|drug467||BI 730357 Wiki||0.21|
|drug4116||Two doses of placebo at the routine vaccination schedule Wiki||0.21|
|drug4104||Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Wiki||0.21|
|drug3184||Quantitative analysis of anti-SARS-CoV-2-antibodies Wiki||0.21|
|drug2557||Nitazoxanide with ivermectin Wiki||0.21|
|drug4115||Two doses of placebo at the emergency vaccination schedule Wiki||0.21|
|drug3506||Saline containing 1% Human serum albumin（solution without UC-MSCs） Wiki||0.21|
|drug3197||Questionnaire for evaluation of confinement on deviant sexual fantasies Wiki||0.21|
|drug4105||Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Wiki||0.21|
|drug4109||Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Wiki||0.21|
|drug347||Artemesia annua Wiki||0.21|
|drug2850||Pegylated Interferon-α2b Wiki||0.21|
|drug2971||Placebo of FX06 Wiki||0.21|
|drug4110||Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Wiki||0.21|
|drug3159||Pulse oximetry Wiki||0.21|
|drug1750||Home-based exercise Wiki||0.21|
|drug2048||Ivermectin wth chloroquine Wiki||0.21|
|drug1266||Doxycycline Hcl Wiki||0.21|
|drug2869||Peripheral blood sampling Wiki||0.21|
|drug2356||MetfoLiquid GeriaSan® Wiki||0.21|
|drug3766||Standard treatment for COVID-19 Wiki||0.21|
|drug1769||Humanistic Care Wiki||0.21|
|drug1564||Follow up Wiki||0.15|
|drug3431||SARS-CoV-2 diagnostic rapid test Wiki||0.15|
|drug1052||Convalescent Plasma Transfusion Wiki||0.15|
|drug617||Blood tests Wiki||0.15|
|drug2560||Nitric Oxide Gas Wiki||0.12|
|drug1959||Interferon Beta-1A Wiki||0.11|
|drug4253||Vitamin D3 Wiki||0.09|
|drug832||Camostat Mesilate Wiki||0.08|
|drug4249||Vitamin C Wiki||0.06|
|drug3728||Standard of Care Wiki||0.03|
|D011470||Prostatic Hyperplasia NIH||0.21|
|D000073296||Noncommunicable Diseases NIH||0.15|
|D018352||Coronavirus Infections NIH||0.12|
|D001927||Brain Diseases NIH||0.10|
|D045169||Severe Acute Respiratory Syndrome NIH||0.09|
|D003327||Coronary Disease NIH||0.08|
|D006331||Heart Diseases NIH||0.06|
|D003141||Communicable Diseases NIH||0.05|
|D002318||Cardiovascular Diseases NIH||0.04|
|D012127||Respiratory Distress Syndrome, Newborn NIH||0.04|
|D055371||Acute Lung Injury NIH||0.04|
|D012128||Respiratory Distress Syndrome, Adult NIH||0.03|
|D014777||Virus Diseases NIH||0.02|
There are 22 clinical trials
There are four species of intestinal worms collectively known as soil-transmitted helminthiasis (STH): Ancylostoma duodenale and Necator americanus (hookworms), Ascaris lumbricoides (roundworms), and Trichuris trichiura (whipworms). These parasites affect over two billion people and contribute to significant morbidity and disability, especially in high risk groups, for example children, agricultural workers and pregnant women. In children, STH are associated with impaired nutritional status evidenced by stunting, thinness and underweight. As is the case in most Latin America, STH are a public health problem in Honduras. The World Health Organization (WHO) informs that more than 2.5 million children (under 15 years of age) in the country are at risk of infection. To control these infections Honduras has established a national deworming program that operates since 2001 but despite these efforts, the prevalence of STH infections remains unacceptably high. This is especially true in rural communities where prevalence can be as high as 70% of the children population. Ivermectin (IVM) in combination with albendazole (ALB) has demonstrated the capacity to improve efficacy compared to any of these drugs in monotherapy; the efficacy is however, still inadequate in terms of cure rate, although egg reduction rates are significant. The purpose of the current trial is to assess the safety and efficacy of 3 experimental regimens for the treatment of infections by Trichuris trichiura in children in comparison with the current standard of practice in Mass Drug Administration (MDA) campaigns. The experimental regimens will explore the effect of multiple day regimens and high dose ivermectin. Treatment arms: - Group 1: single dose of ALB 400 mg. (active control arm). N:39 - Group 2: single dose ALB 400mg + IVM 600µg/Kg. N: 57 - Group 3: daily dose ALB 400mg for 3 consecutive days. N:24 - Group 4: daily dose ALB 400mg + IVM 600µg for 3 consecutive days. N:57 Total Study Population: 177
Description: Number of individuals cured from Trichuris trichiura infection using the duplicate Kato Katz laboratory method on a single sample of fresh stools as the measurement tool. Cure rate is defined as the absence of Trichuris trichiura eggs in post-treatment samples.Measure: Cure Rate Time: 21 days
Description: Calculation details: 100 x (1 - arithmetic mean fecal egg count post-intervention / arithmetic mean fecal egg count pre-intervention) Egg change rate was calculated across all participants, as described in reference: Levecke B et al., PLoS Negl Trop Dis. 2014;8(10).Measure: Egg Change Rate Time: 21 days
Description: Measurement of the incidence of mutations of tubulin in Trichuris trichiura eggs collected pre and post treatment using molecular biology techniques. This data is not available yet due to the COVID-19 pandemic, but the data will be available and reported in the future. Anticipated reporting date for this outcome measure is estimated by 2021 and will be confirmed once the pandemic is over.Measure: Beta Tubulin Resistance Time: 21days
Efficacy of Ivermectin and Nitazoxanide in COVID-19 treatment
Description: The number of patients with improvement or deathMeasure: Number of patients with improvement or died Time: 1 month
At present, there are no specific treatments for COVID-19. WHO recommends four treatments for COVID 19 with drugs i.eRemdesivir, Lopinavir/ ritonavir, Lopinavir/ ritonavir with interferon beta -1a, and chloroquine or hydroxychloroquine. Currently, there are several ongoing clinical trials evaluating potential treatments. Recently, LeonCaly reported that Ivermectin, an FDA-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 hours post infection with SARSCoV-2 able to effect about 5000-fold reduction in viral RNA at 48 h. Ivermectin therefore warrant further investigation for possible benefits in humans. The study rationale is to understand the effect of the drug on eradication of virus.
Description: Test for virus at 1, 3 & 5 days from beginning of trial drug started for the patient in the hospitalMeasure: effect of Ivermectin on eradication of virus. Time: 3 months
This is a multi-arm, phase II trial for rapid efficacy and toxicity assessment of multiple therapies immediately after COVID19 positive testing in high-risk individuals. Therapies include stand-alone or combination treatment with hydroxychloroquine, azithromycin, ivermectin, or camostat mesilate, artemesia annua. The hypothesis of this study is that the addition of agents that inhibit viral entry or replication of SARS-CoV-2 virus replication in will be devoid of additional moderate to severe toxicities, will prevent clinical deterioration, and will improve viral clearance in high risk individuals.
Description: Proportion of patients experiencing clinical deterioration. Clinical deterioration is defined as a less than a 2-point change from the initial COVID 7-Point Ordinal Outcomes Scale within 14 days from the study start. This scale ranges from 1-7. Lower scores indicate worse outcomes (death); higher scores indicate fewer symptoms and better outcomes.Measure: Clinical Deterioration Time: 14 days
Description: The change in (clearance of) viral RNA will be measured by PCR testing at days 1, 14, 28, and 40 days.Measure: Change in Viral Load Time: 40 days
Description: Percentage of patients that experience severe respiratory or other organ failure.Measure: Rate of Organ Failure Time: 28 days
Description: Percentage of patients requiring ICU admission or ventilation.Measure: Progression to ICU Care or Ventilation Time: 28 days
Description: Clinical status will be assessed using the COVID 7-Point Ordinal Outcomes Scale. This scale ranges from 1-7. Lower scores indicate worse outcomes; higher scores indicate fewer symptoms and better outcomes.Measure: Change in Clinical Status Time: 14 days
Description: Percentage of patients who have died by day 14.Measure: Mortality Time: 14 days
Description: Percentage of patients experiencing severe adverse events, defined as grade 3 non-hematologic or greater by DMID Toxicity Scale for Determining Severity of Adverse Events.Measure: Rate of severe adverse events Time: 14 days
Description: Number of days patients do not require oxygen supplementation.Measure: Oxygen-free days Time: 28 days
Description: Number of days patients do not require mechanical ventilation.Measure: Ventilator-free days Time: 28 days
Description: Number of days patients do not require vasopressor treatment.Measure: Vasopressor-free days Time: 28 days
Description: Number of days patients do not require ICU services.Measure: ICU-free days Time: 28 days
Description: Number of days patients do not require hospitalization.Measure: Hospital-free days Time: 28 days
Description: Proportion of patients meeting Hy's law criteria.Measure: Patients meeting Hy's Law criteria Time: 28 days
Description: Proportion of patients with changes in the following liver function tests: Any ALT or AST ≥ 5 x ULN; any AST or ALT ≥ 3 x ULN together with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash and/or eosinophilia (eosinophil percent or count above the ULN); Persistent ALT ≥ 3 x ULN for a period of more than 4 weeksMeasure: Liver Function Time: 28 days
Description: Proportion of patients with significant changes in ECG findings, including heart rate, ECG intervals (PR, QTcB, QTcF), conduction changes, or abnormalities including severe QTc prolongation of > 500 ms.Measure: Heart Function Time: 28 days
Azithromycin has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019.
Description: the number of patients with virological cureMeasure: Number of patients with virological cure Time: 6 months
We have to be aware of the challenge and concerns brought by 2019-nCoV to our healthcare workers. Front-line healthcare workers can become infected in the management of patients with COVID-19; the high viral load in the atmosphere, and infected medical equipment are sources for the spread of SARS-CoV-2. If prevention and control measures are not in place, these healthcare workers are at great risk of infection and become the inadvertent carriers to patients who are in hospital for other diseases. Nowadays a question that has not yet been clarified by science has been arises: is hydroxychloroquine associated with zinc compared to ivermectin associated with zinc effective as a prophylaxis for asymptomatic professionals involved in the treatment of suspected or confirmed case of COVID-19?
Description: Proportion of participants in whom there was a a positivity for SARS-CoV-2 through specific examination (RT-PCR) or by serology for antibodies specific (IgM and IgG), corroborated or not with clinical finding of COVID-19, defined as the occurrence of signs and symptoms suggestive of this disease.Measure: Proportion of participants in whom there was a positivity for SARS-CoV-2. Time: Post-intervention at day 52
Description: Proportion of participants who developed mild, moderate, or severe forms of COVID-19.Measure: Participants who developed mild, moderate, or severe forms of COVID-19. Time: Post-intervention at day 52.
Description: Measurement of the QT interval through electrocardiogram evaluation.Measure: Measurement of the QT interval. Time: Baseline, 3, 15 and 45 days post-intervention.
Description: Proportion of participants who evolved with widening of the corrected QT interval or with changes in heart rate on the ECG.Measure: Widening of the corrected QT interval or with changes in heart rate on the ECG. Time: Day 52.
Description: Comparison of baseline (visit 0) and final (visit 5) values of hematological and biochemical parameters.Measure: Comparison of hematological and biochemical parameters. Time: Day 52.
Description: Proportion of occurrence of adverse events reported by participants or verified by the attending physician, or even observed in laboratory tests.Measure: Occurrence of adverse events. Time: Post-intervention at day 52.
Description: Severity of symptoms of COVID-19 measured by a visual analog scale (VAS), with scores ranging from zero to 10, where zero represents the absence of the symptom and 10 corresponds to the most intense manifestation of symptoms (severe dyspnoea).Measure: Assessment of COVID-19 symptom severity. Time: Post-intervention at day 52.
Description: Proportion of participants who discontinue study intervention,Measure: Proportion of participants who discontinue study intervention. Time: Post-intervention at day 52.
Description: Proportion of participants who required hospital care.Measure: Proportion of participants who required hospital care. Time: Post-intervention at day 52.
Description: Proportion of participants who required mechanical ventilation.Measure: Proportion of participants who required mechanical ventilation. Time: Post-intervention at day 52.
SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial is currently planned at a single center in Navarra.
Description: Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatmentMeasure: Proportion of patients with a positive SARS-CoV-2 PCR Time: 7 days post-treatment
Description: Change from baseline quantitative and semi-quantitative PCR in nasopharyngeal swabMeasure: Mean viral load Time: Baseline and on days 4, 7, 14 and 21
Description: Proportion of patients with fever and cough at days 4, 7, 14 and 21 as well as proportion of patients progressing to severe disease or death during the trialMeasure: Fever and cough progression Time: Up to and including day 21
Description: Proportion of participants with positive IgG at day 21Measure: Seroconversion at day 21 Time: Up to and including day 21
Description: Proportion of drug-related adverse eventsMeasure: Proportion of drug-related adverse events Time: 7 days post treatment
Description: Levels in median fluorescence intensity (MFI) of IgG, IgM and IgA against the receptor-binding domain of the spike glycoprotein of SARS-CoV-2 in plasma, measured by a Luminex assayMeasure: Levels of IgG, IgM and IgA Time: Up to and including day 28
Description: Frequency (% over total PBMC) of innate immune cells (myeloid and plasmacytoid dendritic cells, NK cell, classical, intermediate and pro-inflammatory macrophages) measured in cryopreserved PBMC by flow cytometryMeasure: Frequency of innate immune cells Time: Up to and including day 7
Description: Frequency of CD4+ T and CD8+ T cells (% over total CD4+T and CD8+ T) expressing any functional marker upon in vitro stimulation of PBMC with SARS-CoV-2 peptides, measured by flow cytometryMeasure: Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T cells Time: Up to and including day 7
Description: Concentration (all in pg/mL) of epidermal growth factor (EGF), fibroblast growth factor (FGF), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF), tumour necrosis factor (TNF), interferon (IFN)-α, IFN-γ, interleukin (IL)-1RA, IL-1β, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12(p40/p70), IL-13, IL-15, IL-17, IFN-γ induced protein (IP-10), monocyte chemoattractant protein (MCP-1), monokine induced by IFN-γ (MIG), macrophage inflammatory protein (MIP)-1α, MIP-1β in plasma measured by a Luminex assay using a commercially available kit (Cytokine Human Magnetic 30-Plex Panel from ThermoFisher)Measure: Results from cytokine Human Magnetic 30-Plex Panel Time: Up to and including day 28
Background: In December 2019, patients with pneumonia secondary to a new subtype of Coronavirus (COVID-19) were identified in China. In a few weeks the virus spread and cases started practically all over the world. In February 2020, the WHO declared a pandemic. Severe symptoms have been found in patients mainly with comorbidities and over 50 years of age. At this time there is no proven therapeutic alternative. In vitro studies and observational experiences showed that antimalarial drugs (Chloroquine and hydroxychloroquine) had antiviral activity and increased viral clearance. Ivermectin, on the other hand, has been shown in vitro to reduce viral replication and in an observational cohort, greater viral clearance with promising clinical results. So far there is no standard of treatment and clinical trials are needed to find effective treatment alternatives. Objective: To evaluate the safety and efficacy of treatment with hydroxychloroquine and ivermectin for serious COVID-19 infections in no critical hospitalized patients. Material and methods: Randomized controlled trial of patients diagnosed with respiratory infection by COVID-19, who present criteria for hospitalization. Randomization will be performed to receive hydroxychloroquine at a dose of 400 mg every 12 hours for one day and then 200 mg every 12 hours, to complete a 5-day treatment schedule. Group 2: Ivermectin 12 mg every 24 hours for one day (less than 80 kg) or Ivermectin 18 mg every 24 hours for one day (greater than 80 kg) + placebo until the fifth day. Group 3: Placebo. Prior to randomization, the risk of cardiovascular complications determined by corrected QT interval, related to hydroxychloroquine intake will be assessed. If the patient is at high risk, the allocation will be to ivermectin only or to placebo in an independent randomization, if the risk is low, any of the three groups could be assigned. Outcomes: The primary outcome will be discharge from hospital for improvement. The safety outcomes will be requirement of mechanical intubation, septic shock or death. Viral clearance will also be evaluated by means of PCR, which will be taken on the 5th day after admission, day 14 and 21.
Description: Days from admission as a suspected case of COVID with hospitalization criteria until dischargeMeasure: Mean days of hospital stay Time: Three months
Description: Respiratory deterioration defined by respiratory rate > 25 per minute, requirement of high oxygen supply (FiO2 > 80% ) to maintain oxygen saturation > 90 %, invasive mechanical ventilation or dead.Measure: Rate of Respiratory deterioration, requirement of invasive mechanical ventilation or dead Time: Three months
Description: Daily delta of oxygenation index during the hospitalizationMeasure: Mean of oxygenation index delta Time: Three months
Description: Mean time to viral negativization of RT-qPCR SARS-CoV-2. Pre Specified time: 5, 14, 21 and 28 days after the first positive PCR.Measure: Mean time to viral PCR negativization Time: 5, 14, 21 and 28 days after the first positive PCR
As the world faces COVID-19, the search for effective treatments against the disease and its complications has turned its gaze to drugs that are classically used in other infectious diseases. Some drugs are being examined for the recent evidence on its effects on viral replication and inflammation, one is Azithromycin, used to treat a wide variety of bacterial infections, Ivermectin, an anti-parasitic drug and the other is Cholecalciferol to increase serum concentration of 25-hydroxyvitamin D.
Description: Test for virus at day 1 and 14 from beginning of trial drug startedMeasure: Viral clearance Time: 14 days
Description: The duration of symptoms in daysMeasure: Symptoms duration Time: 14 days
Description: oxygen saturationMeasure: SpO2 Time: 14 days
Description: Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2) RatioMeasure: SpO2/FiO2 Time: 14 days
Efficacy of Ivermectin and Doxycycline in COVID-19 treatment
Description: The number of patients with improvement or mortalityMeasure: The number of patients with improvement or mortality Time: 1 month
This study aims to evaluate the efficacy, safety and tolerability of Ivermectin in patients with mild SARS-CoV-2 infection, in the rate of progression to severe 2019 novel coronavirus disease (COVID-19). The primary efficacy endpoint is the proportion of participants with a disease control status defined as no progression of severe disease Hypothesis (H0): There is no difference between group A (ivermectin + paracetamol) and group B (ivermectin + paracetamol) in terms of the primary endpoint on day 14.
Description: The subject is considered to have progressed to severe illness when one or more of the following criteria are present: Breathing difficulty (≥30 breaths per minute); Resting oxygen saturation ≤93%; Severe complications such as: respiratory failure, need for mechanical ventilation, septic shock, non-respiratory organic failure.Measure: Participants with a disease control status defined as no disease progression to severe. Time: 14 days
as Egypt suffered a lot during the pandemic of COVID 19 with limited drug choices, many of the patients could not acheive viral clearence with the standard module of care teh idea of introduction of new medications in the treatment protocol of COVID 19 managment. Ivermectin had shown a promising results in vitro studies and in limited in vivo studies. this clinical trial may open a new hope for COVID 19 patients as a new and cheap line of treatment
Description: the role of ivermectin in the cure of COVID 19 patientsMeasure: to evaluate the role of Ivermectin as a line of treatment for COVID 19 Time: 2 months
Description: to compare the results of ivermectin with the standard careMeasure: To asses the rate of viral clearance in comparison to other treatment protocols. Time: 2 months
In December 2019, a group of patients with pneumonia of unknown cause was linked to a wholesale seafood market in Wuhan, China. The genetic analysis of samples from the lower respiratory tract of these patients indicated a new coronavirus as the causative agent, which was named SARS-CoV-2. The virus spread rapidly to more than 45 countries, including Brazil, causing an international alarm. However, in spite of its epidemiological magnitude, so far, there is no antiviral treatment or vaccine approved for the treatment of this infection. With about 15% to 20% of SARS-CoV-2 patients suffering from serious illnesses and overburdened hospitals, therapeutic options are desperately needed. So, instead of creating compounds from scratch that can take years to develop and test, researchers and public health agencies have sought to redirect drugs already approved for other diseases and known to be widely safe. In this context, the analysis of the international literature shows the existence of an in vitro antiviral activity of ivermectin against SARS-CoV-2. However, there are no studies that have evaluated its clinical effectiveness in patients diagnosed with SARS-CoV-2 infection. Therefore, and considering this knowledge gap, the present study aims to determine the clinical efficacy and safety of different doses of ivermectin in patients diagnosed with SARS-CoV-2 infection.
Description: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab after Intervention Initiation.Measure: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. Time: 7 days following intervention
Description: Viral load variation in the nasopharyngeal swab during treatment.Measure: Viral load variation in the nasopharyngeal swab. Time: 7 days following intervention.
Description: Variation of serum lymphocyte counts during treatment.Measure: Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. Time: 7 days following intervention.
Description: Proportion of patients with undetectable SARS-CoV-2 viral load in the nasopharyngeal swab at the end of follow-up.Measure: Proportion of patients with undetectable SARS-CoV-2 viral load in the nasopharyngeal swab. Time: 7 after intervention.
Description: Proportion of patients with clinical improvement, defined as the time to normalize fever, respiratory rate and oxygen saturation and cough relief at the end of follow-up.Measure: Proportion of patients with clinical improvement. Time: 7 after intervention.
Prospective, multi-centre, randomized, double-blind trial to assess efficacy and safety of ivermectin for the treatment of initial infection with SARS-CoV2 infection. Study arms: A) placebo B) ivermectin 600 μg/kg daily for 5 consecutive days (I_600) + placebo. C) ivermectin 1200 μg/kg daily at empty stomach with water for 5 consecutive days (I_1200). Patients will be randomized at emergency room of hospitals as well as at outpatient ambulatory care as well as at home, according to routine procedures of recruiting centres. In arm A and B, the number of placebo tablets to be administered will be calculated by the study dedicated pharmacist considering the number of tablets that should be taken in case a patient with the same weight is assigned to arm C.
Description: Number of serious adverse drug reactionMeasure: SADR Time: 14 days
Description: Quantitative viral load as measured by quantitative, digital droplet PCR.Measure: Viral load Time: Assessed at day 7
Description: 1. Trend over time of quantitative viral load at Day 7 and 14 as measured by quantitative, digital droplet PCR.Measure: Trend viral load Time: Days 7 and 14 from baseline
Description: Time to clinical resolution (for symptomatic patients).Measure: Clinical resolution Time: Assessed on Day 30
Description: Time from diagnosis to documented viral clearanceMeasure: Viral clearance Time: assessed on days 14 and 30
Description: Proportion of patients with virological clearanceMeasure: Virological clearance Time: Assessed at day 14 and 30
Description: rate of hospitalizationMeasure: hospitalization rate Time: Day 30
Description: COVID-19 Severity Score (Coronavirus Diseases 19 Severity Score) - min value 1 ("no limitation of activities), max value 8 ("death"). Higher scores mean worse outcomeMeasure: Severity score Time: Assessed at Day 14 and Day 30
confirmed cases with COVID-19 will receive ivermectin as a therapeutic option as well as standard of care treatment and will be compared to those that will receive only standard of care ttt
Description: duration from day 1 symptoms till 3 days without symptomsMeasure: time to be symptoms free Time: within 21 days after enrollment
Description: need hospital admissionMeasure: hospitalization Time: within 21 days after enrollement
Description: need mechanical ventilationMeasure: Mechanical ventilation Time: within 21 days after enrollement
Description: days spent in hospitalMeasure: length of stay Time: within one month days after enrollement
Description: survived or diedMeasure: mortality Time: within one month days after enrollement
This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection
Description: Percentage of subjects hospitalized due to COVID-19Measure: COVID-19 hospitalization Time: 30 days
Description: COVID Ordinal Scale defined as: Death Hospitalized on invasive mechanical ventilation or ECMO ( extracorporeal membrane oxygenation) Hospitalized on non-invasive ventilation or high flow nasal cannula Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with limitation in activity (continued symptoms) Not hospitalized without limitation in activity (no symptoms)Measure: COVID-19 Ordinal Outcomes Scale Time: 30 days
Description: Symptoms severity of COVID-19 using Brescia-COVID Respiratory Severity Scale (BCRSS)/AlgorithmMeasure: Symptoms severity of COVID-19 Time: 30 days
Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19
Description: Incidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or deathMeasure: Incidence of severe complications due COVID-19 infection Time: 28 days
Description: Severe Acute Respiratory Syndrome defined as oxygen saturation less than 93%Measure: Incidence of Severe Acute Respiratory Syndrome Time: 28 days
Description: Severe Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minuteMeasure: Incidence of Severe Acute Respiratory Syndrome Time: 28 days
Description: Incidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L)Measure: Adverse events Time: 28 days
Description: Incidence of hepatic toxicity (elevation of bilirubin above the upper limit of normal, measured by mg/dL)Measure: Adverse events Time: 28 days
Description: Incidence of renal toxicity (elevation of serum creatinine levels above the upper limit of normal, measured by mg/dL)Measure: Adverse events Time: 28 days
Description: Incidence of symptomatic postural hypotension, diagnosed by clinical assessment of reduction of > 20 mmHG of arterial systolic pressure after measurement in prone position and orthostatic position.Measure: Adverse events Time: 28 days
Description: Death of any cause since protocol enrollmentMeasure: Overall survival Time: 28 days
On 11th of March 2020, WHO characterized COVID-19 infection as a Pandemic. After the COVID-19 infection is declared as a Pandemic there was an outburst regarding COVID-19 Research. The Research interest led to registration of Interventional and Observational studies world wide. There are constant efforts by Health care workers to seek information regarding the Interventional and Observational studies which can help in decision making regarding effective handling of COVID-19 infected patients. It is also important to track on the happenings in various frontiers of COVID-19 Research in view of historical interest and clinical relevance. This Observational Cross sectional study aims to explore the completed Researches in WHO-compliant registries to understand the trends of COVID-19 Research. This study aims to get a birds eye view of ongoing COVID-19 Research scenario worldwide. This study results can directly benefit the worldwide Academicians and Health Care Professionals to understand the ongoing COVID-19 Research trends.
Description: To understand the geographical distribution of the interventional studies after 11th of March 2020.Measure: Geographical distribution of the interventional studies after 11th of March 2020. Time: 15th of August 2020
Description: To understand the geographical distribution of the Observational studies after 11th of March 2020.Measure: Geographical distribution of the Observational studies after 11th of March 2020. Time: 15th of August 2020
Description: To understand the monthly Research study completion rate as per geographic distribution of the Research.Measure: Monthly Research study completion rate as per geographic distribution of the Research. Time: 15th of August 2020
Description: To understand the statistical correlation of the interventional studies Research with developed, developing and under developed countries.Measure: Statistical correlation of the interventional studies Research with developed, developing and under developed countries. Time: 15th of August 2020
Description: To understand the statistical correlation of the observational studies Research with developed, developing and under developed countries.Measure: Statistical correlation of the observational studies Research with developed, developing and under developed countries. Time: 15th of August 2020
Description: To understand the statistical correlation of the Drug based interventional studies Research with developed, developing and under developed countries.Measure: Statistical correlation of the Drug based interventional studies Research with developed, developing and under developed countries. Time: 15th of August 2020
Description: To understand the statistical correlation of the Diagnostic test based interventional studies Research with developed, developing and under developed countries.Measure: Statistical correlation of the Diagnostic test based interventional studies Research with developed, developing and under developed countries. Time: 15th of August 2020
Description: To understand the statistical correlation of the Device based interventional studies Research with developed, developing and under developed countries.Measure: Statistical correlation of the Device based interventional studies Research with developed, developing and under developed countries. Time: 15th of August 2020
In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.
Description: Time to negative RT-PRC result indicating that patient is no longer infectiveMeasure: Time to Non-Infectivity by RT-PCR Time: 6 months
Description: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.Measure: Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score) Time: 6 months
Description: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.Measure: Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score) Time: 6 months
Description: Patients will have serum stored for titer testing to compare antibody levels over timeMeasure: Efficacy of Treatment as measured by Titer Time: 6 months
Description: Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatmentMeasure: Efficacy of Treatment as measured by RT-PCR Time: 10 days
Description: Blood D-Dimer levelsMeasure: Safety of Treatment as Measured by D-Dimer Time: 6 Months
Description: Blood Pro-Calcitonin levelsMeasure: Safety of Treatment as Measured by Pro-Calcitonin Time: 6 Months
Description: Blood CRP levelsMeasure: Safety of Treatment as Measured by C-Reactive Protein Time: 6 Months
Description: Blood ferritin levelsMeasure: Safety of Treatment as Measured by Ferritin Time: 6 Months
Description: Blood enzyme levelsMeasure: Safety of Treatment as Measured by Liver Enzymes Time: 6 Months
Description: CBCMeasure: Safety of Treatment as Measured by Complete Blood Count Time: 6 Months
Description: Blood electrolytesMeasure: Safety of Treatment as Measured by Electrolyte Levels Time: 6 Months
Description: Presence or absence of Grade 3 or high treatment related adverse eventsMeasure: Safety of Treatment as Measured by Treatment Related Adverse Events Time: 6 months
It will be performed a randomized, multicenter, triple-masked, placebo-controlled clinical experiment to determine the effectiveness and safety of the administration to of ivermectin at a dose of 200 mcg/kg once a week for 7 weeks in a prophylactic treatment against SARS COV-2 infection in 550 Colombian health workers during the COVID-19 pandemic.
Description: Development of of the disease according to the definitions of cases found in the guidelines from the Colombian National Institute of HealthMeasure: Clinical development of covid-19 disease during the intervention period Time: 8 weeks
Description: Indicate if the patient had positive serological antibodies at the end of the studyMeasure: Seroconversion Time: 8 weeks
Description: Need for hospitalization independent of the level of complexity due to covid-19Measure: Hospitalization requirement Time: 8 weeks
Description: ICU need due to Covid-19Measure: Intensive Care Unit Requirement Time: 8 weeks
Description: Adverse effect due to medication or placeboMeasure: Safety of the intervention Time: 8 weeks
It is a single-center, prospective, randomized, double-blind, placebo-controlled study carried out by the Ministry of Public Health of the Province of Corrientes, Argentina, in coordination with the Corrientes Institute of Cardiology "Juana F. Cabral". Patients who meet all the inclusion criteria and none of the exclusion criteria are randomized via the web system to receive placebo or ivermectin. The need for hospitalization in patients with COVID-19 is assessed as the primary end point. As secondary end points are evaluated: time to hospitalization (in days); use of invasive mechanical ventilation; time to invasive mechanical ventilation (in days); dialysis; all-cause mortality; negative of the swab at 3 ± 1 days and 12 ± 2 days after entering the study and ivermectin safety. Intermediate internal analyzes of study objectives and serious adverse events will be performed, including 125; 250 and 375 patients in order to assess the possible need for early termination of the study. For these intermediate internal analyzes, the Haybittle-Peto rule will be followed, therefore a value of p <0.001 will be considered significant
Description: Hospitalization will be considered when at least 24 hours have elapsed in a health institution, in any of its services.Measure: Percentage of Hospitalization of medical cause in patients with COVID-19 in each arm Time: through study completion, an average of 30 days
Description: Number of days elapsedMeasure: Time to hospitalization Time: through study completion, an average of 30 days
Description: All patients who are connected to invasive mechanical ventilation supportMeasure: Percentage of Use of invasive mechanical ventilation support in each arm Time: through study completion, an average of 30 days
Description: Number of days elapsedMeasure: Time to invasive mechanical ventilation support Time: through study completion, an average of 30 days
Description: All patients who require temporary or permanent renal replacement therapyMeasure: Percentage of dialysis in each arm Time: through study completion, an average of 30 days
Description: Death of the patient, from any cause.Measure: All-cause mortality Time: through study completion, an average of 30 days
Description: Negative Nasal Swab Using Polymerase Chain Reaction TechniqueMeasure: Negative of the swab at 3±1 days and 12±2 days after entering the study Time: At days 3±1 and 12±2
Description: According to the adverse events that patients may present.Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) Time: through study completion, an average of 30 days
Since the onset of the disease, more than 40.5 million people have been diagnosed with COVID-19 and nearly 1.2 million people have died (October 21, 2020). There is no complete understanding of the pathogenesis of SARS-CoV-2 infection and to this day there is no specific therapy or vaccine available. Thus, patient care is based on symptomatic therapy and treatment of complications. Ivermectin has been used for more than 30 years for the treatment of several diseases. More than one million doses of the drug are administered daily, particularly in low- and middle-income countries. Due to the low prevalence of adverse events with the use of this drug, ivermectin is considered to have a good safety profile and its potential benefit in other diseases is currently under investigation. An in vitro study of ivermectin in SARS-CoV-2 in Australia showed a significant reduction of viral load in infected cells. Subsequently, a descriptive study of 704 critical patients with COVID-19 showed a reduction in mortality, hospitalization, and intensive care unit length-of-stay in those patients who received the drug. Unfortunately, this study was withdrawn by its authors, leaving more questions than answers. Some countries in Latin America have authorized its use for the management of patients with COVID-19 even in the absence of solid evidence, and several other countries are conducting clinical trials to evaluate its efficacy for the treatment of moderate and severe disease. Since there is no specific treatment for COVID-19 and the therapeutic options are scarce, the researchers believe it is completely plausible, urgent, and necessary to evaluate if ivermectin use reduces the risk of admission to an intensive care unit (ICU) in hospitalized adults with severe COVID-19. The proposal is a randomized, double-blind clinical trial, conducted at CES Clinic, Medellin-Colombia. The investigators will randomize 100 patients with severe, non-critical illness, into two groups, one group will receive ivermectin in addition to standard management and the other group will receive placebo plus standard management. Clinical outcomes to evaluate will be ICU admission, need for mechanical ventilation, length of hospital stay, days in the ICU and mechanical ventilation, and finally, the incidence of adverse events related to the intervention. The estimated time to complete the study is approximately five months.
Description: Cumulative incidence of ICU admission.Measure: Admission to the intensive care unit. Time: 21 days
Description: Duration of hospitalization (days).Measure: Hospital length of stay. Time: 21 days
Description: 21-day mortality.Measure: Mortality rate. Time: 21 days
Description: Number of days in ICU.Measure: ICU length of stay. Time: 21 days
Description: Number of days with mechanical ventilator.Measure: Length of stay in ventilator time. Time: 21 days
Description: Cumulative incidence of adverse effects: headache, rash, pruritus, arthralgia, tachycardia, dizziness, hypotension, uveitis, Steven Johnson Syndrome.Measure: Adverse effects of ivermectin. Time: 21 days
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