|drug3410||Transcutaneous Auricular Vagus Nerve Stimulation Wiki||0.50|
|drug2067||N-acetyl cysteine Wiki||0.50|
|drug3331||The usual treatment Wiki||0.50|
|drug2451||Placebo (Methylcellulose) capsule Wiki||0.50|
|drug3580||Vitamin E Wiki||0.50|
|drug968||Data Collection: Clinical Care Assessments Wiki||0.50|
|drug437||Biological sample collection Wiki||0.35|
|drug3572||Vitamin C Wiki||0.13|
|D011024||Pneumonia, Viral NIH||0.06|
|D018352||Coronavirus Infections NIH||0.05|
There are 4 clinical trials
The leading cause of death in patients with COVID19 is a severe inflammatory response caused by a cytokine storm that results in acute respiratory distress syndrome and acute pulmonary insufficiency, as well as dysfunction of several vital organs. Therefore, preventing the occurrence of uncontrolled inflammation is the main goal of the ongoing clinical trials. Chloroquine and tocilizumab, which have the best results, are also prescribed to control inflammation. But it can be said that treatments are the main source of inflammation. Inflammasome NLRP3 is one of the mechanisms involved in many severe inflammatory disorders. Inflammatory activation has already been demonstrated by many viruses. Melatonin, on the other hand, is a hormone in the body that can inhibit Inflammation NLRP3 in addition to various anti-inflammatory effects, especially after severe inflammation. Older adults with lower levels of melatonin and children with maximum levels of melatonin are the risk groups and low-risk groups for the disease, respectively. In the present study, while measuring melatonin in patients with COVID19, its effectiveness as a treatment method along with the common antiviral drug regimen in patients with severe disease will be evaluated.
Description: Immune system modulator. The amount of it is determined by laboratory methodsMeasure: Melatonin Time: up to 10 days
Description: is a type of signaling molecule (a cytokine) that is secreted from immune cells like helper T cells (Th) and macrophages, and certain other cell types that promote inflammation which is measured by serological or analyzer methodMeasure: Inflammatory cytokines Time: up to 10 days
Description: C-reactive protein (CRP) is a protein made by the liver that measured by serological or analyzer methodMeasure: C-reactive protein (CRP) Time: up to 10 days
Description: A sudden, audible expulsion of air from the lungs through a partially closed glottis, preceded by inhalation. It is a protective response that serves to clear the trachea, bronchi, and/or lungs of irritants and secretions that measured by Physical examination.Measure: Cough Time: up to 10 days
Description: Oxygen saturation of the blood will measure by pulse oximeterMeasure: Oxygen saturation of the blood Time: up to 10 days
Description: Red blood cell sedimentation rate will measure by AutoanalyzerMeasure: ESR Time: up to 10 days
Description: Radiological Treatment Response (CT scan), more than 50% reduction in the affected areaMeasure: Radiological Treatment Response Time: up to 10 days
Description: Cellular pathway active in inflammationMeasure: Inflammatory route Time: up to 10 days
This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in adult outpatients suspected to be afflicted with COVID-19.
Description: Evaluate the incidence of serious adverse effects and discontinuation secondary to toxicity through 28 days of follow-up as compared to the control arm as assessed by: Cumulative incidence of serious adverse events (SAEs), Cumulative incidence of Grade 3 and 4 adverse events (AEs), Discontinuation or temporary suspension of the investigational medication (for any reason).Measure: Cumulative Incidence of Treatment-Emergent Adverse Events Time: 28 days
Description: Incidence of COVID-19 related hospitalization at 28 daysMeasure: Hospitalization Time: 28 days
Description: COVID-19 related symptoms (Fever, chills, cough, nasal symptoms, body aches/muscle aches, headache, loss of smell, loss of taste, nausea, vomiting, diarrhea, fatigue, dizziness) that are self-reported and on interview.Measure: COVID-19 related symptoms Time: 28 days
Description: Change from baseline (day 1) as assessed to days 3, 7, 14, and 28Measure: Rate of resolution of COVID-19 related symptoms Time: 28 days
Description: 28-day mortalityMeasure: Mortality Time: 28 days
This study is a randomized, double-blind, controlled clinical trial to evaluate the effects of toremifene and/or melatonin in adults with mild COVID-19.
Description: Score total of 0-12 assessed daily. Each category based on severity of symptoms of Cough, Shortness of breath, Fatigue/tiredness and daily temperature on a rating scale of 0-3.Measure: Peak increase in COVID-19 Sign and Symptom score Time: Screening to 28 days
Description: Daily mean valuesMeasure: Nadir Oxygen Saturation Time: Day 1 through day 14
Description: Daily mean valuesMeasure: Peak Heart Rate Time: Day 1 through day 14
Description: Score total of 0-12 assessed daily. Each category based on severity of symptoms of Cough, Shortness of breath, Fatigue/tiredness and daily temperature on a rating scale of 0-3.Measure: Time to COVID-19 Sign and Symptom score resolution Time: Screening to 28 days
Description: not hospitalized, no limitation of activities (or resumption of normal activity) not hospitalized but limitation on activities hospitalized, not requiring supplemental oxygen hospitalized, requiring supplemental oxygen (low-flow, e.g., nasal prong) hospitalized, requiring non-invasive ventilation and/or high-flow oxygen hospitalized, on invasive ventilation or ECMO deathMeasure: Time to WHO 7-point ordinal scale score of 3 or higher Time: Day 1 to Day 30
Introduction: SARS-CoV2 infection produces severe pneumonia with pulmonary alveolar collapse. There is no specific treatment to date. In experimental models and humans with septic shock, there is a high production of nitric oxide (NO) and reactive nitrogen species (RNS) and can cause multiple organ failure. The administration of antioxidants such as n-acetylcysteine (NAC), vitamin C, melatonin, and vitamin E participate in increasing the intracellular content of GSH, ROS sequestration, protection of the lipids of cell membranes, cytosol proteins, nuclear DNA, mitochondrial and decrease LPO. Justification: as there is no specific antiviral therapy, the therapeutic options are limited, complications and mortality are high; It is intended to evaluate the effect of antioxidants on the storm outcome of the dysregulation of oxidative stress. Hypothesis: It is postulated that adjuvant therapy with antioxidants and Pentoxifylline reduces the use of ventilators in patients with or without septic shock secondary to severe SARS-COV2 pneumonia as decreases lipoperoxidation, and corrects dysregulation of oxidative stress by increasing the antioxidant capacity. Objectives: To evaluate whether it is possible to avoid intubation or decrease assisted mechanical ventilation days, improve oxidative stress dysregulation in patients with SARS-COV2 infection with severe pneumonia with or without septic shock. Methodology: Quasi-experimental, open analytical, prospective, and longitudinal study (before-after). In patients over 18 years of age who are admitted to the CITIBANAMEX Center with or without septic shock secondary to severe SARS-COV2 pneumonia. There will be two groups: 1) patients without septic shock and 2) patients with septic shock secondary to severe pneumonia due to SARS-COV2. A single antioxidant will be applied following the clinical decision tree (NAC, Vit C, Vit E, melatonin) more Pentoxifylline orally or by orogastric tube for a total of 5 days from the start of the protocol. APACHE II will calculate the risk, SOFA, MEXSOFA, measurements of IL-8, vitamin C, NO3 / NO2, LOP, total antioxidant capacity will be carried out at baseline and 48 hours. SOFA will be calculated for seven days, in addition to days of hospitalization, days of mechanical ventilation. It was evaluated 28 days after discharge by telephone.
Description: It will be evaluated whether secondary to SARS-COV2 pneumonia, the outcome of the patient is dead.Measure: Death from any cause Time: From admission to discharge, up to 30 days.
Description: The percentage of patients with SARS-COV2 pneumonia in whom orotracheal intubation was avoided will be evaluated.Measure: Percentage of patients who required orotracheal intubation Time: From admission to discharge, up to 1 week
Description: It will be evaluated if it is possible to reduce the days of mechanical ventilationMeasure: Assisted mechanical ventilation Time: From admission to discharge, up to 1 week
Description: The number of days of stay in the intensive care unit will be evaluated.Measure: Stay in an intensive care unit Time: From admission to discharge, up to 1 week
Description: For the measurement of lipid peroxidation, 50 µL of CH3-OH with 4% BHT plus a phosphate buffer pH 7.4 was added to 100 µL of plasma. The mixture was vigorously vortexed for 5 seconds and subsequently incubated in a water bath at 37 ° C for 30 minutes. 1.5 mL of 0.8 M tribarbituric acid was added to the sample, which was incubated in a water bath with boiling temperature for one hour. After this time and to stop the reaction, the sample was placed on ice; 1 mL 5% KCl was added to each sample, as was 4 mL of n-butanol; The sample was vortexed for 30 seconds and centrifuged at 4000 rpm at room temperature for 2 min. Subsequently, the butanol phase was extracted, and the absorbance at 532 nm was measured. The calibration curve was obtained using tetra ethoxy propane as a standard.Measure: Measure lipoperoxidation in basal and post-therapy samples Time: Baseline and 5 days post-dose
Description: 100 mL of plasma was suspended in 1.5 mL of a reaction mixture prepared as follows: 300 mM of acetate buffer with pH 3.6, 20 mM of ferric chloride hexahydrate, and 10 mM of 2,4,6-Tris-2- Pyridyl-s-triazine dissolved in 40 mM hydrochloric acid in a ratio 10: 1: 1 v / v, respectively. The mixture was vigorously vortexed for 5 seconds. It was incubated at 37 ° C for 15 min in the dark. The absorbance was measured at 593 nm. The calibration curve was obtained using TroloxMeasure: Evaluation of the total antioxidant capacity Time: Baseline and 5 days post-dose
Description: For the measurement of NO3- / NO2-, 100 µl of plasma were added 100 µL of a 10% solution of ZnSO4, 100 µL of 0.5 N NaOH and 700 µl of tridestated water. It was shaken vigorously and centrifuged at 10,000 rpm for 5 minutes. To the resulting supernatant, Griess reagent (200 µL of 1% sulfanilamide and 200 µL of 1% N- (1-naphthyl) ethylenediamine hydrochloride) was added and incubated for 10 min protected from light at room temperature. The coloration developed after incubation was measured at an analytical wavelength of 540 nm in a double beam UV-Vis spectrometer (DW2000, SLM-Aminco, Urbana, Illinois, USA). The calibration curve was performed with a KNO3 stock solution (Spectrum Quality Products, Inc., Gardena CA) in a concentration range from 0.001 nM to 10 nM.Measure: Oxidative and antioxidant stress Time: Baseline and 5 days post-dose
Description: Measurements will be made using the Sequential Organ Failure Assessment (SOFA) every 24 hours. With a minimum score of 0-1 which translates a mortality in initial score and the highest of 0%. The maximum score of more than 14 translates a mortality of 95.2% in the initial evaluation and 89.7% in the highest evaluation.Measure: Effect of antioxidant therapy at the level on organ failure secondary to SARS-COV2 Time: From day 0 to day 7 post antioxidant dose.
Description: Measurements will be made using the Mexico Sequential Organ Failure Assessment (MEXSOFA) every 24 hours. highest evaluation. Patients with an initial MEXSOFA score of 9 points or less calculated during the first 24 hours after admission to the ICU had a mortality rate of 14.8%, while those with an initial MEXSOFA score of 10 points or more had a mortality rate. 40% mortality rate. The MEXSOFA score at 48 h was also associated with mortality: patients with a score of 9 points or less had a mortality rate of 14.1%, while those with a score of 10 points or more had a rate of 50% mortality.Measure: Effect of antioxidant therapy at the level on organ failure secondary to SARS-COV2 Time: From day 0 to day 7 post antioxidant dose.
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports