Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2298 | Mavrilimumab Wiki | 0.26 |
| drug2180 | Low Dose (10 mg) Control Wiki | 0.17 |
| drug709 | CLBS119 Wiki | 0.17 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4568 | mavrilimumab Wiki | 0.17 |
| drug213 | Ad26.ZEBOV Wiki | 0.17 |
| drug85 | ABX464 Wiki | 0.17 |
| drug2936 | Placebo Control Wiki | 0.17 |
| drug3808 | Supplement Drink Wiki | 0.17 |
| drug3304 | Regadenoson Wiki | 0.17 |
| drug3777 | Stem Cell Educator-Treated Mononuclear Cells Apheresis Wiki | 0.17 |
| drug299 | Anthocyanins Wiki | 0.17 |
| drug2261 | MVA-BN-Filo Wiki | 0.17 |
| drug2159 | Lopinavir 200 MG / Ritonavir 50 MG [Kaletra] Wiki | 0.17 |
| drug4174 | V-SARS Wiki | 0.17 |
| drug1199 | Dexmedetomidine Injectable Product Wiki | 0.17 |
| drug4599 | nangibotide Wiki | 0.17 |
| drug3376 | Risk factors Wiki | 0.17 |
| drug3608 | Sham Device Treatment Wiki | 0.17 |
| drug2993 | Placebo-LDE phase 2 Wiki | 0.17 |
| drug297 | Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB) Wiki | 0.17 |
| drug1563 | Folic Acid Wiki | 0.17 |
| drug2360 | Methotrexate-LDE phase 1 Wiki | 0.17 |
| drug4123 | UCMSCs Wiki | 0.17 |
| drug2611 | Non-invasive red LLLT treatment to chest of patient. Wiki | 0.17 |
| drug281 | Anakinra and Ruxolitinib (overcome stage 3) Wiki | 0.17 |
| drug279 | Anakinra alone (stages 2b/3) Wiki | 0.17 |
| drug318 | Antibody testing Wiki | 0.17 |
| drug2482 | NK-1R antagonist Wiki | 0.17 |
| drug1818 | Hydroxychloroquine sulfate &Azithromycin Wiki | 0.17 |
| drug2361 | Methotrexate-LDE phase 2 Wiki | 0.17 |
| drug3106 | Prone Wiki | 0.17 |
| drug2854 | Pemziviptadil (PB1046) Wiki | 0.17 |
| drug3874 | TD-0903 Wiki | 0.12 |
| drug2040 | Ivermectin Oral Product Wiki | 0.12 |
| drug3968 | Tezepelumab Wiki | 0.12 |
| drug2251 | MSC Wiki | 0.12 |
| drug1795 | Hydroxychloroquine Sulfate Wiki | 0.10 |
| drug354 | Ascorbic Acid Wiki | 0.09 |
| drug2998 | Placebos Wiki | 0.08 |
| drug3287 | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Wiki | 0.08 |
| drug1127 | DAS181 Wiki | 0.07 |
| drug2916 | Placebo Wiki | 0.07 |
| drug4168 | Usual Care Wiki | 0.06 |
| drug1193 | Dexamethasone Wiki | 0.06 |
| drug963 | Colchicine Wiki | 0.05 |
| drug4650 | placebo Wiki | 0.04 |
| drug3738 | Standard of care Wiki | 0.03 |
| drug2981 | Placebo oral tablet Wiki | 0.03 |
| drug4025 | Tocilizumab Wiki | 0.03 |
| drug421 | Azithromycin Wiki | 0.03 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D019954 | Neurobehavioral Manifestations NIH | 0.17 |
| D001982 | Bronchial Diseases NIH | 0.17 |
| D008589 | Meningococcal Infections NIH | 0.17 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D015817 | Eye Infections NIH | 0.17 |
| D006969 | Hypersensitivity, Immediate NIH | 0.17 |
| D012130 | Respiratory Hypersensitivity NIH | 0.17 |
| D000071257 | Emergence Delirium NIH | 0.17 |
| D008585 | Meningitis, Meningococcal NIH | 0.12 |
| D008581 | Meningitis, Mening NIH | 0.12 |
| D000075902 | Clinical Deterioration NIH | 0.12 |
| D000073296 | Noncommunicable Diseases NIH | 0.12 |
| D003231 | Conjunctivitis NIH | 0.12 |
| D011014 | Pneumonia NIH | 0.11 |
| D009080 | Mucocutaneous Lymph Node Syndrome NIH | 0.10 |
| D011654 | Pulmonary Edema NIH | 0.10 |
| D003693 | Delirium NIH | 0.08 |
| D006967 | Hypersensitivity, NIH | 0.08 |
| D007154 | Immune System Diseases NIH | 0.07 |
| D008171 | Lung Diseases, NIH | 0.07 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.06 |
| D003704 | Dementia NIH | 0.06 |
| D055371 | Acute Lung Injury NIH | 0.06 |
| D011665 | Pulmonary Valve Insufficiency NIH | 0.06 |
| D003324 | Coronary Artery Disease NIH | 0.06 |
| D006333 | Heart Failure NIH | 0.05 |
| D001249 | Asthma NIH | 0.05 |
| D013577 | Syndrome NIH | 0.05 |
| D006331 | Heart Diseases NIH | 0.05 |
| D008173 | Lung Diseases, Obstructive NIH | 0.05 |
| D002908 | Chronic Disease NIH | 0.05 |
| D060825 | Cognitive Dysfunction NIH | 0.04 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.04 |
| D018352 | Coronavirus Infections NIH | 0.04 |
| D012140 | Respiratory Tract Diseases NIH | 0.03 |
| D055370 | Lung Injury NIH | 0.03 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
| D011024 | Pneumonia, Viral NIH | 0.02 |
| D014777 | Virus Diseases NIH | 0.02 |
| D003141 | Communicable Diseases NIH | 0.01 |
| D007239 | Infection NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001287 | Meningitis HPO | 0.12 |
| HP:0000509 | Conjunctivitis HPO | 0.12 |
| HP:0002090 | Pneumonia HPO | 0.11 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100598 | Pulmonary edema HPO | 0.10 |
| HP:0012393 | Allergy HPO | 0.08 |
| HP:0002088 | Abnormal lung morphology HPO | 0.07 |
| HP:0000726 | Dementia HPO | 0.06 |
| HP:0001677 | Coronary artery atherosclerosis HPO | 0.06 |
| HP:0010444 | Pulmonary insufficiency HPO | 0.06 |
| HP:0001635 | Congestive heart failure HPO | 0.05 |
| HP:0002099 | Asthma HPO | 0.05 |
| HP:0006536 | Pulmonary obstruction HPO | 0.05 |
| HP:0001268 | Mental deterioration HPO | 0.04 |
Navigate: Correlations HPO
There are 33 clinical trials
The aim of this project is to study the safety and efficacy of anthocyanins in improving key dementia-related mechanisms and cognitive functioning in older people at risk for dementia. Secondary analyses will include a variety of biological measures, including biochemistry, imaging and cardiovascular measures.
Description: A composite measure from the CogTrack battery
Measure: Quality of episodic memory. Time: Baseline to 24 weeksDescription: CogTrack evaluates attentional intensity index, sustained intensity index, cognitive reaction time, attentional fluctuation index, quality of working memory, quality of episodic memory and speed of memory retrieval.
Measure: Secondary endpoints from CogTrack Time: Baseline to 24 weeksDescription: Lipid profile, fatty acids, cytokines ( among others: IL-1, IL-2, IL-6, TNF-a), plasma antoxidant status and vitamins (lipid peroxidation markers, vitamins E, C, A, total plasma antioxidant capacity, glutathion)., carinthine, blood glucose, HbA1c, anthocyanins and metabolites, mapping of a-beta degradation products.
Measure: Blood outcome analysis Time: Baseline to 24 weeksDescription: Flow-mediated dilation (FMD), Cardiac-ankle vascular index (CAVI), photoplethysmogram (PPG).
Measure: Cardiovascular parameters Time: Baseline to 24 weeksDescription: Microbiota
Measure: Fecal analysis Time: Baseline to 24 weeksDescription: kyrinin
Measure: Urine analysis Time: Baseline to 24 weeksDescription: anthocyanin metabolites
Measure: CSF measurements Time: Baseline to 24 weeksDescription: Diagnosing and follow-up of cerebrovascular disease
Measure: MR-imaging/CT Time: Baseline to 24 weeksA phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in adults with inadequately controlled asthma.
Description: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.
Measure: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies. Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.Description: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.Description: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.Description: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.Currently, the growing epidemic of a new coronavirus infectious disease (Covid-19) is wreaking havoc worldwide, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is a RNA virus that display high similarity in both genomic and proteomic profiling with SARS-CoV that first emerged in humans in 2003 in China. Therefore, preventing and controlling the pandemic occurrences are extremely urgent as a global top priority. Due to the lack of effective antiviral drugs, patients may be treated by only addressing their symptoms such as reducing fever. Clinical autopsies from SARS-CoV-infected patients demonstrated that there were major pathological changes in the lungs, immune organs, and small systemic blood vessels with vasculitis. However, the detection of SARS-CoV were primarily found in the lung and trachea/bronchus, but was undetectable in spleen, lymph nodes, bone marrow, heart and aorta, highlighting the overreaction of immune responses induced by viral infection were really harmful, resulting in the pathogenesis of lungs, immune organs, and small systemic blood vessels. To this respect, immune modulation strategy may be potentially beneficial to enhance anti-viral immunity and efficiently reduce the viral load, improve clinical outcomes, expedite the patient recovery, and decline the rate of mortality in patients after being infected with SARS-CoV-2. Tianhe Stem Cell Biotechnologies Inc. has developed a novel globally-patented Stem Cell Educator (SCE) technology designed to reverse the autoimmune response in Type 1 diabetes (T1D), Alopecia Areata (AA) and other autoimmune diseases. SCE therapy uses human multipotent cord blood stem cells (CB-SC) from human cord blood. Their properties distinguish CB-SC from other known stem cell types, including mesenchymal stem cells (MSC) and hematopoietic stem cells (HSC). Several clinical studies show that SCE therapy functions via CB-SC induction of immune tolerance in autoimmune T cells and restore immune balance and homeostasis in patients with T1D, AA and other inflammation-associated diseases. To correct the overreaction of overreaction of immune responses, the investigators plan to treat SARS-CoV-2 patients with Stem Cell Educator therapy.
Description: The feasibility will be evaluated by the number of Covid-19 patients who were unable to complete SCE Therapy.
Measure: Determine the number of Covid-19 patients who were unable to complete SCE Therapy Time: 4 weeksDescription: Measurements of immune markers' changes will be preformed by flow cytometry such as activated T cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.
Measure: Examine the percentage of activated T cells after SCE therapy by flow cytometry Time: 4 weeksDescription: Measurements of immune marker's changes will be preformed by flow cytometry such as the percentage of Th17 cells. Peripheral blood mononuclear cells (PBMC) will be collected at 1, 3, 6, 9, 12, 28 day post the SCE therapy.
Measure: Assess the percentage of Th17 cells after SCE therapy by flow cytometry Time: 4 weeksDescription: Patients will be monitored for their chest imaging every 3 - 5 days for 4 weeks after receiving SCE therapy.
Measure: Chest imaging changes by computed tomography (CT) scan of the chest Time: 4 weeksDescription: To determine the viral load by real time RT-PCR, samples of blood, sputum, nose / throat swab will be collected from patients during the follow-up studies after receiving SCE therapy.
Measure: Quantification of the SARS-CoV-2 viral load by real time RT-PCR Time: 4 weeksThe aim of the present study is to examine the inflammatory response in the pulmonary compartment and blood of critically ill patients admitted to the ICU with COVID-19.
Description: Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood
Measure: White blood cell counts Time: Day 0 (subsequent to study inclusion in the ICU)Description: Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood
Measure: White blood cell counts Time: Day 7Description: Cell populations and subpopulations evaluated by 10 colored flow cytometry (B cells, T cells, TCR subsets, Tregs/Th17, dendritic cells, myeloid cells and neutrophils) in bronchoalveolar lavage fluid and blood
Measure: Lymphocyte populations Time: Day 0 (subsequent to study inclusion in the ICU)Description: Cell populations and subpopulations evaluated by 10 colored flow cytometry (B cells, T cells, TCR subsets, Tregs/Th17, dendritic cells, myeloid cells and neutrophils) in bronchoalveolar lavage fluid and blood
Measure: Lymphocyte populations Time: Day 7Description: Multiplex assay for measuring cytokines in bronchoalveolar lavage fluid and plasma (e.g. IL-1-beta, IL-1RA, IL-2, IL-6, IL-8, IL-10, IL-17, IL-18, IL-33, IL-35, TGF-beta, TNF-alpha, HMGB1)
Measure: Cytokines Time: Day 0 (subsequent to study inclusion in the ICU)Description: Multiplex assay for measuring cytokines in bronchoalveolar lavage fluid and plasma (e.g. IL-1-beta, IL-1RA, IL-2, IL-6, IL-8, IL-10, IL-17, IL-18, IL-33, IL-35, TGF-beta, TNF-alpha, HMGB1)
Measure: Cytokines Time: Day 7Description: MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma
Measure: Lectin complement pathway Time: Day 0 (subsequent to study inclusion in the ICU)Description: MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma
Measure: Lectin complement pathway Time: Day 7Description: Growth of pathogenic microorganisms in body fluids (e.g. urine, blood, bronchoalveolar lavage fluid)
Measure: Microorganisms Time: Up to 12 weeksDescription: Respiratory filmarray PCR for testing for pathogens
Measure: Respiratory pathogens Time: Day 0 (subsequent to study inclusion in the ICU)Description: Respiratory filmarray PCR for testing for pathogens
Measure: Respiratory pathogens Time: Day 7Description: 16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid
Measure: Ribosomal RNA in the airways Time: Day 0 (subsequent to study inclusion in the ICU)Description: 16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid
Measure: Ribosomal RNA in the airways Time: Day 7Description: Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid
Measure: Levels of SARS-CoV-2 in the airways Time: Day 0 (subsequent to study inclusion in the ICU)Description: Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid
Measure: Levels of SARS-CoV-2 in the airways Time: Day 7Description: ICU mortality
Measure: Mortality Time: Up to 6 monthsDescription: In hospital mortality
Measure: Mortality II Time: Up to 6 monthsDescription: C-reactive protein, procalcitonin, ferritin
Measure: Blood markers of inflammation Time: Daily assessment in the ICU up to 12 weeksDescription: Platelets, creatinine, urea, sodium, potassium, D-dimer, lactate dehydrogenase, bilirubin, lactate
Measure: Blood markers of organ dysfunction Time: Daily assessment in the ICU up to 12 weeksDescription: Number of participants with unilateral infiltrates or bilateral infiltrates and/or air bronchogram
Measure: Infiltrates on conventional chest x-ray Time: Up to 12 weeksA continuous infusion of Dexmedetomidine (DEX) will be administered to 80 patients admitted to Critical Care because of signs of Respiratory Insufficiency requiring non-invasive ventilation. Measurements of respiratory performance and quantification of cellular and molecular inflammatory mediators. The primary outcome will be the avoidance of mechanical ventilation with secondary outcomes duration of mechanical ventilation, avoidance of delirium after sedation and association of mediators of inflammation to outcomes. Outcomes will be compared to a matched historical control (no DEX) series
Description: (Presence/Absence) requirement of mechanical ventilation
Measure: Mechanical ventilation Time: expected within first three days (non conclusive due to lack of evidence yet)Description: Duration of mechanical ventilation if it is required (hours from the start)
Measure: Duration of mechanical ventilation Time: expected within first seven days (non conclusive due to lack of evidence yet)Description: Delirium criteria as defined in DSM-4
Measure: Delirium on recovery from sedation Time: First 24 hours after retiring dexmedetomidine sedationDuring SARS-Cov2 infection with serious respiratory implication and high systemic inflammation level, intravenous ANAKINRA alone or associated with RUXOLITINIB for severe cases might reduce inappropriate systemic inflammatory response, improve breathing and decrease occurrence or duration of ARDS and associated mortality.
Description: At least 3 parameters are met including CRP and/or Ferritin among: CRP: decrease > 50% Ferritinemia: decrease > 1/3 Serum creatinine: decrease > 1/3 AST/ALT: decrease > 50% Eosinophils > 50 /mm3 Lymphocytes > 1000 /mm3
Measure: Biological criteria Time: 7 days from enrolmentDescription: Number of days without mechanical ventilation
Measure: Duration of oxygen therapy (days) Time: 28 days from enrolmentDescription: Number of patients included in stage 2b
Measure: Number of intensive care units admissions Time: 28 days from enrolmentDescription: Number of days in intensive care units for patients managed in intensive care units
Measure: Number of days in intensive care units Time: 28 days from enrolmentDescription: Mortality rate
Measure: Mortality rate Time: 28 days from enrolmentDescription: Total number of days in hospital
Measure: Total number of days in hospital Time: 28 days from enrolmentDescription: Organ failure score modification (Sepsis-related Organ Failure Assessment (SOFA) score); Sofa score's minimum and maximum values are 0 and 24, the lowest score corresponds to a better outcome.
Measure: Organ failure score modification (Sepsis-related Organ Failure Assessment (SOFA) score) Time: 28 days from enrolmentDescription: Number of bacterial and/or fungal sepsis
Measure: Number of bacterial and/or fungal sepsis Time: 28 days from enrolmentThe world is currently facing a pandemic due to the outbreak of a new coronavirus causing acute respiratory failure called SARS-Cov2. The majority of patients (8 out of 10) are known to have mild disease, manifested by respiratory tract symptoms associated with fever, headache, and body pain. However, it is possible that the disease progresses to a severe stage, whith the need for mechanical ventilation support associated with high morbidity and mortality. The progression of the disease is mainly due to the appearance of uncontrolled inflammation that also favors the development of disseminated clots. So far, there is no effective treatment to combat coronavirus; however, the use of anti-inflammatory drugs is potentially effective in preventing complications from the disease. In this regard, low dose colchicine is relatively safe and effective as an anti-inflammatory. It has been used for many years in the control of inflammation secondary to the accumulation of uric acid crystals. The aim of this study is to test if the administration of colchicine at a dose of 1.5 mg the first day and subsequently 0.5 mg BID until completing 10 days of treatment is effective as a treatment for inflammation related symptoms in patients with mild and severe disease secondary to coronavirus infection. The primary outcome is improvement of symptoms related to inflammation and avoiding progression to severe and critical stages of the disease. Colchicine can be discontinued before the end of 10 days in case of serious adverse effects or if the patient progresses to the critical stages of the disease.
Description: Resolution of fever, myalgia and arthralgia and 50% improvement of total lymphocyte count, D-dimer, fibrinogen and ferritin
Measure: Number of patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels Time: Up to 24 daysDescription: At least one of the following: respiratory failure, respiratory rate > 30 rpm, oxygen saturation < 92%, PaO2/FiO2 < 300 mmHg
Measure: Progression to severe disease Time: Up to 10 daysSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly identified, highly contagious RNA virus causing respiratory infectious disease, Coronavirus Disease 2019 (COVID-19). Conjunctivitis has been reported as a rare finding of the disease, and preliminary studies showed that the virus RNA could be detected in ocular secretions using polymerase chain reaction (PCR) assays when conjunctivitis present. This study aims to estimate the proportion of SARS-CoV-2 associated conjunctivitis among patients with suspected viral conjunctivitis presented to the ophthalmology clinics of Wilmer Eye Institute during the COVID-19 pandemic. The investigators also aim to identify whether SARS-CoV-2 associated conjunctivitis is an isolated finding or an early sign of COVID-19.
Description: Number of conjunctival samples with positive PCR divided by the total number of conjunctival samples
Measure: Proportion of conjunctival samples tested positive for SARS-CoV-2 Time: 1 yearDescription: Number of nasal samples with positive PCR divided by the number of conjunctival samples with positive PCR
Measure: Proportion of nasal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples Time: 1 yearDescription: Number of nasopharyngeal samples with positive PCR divided by the number of conjunctival samples with positive PCR
Measure: Proportion of nasopharyngeal samples tested positive for SARS-CoV-2 among patients with positive conjunctival samples Time: 1 yearDescription: Number of patients developed COVID-19 divided by the number of the study population
Measure: Rate of development of COVID-19 in the study patient population Time: 1 yearDescription: Number of conjunctival samples with positive PCR divided by the number of patients developed COVID-19
Measure: Positive conjunctival sample rate in patient developed COVID-19 Time: 1 yearTo evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Description: improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points
Measure: lung injury score Time: day 10Description: D-dimers blood levels
Measure: D-dimers Time: day 0, 1, 2, 3, 10 and 15Description: distribution of phenotypes of immune cells
Measure: phenotype Time: day 0, 1, 2, 3, 10 and 15Description: Levels of specialized pro-resolving lipid mediators within alveolar macrophages and bronchoalveolar lavage
Measure: pro-resolving lipid mediators Time: day 0, 1, 2, 3, 10 and 15Description: Cytokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions
Measure: cytokines Time: day 0, 1, 2, 3, 10 and 15Description: Chemokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions
Measure: chemokines Time: day 0, 1, 2, 3, 10 and 15Description: Survival at 10 days and 28 days
Measure: Survival Time: day 10 and 28Description: Time to removal of endotracheal tube
Measure: extubation Time: day 28Description: lymphocyte subpopulations in peripheral blood by flow cytometry prior and after MSC infusion (day 0,3,5,10)
Measure: lymphocyte subpopulations Time: day 0, 3, 5 and 10Description: evaluate SARS-CoV-2-specific antibody titers in the serum of patients prior and post MSC infusion.
Measure: SARS-CoV-2-specific antibody titers Time: day 0, 5 and 10Description: evaluate levels of complement molecules (C5-C9) in the serum of patients prior and post MSC infusion
Measure: complement molecules (C5-C9) Time: day 0, 5 and 10A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing acute respiratory failure in patients aged ≥65 and patients aged ≥18 with at least one additional risk factor who are infected with SARS-CoV-2 (the MiR-AGE study).
Description: 7-point ordinal scale is defined as Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death
Measure: Percentage of patients reporting each severity rating on a 7-point ordinal scale Time: 28-day treatment periodDescription: Nasopharyngeal sample and/or in blood
Measure: SARS-CoV-2 viral load Time: at each study visit during the 28-day treatment periodThis study is a prospective, phase II, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of mavrilimumab in hospitalized patients with acute respiratory failure requiring oxygen supplementation in COVID- 19 pneumonia and a hyper-inflammatory status. The study will randomize patients to mavrilimumab or placebo, in addition to standard of care per local practice. The total trial duration will be 12 weeks after single mavrilimumab or placebo dose.
Description: Time to the absence of need for oxygen supplementation (time to first period of 24 hrs with a SpO2 of 94%) within day 14 of treatment, stated as Kaplan- Mayer estimates of the proportion of patients on room air at day 14 and median time to room air attainment in each arm
Measure: Reduction in the dependency on oxygen supplementation Time: within day 14 of treatmentDescription: Response is defined as a 7-point ordinal scale of 3 or less, i.e. no supplemental oxygen
Measure: Proportion of responders (using the WHO 7-point ordinal scale) Time: Day 7, 14, and 28Description: Time from date of randomization to the date with a 7-point ordinal scale of 3 or less, i.e. no supplemental oxygen
Measure: Time to response (using the WHO 7-point ordinal scale) Time: Within day 28 of interventionDescription: Proportion of patients with at least two-point improvement in clinical status
Measure: Proportion of improving patients (using the WHO 7-point ordinal scale) Time: At day 7, 14, and 28Description: Time to resolution of fever (for at least 48 hours) in absence of antipyretics, or discharge, whichever is sooner
Measure: Time to resolution of fever Time: Within day 28 of interventionDescription: COVID-19-related death
Measure: Reduction in case fatality Time: Within day 28 of interventionDescription: Proportion of hospitalized patients who died or required mechanical ventilation (WHO Categories 6 or 7)
Measure: Proportion of patient requiring mechanical ventilation/deaths Time: Within day 14 of interventionDescription: Change of the following serological markers over follow-up (C-reactive protein; Ferritin; D-Dimer)
Measure: Change in biochemical markers Time: Within day 28 of intervention or discharge -whatever comes firstDescription: Median changes of NEWS2 score from baseline
Measure: Median changes in the National Early Warning Score 2 (NEWS2) Time: At day 7, 14, and 28Description: Time to clinical improvement (as defined as a NEWS2 score of 2 or less maintained for at least 24 hours or discharge, whichever comes first)
Measure: Time to clinical improvement as evaluated with the National Early Warning Score 2 (NEWS2) Time: Within day 28 of intervention or discharge -whatever comes firstDescription: Variations from baseline to subsequent timepoints (when available) in terms of percentage of lung involvement, modifications in the normal parenchyma, ground glass opacities (GGO), crazy paving pattern,parenchymal consolidations, and evolution towards fibrosis.
Measure: Variations in radiological findings Time: Within day 28 of intervention or discharge -whatever comes firstDescription: Number of patients with treatment- related side effects (as assessed by Common Terminology Criteria for Adverse Event (CTCAE) v.5.0), serious adverse events, adverse events of special interest, clinically significant changes in laboratory measurements and vital signs
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Time: By day 84Description: To evaluate the primary and secondary endpoints in different subgroups of patients: mild respiratory failure: PaO2/FiO2 ≤ 300 and > 200 mmHg; moderate respiratory failure: PaO2/FiO2 ≤ 200 and > 100 mmHg
Measure: Clinical efficacy of mavrilimumab compared to the control arm by clinical severity Time: Within day 28 of interventionDescription: Median changes in serum IL-6
Measure: Changes in serum IL-6 (exploratory biomarker) Time: By day 84Description: Median changes in serum IL-1 receptor antagonist
Measure: Changes in serum IL-1RA (exploratory biomarker) Time: By day 84Description: Median changes in serum TNF-alpha
Measure: Changes in serum TNF-alpha (exploratory biomarker) Time: By day 84Description: Median variations in haemoglobin and leucocyte counts
Measure: Changes in CBC + differential (exploratory biomarker) Time: By day 84Description: Median titres od anti-SARS-CoV2 antibodies
Measure: Level of anti-SARS-CoV2 antibodies (exploratory biomarker) Time: By day 84Description: Proportion of patients with a positive swab for SARS-CoV2 by PCR
Measure: Virus eradication (exploratory biomarker) Time: By day 84Description: Proportion of patients who developed anti-drug antibodies
Measure: Anti-drug antibodies (exploratory biomarker) Time: By day 84The 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 28Background: COVID-19 virus infection differs among people. Some people have no or mild symptoms. For others, COVID-19 is life threatening and causes damage to the body s organs. Researchers want to better understand the virus to learn how to kill it. Objective: To understand how the COVID-19 virus causes wide differences in how sick one can become from the infection. Eligibility: People ages 18-80 with COVID-19 infection Design: Participants will be screened with a review of their medical records. Participants who enter the study at the beginning of their COVID-19 infection will stay in the hospital until they are healthy enough to go home. Those who enter after they have recovered may need to stay in the hospital 1-2 nights to perform the study tests. Participants will have MRI and CT scans of the brain, heart, and lungs. They will lie in a machine that takes pictures of the body. For the MRI, soft padding or a coil will be placed around their head and chest. They may receive a dye injected into a vein. Participants will have an ultrasound of the kidneys and heart. Participants will provide blood and urine samples. They will provide nasal swabs. Participants will have a bronchoscopy. A thin tube will be placed through the nose or mouth into the airway. Saltwater will be squirted into the lungs and removed by suction. Participants may provide a spinal fluid sample. A needle injected into the spinal canal will obtain fluid. Participants will have lung and heart function tests. At various points after recovery, participants will repeat many of these tests.
Description: Link inflammatory responses present in blood, urine and bronchoalveolar lavage with imaging of COVID-19 target organs (lungs, heart, brain and kidneys) during the earliest stages of infection and at subsequent time points as the infection and host responses evolve, through recovery.
Measure: Inflammatory responses of cells in lung and circulation Time: From onset of illness in hospital through acute phase ( days 1 28 more or less 7), at the time of resolution of infection ( day 28 more or less 7 to 6 weeks, andduring convalescence (6 months to 1 year after the infection)This Phase 2 study will evaluate the efficacy, safety, pharmacodynamics and pharmacokinetics of inhaled TD-0903 compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation.
Description: Number of Respiratory Failure-Free Days (RFDs) from randomization through Day 28
Measure: Part 2: Respiratory Failure-Free Days (RFDs) Time: Baseline through Day 28Description: Proportion of subjects in each category of the 8-point Clinical Status scale. The Clinical Status scale contains 8 different categories that are each assigned a numeric score. The values range from 1 (representing 'Not hospitalized, no limitations on activities') to 8 (representing 'Death'). The various measures describe hospitalization status and the various limitations and requirements for oxygen support.
Measure: Part 2: Clinical Status Scale Time: Day 7, 14, 21 and 28Description: Proportion of subjects alive and respiratory failure-free on Day 28
Measure: Part 2: Subjects alive and respiratory failure-free Time: Day 28Description: Change from baseline in SaO2/FiO2 ratio on Day 7
Measure: Part 2: SaO2/FiO2 ratio Time: Baseline, Day 7COVID-19 is a rapidly evolving pandemic with approximately 5% of all patients which require intensive care unit admission. In critically ill patients infected with COVID-19, approximately 15% had severe shock requiring medications to increase blood pressure. It appears that blood vessel tone is altered and microcirculation is not well regulated in patients with COVID-19. The underlying pathophysiology and contributing factors are unknown. The association with subsequent organ dysfunction and outcome is also unclear. Therefore, we aim to investigate serial changes of relevant biomarkers in this population to improve the understanding of this disease, to investigate the association with clinically important outcomes and to find out how best to treat patients. The data will serve to develop strategies for individualised management of this high-risk group.
Description: Plasma bio-adrenomedullin, proenkephalin, dipeptidyl peptidase-3, renin and angiotensin II
Measure: Plasma bio-adrenomedullin, proenkephalin, dipeptidyl peptidase-3, renin and angiotensin II Time: Daily from admission, and around the onset of vasodilatory shock until day 7Description: Duration of vasodilatory shock
Measure: Duration of vasodilatory shock Time: 7 and 28 daysDescription: As defined by the Kidney Disease: Improving Global Outcomes criteria
Measure: Acute kidney injury Time: 7 and 28 daysDescription: Need for renal replacement therapy
Measure: Need for renal replacement therapy Time: 7 and 28 daysDescription: Duration of ventilation
Measure: Duration of ventilation Time: 7 and 28 daysDescription: Duration of extracorporeal membrane oxygenation
Measure: Duration of extracorporeal membrane oxygenation Time: 7 and 28 daysDescription: ICU and hospital
Measure: Mortality Time: 28 daysThis is a cohort study of COVID-19 patients with hyperinflammation. It aims to determine the impact of adjunctive Tocilizumab (TCZ) to standard of care on the reduction of hyperinflammation-related mortality in COVID-19. Patients with COVID-19 are at high risk of life-threatening hyperinflammation and death. One in three COVID-19 patients admitted to ICU was found to develop life-threatening hyperinflammation. The risk of death when untreated is estimated to be 50-80%.
Description: Mortality status of participants
Measure: All-cause mortality Time: Assessed at 30 days post treatmentDescription: Uninfected, ambulatory, hospitalized: mild disease, hospitalized: severe disease, death
Measure: Ordinal Scale for evaluating subject clinical status at days 3, 8, 15, 30, 60 post treatment. Time: Assessed at days 3, 8, 15, 30, 60 post treatmentThis is a randomized, double-blind, placebo-controlled, in which one dose of nangibotide will be tested versus placebo. All patients with a diagnosis of coronavirus disease 2019 (COVID-19), and a requirement for invasive mechanical ventilation will be considered for study participation. All study patients will receive standard of care treatment throughout the study. After screening for eligibility, patients will be randomized to one of two treatment arms. Patients will receive a continuous intravenous (i.v.) infusion of nangibotide at 1.0 mg/kg/h or a matching placebo. Treatment with study drug must be initiated as early as possible but no later than 48 hours after the initiation of invasive mechanical ventilation. Patients will be treated for 5 days or until discharge from critical care, whichever is sooner. The treatment with study drug will be in addition to standard of care. A follow-up visit will be performed on days 8 and 14. The end of study visit is at day 28.
Description: Incidence of adverse events until day 28
Measure: Adverse Events Time: 28 daysDescription: Incidence of mortality until day 28
Measure: Mortality Time: 28 daysThis is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of pemziviptadil (PB1046) by improving the clinical outcomes and increasing days alive and free of respiratory failure in hospitalized COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress syndrome (ARDS) and death. The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent decision-making and treatment at approximately 20 centers in the United States.
Description: PaO2:FiO2 ratio is the ratio of partial pressure of arterial oxygen to percentage of inspired oxygen
Measure: Development of ARDS (PaO2:FiO2 ratio < 300 mm Hg) during hospitalization Time: Any time point between injection initiation and Day 28Description: Composite of: Total hospital days, Total ICU days, Total days of ventilator use, Total days of ECMO, Total days of invasive hemodynamic monitoring, Total days of mechanical circulatory support, Total days of inotropic or vasopressor therapy
Measure: Reduction in hospital resource utilization defined as a composite of:total days: in hospital, in ICU, on ventilator, on ECMO, with invasive hemodynamic monitoring, with mechanical circulatory support, and with inotropic or vasopressor therapy Time: 28 daysThe aim of the study was to assess the inflammatory status at the presumed peak of the inflammatory phase in non-critically ill patients requiring admission for COVID-19. Patients admitted with COVID-19 from March 27th to May 3rd, 2020 were prospectively enrolled. All patients had an initial chest CT-scan for diagnosis on admission and a second chest CT-scan for follow-up concomitant with a FDG PET/CT between day 6 and day 14 after the onset of symptoms.
Description: Amount of FDG pathological uptake expressed by maximum signal intensity standardized uptake values (SUVmax)
Measure: Primary endpoint Time: Day 6 to Day 14By the end of 2019 a new coronavirus, named SARS-CoV-2, was discovered in patients with pneumonia in Wuhan, China. In the following weeks and months the virus spread globally, having a tremendous impact on global health and economy. To date, no vaccine or therapy is available. Severe courses of the infection not only affect the lungs, but also other organs like the heart, kidney, or liver. The lack of preexisting immunity might at least partially explain the affection of extra pulmonary organs not yet seen in infections due to other respiratory viruses. In this observational investigation the study group will follow up on patients that have been hospitalized due to a SARS-CoV-2 infection, and monitor sequelae in various organs, with an emphasis on the pulmo-cardiovascular system. Our that in some patients, organ damage will persist and require long-term medical care.
Description: Identify organ dysfunction after SARS-CoV-2 infections
Measure: Sequelae after COVID-19 Time: 12 months, extension if requiredAs of May 30th more than 23,000 cases of COVID -19 cases were confirmed in Egypt with total deaths of 913. Post viral entry, intense immune response against the virus with infiltration of monocytes and macrophages into alveolar cells with decreasing number of lymphocytes in peripheral blood along with reduced lymphocytes in lymphoid organs, hypercoagulability, thrombosis and multiple organ damage, The gut microbiota and immune homeostasis seem to have a back and forth relationship. Also, gut microbiota derived signals are known to tune the immune cells for pro and anti-inflammatory responses thereby affecting the susceptibility to various diseases. Healthy gut microbiome essentially could be pivotal in maintaining an optimal immune system to prevent an array of excessive immune reactions that eventually become detrimental to lungs and vital organ systems. Numerous studies have shown that the patient's nutritional status have a significant effect on an individual's immunity and over all health status and it has been suggested that nutritional deficiencies may predispose to severe forms of COVID-19 infections. Co-existing non-communicable chronic diseases (NCDs) in COVID-19 patients have been found to delay patients recovery and worsen their prognosis, the reason may be due to aggravated inflammatory pathology found in NCDs exacerbating COVID-19 infection. The aim of the study is to evaluate the role dietary habits among COVID-19 Egyptian patients and whether type of diet (Mediterranean or Western) will affect disease outcomes
Description: To assess the relation between type of diet in mild to moderate COVID 19, to the fate of their course; either improvement or progression
Measure: Western versus Mediterranean diet in COVID-19 outcome Time: 2 monthsDescription: To asses any possible links between gut microbiome and the lung affecting clinical presentation of mild to moderate COVID cases; as diarrhea, loss of taste or smell
Measure: Gut- Lung axis in COVID-19 Time: 2 monthsDescription: Possible protective effects of minerals and vitamins against COVID-19 respiratory illness
Measure: Protective role of minerals and vitamins in COVID-19 patients Time: 2 monthsDescription: Trying to explain the link between non-communicable disease severity and COVID-19 prognosis
Measure: non-communicable diseases and COVID-19 Time: 2 monthsInterventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).
Description: Respiratory failure is defined as the need for high flow oxygen (HFO), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Measure: Cohort 1: Proportion of Participants Alive and Without Respiratory Failure at Day 15 Time: Day 15Description: Mortality rate is defined as the proportion of participants who die.
Measure: Cohort 2: Mortality Rate at Day 15 Time: Day 15Description: Return to room air is defined as time from the date of randomization to the start of a period of 24 hours while breathing room air (National Institute of Allergy and Infectious Diseases [NIAID] scale ≥ 5), or discharge from the hospital, whichever occurs first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Measure: Cohort 1: Time to Return to Room Air by Day 15 Time: up to Day 15Description: Clinical Improvement, defined as time from randomization to a 2-point improvement on the NIAID scale, or discharge from the hospital, whichever comes first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Measure: Cohort 1: Time to 2-point Clinical Improvement by Day 15 Time: up to Day 15Description: Mortality rate is defined as the proportion of participants who die.
Measure: Cohort 1: Mortality Rate at Day 29 Time: Day 29Description: Clinical improvement, defined as time from randomization to a 1-point improvement on the NIAID scale, or discharge from the hospital, whichever comes first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Measure: Cohort 1: Time to 1-Point Clinical Improvement by Day 15 Time: up to Day 15Description: Mortality rate is defined as the proportion of participants who die.
Measure: Cohort 2: Mortality Rate at Day 29 Time: Day 29Description: Respiratory failure is defined as the need for HFO, NIV, IMV, or ECMO.
Measure: Cohort 2: Proportion of Participants Alive and Without Respiratory Failure at Day 15 Time: Day 15Description: Respiratory failure is defined as the need for HFO, NIV, IMV, or ECMO
Measure: Cohorts 1 and 2: Proportion of Participants Alive and Without Respiratory Failure At Day 29 Time: Day 29Description: Return to room air is defined as time from the date of randomization to the start of a period of 24 hours while breathing room air (NIAID scale ≥ 5), or discharge from the hospital, whichever occurs first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Measure: Cohorts 1 and 2: Time to Return to Room Air by Day 29 Time: up to Day 29Description: Clinical Improvement, defined as time from randomization to a 2-point improvement on the NIAID scale, or discharge from the hospital, whichever comes first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Measure: Cohort 2: Time to 2-point Clinical Improvement by Day 15 Time: up to Day 15Description: Clinical Improvement, defined as time from randomization to a 1-point improvement on the NIAID scale, or discharge from the hospital, whichever comes first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Measure: Cohorts 1 and 2: Time to 1-point Clinical Improvement by Day 29 Time: up to Day 29Description: Clinical Improvement, defined as time from randomization to a 2-point improvement on the NIAID scale, or discharge from the hospital, whichever comes first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Measure: Cohorts 1 and 2: Time to 2-point Clinical Improvement by Day 29 Time: up to Day 29Description: Respiratory failure is defined as the need for HFO, NIV, IMV, or ECMO.
Measure: Cohort 1: Respiratory Failure-Free Survival by Day 15 Time: up to Day 15Description: Respiratory failure is defined as the need for HFO, NIV, IMV, or ECMO
Measure: Cohort 1: Respiratory Failure-Free Survival by Day 29 Time: up to Day 29Description: Return to room air is defined as time from the date of randomization to the start of a period of 24 hours while breathing room air (NIAID scale ≥ 5), or discharge from the hospital, whichever occurs first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Measure: Cohort 1: Proportion of Participants Who Return to Room Air by Day 15 Time: up to Day 15Description: Return to room air is defined as time from the date of randomization to the start of a period of 24 hours while breathing room air (NIAID scale ≥ 5), or discharge from the hospital, whichever occurs first. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Measure: Cohorts 1 and 2: Proportion of Participants Who Return to Room Air by Day 29 Time: up to Day 29Description: Mortality rate is defined as the proportion of participants who die.
Measure: Cohort 1: Mortality Rate at Day 15 Time: Day 15Description: Overall survival is defined as time from date of randomization to the date of death.
Measure: Cohorts 1 and 2: Overall Survival by Day 29 Time: up to Day 29Description: Clinical status, based on the NIAID 8-point ordinal scale. The NIAID is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities.
Measure: Cohorts 1 and 2: Clinical Status Over Time Time: Days 4, 8, 15, 22, and 29COVID-19 is a new disease and therefore it is still not clear exactly how the virus affects the body and why people are affected so differently. It causes infection in the lungs and the virus can then attack blood vessels in the lungs and other organs to spark off an inflammatory process that can make a person very ill. It also can cause damage within tiny blood vessels that makes a person's blood thicken up and stop flow in vital organs. The investigators believe complement (which is a chemical in the body which can be harmful in excess) orchestrates the inflammation and thickening of the blood that can make a person sick. The investigators now need to know which of these complement chemicals are elevated in COVID-19 and compare to healthy volunteers, and assess whether the levels are higher in people with severe lung disease. The investigators believe that if levels are increased there are special treatments that can counteract them and potentially be an effective treatment for COVID-19. In this study the investigators will measure different parts of the inflammation process to better understand what may be causing severe disease and to see if there may be benefits from a new treatment to reduce inflammation
Description: C5a, C5, C3, sC5b9, Bb concentration from serum
Measure: Complement Activation Time: 14 days sampling time periodDescription: LTB4 concentration from plasma
Measure: Leukotrienes Measure Time: 14 days sampling time periodDescription: Level of platelets, INR, APTS, D-Dimer, Fibrinogen, thrombin antithrombin complex (TAT), from citrate plasma
Measure: Coagulation Measure Time: 14 days sampling time periodDescription: • CRP, Ferritin, PCT, LDH, Troponin, ALT from plasma
Measure: Hyperinflammation Measure Time: 14 days sampling time periodDescription: Total White Blood Cell count (including lymphocytes, monocytes and neutrophils)
Measure: Cell Count Time: 14 days sampling time periodDescription: Level of • Pro-inflammatory - IL-1α, IL-1β, IL-2, IL-5, IL-6, IL-7, IL-8, IL-17, GCSF, GMCSF, IFN γ, IP10, MCP-1, MIP1α, TNFα and anti inflammatory IL-4, IL-10, IL-13, IL-22, TGF-α from plasma
Measure: Cytokines and Chemokine Measure Time: 14 days sampling time periodDescription: VEGF, tissue factor and PAI-1, from plasma
Measure: Endothelial dysfunction measures: Time: 14 days sampling time periodTo perform comprehensive cardiac and thoracic non invasive imaging assessment by MRI and/or CT scan including cardiac functional evaluation and myocardial tissue characterization of COVID_19 related disease in pediatric patients with cardiac involvement.
Description: Description of imaging data from MRI ans CT scan and associated clinical data.
Measure: Imaging data at Baseline Time: BaselineDescription: Description of imaging data from MRI ans CT scan and associated clinical data.
Measure: Imagine data at Follow-up Time: During the 2 years follow-up periodThe 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 daysThis is a randomized, randomized controlled trial to investigate the efficacy and safety of Neurokinin-1 Receptor (NK-1R) 80 mg orally given daily to treat cytokine storm causing inflammatory lung injury and respiratory failure associated with severe or critical COVID-19 infection. NK-1R is the receptor of Substance P (SP) and responsible for its functionality. Here, we propose that SP via its tachykinin receptor, NK-1R may cause inflammation in Covid-19 infection. It may initiate the cytokine storming via binding to its receptor NK-1 and many inflammatory mediators are released. If SP release is reduced by NK-1R antagonist, it may control the cytokine storming and hence the hyper-responsiveness of the respiratory tract through reduction in cytokine storming It may serve as the treatment strategy for Covid-19 infected patients. Patients fulfilling the inclusion criteria will be enrolled after giving consent. They wll be randomized to treatment with either NK-1R antagonist or placebo in addition to Dexamethasone as a standard treatment given to both groups for Covid-19 infection as per the protocol at the treating hospital. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.
The purpose of this study is to demonstrate the safety of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UCMSCs) administered intravenously in patients with acute pulmonary inflammation due to COVID-19 with moderately severe symptoms
Description: Safety of UCMSCs will be reported as the percentage of participants in each treatment group that experienced a treatment related SAEs.
Measure: Percent of participants with treatment related Serious Adverse Events (SAE) Time: 12 monthsDescription: Change in serum inflammatory marker levels including Interleukin (IL) IL-6, IL-2, Tumor Necrosis Factor Alpha (TNF-a) and procalcitonin will be evaluated in ng/L.
Measure: Change in inflammatory marker levels Time: Baseline, Day 30Description: Change in serum systemic inflammatory marker levels including D-dimer, high sensitivity C-reactive protein (hsCRP) and ferritin will be evaluated in mg/L.
Measure: Change in systemic inflammatory marker levels Time: Baseline, Day 30Description: Assessed using blood samples or nose/throat swabs.
Measure: COVID-19 Viral Load Time: Up to 30 DaysDescription: Sequential Organ Failure Assessment (SOFA) will be used to assess organ failure including the cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs. SOFA score ranges from 0-24 with the higher score indicating worse outcomes.
Measure: Change in SOFA score Time: Baseline, Up to 30 DaysDescription: Sodium, Potassium, Chloride and Carbon Dioxide (CO2) will be evaluated in mmol/L. Changes from baseline to Day 30 will be compared between groups.
Measure: Change in electrolytes levels Time: Baseline, Up to 30 DaysDescription: Serum Lactate Dehydrogenase (LDH) levels assessed in U/L. Changes in LDH from baseline to Day 30 will be compared between groups.
Measure: Change in LDH levels Time: Baseline, Up to 30 DaysDescription: ICU monitoring status will be reported as the number of subjects discharged from the ICU within 7 days.
Measure: Number of subjects discharged from the ICU Time: Up to 7 DaysDescription: Percentage of participants requiring less use of vasoactive agents will be reported.
Measure: Percentage of participants with less requirement for vasoactive agents Time: Up to 30 DaysDescription: Percentage of participant deaths throughout the study period.
Measure: Rate of Mortality Time: Up to 30 DaysDescription: The percentage of participants with changes in serum immune marker levels including Cluster of Differentiation (CD) CD 4+ and CD 8+, as evaluated by treating physician will be reported.
Measure: Percentage of participants with changes in immune marker expression Time: Up to 30 DaysDescription: Percentage of participants with changes in their chest imaging such as ground-glass opacity, local patch shadowing, bilateral patch shadowing and interstitial abnormalities will be reported. Imaging will be assessed by treating physician using chest radiography or chest Computed Tomography (CT).
Measure: Percentage of participants with changes in radiologic findings Time: Up to 30 DaysDescription: Percentage of participants showing less pneumonia symptoms will be reported as evaluated by treating physician using chest radiography or chest CT.
Measure: Percentage of participants with less pneumonia symptoms Time: Up to 30 DaysThe purpose of this study is to evaluate the health related benefits of a superfoods nutrition supplement on health related quality of life.
Description: The PSQI is a validated, self reporting instrument assessing sleep. Possible scores range from 0 to 21 with higher scores indicating lower quality sleep. The instrument contains 19 items.
Measure: Change from baseline in sleep quality on Pittsburgh Sleep Quality Index (PSQI) on Day 60 Time: Baseline and day 60Description: The PHQ is a validated, self reporting instrument assessing general wellbeing through sleep, respiratory health, headache, and gastrointestinal symptoms. Possible scores on each item range from 1 to 7 with higher scores indicating greater frequency of symptoms. The instrument contains 14 items.
Measure: Change from baseline in general wellbeing on the Physical Health Questionnaire (PHQ) on Day 60 Time: Baseline and day 60Description: The SRMCA is a validated, self reporting instrument assessing cognitive wellbeing. Possible scores range from 0 to 27 with higher scores indicating greater cognitive wellbeing. The instrument contains 44 items.
Measure: Change from baseline in cognitive wellness on the Self Report Measure of Cognitive Abilities (SRMCA) on Day 60 Time: Baseline and day 60Description: The Jackson Symptom Score is a validated, self reporting instrument which contains 8 cold and flu symptoms. Scores range from 0 (no symptoms) to 8 (every one of the listed symptoms.)
Measure: Number of days with any cold symptoms as defined by the Jackson Symptom Score on day 60. Time: Day 60Description: The PSS is a validated, self reporting instrument assessing perceived stress. Possible scores range from 0 to 40 with higher scores indicating higher stress levels. The instrument contains ten items.
Measure: Change from baseline in stress on the Perceived Stress Scale (PSS) on Day 60 Time: Baseline and Day 60To determine if a reduction of pneumonic inflammation occurs after treatment with Low-Level Laser Therapy (LLLT) applying red-light technology in the respiratory system of COVID-19 patients suffering from acute viral pneumonia.
Description: Change in inflammation of the lungs as measured by O2 saturation levels
Measure: Inflammation of the lungs - O2 Time: 10 daysDescription: Change in inflammation of the lungs as measured by C-Reactive Protein (CRP) Test
Measure: Inflammation of the lungs - CRP Time: 10 daysDescription: Change in inflammation of the lungs as measured by IL-6 Levels
Measure: Inflammation of the lungs - IL6 Time: 10 daysBeginning in mid-March 2020, pediatricians in communities in Western Europe, the UK, and the Eastern U.S. that had been severely affected by the Covid-19 pandemic noted an increased number of children presenting with fever and evidence of severe inflammation who required admission to intensive care. The syndrome was branded by the CDC in the U.S. as Multisystem Inflammatory Syndrome in Children (MIS-C). The most severely affected children presented with heart failure leading to shock and the absence of significant pulmonary disease. The clinical presentation in these patients shared many features with Kawasaki disease (KD), a self-limited pediatric vasculitis that can result in coronary artery aneurysms.The inflammatory markers, however, were much higher even than KD shock syndrome, a variant of KD presenting with distributive shock and requiring inotropic and vasoactive support in the ICU. Some patients were polymerase chain reaction (PCR)+ for SARS-CoV-2 while most were virus-negative but had detectable antibody suggesting that MIS-C was an immune-mediated reaction to antecedent exposure to the virus. While patients were being diagnosed with shock and MIS-C, children with a milder version of MIS-C that shared many features of KD were being diagnosed in these same regions.
Description: Collection of clinical data and patient samples from children with MIS-C and KD to understand the relationship between these two conditions.
Measure: Collection of clinical data and patient samples from children with MIS-C and KD to Time: We will collect demographic and clinical data on all KD patients at participating sites throughout the 8-month study period.As Covid 19 manifestations that have been recently described, inflammatory manifestation have major impact in infectious disease lesions. Some of them are delayed and provide Post infectious inflammatory reaction (PIIR), they are challenging for diagnosis and for management. Clinician have to avoid unnecessary antibiotic thearapy and in if necessary have to give immunosuppressive therapy. Except for rheumatic disease for group A streptococcus (GAS) infections there are not stanrdized diagnostic criteria and therapeutic protocol, and PIIR have probably a suboptimal management. In this context the investigators aim to explore PIIR in the 3 most frequent bacterial invasive infection in France, by a retrospective monocentric study. The investigators include all children betwwen 2012 and 2018 hospitalized for infections by Streptococcus pneumoniae (SP), Neisseria meningitidis (NM), and GAS invasive infections.
Description: Describe the frequency PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection
Measure: Describe the frequency PIIRs Time: 1 dayDescription: Describe the characteristics PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection
Measure: Characteristics PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection Time: 1 dayDescription: Identified the predictors of PIIRs in order to find warning symptoms
Measure: Predictors of PIIRs Time: 1 dayMore than 17 million people have been infected and more than 677K lives have been lost since the COVID-19 pandemic. Unfortunately, there is neither an effective treatment nor is there a vaccination for this deadly virus. The moderate to severe COVID-19 patients suffer acute lung injury and need oxygen therapy, and even ventilators, to help them breathe. When a person gets a viral infection, certain body cells (inflammatory/immune cells) get activated and release a wide range of small molecules, also known as cytokines, to help combat the virus. But it is possible for the body to overreact to the virus and release an overabundance of cytokines, forming what is known as a "cytokine storm". When a cytokine storm is formed, these cytokines cause more damage to their own cells than to the invading COVID-19 that they're trying to fight. Recently, doctors and research scientists are becoming increasingly convinced that, in some cases, this is likely what is happening in the moderate to severe COVID-19 patients. The cytokine storm may be contributing to respiratory failure, which is the leading cause of mortality for severe COVID-19 patients. Therefore, being able to control the formation of cytokine storms will also help alleviate the symptoms and aid in the recovery of severe COVID-19 patients.
Description: Respiratory failure is defined based on resource utilization requiring at least 1 of the following modalities: Endotracheal intubation and mechanical ventilation Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥0.5) Noninvasive positive pressure ventilation or CPAP Whether patient is on ECMO
Measure: Proportion of patients alive and free of respiratory failure through the 30-day trial. Time: 30 DaysDescription: We will collect blood samples of the regadenoson and placebo treated patients at the baseline, 30mins, 4 hours during drug infusion and 12 hour post drug infusion. It may also including the daily blood collected on normal standard care base. The inflammatory cytokines, including IL-1 beta, IL-6, IL-4, IL-8, IL-10, IL-12, IL-17, TNF-α, and IFN-γ will be measured using the Luminex™ 100 Multi-analyte System at The UM SOM Cytokine Core Laboratory. The levels of of cytokines will be measure in picogram/milliliter (pg/ml).
Measure: Change of the levels of the inflammatory cytokines prior, during and post drug infusion. Time: 30 daysDescription: The same blood samples used in outcomes 2 will be used to measure the levels of matrix metalloproteinase-2 (MMP-2) and MMP-9 using gelatin zymography as described in our previous publications (Zhao et al, 2010 & 2011). The enzyme levels will be quantified using The Image Lab 5.1 software. The unit will be nanogram/ml (ng/ml).
Measure: Change of the levels of MMP-2 and MMP-9 prior, during and post drug infusion. Time: 30 daysThe investigators propose a prospective, randomized, double-blind, placebo-controlled study, conducted in two phases. The purpose of the study is to evaluate the safety and efficacy of methotrexate in a cholesterol-rich non-protein nanoparticle (MTX -LDE) in adults diagnosed with mild Coronavirus-19(COVID-19) disease. A total of 100 patients will be randomized to receive MTX-LDE or placebo each 7 days, up to 3 times, during in hospital treatment.
Description: Compare the duration of hospital stay between groups
Measure: Duration of hospital stay Time: 30 days after randomizationDescription: The secondary outcome is the need for mechanical ventilation between groups
Measure: Number of participants requiring mechanical ventilation Time: 15 days after randomizationDescription: The secondary outcome is the need for vasoactive drugs between groups
Measure: Number of participants requiring vasoactive drugs Time: 15 days after randomizationDescription: The secondary outcome is the need for renal replacement therapy between groups
Measure: Number of participants requiring renal replacement therapy Time: 15 days after randomizationDescription: The secondary outcome is the incidence of secondary infection between groups
Measure: Incidence of secondary infection Time: 15 days after randomizationDescription: The secondary outcome is the comparison of Sequential Organ Failure Assessment (SOFA) score between groups
Measure: Sequential Organ Failure Assessment (SOFA) score Time: Baseline and change from baseline to 15 days after randomizationDescription: The secondary outcome is the comparison of World Health Organization (WHO) COVID-19 clinical score between groups
Measure: World Health Organization (WHO) COVID-19 score Time: Baseline and change from baseline to 15 days after randomizationDescription: The secondary outcome is the comparison of IL-6 levels between groups
Measure: Interleukin 6 (IL-6) Time: Baseline and change from baseline to 15 days after randomizationDescription: The secondary outcome is the comparison of dimer-D levels between groups
Measure: Dimer-D Time: Baseline and change from baseline to 15 days after randomizationDescription: The secondary outcome is the comparison of chest CT scan between groups
Measure: Chest CT scan Time: Baseline and change from baseline to 15 days after randomizationDescription: The secondary outcome is the comparison of red blood cells; white blood cells;Platelets; Urea;Creatinine levels between groups
Measure: Incidence and severity of laboratory alterations Time: 30 days after randomizationDescription: Compare the incidence of clinical significant symptoms (new and persistent stomatitis, vomiting, diarrhea, alopecia, neurotoxicity, bradycardia, hypotension, local pain) reported between groups.
Measure: Clinical side effects Time: 30 days after randomizationDescription: Compare the incidence of other adverse events (not expected) between groups
Measure: Other adverse events Time: 30 days after randomizationAlphabetical 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