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Sections: Correlations,
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Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1823 | Leronlimab (700mg) Wiki | 0.34 |
| drug245 | Angiotensin 1-7 Wiki | 0.24 |
| drug3842 | congenital malformation Wiki | 0.24 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1500 | Honey Wiki | 0.24 |
| drug721 | Canakinumab Injection 300mg Wiki | 0.24 |
| drug407 | BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM Wiki | 0.24 |
| drug237 | Anakinra and Zinc Wiki | 0.24 |
| drug1985 | Measles-Mumps-Rubella Vaccine Wiki | 0.24 |
| drug722 | Canakinumab Injection 600mg Wiki | 0.24 |
| drug3447 | The usual treatment Wiki | 0.24 |
| drug2166 | Nebulised heparin Wiki | 0.24 |
| drug2160 | Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR Wiki | 0.24 |
| drug3944 | lopinavir/ritonavir Wiki | 0.24 |
| drug1980 | Mavrilimumab Wiki | 0.24 |
| drug2189 | Nigella Sativa / Black Cumin Wiki | 0.17 |
| drug1880 | Low Dose Radiotherapy Wiki | 0.17 |
| drug1033 | Dexamethasone injection Wiki | 0.17 |
| drug1698 | Interleukin-7 Wiki | 0.17 |
| drug1433 | HB-adMSCs Wiki | 0.17 |
| drug3680 | Vitamin Super B-Complex Wiki | 0.14 |
| drug2006 | Melatonin Wiki | 0.14 |
| drug2194 | Nitazoxanide Wiki | 0.13 |
| drug3046 | Sarilumab Wiki | 0.11 |
| drug2632 | Prednisone Wiki | 0.10 |
| drug1874 | Losartan Wiki | 0.09 |
| drug1196 | Enoxaparin Wiki | 0.06 |
| drug1296 | Favipiravir Wiki | 0.05 |
| drug3485 | Tocilizumab Wiki | 0.04 |
| drug364 | Azithromycin Wiki | 0.04 |
| drug1520 | Hydroxychloroquine Wiki | 0.02 |
| drug2505 | Placebo Wiki | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D006505 | Hepatitis NIH | 0.24 |
| D006506 | Hepatitis A NIH | 0.24 |
| D006519 | Hepatitis, Alcoholic NIH | 0.24 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D008457 | Measles NIH | 0.14 |
| D008231 | Lymphopenia NIH | 0.11 |
| D007249 | Inflammation NIH | 0.09 |
| D018352 | Coronavirus Infections NIH | 0.08 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.08 |
| D011014 | Pneumonia NIH | 0.07 |
| D020141 | Hemostatic Disorders NIH | 0.06 |
| D001778 | Blood Coagulation Disorders NIH | 0.06 |
| D003141 | Communicable Diseases NIH | 0.05 |
| D055370 | Lung Injury NIH | 0.05 |
| D014947 | Wounds and Injuries NIH | 0.05 |
| D007239 | Infection NIH | 0.04 |
| D011024 | Pneumonia, Viral NIH | 0.03 |
| D014777 | Virus Diseases NIH | 0.03 |
| D055371 | Acute Lung Injury NIH | 0.02 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012115 | Hepatitis HPO | 0.24 |
| HP:0001888 | Lymphopenia HPO | 0.11 |
| HP:0002090 | Pneumonia HPO | 0.07 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001928 | Abnormality of coagulation HPO | 0.06 |
Navigate: Correlations HPO
There are 17 clinical trials
This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases. The primary objective of the study is to determine the clinical efficacy and safety of Anakinra (plus zinc) compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH. Key secondary objectives broadly are as follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment response; and (b) to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH.
Description: The primary analysis will be comparisons of 90-day mortality of Prednisone and Anakinra plus zinc vs Prednisone.
Measure: Survival at 90 days Time: 90 daysDescription: Score will be calculated using the following website: https://www.mdcalc.com/lille-model-alcoholic-hepatitis (exp(-R))/(1 + exp(-R)) where the variables are as follows: R = 3.19 - 0.101*(age, years) + 0.147*(albumin day 0, g/L) + 0.0165* (evolution in bilirubin level, µmol/L) - 0.206*(renal insufficiency) - 0.0065*(bilirubin day 0, µmol/L) - 0.0096*(PT, sec) Renal insufficiency = 1 (if Cr >1.3 mg/dL (115 µmol/L)) or 0 (if ≤1.3 mg/dL (115 µmol/L))
Measure: Changes is Lille score Time: 7, 30, and 90 daysDescription: The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.
Measure: Changes in MELD score Time: 7, 30, and 90 daysDescription: Increase in creatinine of 50% above baseline over a period of 7 days Increase in creatinine of 0.3 mg/dl within a period of 48 hrs Onset of renal failure requiring dialysis
Measure: Progression of the development of AKI (acute kidney injury) Time: 7, 30, and 90 daysDescription: Defined as failure ≥2 organs
Measure: Progression of the development of multi-organ failure Time: 7, 30, and 90 daysDescription: Defined as two or more abnormalities in temperature, increased heart rate, respiration, or white blood cell count with increase in SOFA score ≥2 points
Measure: Progression of the development of SIRS (Systemic Inflammatory Response Syndrome) Time: 7, 30, and 90 daysDescription: Recording the change of hospital word from regular floor to ICU floor as a marker for worsening illness and care escalation
Measure: Number of Transfers to ICU Time: 7, 30, and 90 daysDescription: New onset of ascites if not present on admission to study New onset of variceal hemorrhage New onset of hepatic encephalopathy (HE).
Measure: Rate of changes in liver function Time: 7, 30, and 90 daysDescription: The SOFA score will be modified and re-evaluated without platelet counts given that these are usually low in AH.
Measure: Measure of changes in sequential organ failure Assessment (SOFA) scores and proportions requiring hemodynamic support for MAP < 65 mm Hg and lactate > 2 mmol/l, renal replacement therapy or mechanical ventilation. Time: 180 daysDescription: Pneumonia defined as new infiltrate by CXR or Chest CT scan not explained by "fluid overload" Positive blood cultures for bacteria or fungus, not suspected as contaminant Positive urine fungal culture > 50,000 colonies/ml Positive urine bacterial culture > 100,000 colonies/ml (mixed flora is excluded) Soft tissue or bone infections including cellulitis or abscess documented by exam or scan CNS infection defined as positive culture of CSF or > 5 WBC/ml Ascitic fluid white cell count >500/ml or neutrophils>250/ml. with or without positive bacterial or fungal cultures
Measure: Measuring the types of infections Time: 180 daysDescription: Life-threatening organ dysfunction caused by a dysregulated host response to infection An increase in SOFA score of 2 points of more Note: most participants with severe AH have 4 points based on bilirubin only
Measure: Rate of the progression of sepsis Time: 180 daysDescription: Defined by a creatinine > 2 mg/dl
Measure: Rate of the progression of renal dysfunction Time: 180 daysDescription: Proportion of participants requiring transfer to ICU for care, intubation for airway control, need for ventilator support or RRT.
Measure: Need for care escalation Time: 180 daysAlthough a number of therapeutics are being utilized by clinicians to treat patients with COVID-19, none have been systematically evaluated in clinical trials. Lopinavir/ritonavir, an antiretroviral medication, showed equivocal but possibly positive efficacy and safety in a RCT conducted in China and published in NEJM in March of 2020. Losartan, an angiotensin II receptor blocker (ARB), has theoretical benefit as SARSCoV-2 appears to bind to lung tissue via Angiotensin-Converting Enzyme 2 (ACE-2) receptors which might be inhibited by ARBs. This pragmatic adaptive trial compares outcome in COVID-19 patients treated with lopinavir/ritonavir, losartan, and placebo.
Description: difference in NCOSS scores between the different treatment groups
Measure: National Institute of Allergy and Infectious Diseases COVID-19 Ordinal Severity Scale (NCOSS) Time: 60 daysDescription: difference in the total inpatient LOS between the three treatment groups
Measure: Hospital length of stay (LOS) Time: 60 daysDescription: difference in the total ICU level care LOS between the three treatment groups
Measure: Intensive care unit level LOS Time: 60 daysDescription: difference in length of use of mechanical ventilation between the three treatment groups
Measure: Mechanical ventilation Time: 60 daysDescription: difference in all cause mortality between the four treatment groups
Measure: survival Time: 60 daysThe investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.
Description: Confirmed cases of a COVID-19 (defined by a positive PCR for SARS-CoV-2 or symptoms compatible with COVID-19 with seroconversion) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative PCR for SARS-CoV-2 on day 0 and negative serology for SARS-CoV-2 on day 0.
Measure: Confirmed cases of a COVID-19 Time: Up to 6 months after start of treatmentDescription: SARS-CoV-2 seroconversion in the PrEP group compared to placebo in during 6 months of follow-up in healthcare workers with negative serology at day 0.
Measure: SARS-CoV-2 seroconversion Time: Up to 6 months after start of treatmentDescription: Incidence of clinical and/or laboratory adverse events will be compared in the PrEP group and in the placebo arm.
Measure: Occurrence of any adverse event related with hydroxychloroquine treatment Time: Up to 6 months after start of treatmentDescription: Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers will be estimated by the number of healthcare workers diagnosed with COVID-19 in the placebo group, among the total of healthcare workers included in the non-PrEP group during the study period.
Measure: Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers Time: Up to 6 months after start of treatmentDescription: A repository (biobank) of serum samples obtained from healthcare workers confirmed COVID-19 cases for future research on blood markers to predict SARS-CoV-2 infection.
Measure: COVID-19 Biobank Time: Up to 6 months after start of treatmentThis individually randomized telemedicine-based trial aims to evaluate the efficacy of a single dose of azithromycin for prevention of progression of COVID-19 in patients with a recent positive SARS-CoV-2 test who are not currently hospitalized.
Description: All-cause hospitalization or emergency room stay of >24 hours
Measure: Hospitalization Time: 14 daysDescription: Viral load by self-collected nasal swab
Measure: Viral load Time: 3 daysDescription: Viral load by self-collected saliva swab
Measure: Viral load Time: 3 daysDescription: All-cause mortality
Measure: Mortality Time: 14 daysDescription: Proportion of participants experiencing adverse events, including gastrointestinal side effects and rash
Measure: Adverse events Time: 3 daysDescription: Prevalence of positive SARS-CoV-2 test by self-collected nasal swab
Measure: Positive SARS-CoV-2 test - nasal swab Time: 3 daysDescription: Prevalence of positive SARS-CoV-2 test by self-collected saliva swab
Measure: Positive SARS-CoV-2 test - saliva swab Time: 3 daysDescription: Prevalence of positive SARS-CoV-2 test by self-collected rectal swab
Measure: Positive SARS-CoV-2 test - rectal swab Time: 3 daysDescription: Prevalence of genetic macrolide resistance determinants by self-collected rectal swab
Measure: Genetic macrolide resistance determinants Time: 3 daysDescription: Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms
Measure: COVID-19 symptoms Time: 3, 7, 14, 21 daysDescription: Number of emergency room visits <24 hours
Measure: Number of emergency room visits Time: 14 daysDescription: Number of household members with confirmed or symptomatic COVID-19
Measure: Number of household members with COVID-19 (confirmed or symptomatic) Time: 14 daysDescription: Deaths within the study will be attempted to be matched with the US National Death Index
Measure: Death Time: 21 daysBackground: A novel Coronavirus (SARS-CoV-2) described in late 2019 in Wuhan, China, has led to a pandemic and to a specific coronavirus-related disease (COVID-19), which is mainly characterized by a respiratory involvement. While researching for a vaccine has been started, effective therapeutic solutions are urgently needed to face this threaten. The renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host 's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a key role in the modulation of the inflammatory response that characterizes the lung involvement. Angiotensin-(1-7) is a peptide that is downregulated in COVID-19 patient and it may potentially improve respiratory function in this setting. Methods/Design: The Investigators describe herein the methodology of a randomized, controlled, adaptive Phase II/Phase III trial to test the safety, efficacy and clinical impact of the infusion of angiotensin-(1-7) in COVID-19 patients with respiratory failure requiring mechanical ventilation. A first phase of the study, including a limited number of patients (n=20), will serve to confirm the safety of the study drug, by observing the number of the severe adverse events. In a second phase, the enrollment will continue to investigate the primary endpoint of the study (i.e. number of days where the patient is alive and not on mechanical ventilation up to day 28) to evaluate the efficacy and the clinical impact of this drug. Secondary outcomes will include the hospital length of stay, ICU length of stay, ICU and hospital mortality, time to weaning from mechanical ventilation, reintubation rate, secondary infections, needs for vasopressors, PaO2/FiO2 changes, incidence of deep vein thrombosis, changes in inflammatory markers, angiotensins plasmatic levels and changes in radiological findings. The estimated sample size to demonstrate a reduction in the primary outcome from a median of 14 to 11 days is 56 patients, 60 including a dropout rate of 3% (i.e. 30 per group), but a preplanned recalculation of the study sample size is previewed after the enrollment of 30 patients. Expected outcomes/Discussion: This controlled trial will assess the efficacy, safety and clinical impact of the Angiotensin-(1-7) infusion in a cohort of COVID-19 patients requiring mechanical ventilation. The results of this trial may provide useful information for the management of this disease.
Description: composite outcome of mortality and necessity of mechanical ventilation
Measure: ventilator free days Time: 28 daysDescription: number of days free from intensive care unit
Measure: ICU free days Time: trough study completion, on average 40 daysDescription: Hospital length of stay
Measure: Hospital length of stay Time: through study completion, on average 60 daysDescription: Time to wean from mechanical ventilation
Measure: Time to wean from mechanical ventilation Time: through study completion, on average 14 daysDescription: PaO2/FiO2 changes during drug administration
Measure: PaO2/FiO2 changes during drug administration Time: 48 hoursDescription: US confirmed deep vein thrombosis
Measure: Deep vein thrombosis incidence Time: through study completion, on average 30 daysDescription: including IL-1, IL-2, IL-6, IL-7, IL-8, IL-10, TNF-alpha, interferon gamma
Measure: Changes in inflammatory markers Time: at randomization, 48 hours after randomization and 72 hours after randomizationDescription: Ang II and Ang-(1-7) plasmatic levels
Measure: RAS effectors levels Time: at randomization, 48 hours after randomization and 72 hours after randomizationDescription: Chest x-ray or CT scan changes
Measure: Radiological findings Time: through study completion, on average 30 daysDescription: phase 2b = principal safety outcome; phase 3 = secondary outcome
Measure: Rate of serious adverse events Time: study drug administration/day 28 or ICU discharge or deathThis is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.
Description: Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. [0=none, 1=mild, 2=moderate, and 3=severe]. Higher scores mean a worse outcome.
Measure: Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) Time: Day 14Description: This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). Higher scores mean a worse outcome.
Measure: Change from baseline in National Early Warning Score 2 (NEWS2) Time: Days 3, 7, and 14Description: A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. Lower scores mean a worse outcome.
Measure: Change from baseline in the patient's health status on a 7-category ordinal scale Time: Days 3, 7, and 14The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.
Description: Day 0 refers to the data of randomization/first treatment.
Measure: All-cause mortality at Day 28 Time: Day 28Description: Day 0 refers to the data of randomization/first treatment.
Measure: All-cause mortality at Day 14 Time: Day 14Description: A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measure: Change in clinical status of subject at Day 14 (on a 7 point ordinal scale) Time: Day 14Description: A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measure: Change in clinical status of subject at Day 28 (on a 7 point ordinal scale) Time: Day 28Description: The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine
Measure: Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. Time: Day 14To evaluate the effectiveness of Nigella Sativa (1 gm seed powder in a capsule orally) and 30 ml of honey stirred in 250 ml of distilled water 12 hourly till patient becomes asymptomatic or a maximum of 14 days with standard hospital care versus standard hospital care alone with placebo capsule and 250 ml water, in clearing the COVID-19 nucleic acid from throat and nasal swab, lowering disease detrimental effects on HRCT chest/X-ray and severity of symptoms along with duration of hospital stay till day 14th day of follow up and 30 days mortality (primary outcomes).
Description: RT-PCR will be done on admission day (0 day) and then after every 4th day for 14 days or till the symptoms resolved and RT-PCR gets negative. RT-PCR will only be shown as positive or negative (as per limitation of Pakistan).
Measure: Days required to get a positive COVID-19 PCR to negative Time: upto max 14 daysDescription: HRCT will be conducted at admission day (0-day) and a total of maximum four CT-scan will be conducted after every 4th day. The minimum and score at which we label covid-19 positive will be 5 and 25 respectively using internationally standard nomenclature as described by Fleischner Society glossary and peer-reviewed literature on viral pneumonia.
Measure: HRCT/ X-ray findings of disease progression Time: upto max 14 daysDescription: Clinically disease progression will be evaluated depending upon the severity of symptoms being classified as mild, moderate and severe.
Measure: Severity of symptoms progression Time: upto max 14 daysDescription: Duration of hospital stay would be categorized as the number of days the patient stayed in the ward during treatment. The date of admission and date of discharge would give us total duration of stay.
Measure: Duration of Hospital Saty Time: upto max 14 dayDescription: 30 days mortality rate in each arm
Measure: 30 day mortality Time: 30 daysDescription: every 4th day oxygen saturation at room air will be checked to evaluate the disease progression
Measure: Oxygen Saturation at room air Time: upto max of 14 daysDescription: Involvement of cardiac complications will be assessed
Measure: Incidence of viral myocarditis Time: upto max 14 daysDescription: Lethal complication like ARDS will be assessed to evaluate disease severity
Measure: Incidence of Acute respiratory Distress Syndrome Time: upto max 14 daysHope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) to provide immune support against COVID-19. The study purpose is to evaluate the safety and efficacy of five IV infusions of HB-adMSCs in subjects with no signs of COVID-19.
Description: Number of subjects that must be hospitalized for COVID-19 during the conduct of this study
Measure: Incidence of hospitalization for COVID-19 Time: week 0 through week 26 (end of study)Description: Number of subjects who experience symptoms defined to be associated with COVID-19, such as fever, shortness of breath/difficulty breathing, cough.
Measure: Incidence of symptoms associated with COVID-19 Time: week 0 through week 26 (end of study)Description: Number of subjects that develop upper/lower respiratory infection with hospitalization criteria
Measure: Absence of upper/lower respiratory infection Time: week 0 through week 26Description: change from baseline in leukocyte differential
Measure: Leukocyte differential Time: weeks 0, 6, 14, 26Description: change from baseline in C Reactive protein
Measure: C Reactive protein Time: weeks 0, 6, 14, 26Description: change from baseline in TNF alpha
Measure: TNF alpha Time: weeks 0, 6, 14, 26Description: change from baseline in IL-6
Measure: IL-6 Time: weeks 0, 6, 14, 26Description: change from baseline in IL-10
Measure: IL-10 Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of glucose in the blood (mg/dL)
Measure: Glucose Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of calcium in the blood (mg/dL)
Measure: Calcium Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of albumin in the blood (g/dL)
Measure: Albumin Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of total protein in the blood (g/dL)
Measure: Total protein Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of sodium in the blood (mol/L)
Measure: Sodium Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of total carbon dioxide in the blood (mmol/L)
Measure: Total carbon dioxide Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of potassium in the blood (mmol/L)
Measure: Potassium Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of chloride in the blood (mmol/L)
Measure: Chloride Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of BUN in the blood (mg/dL)
Measure: BUN Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of creatinine in the blood (mg/dL)
Measure: Creatinine Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of alkaline phosphatase in the blood (IU/L)
Measure: Alkaline phosphatase Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of alanine aminotransferase in the blood (IU/L)
Measure: Alanine aminotransferase Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of total bilirubin in the blood (mg/dL)
Measure: Total bilirubin Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of white blood cells in the blood (x 10^3/uL)
Measure: white blood cells Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of red blood cells in the blood (x 10^6/uL)
Measure: red blood cells Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of hemoglobin in the blood (g/dL)
Measure: hemoglobin Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of level of hematocrit in the blood (%)
Measure: hematocrit Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of mean corpuscular volume in the blood (fL)
Measure: mean corpuscular volume Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of mean corpuscular hemoglobin in the blood (pg)
Measure: mean corpuscular hemoglobin Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of mean corpuscular hemoglobin concentration in the blood (g/dL)
Measure: mean corpuscular hemoglobin concentration Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of red cell distribution width in the blood (%)
Measure: red cell distribution width Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of neutrophils in the blood (%)
Measure: neutrophils Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of lymphocytes in the blood (%)
Measure: Lymphs Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of monocytes in the blood (%)
Measure: Monocytes Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of eosinophils in the blood (%)
Measure: Eosinophils Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of basophils in the blood (%)
Measure: Basophils Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of absolute neutrophils in the blood (x 10^3/uL)
Measure: Absolute neutrophils Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of absolute lymphocytes in the blood (x 10^3/uL)
Measure: Absolute lymphs Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of absolute monocytes in the blood (x 10^3/uL)
Measure: Absolute monocytes Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of absolute eosinophils in the blood (x 10^3/uL)
Measure: Absolute eosinophils Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of absolute basophils in the blood (x 10^3/uL)
Measure: Absolute basophils Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of immature granulocytes in the blood (x 10^3/uL)
Measure: Immature granulocytes Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of platelets in the blood (x 10^3/uL)
Measure: Platelets Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of time for blood to coagulate (seconds)
Measure: Prothrombin time Time: weeks 0, 6, 14, 26Description: clinical lab evaluation of international normalized ratio of blood coagulation (no unit)
Measure: INR Time: weeks 0, 6, 14, 26Description: Short-form 36 Health Survey; scored on a scale of 0-100; lower score equals more disability
Measure: SF-36 Time: weeks 0, 6, 14, 26Description: Depression module; scores DSM-IV criteria 0-3 to monitor severity of depression
Measure: PHQ-9 Time: weeks 0, 6, 14, 26Faviprevir in COVID-19 treatment
Description: The total number of patients with viral cure
Measure: Number of patients with viral cure Time: 6 monthsThis is a randomized, double blind, multi-center study to evaluate the effects of tocilizumab compared to placebo on patient outcomes in participants with confirmed SARS-CoV-2 infection and evidence of systemic inflammation. The aim of this study is to test the effect of Tocilizumab on multi-organ dysfunction in a phase 3 randomized controlled trial among hospitalized patients with COVID-19 infection. Specifically, as compared to placebo, we will test whether tocilizumab is associated with a reduction in multi-organ dysfunction among hospitalized COVID-19 adult patients with elevated inflammatory measures. Multi-organ dysfunction will be measured as the incidence of the following composite endpoint (mechanical ventilation, renal replacement therapy, mechanical support, need for inotropes or vasopressors, liver dysfunction (increased bilirubin), and all-cause mortality). We will also assess multiple pre-specified secondary (exploratory) endpoints and safety endpoints. We hypothesize that, as compared to placebo, tocilizumab will reduce transfer to the ICU, need for mechanical ventilation, increase rates of hospital discharge in patients diagnosed with severe COVID-19 infection and evidence of exaggerated inflammatory response.
Description: The primary endpoint is the time from administration of the investigational agent (or placebo) to requiring mechanical ventilation and intubation, or death for subjects who die prior to intubation
Measure: The primary endpoint is the time from administration of the investigational agent (or placebo) to requiring mechanical ventilation and intubation, or death for subjects who die prior to intubation Time: 28 daysDescription: Time to improvement will be assessed by changes in subjects' status, ranked on the ordinal scale: Clinical Improvement Scale Discharged (or "ready for discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or <= 2L supplemental oxygen) Non-ICU hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring ECMO or mechanical ventilation and additional organ support (e.g. vasopressors, renal replacement therapy) Death Higher scores indicate a worse outcome.
Measure: Time from investigational medication (or placebo) to at least one point worsening on clinical improvement scale for subjects requiring supplemental oxygen (score >= 3) at baseline, or at least two point worsening otherwise (score = 2 at baseline Time: 28 daysDescription: Time from administration of the investigational agent (or placebo) to absence of the need for supplemental oxygen among those who require at least supplemental oxygen at baseline
Measure: Time from administration of the investigational agent (or placebo) to absence of the need for supplemental oxygen among those who require at least supplemental oxygen at baseline Time: 28 daysDescription: Time to improvement will be assessed by changes in subjects' status, ranked on the ordinal scale: Clinical Improvement Scale Discharged (or "ready for discharge" as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or <= 2L supplemental oxygen) Non-ICU hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring ECMO or mechanical ventilation and additional organ support (e.g. vasopressors, renal replacement therapy) Death Higher scores indicate a worse outcome.
Measure: Time to first improvement from baseline of at least 2 points (or the maximum amount) on the ordinal scale given in Table 2. Time: 28 daysDescription: Time to absence of the need for supplemental oxygen will be measured from time of investigational treatment administration. We will use the same approach as that employed for the comparison of time to clinical improvement. Only subjects on supplemental oxygen at the time of randomization will contribute to this analysis. Subjects who die will be censored at 29 days, and the groups will be compared using a stratified log-rank test and stratified Cox proportional hazards model. The duration of supplemental oxygen will be compared between the groups. For this analysis, we will include all subjects in the analysis by assigning all subjects who did not receive supplemental oxygen a value of 0. Subjects who died following supplemental oxygen will be given a value of the number of days from when supplemental oxygen began until the end of the follow-up period. The groups will be compared using a Wilcoxon rank sum test.
Measure: Time from initiation of supplemental oxygen to end of supplemental oxygen use during 28-day study follow-up period. Time: 28 daysDescription: Time to death will be measured from the time the investigational medication is administered until the time of the subject's death. We will compare the groups using a stratified log-rank test and estimate the hazard ratio comparing the groups using a stratified Cox proportional hazards model.
Measure: Time from administration of the investigational agent (or placebo) to death Time: 28 daysDescription: Time to intubation will be measured from time of investigational treatment administration to the time of intubation. For this analysis, death will be treated as a competing risk. The analysis will compare the cause-specific hazard in the treatment groups using a Cox proportional hazards model. We will also compare the cumulative incidence functions between groups using the approach of Fine and Gray.
Measure: Time from administration of the investigational medication (or placebo) to intubation. Time: 28 daysDescription: Mortality at 28 days will be compared using a Mantel-Haenszel test to allow stratification on study site. The relative risk will be estimated using the Mantel-Haenszel method. If we have missing mortality data on any subjects, we will estimate the proportion of subjects who died in each treatment group using the estimate from the Kaplan-Meier curve in each group. Then, we will compare the two groups using the approaches described in Klein et al (citation: Klein JP, Logan B, Harhoff M, Anderson PK. Analyzing survival curves at a fixed point in time. Statistics in Medicine. 2007;26:4505-4519.)
Measure: Mortality at 28 days after administration of investigational agent (or placebo). Time: 28 daysDescription: The duration of mechanical ventilation will be compared between the groups using two approaches. First, we will include all subjects in the analysis by assigning all subjects who were not intubated a value of 0. Subjects who died following intubation will be given a value of the number of days from when mechanical ventilation began until the end of the follow-up period. The groups will be compared using a Wilcoxon rank sum test. Second, we will analyze only subjects who were intubated and compare the time on mechanical ventilation using a stratified log-rank test. Subjects who die without being taken off the ventilator will be censored at a duration of mechanical ventilation longer than the longest time.
Measure: Duration of mechanical ventilation during 28-day study follow-up period. Time: 28 daysDescription: The proportion of subjects requiring ICU admission between baseline and 28 days will be measured as the number of subjects requiring ICU admission over their hospitalization over the number of evaluable subjects (i.e., the number of subjects not in the ICU at the time of investigational treatment administration). The groups will be compared using a Mantel-Haenszel test to allow stratification on study site. The relative risk will be estimated using the Mantel-Haenszel method.
Measure: ICU admission or death among those not in the ICU at the time of administration of investigational agent (or placebo). Time: 28 daysDescription: The time to discharge from the hospital in subjects, measured from the time of investigational treatment administration to time of discharge, will be compared using a stratified log-rank test. Subjects who die will be censored at Day 29 to indicate that they never left the hospital during the study.
Measure: Time from administration of the investigational medication (or placebo) to hospital discharge Time: 28 daysDescription: The proportion of adverse events graded by CTCAE v5.0
Measure: Safety and tolerability Time: 28 daysDescription: The raw ordinal scale scores at days 4, 7, 14, 21, and 28 in subjects treated with tocilizumab therapy versus controls will be compared at each time point using a random intercept proportional odds logistic regression model. This model will be used to model all measurements together to estimate the differences between the treatment groups at each time point.
Measure: Ordinal Clinical Improvement Scale (Table 2) score at day: 4, 7, 14, 21, and 28. Time: Days 4, 7, 14, 21, and 28Till now, mortality reports among children below 9 years remains extremely low despite that the incidence of death toll is high and exceeding 50,000 patients among older population, One speculation for lower SARS infectivity is that cross-protective antibodies against measles vaccine ( MV). In mice susceptible to measles virus, recombinant MV induced the highest titers of neutralizing antibodies and fully protected immunized animals from intranasal infectious challenge with SARS-CoV, The primary objective of the present study is to determine the benefit of measles vaccine in health care professional to decrease the incidence of COVID-19. We Hypothesized that, measles vaccine may lower the incidence of serologically proven SARS-CoV-2 infection and reported respiratory illness
Description: Number of participants with asymptomatic or mild COVID-19 disease defined as fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, runny/blocked nose (using self-reported questionnaire), plus positive SARS-Cov-2 test (PCR or serology)
Measure: COVID-19 disease incidence Time: Time Frame: Measured over the 6 months following randomizationDescription: Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Measure: SARS-CoV-2 pneumonia Time: Time Frame: Measured over the 6 months following randomizationDescription: Number of days admitted to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Measure: Critical care admission duration with SARS-CoV-2 Time: Time Frame: Measured over the 6 months following randomizationDescription: Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Measure: Oxygen therapy with SARS-CoV-2 Time: Time Frame: Measured over the 6 months following randomizationThis trial will determine the safety and estimate efficacy of targeted corticosteroids in mechanically ventilated patients with the hyper-inflammatory sub phenotype of ARDS due to coronavirus disease 2019 (COVID-19) by implementing a Phase 2A clinical trial.
Description: Total number of ventilator free days to day 28 of hospitalization. If a patient dies prior to day 28, they will be counted as zero ventilator free days. Follow up will be performed via phone or electronically to determine ventilator free status of those patients discharged prior to day 28.
Measure: Ventilator Free Days (VFD) at Day 28 Time: 28 DaysDescription: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.
Measure: Clinical Status at day 14 as measured by World Health Organization (WHO) 7-point ordinal scale. Time: 14 DaysTThe purpose of this prospective, Phase 2, single center, blinded, randomized controlled study is to demonstrate as a proof of concept that early treatment with canakinumab prevents progressive heart and respiratory failure in patients with COVID-19 infection. These results will lead to and inform a Phase III randomized placebo-controlled trial.
Description: Number of days
Measure: Time to clinical improvement up to day 14, defined as the time in days from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever occurs first. Time: Up to day 14Description: Number of days
Measure: Mortality at day 28 Time: Up to day 28Comparison of the effects of CYT107 vs Placebo administered IM at 10µg/kg twice a week for two weeks on immune reconstitution of lymphopenic COVID-19 patients.
Description: A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or Hospital Discharge
Measure: Improvement of the absolute lymphocyte count (ALC) of lymphopenic (ALC≤1000/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whicheve Time: 1 monthDescription: The time to clinical improvement to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by clinical improvement score
Measure: To obtain "clinical improvement" as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD. Time: 1 monthDescription: The decrease of SARS-CoV-2 viral load from measurements at baseline and days of treatment dose 4 and dose 5, Day 21 and Day 30 or HD (whichever occurs first)
Measure: determine if CYT107 will lead to a significant decline of SARS-CoV-2 viral load through day 30 or HD Time: one monthDescription: Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45
Measure: To compare the effect of CYT107 versus placebo on the frequency of secondary infections through day 45 Time: 45 daysDescription: Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)
Measure: To compare the effect of CYT107 versus placebo on the length of hospitalization Time: 45 daysDescription: Number of days in ICU during index hospitalization
Measure: To compare the effect of CYT107 versus placebo on the length of stay in ICU Time: 45 daysDescription: Readmissions to ICU through Day 45
Measure: To compare the effect of CYT107 versus placebo on readmissions to ICU Time: 45 daysDescription: Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days.)
Measure: To compare the effect of CYT107 versus placebo on organ support free days Time: 45 daysDescription: Number of readmissions to the hospital through Day 45
Measure: To compare the effect of CYT107 versus placebo on the frequency of re-hospitalization through day 45 Time: 45 daysDescription: All-cause mortality through Day 45
Measure: To assess the impact of CYT107 on all-cause mortality through day 45 Time: 45 daysDescription: Absolute numbers of CD4+ and CD8+ T-cell counts at timepoints indicated on the Schedule of Activities (SoA) through Day 30 or HD
Measure: To determine the effect of CYT107 on CD4+ and CD8+ T cell counts Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30
Measure: To track and evaluate other known biomarkers of inflammation: Ferritin Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30
Measure: To track and evaluate other known biomarkers of inflammation: CRP Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30
Measure: To track and evaluate other known biomarkers of inflammation: D-dimer Time: 30 daysDescription: Evaluate improvement of the NEWS2 score value
Measure: Evaluation of physiological status through NEWS2 score Time: 30 daysDescription: Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0 to assess severity)
Measure: Safety assessment Time: 45 daysThe purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation.
Description: Number of subjects alive and off of oxygen
Measure: Proportion of subjects alive and off of oxygen at day 14 Time: Day 14Description: Number of subjects that are alive
Measure: Proportion of subjects alive at 28 days Time: Day 28Description: Number of subjects alive and without respiratory failure
Measure: Proportion of subjects alive and without respiratory failure at 28 days Time: Day 28The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation.
Description: Number of subjects alive and off of oxygen
Measure: Proportion of subjects alive and off of oxygen at day 14 Time: 14 daysDescription: Number of subjects alive and without respiratory failure
Measure: Proportion of subjects alive and without respiratory failure at 28 days Time: 28 daysAlphabetical 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.
Drug Reports MeSH Reports HPO Reports