3.8 mmol/L
Measure: Hypoglycemia Time: During the time participants receive the 16 doses of the investigational product and the 7 days following the last doseDescription: Assessed by chromatography-tandem mass spectrometry
Measure: Vitamin C volume of distribution Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)Description: Assessed by chromatography-tandem mass spectrometry
Measure: Vitamin C clearance Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)Description: Assessed by chromatography-tandem mass spectrometry
Measure: Vitamin C plasma concentration Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)Different studies showed that ascorbic acid (vitaminC) positively affects the development and maturation of T-lymphocytes, in particular NK (natural Killer) cells involved in the immune response to viral agents. It also contributes to the inhibition of ROS production and to the remodulation of the cytokine network typical of systemic inflammatory syndrome. Recent studies have also demonstrated the effectiveness of vitamin C administration in terms of reducing mortality, in patients with sepsis hospitalized in intensive care wards. Given this background, in the light of the current COVID-19 emergency, since the investigators cannot carry out a randomized controlled trial, it is their intention to conduct a study in the cohort of hospitalized patients with covid-19 pneumonia, administering 10 gr of vitamin C intravenously in addition to conventional therapy.
Description: Change of hospital mortality
Measure: In-hospital mortality Time: 72 hoursDescription: Reduction of PCR levels > 50% in comparison with PCR levels at the admission, within 72 hours after the administration
Measure: PCR levels Time: 72 hoursDescription: Change of the lactate clearance
Measure: Lactate clearance Time: 72 hoursDescription: Change of hospital stay days
Measure: Hospital stay Time: 72 hoursDescription: Resolution of symptoms (Fever, Cough, Shortness of breath or difficulty breathing)
Measure: Symptoms Time: 72 hoursDescription: Change of duration of positive swab (nasopharynx and throat)
Measure: Positive swab Time: 72 hoursDescription: Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)
Measure: Tomography imaging Time: 72 hoursThis is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).
Description: Number of days from COVID-19 diagnosis to recovery via RT-PCR
Measure: The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy Time: 12 weeksDescription: Reduction and/or progression of symptomatic days, reduction of symptom severity
Measure: Reduction or Progression of Symptomatic Days Time: 12 weeksDescription: Assess the symptom response to study therapy as measured by the survey in the EDC
Measure: Assess the safety of Quintuple Therapy Time: 12 weeksDescription: Pulse from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via pulse Time: 12 weeksDescription: Oxygen saturation from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via oxygen saturation Time: 12 weeksDescription: EKG response from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via EKG Time: 12 weeksDescription: Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy
Measure: Assess Tolerability of Quintuple Therapy Time: 12 weeksThis study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19
Description: This outcome will be assessed by comparing the percentages of enrolled patients that are hospitalized in the treatment and control arms.
Measure: Total Hospitalization Time: 14 daysDescription: This outcome will be assessed by comparing the percentages of enrolled patients that have received mechanical ventilation in the treatment and control arms.
Measure: Total Mechanical Ventilation Time: 14 daysDescription: Self-reported body temperature. Each report scored low (less than 100.4), medium (100.4-102.2), or high (higher than 102.2). Outcome will be assessed by calculating percentage of patients with reported high, medium, low temperature at specified time points.
Measure: Fever intensity measure Time: 2 daysDescription: Self-reported body temperature. Each report scored low (less than 100.4), medium (100.4-102.2), or high (higher than 102.2). Outcome will be assessed by calculating percentage of patients with reported high, medium, low temperature at specified time points.
Measure: Fever intensity measure Time: 5 daysDescription: Self-reported body temperature. Each report scored low (less than 100.4), medium (100.4-102.2), or high (higher than 102.2). Outcome will be assessed by calculating percentage of patients with reported high, medium, low temperature at specified time points.
Measure: Fever intensity measure Time: 10 daysDescription: Self-reported body temperature. Each report scored low (less than 100.4), medium (100.4-102.2), or high (higher than 102.2). Outcome will be assessed by calculating percentage of patients with reported high, medium, low temperature at specified time points.
Measure: Fever intensity measure Time: 14 daysDescription: Self-reported worsening shortness of breath. Each report scored yes/no. Outcome will be assessed by calculating percentage of patients with reported worsening of shortness of breath at specified time points.
Measure: Shortness of breath measure Time: 2 daysDescription: Self-reported worsening shortness of breath. Each report scored yes/no. Outcome will be assessed by calculating percentage of patients with reported worsening of shortness of breath at specified time points.
Measure: Shortness of breath measure Time: 5 daysDescription: Self-reported worsening shortness of breath. Each report scored yes/no. Outcome will be assessed by calculating percentage of patients with reported worsening of shortness of breath at specified time points.
Measure: Shortness of breath measure Time: 10 daysDescription: Self-reported worsening shortness of breath. Each report scored yes/no. Outcome will be assessed by calculating percentage of patients with reported worsening of shortness of breath at specified time points.
Measure: Shortness of breath measure Time: 14 daysDescription: Self reported changes in daytime cough. Each report scored 0 (no cough), 1 (one short coughing attack), 2 (two or more short coughing attacks), 3 (frequent coughing that did not interfere with activities), 4 (frequent coughing that did interfere with activities, 5 (distressing cough throughout most of the day). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in daytime cough measure Time: 2 daysDescription: Self reported changes in daytime cough. Each report scored 0 (no cough), 1 (one short coughing attack), 2 (two or more short coughing attacks), 3 (frequent coughing that did not interfere with activities), 4 (frequent coughing that did interfere with activities, 5 (distressing cough throughout most of the day). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in daytime cough measure Time: 5 daysDescription: Self reported changes in daytime cough. Each report scored 0 (no cough), 1 (one short coughing attack), 2 (two or more short coughing attacks), 3 (frequent coughing that did not interfere with activities), 4 (frequent coughing that did interfere with activities, 5 (distressing cough throughout most of the day). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in daytime cough measure Time: 10 daysDescription: Self reported changes in daytime cough. Each report scored 0 (no cough), 1 (one short coughing attack), 2 (two or more short coughing attacks), 3 (frequent coughing that did not interfere with activities), 4 (frequent coughing that did interfere with activities, 5 (distressing cough throughout most of the day). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in daytime cough measure Time: 14 daysDescription: Self reported changes in nighttime cough. Each report scored 0 (no cough), 1 (cough on waking only), 2 (wake once or early due to cough), 3 (frequent waking due to cough), 4 (frequent coughing throughout the night, 5 (distressing cough preventing any sleep). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in nighttime cough measure Time: 2 daysDescription: Self reported changes in nighttime cough. Each report scored 0 (no cough), 1 (cough on waking only), 2 (wake once or early due to cough), 3 (frequent waking due to cough), 4 (frequent coughing throughout the night, 5 (distressing cough preventing any sleep). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in nighttime cough measure Time: 5 daysDescription: Self reported changes in nighttime cough. Each report scored 0 (no cough), 1 (cough on waking only), 2 (wake once or early due to cough), 3 (frequent waking due to cough), 4 (frequent coughing throughout the night, 5 (distressing cough preventing any sleep). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in nighttime cough measure Time: 10 daysDescription: Self reported changes in nighttime cough. Each report scored 0 (no cough), 1 (cough on waking only), 2 (wake once or early due to cough), 3 (frequent waking due to cough), 4 (frequent coughing throughout the night, 5 (distressing cough preventing any sleep). Outcome will be measured by calculating change in reported cough at each time point.
Measure: Changes in nighttime cough measure Time: 14 daysDescription: Number of enrolled patients who have died within the specified time frame
Measure: Total mortality Time: 28 daysThis is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19
Description: Any symptoms of COVID-19 will be recorded in a daily diary. Symptoms (including fever measured in degrees Fahrenheit, dry cough, productive cough, difficulty speaking, wheezing, dry mouth, headache, chest tightness, difficulty with exertion, shortness of breath, sore throat, malaise, and diarrhea) will be rated as not present, mild, moderate, or severe.
Measure: Prevention of COVID-19 symptoms as recorded in a daily diary Time: 24 weeksDescription: To assess the presence or absence of side effects (graded 1-5), and whether they are tolerable (grade 1-2). AE and SAE will be recorded.
Measure: Safety as determined by presence or absence of Adverse Events and Serious Adverse Events Time: 24 weeksHealthcare workers (HCW) at risk of Covid-19 will have baseline serology for SARS-CoV-2 to see if they are already immune to Covid-19. HCW will get baseline assessment and if meeting inclusion criteria and no exclusion criteria they will be randomized in a 2:1 ratio to hydroxychloroquine or Vitamin C on a weekly basis for three months. Subjects will complete daily diary of symptoms and temperature, and will have repeat SARS-CoV-2 serology at 6 weeks and 3 months to determine seroconversion.
Description: Percentage of healthcare worker who develop antibodies to SARS-CoV-2
Measure: COVID-19 Seroconversion rate Time: 3 monthsDescription: Percentage of study subjects who require admission to a hospital for Covid-19
Measure: Admission for Covid-19 Time: 3 monthsCOVID-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 enrolmentLOVIT-COVID is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in hospitalized COVID-19 patients.
Description: Number of deceased participants or with persistant organ dysfunction (dependency on mechanical ventilation, new renal replacement therapy, or vasopressors).
Measure: Death or persistent organ dysfunction Time: Both assessed at 28 daysDescription: Number of whole and part study days for which the patient is alive and not admitted to an intensive care unit
Measure: Number of intensive care unit-free days Time: Assessed at 21 daysDescription: Number of study days in ICU without persistant organ dysfunction
Measure: Persistent organ dysfunction-free days in ICU Time: Assessed at 28 daysDescription: Mortality at 6 months
Measure: Number of patients deceased at 6 months Time: 6 monthsDescription: Assessed by the EQ-5D-5L EuroQol questionnaire (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ-5D visual analog scale (EQ VAS). The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The patient is asked to indicate her/his health state by ticking the box next to the most appropriate statement in each of the 5 dimension. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ-VAS records the patient's self-rated health on a vertical visual analog scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measure: Health related quality of life in 6-month survivors Time: 6 monthsDescription: Assessed by the Sequential Organ Failure Assessment (SOFA) score. Used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on six different sub-scores, one each for the respiratory (PaO2/fraction of inspired oxygen FiO2) mmHg), cardiovascular (mean arterial pressure OR administration of vasopressors required), hepatic (liver bilirubin mg/dl [µmol/L]), coagulation (platelets x 103/µl), renal (kidneys creatinine (mg/dl) [µmol/L] (or urine output)), and neurological (Glasgow coma scale). The sub-score of each system ranges from 0 (best) to +4 (worst).
Measure: Organ function Time: Days 1, 2, 3, 4, 7, 10, 14, 28Description: Assessed by serum lactate concentration
Measure: Global tissue dysoxia Time: Days 1, 3, 7Description: Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP).
Measure: Rate of inflammation Time: Days 1, 3, 7Description: Assessed by procalcitonin (PCT).
Measure: Rate of infection Time: Days 1, 3, 7Description: Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2).
Measure: Rate of endothelial injury Time: Days 1, 3, 7Description: Assessed by Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Measure: Occurrence of stage 3 acute kidney injury Time: Up to day 28Description: clinician judgment of hemolysis, as recorded in the chart, OR
hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product plus 2 of the following:
reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin
Description: Core lab-validated glucose level <3.8 mmol/L
Measure: Hypoglycemia Time: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose.In December 2019, a novel coronavirus, now called COVID-19, emerged as a global health threat from Wuhan, China. Within weeks, the contagious virus spread within and between communities, causing a lower respiratory tract infection dominated by symptoms of fever, cough and sore throat. The incubation period was estimated at between 5 to 7 days, but could last as long as 14 days. Although COVID-19 causes a mostly mild and self-limiting disease, respiratory involvement has been reported in about 5% of the population, requiring supplemental oxygen and even ventilatory support to relieve hypoxia. Alveolar damage, fibrosis and consolidation have been reported in radiologic and post-mortem studies. Existing data suggest a mortality rate of COVID-19 is approximately 1-2%, higher among individuals with pre-existing comorbidities and in healthcare systems with suboptimal access to ventilatory support. Given its high transmissibility, COVID-19 has quickly spread across the globe within a short interval. By 27 April 2020, over 3 million people around the world have been diagnosed with COVID-19, and more 200,000 have succumbed to the disease. As a proportion of patients manifest mild or no symptoms, these numbers are likely an underestimate of the actual number of patients with COVID-19. More disconcertingly, patients are known to shed viruses despite mild or no symptoms, making it essential that a collective approach against COVID-19 incorporate active pharmacological treatment to prevent or mitigate virus pathogenesis prior to its potential evolution to cause respiratory distress. To date, clinical trials have focused on the treatment of hospitalised patients diagnosed with COVID-19; only few have examined the clinical benefits of pharmacological agents despite few compelling in vitro data. The relatively high transmission of COVID-19 in a closed dormitory environment of migrant workers in Singapore presents a real-life scenario where a prophylaxis treatment could reduce the impact of the disease. In Singapore, there are well grounded concerns an excess in cases could pose the possibility of strain in healthcare system and mentally drain her workers. The availability of an effective prophylaxis treatment is highly desirable to potentially reduce this burden. Data from the current study could also have implications on how future outbreaks in high-density areas should be managed, especially when residents are subjected to quarantine and isolation.
Description: Acute respiratory illness is defined by acute onset with any key respiratory symptoms including cough, shortness of breath, sore throat, runny nose and change in smell.
Measure: Acute respiratory illness in treatment arms (hydroxychloroquine, ivermectin, zinc and povidone iodine) Time: At the end of study dosing, which is day 42There are currently no antiviral drugs with proven efficacy nor are there vaccines for its prevention. Unfortunately, the scientific community has little knowledge of the molecular details of SARS-CoV-2 infection. The drugs we are chosen are used as clinical trials for antiviral and there is no proven guide for specificity and effectiveness against the virus so the results are different Now the clinical trials and research authorities are work speedily to target the most proven treatment for the virus so anything is infantile until now. the covid-19 with time be more explained by scientists it is steroid response disease and cause thromosis and cytokine storm , the aim of the study to inhibit viral replication and decrease the severity of the disease as antiviral and anticytokine storm , antithrombosis Zinc is a mineral element needed to regulate adaptive immune cells' functions. Higher level of intracellular zinc showed to increase intracellular pH; which affect on RNA-dependent RNA polymerase and decrease replication mechanism of RNA viruses. Therefore, drugs that described as zinc ionophores could be used with zinc supplement to act as antiviral against many RNA viruses including SARS-CoV-2 Quercetin is natural compound act as zinc ionophore to cause zinc influx intracellular. Quercetin is a safe natural anti-oxidant and anti-inflammatory polyphenolic compound that found in various natural sources include onion, red grapes, honey and citrus fruits. It was shown that quercetin has the ability to chelate zinc ions and act as zinc ionophore. Therefore, quercetin could have antiviral activity against many RNA viruses . Quercetin, a flavonoid found in fruits and vegetables, has unique biological properties that may improve mental/physical performance and reduce infection risk ; These properties form the basis for potential benefits to overall health and disease resistance, including anti-carcinogenic, anti-inflammatory, antiviral, antioxidant, and psychostimulant activities, as well as the ability to inhibit lipid peroxidation, platelet aggregation and capillary permeability, and to stimulate mitochondrial biogenesis .There are various studies that report the immunomodulatory effect of bromelain . Bromelain activates natural killer cells and augments the production of granulocyte-macrophage-colony stimulating factor, IL-2, IL-6 and decreases the activation of Thelper cells. Thus, bromelain decreases the majority of inflammatory mediators and has demonstrated a significant role as an anti-inflammatory agent in various conditions Vitamin C is known as an essential anti-oxidant.,and enzymatic co-factor for physiological reactions such as hormone production, collagen synthesis and immune potentiation . Naturally, an insufficiency of vitamin C leads to severe injuries to multiple organs, especially to the heart and brain, since they are both highly aerobic organs that produce more oxygen radicals. In fact, studies of in vivo effect on vitamin C are difficult since most animals, except human and some primate, are capable of synthesizing vitamin C endogenously
Description: speed the days of recovery and discharge from hospital
Measure: days of stay at hospital after treatment and discharge Time: 28 daysDescription: the level of serum zinc is very important especially at chronic diseases
Measure: serum zinc before and after treatment Time: 5-10 daysDescription: according to questionnaire including BMI, smoking , underlying diseases like hypertension, diabetes , asthmatic , ..etc
Measure: questionnaire including parameters like BMI,,smoking , underling diseases, immunological treatment , Time: 28 daysDescription: day of negative conversion for nasopharyngeal swab for rt-PCR FOR covid-19
Measure: day of negative conversion for nasopharyngeal swab for rt-PCR FOR covid-19 Time: 28 daysIn this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.
Description: Time to negative RT-PRC result indicating that patient is no longer infective
Measure: Time to Non-Infectivity by RT-PCR Time: 6 monthsDescription: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score) Time: 6 monthsDescription: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score) Time: 6 monthsDescription: Patients will have serum stored for titer testing to compare antibody levels over time
Measure: Efficacy of Treatment as measured by Titer Time: 6 monthsDescription: Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment
Measure: Efficacy of Treatment as measured by RT-PCR Time: 10 daysDescription: Blood D-Dimer levels
Measure: Safety of Treatment as Measured by D-Dimer Time: 6 MonthsDescription: Blood Pro-Calcitonin levels
Measure: Safety of Treatment as Measured by Pro-Calcitonin Time: 6 MonthsDescription: Blood CRP levels
Measure: Safety of Treatment as Measured by C-Reactive Protein Time: 6 MonthsDescription: Blood ferritin levels
Measure: Safety of Treatment as Measured by Ferritin Time: 6 MonthsDescription: Blood enzyme levels
Measure: Safety of Treatment as Measured by Liver Enzymes Time: 6 MonthsDescription: CBC
Measure: Safety of Treatment as Measured by Complete Blood Count Time: 6 MonthsDescription: Blood electrolytes
Measure: Safety of Treatment as Measured by Electrolyte Levels Time: 6 MonthsDescription: Presence or absence of Grade 3 or high treatment related adverse events
Measure: Safety of Treatment as Measured by Treatment Related Adverse Events Time: 6 monthsThis is a double-blind placebo controlled trial that seeks to evaluate the impact of melatonin and vitamin C on symptoms and outcomes of patients with COVID-19.
Description: Symptom severity will be tracked electronically
Measure: Symptom Severity Time: 14 daysDescription: Determine symptom course of those with moderate or severe symptoms
Measure: Symptom progression Time: 14 daysIntroduction: SARS-CoV2 infection produces severe pneumonia with pulmonary alveolar collapse. There is no specific treatment to date. In experimental models and humans with septic shock, there is a high production of nitric oxide (NO) and reactive nitrogen species (RNS) and can cause multiple organ failure. The administration of antioxidants such as n-acetylcysteine (NAC), vitamin C, melatonin, and vitamin E participate in increasing the intracellular content of GSH, ROS sequestration, protection of the lipids of cell membranes, cytosol proteins, nuclear DNA, mitochondrial and decrease LPO. Justification: as there is no specific antiviral therapy, the therapeutic options are limited, complications and mortality are high; It is intended to evaluate the effect of antioxidants on the storm outcome of the dysregulation of oxidative stress. Hypothesis: It is postulated that adjuvant therapy with antioxidants and Pentoxifylline reduces the use of ventilators in patients with or without septic shock secondary to severe SARS-COV2 pneumonia as decreases lipoperoxidation, and corrects dysregulation of oxidative stress by increasing the antioxidant capacity. Objectives: To evaluate whether it is possible to avoid intubation or decrease assisted mechanical ventilation days, improve oxidative stress dysregulation in patients with SARS-COV2 infection with severe pneumonia with or without septic shock. Methodology: Quasi-experimental, open analytical, prospective, and longitudinal study (before-after). In patients over 18 years of age who are admitted to the CITIBANAMEX Center with or without septic shock secondary to severe SARS-COV2 pneumonia. There will be two groups: 1) patients without septic shock and 2) patients with septic shock secondary to severe pneumonia due to SARS-COV2. A single antioxidant will be applied following the clinical decision tree (NAC, Vit C, Vit E, melatonin) more Pentoxifylline orally or by orogastric tube for a total of 5 days from the start of the protocol. APACHE II will calculate the risk, SOFA, MEXSOFA, measurements of IL-8, vitamin C, NO3 / NO2, LOP, total antioxidant capacity will be carried out at baseline and 48 hours. SOFA will be calculated for seven days, in addition to days of hospitalization, days of mechanical ventilation. It was evaluated 28 days after discharge by telephone.
Description: It will be evaluated whether secondary to SARS-COV2 pneumonia, the outcome of the patient is dead.
Measure: Death from any cause Time: From admission to discharge, up to 30 days.Description: The percentage of patients with SARS-COV2 pneumonia in whom orotracheal intubation was avoided will be evaluated.
Measure: Percentage of patients who required orotracheal intubation Time: From admission to discharge, up to 1 weekDescription: It will be evaluated if it is possible to reduce the days of mechanical ventilation
Measure: Assisted mechanical ventilation Time: From admission to discharge, up to 1 weekDescription: The number of days of stay in the intensive care unit will be evaluated.
Measure: Stay in an intensive care unit Time: From admission to discharge, up to 1 weekDescription: For the measurement of lipid peroxidation, 50 µL of CH3-OH with 4% BHT plus a phosphate buffer pH 7.4 was added to 100 µL of plasma. The mixture was vigorously vortexed for 5 seconds and subsequently incubated in a water bath at 37 ° C for 30 minutes. 1.5 mL of 0.8 M tribarbituric acid was added to the sample, which was incubated in a water bath with boiling temperature for one hour. After this time and to stop the reaction, the sample was placed on ice; 1 mL 5% KCl was added to each sample, as was 4 mL of n-butanol; The sample was vortexed for 30 seconds and centrifuged at 4000 rpm at room temperature for 2 min. Subsequently, the butanol phase was extracted, and the absorbance at 532 nm was measured. The calibration curve was obtained using tetra ethoxy propane as a standard.
Measure: Measure lipoperoxidation in basal and post-therapy samples Time: Baseline and 5 days post-doseDescription: 100 mL of plasma was suspended in 1.5 mL of a reaction mixture prepared as follows: 300 mM of acetate buffer with pH 3.6, 20 mM of ferric chloride hexahydrate, and 10 mM of 2,4,6-Tris-2- Pyridyl-s-triazine dissolved in 40 mM hydrochloric acid in a ratio 10: 1: 1 v / v, respectively. The mixture was vigorously vortexed for 5 seconds. It was incubated at 37 ° C for 15 min in the dark. The absorbance was measured at 593 nm. The calibration curve was obtained using Trolox
Measure: Evaluation of the total antioxidant capacity Time: Baseline and 5 days post-doseDescription: For the measurement of NO3- / NO2-, 100 µl of plasma were added 100 µL of a 10% solution of ZnSO4, 100 µL of 0.5 N NaOH and 700 µl of tridestated water. It was shaken vigorously and centrifuged at 10,000 rpm for 5 minutes. To the resulting supernatant, Griess reagent (200 µL of 1% sulfanilamide and 200 µL of 1% N- (1-naphthyl) ethylenediamine hydrochloride) was added and incubated for 10 min protected from light at room temperature. The coloration developed after incubation was measured at an analytical wavelength of 540 nm in a double beam UV-Vis spectrometer (DW2000, SLM-Aminco, Urbana, Illinois, USA). The calibration curve was performed with a KNO3 stock solution (Spectrum Quality Products, Inc., Gardena CA) in a concentration range from 0.001 nM to 10 nM.
Measure: Oxidative and antioxidant stress Time: Baseline and 5 days post-doseDescription: Measurements will be made using the Sequential Organ Failure Assessment (SOFA) every 24 hours. With a minimum score of 0-1 which translates a mortality in initial score and the highest of 0%. The maximum score of more than 14 translates a mortality of 95.2% in the initial evaluation and 89.7% in the highest evaluation.
Measure: Effect of antioxidant therapy at the level on organ failure secondary to SARS-COV2 Time: From day 0 to day 7 post antioxidant dose.Description: Measurements will be made using the Mexico Sequential Organ Failure Assessment (MEXSOFA) every 24 hours. highest evaluation. Patients with an initial MEXSOFA score of 9 points or less calculated during the first 24 hours after admission to the ICU had a mortality rate of 14.8%, while those with an initial MEXSOFA score of 10 points or more had a mortality rate. 40% mortality rate. The MEXSOFA score at 48 h was also associated with mortality: patients with a score of 9 points or less had a mortality rate of 14.1%, while those with a score of 10 points or more had a rate of 50% mortality.
Measure: Effect of antioxidant therapy at the level on organ failure secondary to SARS-COV2 Time: From day 0 to day 7 post antioxidant dose.Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 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.
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