Name (Synonyms) | Correlation | |
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drug908 | Weekly Assessment Wiki | 0.22 |
drug501 | Melatonin 2mg Wiki | 0.22 |
drug890 | Valsartan (Diovan) Wiki | 0.22 |
drug395 | Hydroxychloroquine plus standard preventive measures Wiki | 0.22 |
drug516 | Monitoring Visit - Week 8 Wiki | 0.22 |
drug736 | Schirmer Test I Wiki | 0.22 |
drug373 | Hydroxychloroquine Pre-Exposure Prophylaxis Wiki | 0.22 |
drug382 | Hydroxychloroquine Sulfate 400 mg twice a day Wiki | 0.22 |
drug191 | Chloroquine Diphosphate Wiki | 0.22 |
drug864 | Treatment with Dexmedetomidine Wiki | 0.22 |
drug234 | Coping strategies video Wiki | 0.22 |
drug815 | TD-0903 Wiki | 0.22 |
drug514 | Monitoring Visit - Baseline Wiki | 0.22 |
drug804 | Survey and Questionnaire Wiki | 0.22 |
drug515 | Monitoring Visit - Week 4 Wiki | 0.22 |
drug368 | Hydroxychloroquine - Daily Dosing Wiki | 0.22 |
drug384 | Hydroxychloroquine Sulfate 600 mg twice a day Wiki | 0.22 |
drug383 | Hydroxychloroquine Sulfate 600 mg once a day Wiki | 0.22 |
drug360 | Hydroxychloroquine Wiki | 0.22 |
drug628 | Placebo plus standard preventive measures Wiki | 0.22 |
drug791 | Stem Cell Educator-Treated Mononuclear Cells Apheresis Wiki | 0.22 |
drug1015 | remdesivir Wiki | 0.22 |
drug964 | hydroxychloroquine sulfate 200 MG Wiki | 0.22 |
drug208 | Colchicine Wiki | 0.20 |
drug304 | Favipiravir Wiki | 0.18 |
drug370 | Hydroxychloroquine - Weekly Dosing Wiki | 0.16 |
drug82 | Azithromycin Wiki | 0.14 |
drug169 | Camostat Mesilate Wiki | 0.13 |
drug632 | Placebos Wiki | 0.12 |
drug668 | Questionnaire Wiki | 0.11 |
drug190 | Chloroquine Wiki | 0.09 |
drug771 | Standard of Care Wiki | 0.07 |
drug478 | Lopinavir/ritonavir Wiki | 0.07 |
drug691 | Remdesivir Wiki | 0.07 |
drug616 | Placebo Wiki | 0.05 |
Name (Synonyms) | Correlation | |
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D003231 | Conjunctivitis NIH | 0.22 |
D007249 | Inflammation NIH | 0.20 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.19 |
D000077062 | Burnout, Psychological NIH | 0.16 |
D018352 | Coronavirus Infections NIH | 0.15 |
D007239 | Infection NIH | 0.15 |
D003141 | Communicable Diseases NIH | 0.13 |
D014777 | Virus Diseases NIH | 0.12 |
D013577 | Syndrome NIH | 0.10 |
D055371 | Acute Lung Injury NIH | 0.07 |
D055370 | Lung Injury NIH | 0.07 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.06 |
D011014 | Pneumonia NIH | 0.04 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.03 |
There are 20 clinical trials
Double blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease.
Description: incidence of all-cause mortality
Measure: All-cause hospital mortality Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 daysDescription: Days from ER admission to hospital discharge
Measure: Length of hospital stay Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 daysDescription: need of invasive or non invasive mechanical ventilation
Measure: Need of mechanical ventilation Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 daysDescription: 28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization
Measure: Ventilator free days Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 daysDescription: Adverse Reactions
Measure: Grade 3-4 adverse reaction Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 daysTriple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.
Description: Symptomatic infection rate by COVID-19 defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive COVID-19 real-time polymerase chain reaction test.
Measure: Symptomatic COVID-19 infection rate Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment startDescription: Symptomatic infection rate by other non-COVID-19 viral etiologies defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive viral real time polymerase chain reaction test.
Measure: Symptomatic non-COVID viral infection rate Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment startDescription: Number of days absent from labor due to COVID-19 symptomatic infection
Measure: Days of labor absenteeism Time: From date of randomization until study completion 60 days after treatment startDescription: Absenteeism from labor rate due to COVID-19 symptomatic infection
Measure: Rate of labor absenteeism Time: From date of randomization until study completion 60 days after treatment startDescription: Rate of severe respiratory COVID-19 disease in healthcare personnel
Measure: Rate of severe respiratory COVID-19 disease in healthcare personnel Time: From date of randomization until the appearance of symptoms or study completion 60 days after treatment startThe purpose of this study is to test the hypothesis that post-exposure prophylaxis with hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts of known or suspected COVID-19 patients.
Description: This is defined as either 1. COVID-19 infection confirmed within 14 days of enrollment, following self-report of COVID-19 symptoms to the research study; OR, 2. COVID-19 infection confirmed within 14 days of enrollment, with self-report of COVID-19 symptoms to a treating physician.
Measure: Number of participants with symptomatic, lab-confirmed COVID-19. Time: Date of enrollment to 14 days post-enrollment dateSARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease presentation which has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of 18 March 2020, there are 198,193 number of confirmed cases with an estimated case-fatality of 3%. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment. SARS-CoV-2 exploits the cell entry receptor protein angiotensin converting enzyme II (ACE-2) to access and infect human cells. The interaction between ACE2 and the spike protein is not in the active site. This process requires the serine protease TMPRSS2. Camostat Mesilate is a potent serine protease inhibitor. Utilizing research on severe acute respiratory syndrome coronavirus (SARS-CoV) and the closely related SARS-CoV-2 cell entry mechanism, it has been demonstrated that SARS-CoV-2 cellular entry can be blocked by camostat mesilate. In mice, camostat mesilate dosed at concentrations similar to the clinically achievable concentration in humans reduced mortality following SARS-CoV infection from 100% to 30-35%.
Description: Clinical improvement defined as live hospital discharge OR a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale
Measure: Cohort 1: Days to clinical improvement from study enrolment Time: 30 daysDescription: Days to clinical improvement from study enrolment defined no fever for at least 48 hrs AND improvement in other symptoms (e.g. cough, expectoration, myalgia, fatigue, or head ache)
Measure: Cohort 2: Days to clinical improvement from study enrolment Time: 30 daysDescription: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measure: Cohort 1: Clinical status as assessed by the 7-point ordinal scale at day 7, 14 and 30 Time: 30 daysDescription: Mortality
Measure: Cohort 1: Day 30 mortality Time: 30 daysDescription: NEWS2
Measure: Cohort 1: Change in NEW(2) score from baseline to day 30 Time: 30 daysDescription: ICU
Measure: Cohort 1: Admission to ICU Time: 30 daysDescription: invasive mechanical ventilation or ECMO
Measure: Cohort 1: Use of invasive mechanical ventilation or ECMO Time: 30 daysDescription: Nasal or high-flow oxygen
Measure: Cohort 1: Duration of supplemental oxygen (days) Time: 30 daysDescription: Subjective clinical improvement
Measure: Cohort 1+2: Days to self-reported recovery (e.g. limitations in daily life activities) during telephone interviews conducted at day 30 Time: 30 daysDescription: No of new COVID-19 infections in the household
Measure: Cohort 2: Number participant-reported secondary infection of housemates Time: 30 daysDescription: Hospital admission
Measure: Cohort 2: Time to hospital admission related to COVID-19 infection Time: 30 daysThis study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.
Description: The patient will becategorized into one of the following 8 categories depending on status of their hospitalization: Dead (yes/no) Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no) Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) Hospitalized for observation (yes/no) Discharged from hospital with restriction of activity level (yes/no) Discharged from hospital without any restrictions of activity level (yes/no) Only one category can be "yes".
Measure: Categorization of hospitalization status Time: 14 daysDescription: Delta PaO2 measured in arterial puncture
Measure: Change in patient's oxygen partial pressure Time: 4 daysDescription: Delta PaCO2 measured in arterial puncture
Measure: Change in patient's carbondioxid partial pressure Time: 4 daysDescription: pH measured in arterial puncture
Measure: Level of pH in blood Time: 4 daysThis study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.
Description: The patient will becategorized into one of the following 8 categories depending on status of their hospitalization: Dead (yes/no) Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no) Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) Hospitalized for observation (yes/no) Discharged from hospital with restriction of activity level (yes/no) Discharged from hospital without any restrictions of activity level (yes/no) Only one category can be "yes".
Measure: Categorization of hospitalization status Time: 14 daysDescription: Delta PaO2 measured in arterial puncture
Measure: Change in patient's oxygen partial pressure Time: 4 daysDescription: Delta PaCO2 measured in arterial puncture
Measure: Change in patient's carbondioxid partial pressure Time: 4 daysDescription: pH measured in arterial puncture
Measure: Level of pH in blood Time: 4 daysThis is a phase 3, multi-center, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.
Description: The primary endpoint will be the composite of death or the need for hospitalization due to COVID-19 infection in the first 30 days after randomization.
Measure: Number of participants who die or require hospitalization due to COVID-19 infection Time: 30 days post randomizationDescription: The secondary endpoint is the occurrence of death in the 30 days following randomization.
Measure: Number of participants who die Time: 30 days post randomizationDescription: The secondary endpoint is the need for hospitalization due to COVID-19 infection in the 30 days following randomization.
Measure: Number of participants requiring hospitalization due to COVID-19 infection Time: 30 days post randomizationDescription: The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.
Measure: Number of participants requiring mechanical ventilation Time: 30 days post randomizationThe PATCH trial (Prevention And Treatment of COVID-19 with Hydroxychloroquine) is funded investigator-initiated trial that includes 3 cohorts. Cohort 1: a double-blind placebo controlled trial of high dose HCQ as a treatment for home bound COVID-19 positive patients; Cohort 2: a randomized study testing different doses of HCQ in hospitalized patients; Cohort 3: a double blind placebo controlled trial of low dose HCQ as a preventative medicine in health care workers.
Description: Cohort 1 (home quarantined COVID-19 patients): Median time to release from quarantine by meeting the following criteria: 1) No fever for 72 hours 2) improvement in other symptoms and 3) 7 days have elapsed since the beginning of symptom onset.
Measure: Median release from quarantine time Time: 14 days or lessDescription: Cohort 2 (hospitalized COVID-19 patients): Rate of participants discharged at or before 14 days
Measure: Rate of hospital discharge Time: 14 daysDescription: Cohort 3 Physicians and nurse prophylaxis: Rate of COVID-19 infection at 2 months
Measure: Rate of infection Time: 2 monthsDescription: Cohort 1 rate of participant-reported secondary infection of housemates
Measure: Rate of housemate infection Time: 14 daysDescription: Cohort 1 rate of hospitalization
Measure: Rate of hospitalization Time: 14 daysDescription: Cohort 1 rate of treatment related adverse events
Measure: Cohort 1 adverse event rate Time: 14 daysDescription: Cohort 2 Time to condition appropriate for discharge. The primary care team indicates the patients has improved to the point of being discharged.
Measure: Time to condition appropriate for discharge Time: 14 daysDescription: Cohort 2 rate of ICU admission from a floor bed in the hospital
Measure: Rate of ICU admission Time: 14 daysDescription: Cohort 2 the number of days between hospital admission and a negative PCR test for SARS-CoV-2.
Measure: Time to PCR negativity Time: 14 daysDescription: Cohort 2 rate of treatment related adverse events
Measure: Cohort 2 adverse events Time: 14 daysDescription: Cohort 3 number of scheduled shifts at the hospital that are missed.
Measure: Scheduled shifts missed Time: 2 monthsDescription: Cohort 3 rate of treatment related adverse events
Measure: Cohort 3 adverse events Time: 2 monthsRationale: The current SARS-CoV-2 pandemic has a high burden of morbidity and mortality due to development of the so-called acute respiratory distress syndrome (ARDS). The renin-angiotensin-system (RAS) plays an important role in the development of ARDS. ACE2 is one of the enzymes involved in the RAS cascade. Virus spike protein binds to ACE2 to form a complex suitable for cellular internalization. The downregulation of ACE2 results in the excessive accumulation of angiotensin II, and it has been demonstrated that the stimulation of the angiotensin II type 1a receptor (AT1R) increases pulmonary vascular permeability, explaining the increased lung pathology when activity of ACE2 is decreased. Currently available AT1R blockers (ARBs) such as valsartan, have the potential to block this pathological process mediated by angiotensin II. There are presently two complementary mechanisms suggested: 1) ARBs block the excessive angiotensin-mediated AT1R activation, and 2) they upregulate ACE2, which reduces angiotensin II concentrations and increases the production of the protective vasodilator angiotensin 1-7. In light of the above, ARBs may prevent the development of ARDS and avert morbidity (admission to intensive care unit (ICU) and mechanical ventilation) and mortality. Objective: To investigate the effect of the ARB valsartan in comparison to placebo on the occurrence of one of the following items, within 14 days of randomization:1) ICU admission; 2) Mechanical ventilation; 3) Death. Study design: A double-blind, placebo-controlled 1:1 randomized clinical trial Study population: Adult hospitalized SARS-CoV-2-infected patients (n=651). Intervention: The active-treatment arm will receive valsartan in a dosage titrated to blood pressure up to a maximum of 160mg b.i.d. and the placebo arm will receive a matching placebo also titrated to blood pressure. Treatment duration will be 14 days or up to hospital discharge < 14 days or occurrence of the primary endpoint if < 14 days. Main study endpoint: The primary study endpoint is the occurrence within 14 days of randomization of either: 1) ICU admission; 2) Mechanical ventilation; 3) Death.
Description: Death is defined as all-cause mortality
Measure: first occurrence of intensive care unit admission, mechanical ventilation or death Time: within 14 daysDescription: All-cause mortality; and time to all-cause mortality
Measure: Death Time: Within 14 days, 30 days, 90 days and at 1 yearDescription: Occurrence of mechanical ventilation and time to ventilation
Measure: Mechanical ventilation Time: within 14 daysDescription: Occurrence of ICU admission and time to admission
Measure: Intensive care unit admission Time: within 14 daysDescription: Defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of >30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2
Measure: Occurrence of acute kidney injury Time: Within 14 daysThe primary objective of this study is to determine whether the use of daily or weekly oral hydroxychloroquine (HCQ) therapy will prevent SARS-CoV-2 infection and COVID-19 viremia and clinical COVID-19 infection healthcare workers (HCW) and first responders (FR) (EMS, Fire, Police, bus drivers) in Metro Detroit, Michigan. Preventing COVID-19 transmission to HCW, FR, and Detroit Department of Transportation (DDOT) bus drivers is a critical step in preserving the health care and first responder force, the prevention of COVID-19 transmission in health care facilities, with the potential to preserve thousands of lives in addition to sustaining health care systems and civil services both nationally and globally. If efficacious, further studies on the use of hydroxychloroquine to prevent COVID-19 in the general population could be undertaken, with a potential impact on hundreds of thousands of lives.
Description: Plan statistical analyses will include the assumption that up 10% of HCW at risk will become infected if no prophylactic treatment is provided. Therefore we expect that HCQ treatment arm will provide a reduction in the number of SARS-CoV 2 infections by 30%, with an expected study retention rate of 90%, a sample size of ~1500 participants per group, will have an 80% power to detect the difference at p=0.05.
Measure: Reduction in the number of COVID-19 infections in healthcare workers. Time: 8 WeeksA novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has reached 160 countries, infecting over 500,000 individuals and killing more than 24,000 people. SARS-CoV-2 causes an acute and potentially lethal respiratory illness, known as COVID-19, that is threatening to overwhelm health care systems due to a dramatic surge in hospitalized and critically ill patients. Patients hospitalized with COVID-19 typically have been symptomatic for 5-7 days prior to admission, indicating that there is a window during which an effective intervention could significantly alter the course of illness, lessen disease spread, and alleviate the stress on hospital resources. There is no known treatment for COVID-19, though in vitro and one poorly controlled study have identified a potential antiviral activity for HCQ. The rationale for this clinical trial is to measure the efficacy and safety of hydroxychloroquine for reducing viral load and shedding in adult outpatients with confirmed COVID-19.
This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).
Description: Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.
Measure: Proportion of patients with onset of severe acute respiratory syndrome (SARS) Time: 7 days after randomizationDescription: Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization
Measure: Mortality rate Time: after randomization, up to 28 daysDescription: Proportion of participants in need and duration of intensive care support after randomization
Measure: Number of participants in need of intensive care support Time: during and after intervention, up to 28 daysDescription: Viral load change in blood and oropharyngeal swab samples
Measure: Viral concentration Time: After randomization, up to 7 daysDescription: Incidence of serious adverse events during and after treatment
Measure: Cumulative incidence of serious adverse events Time: During and after intervention, up to 28 daysDescription: Incidence of grade 3 and 4 adverse events during and after treatment
Measure: Cumulative incidence of grade 3 and 4 adverse events Time: During and after intervention, up to 28 daysDescription: proportion of discontinuation or temporary suspension of treatment (for any reason)
Measure: Proportion of patients with discontinued treatment Time: after randomization, up to 28 daysDescription: proportion of patients with increased levels of troponin I
Measure: Incidence of cardiac lesions Time: after randomization, up to 120 daysDescription: proportion and magnitude of QTcF interval increases higher than 500ms
Measure: Incidence of cardiac disfunctions Time: after randomization, up to 120 daysDescription: Changes measured on day 120 will be compared to baseline, through spirometry.
Measure: Change in respiratory capacity Time: Day 120 after randomizationThis is a PILOT STUDY, a Phase III double-blind, randomized, placebo-controlled clinical study in which we assess the clinical effect of the prophylactic administration of hydroxychloroquine vs. placebo to healthcare workers working at our University Hospital (HUN). Participants in each arm (n = 43) will be administered with a unique loading dose of 800 mg of hydroxychloroquine the first day followed by 400 mg/week for 90 days. The population to be studied (uninfected healthcare personnel) will be highly exposed to SARS-CoV-2 infection. An active search should be made for individuals who become infected while participating in the study, hence, once the informed consent form is signed, the molecular test for the diagnosis of SARS-CoV-2 infection by RT-PCR will be carried out every 4 days in order to determine as closely as possible the moment the participant becomes positive. The results of the diagnostic RT-qPCR tests will be confronted with: (i) the results of immune monitoring of at least 30 immunological parameters in leukocytes and in plasma (levels of selected cytokines and chemokines analyzed by automated flow cytometry software and (ii) the daily recording of data for the presence or absence of signs and symptoms associated with SARS-Cov-2 infection. For the recording of immune monitoring 20mL blood samples will be taken at eight-time points throughout the 90 days of the stud.
Description: Number of participants with treatment-related adverse events as associated administration of hydroxychloroquine or placebo.
Measure: Adverse effects Time: six months after administration of hydroxychloroquine or placeboDescription: Percentage of expression of immune senescence in cells of the immune system of individuals highly exposed to COVID-19 who receive hydroxychloroquine prophylactically vs. placebo.
Measure: Immune-score Time: six months after administration of hydroxychloroquine or placeboDescription: Correlate the immunological profile of highly exposed individuals with SARS-CoV-2 with the clinic of COVID-19.
Measure: COVID-19 prevention Time: six months after administration of hydroxychloroquine or placeboDescription: Determine the clinical outcome in observation timeframe of highly exposed personnel when receiving hydroxychloroquine vs. placebo prophylactically.
Measure: Clinical response Time: six months after administration of hydroxychloroquine or placeboThe primary objective is to determine the clinical efficacy of Chloroquine (CQ) in health care workers with moderate to high risk of exposure to COVID-19 in preventing symptomatic COVID-19 infections. Secondary endpoints will explore the efficacy of CQ in preventing any infection as defined by seroconversion to positive anti-COVID antibody status.
Description: Symptomatic illness is defined as COVID infection guidelines and confirmed with anti-COVID antibodies that will be done on serum collect at the final visit. Symptoms include fever, chills, muscle pain, cough, shortness of breath, and diarrhea.
Measure: Number of symptomatic illness in at risk healthcare workers Time: Up to 3 monthsDescription: Diagnosis is based on symptoms of COVID-19 and confirmatory anti-COVID antibodies and when available, COVID-19 PCR.
Measure: Number of healthcare workers with symptomatic COVID infections Time: Up to 3 monthsDescription: Severe illness includes worsening of symptoms.
Measure: Number of severe illness in at risk healthcare workers Time: Up to 3 monthsDescription: Confirmation with polymerase chain reaction (PCR) when available.
Measure: Number of sero-conversions in at risk healthcare workers Time: Up to 3 monthsDescription: Adverse events that are NCI-CTCAE Grade 3 or higher will be counted.
Measure: Percentage of patients with adverse events Grade 3 or higher Time: Up to 3 monthsDescription: GI intolerance to chloroquine will be documented and recorded.
Measure: Percentage of patients with GI intolerance Time: Up to 3 monthsThis is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the pandemic. 374 health care workers will be randomized at a 1:1 allocation between the intervention and placebo arms and followed for 90 days. The cumulative incidence of COVID-19 infection in the intervention group will be compared to the cumulative incidence of COVID-19 in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk difference and 95% CI).
Description: Incidence of symptomatic and asymptomatic COVID-19 infection in health care workers
Measure: Cumulative Incidence of COVID-19 Infection Time: 90 daysDescription: Incidence of reported and grade of adverse events
Measure: Adverse events incidence Time: 90 daysDescription: Duration in days of symptomatic COVID-19 disease in HCW who had disease
Measure: Duration of symptomatic COVID-19 disease Time: 90 daysDescription: Duration in days of hospitalization attributed to COVID-19 disease in HCW who had disease
Measure: Days hospitalized attributed to COVID-19 Time: 90 daysDescription: Number of HCW with respiratory failure attributable to COVID-19 disease requiring i) non-invasive ventilation or ii) intubation/mechanical ventilation in HCW who developed disease
Measure: Number or respiratory failure attributable to COVID-19 disease Time: 90 daysDescription: Cumulative Incidence of Mortality attributed to COVID-19 disease in HCW who developed disease
Measure: Mortality Incidence Time: 90 daysDescription: Number of days unable to work attributed to COVID-19 in HCW who developed disease
Measure: Days of work lost Time: 90 daysDescription: Proportion of participants with plasma able to neutralize SARS-CoV-2 virus (plaque reduction neutralization test) in vitro.
Measure: Proportion of HCW with plasma able to neutralize SARS-CoV-2 virus Time: 90 daysDescription: Number of participants with severity markers of host immune and endothelial activation measured at clinical presentation and their ability to predict severity and outcome.
Measure: Number of participants with severity markers of host immune and endothelial activation Time: 90 daysThere is an urgent need to evaluate interventions that can prevent the infection with SARS-CoV 2 of healthcare workers at risk. Melatonin is an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti-inflammatory and anti-oxidative effects. This randomized controlled trial seeks to evaluate is efficacy as a prophylaxis in healthcare workers exposed to the virus in their clinical practice.
Description: Number of confirmed (positive CRP) symptomatic infections in each treatment group
Measure: SARS-CoV 2 infection rate Time: up to 12 weeksCOVID-19 was declared a pandemic on March 11th. Efforts to save lives are essential as we will face increasing morbidity with rising demands on health care resources. Since pregnant women with COVID-19 have systematically been excluded from drug trials, potential treatment options for these high-risk individuals remain untested. The aim of our trial is to determine whether hydroxychloroquine given to COVID-19 positive pregnant women can reduce COVID-19-related hospital admissions, thereby allowing women to stay at home while limiting utilization of hospital resources and resulting exposure of health care providers.
Description: COVID-19-related hospital admissions will be reported by the participants throughout pregnancy until delivery.
Measure: COVID-19-related hospital admissions Time: Hospital Admission at any point from study enrollment to deliveryDescription: Measurement of reported symptoms using a validated questionnaire on Day 3, 7, 10, and every 2 weeks. The FLU-PRO Questionnaire instructs respondents to rate the severity of 37 influenza symptoms over the past 24 hours, including those related to the nose, throat, eye, chest, head, stomach, fatigue, and body aches/pains. For 32 of 37 items, respondents rated the severity of each symptom on 5-point Likert-type scales from 0 ("Not at all), 1 ("A little bit"), 2 ("Somewhat"), 3 ("Quite a bit"), to 4 ("Very much"). For the five remaining items, severity is expressed as frequency of occurrence: vomiting or diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times), and sneezing, coughing, and coughed up mucus or phlegm on a scale from 0 ("Never") to 4 ("Always"), with higher scores indicating more severe symptoms.
Measure: Symptoms related to COVID-19 infection Time: Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to deliveryDescription: Side effects related to hydroxychloqoruine
Measure: Adverse Events Time: Participants will be contacted at day 3, 7, and 10 post-randomization, and every 2 weeks up to to deliveryDescription: Type of delivery (elective non-urgent cesarean, elective urgent cesarean section, non-elective cesarean within labor, instrumental vaginal, spontaneous vaginal)
Measure: Maternal outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.Description: If had cesarean delivery, indication for cesarean section
Measure: Maternal outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.Description: Miscarriage or stillbirth (Yes/No)
Measure: Maternal outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.Description: Labor induction or augmentation (Yes/No) and indication
Measure: Maternal outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.Description: Epidural use (Yes/No)
Measure: Maternal outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their labor and delivery.Description: Gestational age at delivery (weeks)
Measure: Newborn outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.Description: Sex (female/male)
Measure: Newborn outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.Description: Birth weight (kg) Birth weight (kg)
Measure: Newborn outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.Description: Need for resuscitation (Yes/No)
Measure: Newborn outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.Description: NICU admission (Yes/No)
Measure: Newborn outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.Description: Medical conditions (jaundice, IVH, RDS, pneumothorax, PDA, NEC)
Measure: Newborn outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.Description: Current disposition of baby (home or hospital)
Measure: Newborn outcomes Time: Participants will be contacted within 2 weeks after delivery to obtain information about their baby.We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among Veterans in the outpatient setting.
The 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 daysHealthcare personnel are at an increased risk of exposure to SARS-CoV-2 infection while handling such patients. Currently, there is no treatment available for SARS-CoV-2 and stringent preventive measures are advised to avoid or minimize risk of exposure to healthcare workers. There are in vitro studies available which show inhibition of corona virus by hydroxychloroquine, a widely-used agent against malaria and certain autoimmune conditions and of low-cost and limited toxicity. However, evidence regarding its effects in patients is limited. We plan to conduct a randomized controlled trial to evaluate the safety and potential prophylactic efficacy of hydroxychloroquine in preventing secondary SARS-CoV-2 infection among healthcare workers at high-risk of exposure while managing such patients.
Description: Negative RT-PCR for SARS-CoV-2 both at baseline and at end of 12 weeks in experimental arm
Measure: Prevention of SARS-CoV-2 as determined by negative RT-PCR at the end of 12 week study period Time: From date of randomization until study completion 12 weeks after treatment initiationDescription: To assess the presence or absence of side effects from HCQ treatment.
Measure: Safety as determined by presence or absence of any adverse event related with hydroxychloroquine treatment Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiationDescription: Symptomatic infection by SARS-CoV-2 defined as cough, dyspnea, fever, myalgia, arthralgia or rhinorrhea.
Measure: Confirmed SARS-CoV-2 infection based on symptoms and confirmed by RT-PCR Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiationDescription: Disease severity including i) asymptomatic. ii) Mild symptoms but ambulatory. iii) Moderate symptoms requiring hospitalisation. iv) severe symptoms requiring ICU care and oxygen. v) Severe symptoms requiring assisted mechanical ventilation. vi) Death.
Measure: Clinical disease severity in confirmed SARS-CoV-2 participants Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiationDescription: Symptomatic non-COVID viral infection (any other acute respiratory illness with fever but without evidence of epidemiological risk factors such as close contact with SARS-CoV-2 positive patient or travel to or residence in high-risk area).
Measure: Incidence of any acute respiratory infection Time: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation