Name (Synonyms) | Correlation | |
---|---|---|
drug261 | Dexmedetomidine Injectable Product Wiki | 0.45 |
drug48 | Anakinra and Ruxolitinib (overcome stage 3) Wiki | 0.45 |
drug47 | Anakinra alone (stages 2b/3) Wiki | 0.45 |
drug791 | Stem Cell Educator-Treated Mononuclear Cells Apheresis Wiki | 0.45 |
drug964 | hydroxychloroquine sulfate 200 MG Wiki | 0.45 |
drug87 | Azithromycin Tablets Wiki | 0.32 |
drug627 | Placebo oral tablet Wiki | 0.20 |
drug208 | Colchicine Wiki | 0.20 |
drug775 | Standard of care Wiki | 0.16 |
drug375 | Hydroxychloroquine Sulfate Wiki | 0.14 |
Name (Synonyms) | Correlation | |
---|---|---|
D000071257 | Emergence Delirium NIH | 0.45 |
D003693 | Delirium NIH | 0.32 |
D013577 | Syndrome NIH | 0.14 |
D055371 | Acute Lung Injury NIH | 0.07 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.07 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.06 |
D011014 | Pneumonia NIH | 0.04 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.03 |
D018352 | Coronavirus Infections NIH | 0.03 |
There are 5 clinical trials
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: Time to become afebrile for a minimum period of 48 hours, without antipyretics
Measure: Time to become afebrile Time: 28 days from enrolmentDescription: Number of days without mechanical ventilation
Measure: Duration of oxygen therapy (days) Time: 28 days from enrolmentDescription: Evolution from clinical stage 2b/3 to overcome stage 3 Admission in Intensive Care Unit
Measure: Number of days without mechanical ventilation 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% improvment of total lymphocyte count, D-dimer, fibrinogen and ferritin
Measure: 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 days