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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2556 | Placebo oral capsule Wiki | 0.21 |
| drug1520 | Hydroxychloroquine Wiki | 0.20 |
| drug1575 | Hyperbaric oxygen therapy Wiki | 0.18 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1338 | Fluzone High Dose Wiki | 0.18 |
| drug2083 | Monitoring Visit - Baseline Wiki | 0.18 |
| drug1529 | Hydroxychloroquine - Daily Dosing Wiki | 0.18 |
| drug2377 | PDS-08 Wiki | 0.18 |
| drug3514 | Tranexamic acid tablets Wiki | 0.18 |
| drug3714 | Weekly Assessment Wiki | 0.18 |
| drug1333 | Flucelvax Wiki | 0.18 |
| drug1545 | Hydroxychloroquine Sulfate 400 mg twice a day Wiki | 0.18 |
| drug2261 | Normobaric oxygen therapy Wiki | 0.18 |
| drug777 | Chloroquine Diphosphate Wiki | 0.18 |
| drug2512 | Placebo (carrier control) Wiki | 0.18 |
| drug3910 | hydroxychloroquine sulfate 200 MG Wiki | 0.18 |
| drug2141 | NP-120 (Ifenprodil) Wiki | 0.18 |
| drug852 | Community Referral as appropriate Wiki | 0.18 |
| drug367 | Azithromycin 250 MG Oral Capsule Wiki | 0.18 |
| drug1547 | Hydroxychloroquine Sulfate 600 mg twice a day Wiki | 0.18 |
| drug1336 | Fluvirin Wiki | 0.18 |
| drug1831 | Lianhua Qingwen Wiki | 0.18 |
| drug1068 | Dipyridamole 100 Milligram(mg) Wiki | 0.18 |
| drug1789 | LAU-7b Wiki | 0.18 |
| drug3628 | Valsartan (Diovan) Wiki | 0.18 |
| drug1875 | Losmapimod oral tablet Wiki | 0.18 |
| drug2470 | Personal Exercise Intervention Wiki | 0.18 |
| drug3919 | imaging, blood tests Wiki | 0.18 |
| drug1210 | Enzalutamide Wiki | 0.18 |
| drug2084 | Monitoring Visit - Week 4 Wiki | 0.18 |
| drug1290 | Facial mask Wiki | 0.18 |
| drug3575 | Umbilical Cord Lining Stem Cells (ULSC) Wiki | 0.18 |
| drug3432 | Tezacaftor/Ivacaftor + Ivacaftor Wiki | 0.18 |
| drug1213 | Equipment with smartwatch throughout hospital stay on the general ward Wiki | 0.18 |
| drug1235 | Exercise Testing and Training Wiki | 0.18 |
| drug1536 | Hydroxychloroquine Pre-Exposure Prophylaxis Wiki | 0.18 |
| drug3182 | Spironolactone 100mg Wiki | 0.18 |
| drug1927 | MFS Wiki | 0.18 |
| drug1546 | Hydroxychloroquine Sulfate 600 mg once a day Wiki | 0.18 |
| drug703 | CYP-001 Wiki | 0.18 |
| drug1432 | HB-adMSC Wiki | 0.18 |
| drug1278 | FFP2 Wiki | 0.18 |
| drug2007 | Melatonin 2mg Wiki | 0.18 |
| drug3662 | Virtual Group Intervention Wiki | 0.18 |
| drug2085 | Monitoring Visit - Week 8 Wiki | 0.18 |
| drug1531 | Hydroxychloroquine - Weekly Dosing Wiki | 0.13 |
| drug1773 | KB109 + Self Supportive Care (SSC) Wiki | 0.13 |
| drug4171 | vv-ECMO + cytokine adsorption (Cytosorb adsorber) Wiki | 0.13 |
| drug821 | Cognitive Behavioral Therapy Wiki | 0.13 |
| drug4172 | vv-ECMO only (no cytokine adsorption) Wiki | 0.13 |
| drug2116 | N-Acetyl cysteine Wiki | 0.13 |
| drug3063 | Self Supportive Care (SSC) Alone Wiki | 0.13 |
| drug147 | Abatacept Wiki | 0.13 |
| drug2443 | Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances Wiki | 0.13 |
| drug1627 | Imatinib Wiki | 0.13 |
| drug1543 | Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki | 0.13 |
| drug829 | Colchicine Wiki | 0.11 |
| drug2954 | SARS-CoV-2 convalescent plasma Wiki | 0.10 |
| drug154 | Acalabrutinib Wiki | 0.09 |
| drug1521 | Hydroxychloroquine (HCQ) Wiki | 0.08 |
| drug2215 | No intervention Wiki | 0.08 |
| drug776 | Chloroquine Wiki | 0.07 |
| drug717 | Camostat Mesilate Wiki | 0.07 |
| drug364 | Azithromycin Wiki | 0.06 |
| drug2505 | Placebo Wiki | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012817 | Signs and Symptoms, Digestive NIH | 0.18 |
| D003192 | Compulsive Behavior NIH | 0.18 |
| D003248 | Constipation NIH | 0.18 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.15 |
| D018352 | Coronavirus Infections NIH | 0.13 |
| D009771 | Obsessive-Compulsive Disorder NIH | 0.13 |
| D003193 | Compulsive Personality Disorder NIH | 0.13 |
| D003141 | Communicable Diseases NIH | 0.11 |
| D007239 | Infection NIH | 0.11 |
| D004408 | Dysgeusia NIH | 0.10 |
| D003550 | Cystic Fibrosis NIH | 0.08 |
| D059352 | Musculoskeletal Pain NIH | 0.07 |
| D019337 | Hematologic Neoplasms NIH | 0.07 |
| D000070642 | Brain Injuries, Traumatic NIH | 0.06 |
| D001930 | Brain Injuries, NIH | 0.05 |
| D059350 | Chronic Pain NIH | 0.05 |
| D005355 | Fibrosis NIH | 0.05 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.05 |
| D055371 | Acute Lung Injury NIH | 0.05 |
| D000857 | Olfaction Disorders NIH | 0.04 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.04 |
| D013577 | Syndrome NIH | 0.03 |
| D007249 | Inflammation NIH | 0.03 |
| D009369 | Neoplasms, NIH | 0.03 |
| D013313 | Stress Disorders, Post-Traumatic NIH | 0.03 |
| D011014 | Pneumonia NIH | 0.02 |
| D014777 | Virus Diseases NIH | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000722 | Obsessive-compulsive behavior HPO | 0.10 |
| HP:0012532 | Chronic pain HPO | 0.06 |
| HP:0001909 | Leukemia HPO | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000458 | Anosmia HPO | 0.05 |
| HP:0002664 | Neoplasm HPO | 0.03 |
| HP:0002090 | Pneumonia HPO | 0.02 |
Navigate: Correlations HPO
There are 31 clinical trials
People with Cystic Fibrosis (CF) have problems digesting their food properly. More than 8 in 10 people with CF must take medication to assist their digestion. In spite of this, complications such as bowel blockage occur. Finding out how already licenced drugs for CF work in the gut is the first step in repurposing medications. Tezacaftor/Ivacaftor with Ivacaftor is a drug combination which corrects the basic defect in CF an has shown improvements on lung function. The purpose of this study is to evaluate, using Magnetic Resonance Imaging (MRI) and patient-reported outcomes, whether Tezacaftor/Ivacaftor with Ivacaftor has an effect on improving gastrointestinal problems in CF.
Description: Time taken after eating for ingested food to be identifiable at the caecum on MRI
Measure: Oro-caecal Transit Time Time: 1 day of scanningDescription: Volume of stomach at each time point of digestion to measure gastric emptying time
Measure: Gastric volume Time: 1 day of scanningDescription: Volume of water content in small bowel representing secretions and post prandial change in small bowel water content at T240 and T300
Measure: Small bowel water content (corrected for body surface area) Time: 1 day of scanningDescription: Volume of colon representing ease of chyme passage through colon
Measure: Colonic volume (corrected for body surface area) Time: 1 day of scanningDescription: Gastrointestinal symptoms measured by patient reported outcomes to monitor relationships with outcomes measure by MRI
Measure: Gastrointestinal symptoms Time: 1 day of scanningDescription: Volume of sigmoid colon
Measure: Sigmoid colon volume Time: 1 day of scanningDescription: An approximate measure of water content in chyme present in the ascending colon
Measure: T1 relaxation of ascending colon chyme Time: 1 day of scanningDescription: A measure of fat content in chyme present in the ascending colon
Measure: Fat fraction of ascending colon chyme Time: 1 day of scanningDescription: A measure of elastase in stool to evaluate pancreatic function
Measure: Faecal elastase Time: 1 dayDescription: A measure of microbiome in sputum and stool
Measure: Sputum and faecal microbiome Time: 1 dayDescription: A measure of intestinal inflammation
Measure: Faecal calprotectin Time: 1 dayDescription: A measure of motility at the terminal ileum using the GIQuant tool in arbitrary units
Measure: Terminal Ileum motility Time: 1 dayDouble 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 monthsThis is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treatment group (HCQ) or placebo in a double-blind fashion. Course of treatment is 30 days.
Description: Number of participants with clinical infection with COVID-19 infection(hydroxychloroquine vs placebo)
Measure: Number of participants with clinical infection with COVID-19 infection Time: 30 daysDescription: Number of participants with COVID-19 infection shedding (hydroxychloroquine vs placebo)
Measure: Number of participants with COVID-19 viral shedding Time: 30 daysDescription: Safety as measured by number of adverse events (hydroxychloroquine vs placebo)
Measure: Safety as measured by number of adverse events Time: 30 daysRationale: 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 daysA controlled trial of the drug tranexamic acid (TXA) in outpatients who were recently diagnosed with COVID-19. It is hypothesized that TXA will reduce the infectivity and virulence of the virus.
Description: Admission to hospital for COVID-19 treatment
Measure: Hospitalization Time: Randomization to 7 days after randomizationThis is a prospective, multi-site study designed to evaluate whether the use of hydroxychloroquine in healthcare workers (HCW), Nursing Home Workers (NHW), first responders (FR), and Detroit Department of Transportation bus drivers (DDOT) in SE, Michigan, can prevent the acquisition, symptoms and clinical COVID-19 infection The 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 Southeast 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: We will measure the difference in new cases of COVID-19 disease between randomized treatment arms. 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: To determine if the use of hydroxychloroquine as preventive therapy decreases the rate of acquisition of SARS-CoV 2 infections and clinical COVID-19 disease in Study Participants for each randomized treatment arm as compared to placebo. Time: 8 WeeksDescription: Compare the rates of SARS-CoV 2 infections between the randomized treatment arms and the control arms to determine the effect of HCQ dose in the prevention of COVID-19 viremia and disease as determined by study visits, weekly questionnaires, and blood samples.
Measure: Determine the effect of hydroxychloroquine dose in the prevention of COVID-19 viremia and disease. Time: 8 WeeksDescription: Comparison of the rates of SARS-CoV 2 infections in the non-randomized comparator arm to the randomized groups to assess the impact of chronic weight-based dosing of HCQ for COVID-19 prevention via weekly questionnaire and/or blood samples.
Measure: Assess the impact of chronic weight-based dosing of HCQ for COVID-19 prevention. Time: 8 WeeksDescription: Measurement of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized HCQ versus placebo via blood samples.
Measure: Comparison of the rate of SARS-CoV 2 infections as measured by IgM/IgG seroconversion in study participants receiving randomized HCQ versus placebo. Time: 8 WeeksDescription: Measurement of the seroprevalence of SARS-CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving HCQ compared to those receiving placebo via blood samples.
Measure: Compare the seroprevalence of SARS-CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving HCQ compared to those receiving placebo. Time: 8 WeeksDescription: Measurement of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm and via weekly questionnaire and/or blood samples.
Measure: Comparison of the emergence of clinical symptoms or COVID-19 diagnosis in participants presenting asymptomatically at study entry but identified as seropositive by serology at entry between the randomized treatment arms and comparator arm. Time: 8 WeeksDescription: Review of the level of care needed by participants in each arm developing COVID19 as measured as requiring emergency room visit, hospitalization or able to stay home without hospital care via weekly questionnaire.
Measure: To examine the level of care needed by participants in each arm developing COVID19 as measured as requiring emergency room visit, hospitalization or able to stay home without hospital care. Time: 8 WeeksDescription: Measurement of the safety and tolerability of HCQ dosing for preventive strategy against COVID-19 as measured by adverse events and serious adverse events reported via weekly questionnaire.
Measure: Determine the safety and tolerability of HCQ dosing for preventive strategy against COVID-19 as measured by adverse events and serious adverse events. Time: 8 WeeksDescription: Examination of other clinical determinants contributing to the risk of SARS-CoV 2 infection including demographics, work type and location, positive COVID-19 partners, possible exposures and clinical symptoms via study visits and weekly questionnaire.
Measure: To examine other clinical determinants contributing to the risk of SARS-CoV 2 infection in healthcare workers and first responders. Time: 8 WeeksDescription: Examine the association between HCQ drug levels and development of COVID-19 symptoms or positive test results via weekly questionnaire and/or blood samples.
Measure: Examine the association between HCQ drug levels and development of COVID-19 symptoms or positive test results. Time: 8 WeeksDescription: Identification of immunologic, serological and inflammatory markers associated with acquisition and response to COVID-19 in both HCQ and placebo Participants developing laboratory or clinical confirmed disease via study visits, weekly questionnaire, and blood samples.
Measure: identify immunologic, serological and inflammatory markers associated with acquisition and response to COVID-19 in both HCQ and placebo Participants developing laboratory or clinical confirmed disease. 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 study intended to evaluate the effects of commonly used diuretic, spironolactone, on oxygenation in covid-19 ARDS patients.
Description: improvement in oxygenation
Measure: p/f ratio Time: 5 daysDescription: improvement in SOFA Score
Measure: SOFA Time: 5 daysThis 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 placeboAssessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric, Randomized Comparative Study
Description: Clinical Examination: Symptomatic COVID(+) infection rate (from randomization to the onset of signs suggestive of Covid19 infection or to the end of the study at 60 days) The rate of COVID19 infections is defined by the occurrence of the clinical signs below: Cough Dyspnea Fever Myalgia Arthralgia Rhinorrhea Anosmia Asthenia, fatigability Confirmation of the above symptoms and COVID(+) PCR infection during the 60days treatment period. Biological Examination : Measurement of viral load Ion, liver, kidney, haematological assessment Electrical Examination: ECG
Measure: Symptomatic COVID(+) infection rate Time: 60 daysThe 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% improvement of total lymphocyte count, D-dimer, fibrinogen and ferritin
Measure: Number of patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels Time: Up to 24 daysDescription: At least one of the following: respiratory failure, respiratory rate > 30 rpm, oxygen saturation < 92%, PaO2/FiO2 < 300 mmHg
Measure: Progression to severe disease Time: Up to 10 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 initiationOn 11 March 2020, the World Health Organization declared SARS-CoV-2 (commonly called COVID-19) a global pandemic. As in any pandemic, maintaining the health and safety of the healthcare workforce is of great importance as health care workers (HCW) remain a critical line of defence against the spread of COVID-19 and play a vital role in the recovery of those already infected. Frontline HCW, such as those in the emergency department (ED), are at high risk of contracting COVID-19 due to their close proximity to patients who may have the virus. The impact of frontline HCW becoming ill and thus unable to go to work is equally high, and of grave risk to the function of the healthcare system and the ability to minimize the impact of the current pandemic. This study aims to evaluate whether hydroxychloroquine (HCQ), a well-tolerated drug typically used in the prevention of malaria transmission and rheumatic disease, taken before and during exposure to patients with COVID-19, is effective at reducing COVID-19 infections among ED health care workers.
Description: This is a composite endpoint which includes any positive result from a validated SARS-CoV-2 diagnostic assay including detection of viral RNA, or seroconversion by day 104 (14 days after end of the randomization period).
Measure: Microbiologically confirmed COVID-19 (SARS-CoV-2 infection) Time: Samples collected at day 0, 30, 60, 90 and 120Description: Assessed using the DAIDS Table for Grading the Severity of Adverse Events
Measure: Adverse events Time: Assessed at day 30, 60, 90, and day 120Description: Collected weekly from participants via self-report, sent by email
Measure: Symptom duration of COVID-19 Time: Collected every 7 days from day 7 to day 120Description: The number of days (or partial days) spent admitted to an acute care hospital during the study period
Measure: Days of hospitalization attributable to COVID-19 Time: Collected every 7 days from day 7 to day 120Description: the number of days (or partial days) requiring i) non-invasive and ii) endotracheal intubation with ventilation during the study period
Measure: Respiratory failure requiring ventilatory support attributable to COVID-19 Time: Collected every 7 days from day 7 to day 120Description: Mortality attributable to COVID-19 and all-cause mortality during the study period
Measure: Mortality Time: Collected every 7 days from day 7 to day 120Description: Number of days ineligible/unable to work due to COVID-19
Measure: Impact on work eligibility Time: Collected every 7 days from day 7 to day 120Description: COVID-19 reactive serology
Measure: Seropositivity Time: Blood collected at day 0, 30, 60, 90, 120Description: Short-term psychological impact of exposure to COVID-19 measured using the K10, a validated measure of non-specific psychological distress, with a standard cutoff score of ≥16
Measure: Short-term psychological impact Time: Measured at day 1, 60, 120The most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations. Research in humans has shown that dipyridamole can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19. This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization.
Description: Increase in plasma D-dimer level compared with baseline at enrollment.
Measure: Change in D-dimer Time: baseline, up to approximately 28 days after last study drug administrationDescription: Global composite rank score of death, mechanical ventilation, oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2), and World Health Organization (WHO) Ordinal score.
Measure: Global composite rank score Time: up to approximately 28 days after last study drug administrationThe primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies.
Description: Locally evaluated rate of viral response. Favorable response is defined as (1) complete response : negative PCR (absence of detectable signal with a minimum of 40 cycles) or (2) major response : detectable signal but with an increased number of cycles > or egal to 10 compared to initial PCR. Response failure is defined as (1) minor response : detectable signal but with an increased number of cycles < 10 compared to initial PCR or (2) stabilisation or worsening of the viral load.
Measure: Evaluation of the efficacy of hydroxychloroquine and azithromyncine on the viral load drop at day 5. Time: 5 days of treatmentDescription: Duration of fever - duration of respiratory symptoms (cough, dyspnea) - duration of other COVID-19 related symptoms (digestive symptoms, ageusia, anosmia)
Measure: Clinical evolution Time: up to 3 monthsDescription: Less or equal to 94% oxygen saturation - need to initiate oxygenotherapy - occurrence of respiratory distress - patient transfer in intensive care unit - need of mechanical ventilation - occurrence of non-respiratory organ failure - occurrence of septic shock
Measure: Proportion of patients progressing to a severe form Time: up to 3 monthsDescription: Date and cause of death
Measure: Mortality Time: up to 1 and 3 monthsDescription: SARS-CoV-2 viral load by PCR on nasopharyngeal swab at day 10 (if positive at day 5) : rate of negativation and comparison of number of cycles with previous samples
Measure: Evaluation of viral load drop Time: at day 10Description: Frequence and causality of all-grade cardiac adverse events - frequence and causality of grade > 1 adverse events for other adverse events - frequence and causality of serious adverse events (CTCAE v5)
Measure: Tolerance of study treatment Time: up to 3 monthsDescription: Collection of serum to realize serological tests
Measure: Evaluation of the seroconversion Time: at inclusion, day 10, day 30 and day 90 after treatmentDescription: Phenotypic and functional study of NK lymphocytes at inclusion, Retrospective analysis on frozen cells.
Measure: NK immunological study Time: at day 10 and day 30 after treatmentDescription: Duration of hospitalisation (conventional, intensive care, reanimation)
Measure: Hospitalisation duration Time: up to 3 monthsDescription: Patient follow-up during 3 months : hematological status and associated therapy
Measure: Impact of the study treatment on the treatment of the hematological disease Time: up to 3 monthsDescription: ECG (using connected machine to allow monitoring at home)
Measure: Monitoring of the QT space Time: at inclusion, day 2, day 5, day 10Description: Dosage of residual concentration of azithromycine and hydroxychloroquine.
Measure: Dosage of residual concentration of azithromycine and hydroxychloroquine. Time: at day 5 and day 10Description: Phenotypic and functional study of T lymphocytes at inclusion, Retrospective analysis on frozen cells.
Measure: T immunological study Time: at day 10 and day 30 after treatmentThis study is a randomized Double-Blind Placebo-Controlled Trial on the Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19
Description: The ordinal scale is an evaluation of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Measure: The proportion of patients with a two-point change using the 8-category ordinal scale Time: Day 14 from baselineDescription: All-cause mortality post baseline
Measure: All-Cause mortality Time: Day 28 and Day 60 post baselineDescription: Time to a 2-point clinical change difference
Measure: Time to a 2-point clinical change Time: Up to 60 days post baselineDescription: Duration of hospitalization
Measure: Hospitalization Time: Up to 60 days post baselineDescription: For subjects who are on ECMO or mechanical ventilation at Day 1
Measure: Duration of ECMO or invasive mechanical ventilation Time: Up to 60 days post baselineDescription: For subjects who are in ICU at Day 1
Measure: Duration of ICU stay Time: Up to 60 days post baselineDescription: Time to SARS-CoV-2 negative by reverse transcriptase-polymerase chain reaction (RT-PCR)
Measure: SARS-CoV-2 negative Time: Up to 60 days post baselineDescription: Proportion of patients with negative oropharyngeal or nasopharyngeal swab for SARS-CoV-2 by quantitative RT PCR on days 5, 10, 14, 21, and 28 after starting treatment
Measure: Negative oropharyngeal or nasopharyngeal swab Time: Up to 28 days post baselineDescription: Proportion of subjects with serious adverse events
Measure: Serious adverse events (SAEs) Time: Up to 60 days post baselineDescription: Proportion of subjects who discontinue study drug due to adverse events
Measure: Discontinuation due to adverse events Time: Up to 60 days post baselineStudy Objective: To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.
Description: Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.
Measure: Ordinal Scale of COVID19 Disease Severity at 14 days Time: 14 daysDescription: Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.
Measure: Incidence of Hospitalization Time: 14 daysDescription: Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.
Measure: Incidence of COVID-19 related Death Time: 90 daysDescription: Outcome reported as the number of participants in each arm who expire due to all causes.
Measure: Incidence of all-cause Death Time: 90 daysDescription: Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.
Measure: Incidence of All-Cause Study Medicine Discontinuation or Withdrawal Time: 14 daysDescription: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Measure: Overall symptom severity at 5 and 14 days Time: 5 and 14 daysDescription: Repeated Measure mixed regression model of change in: Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Measure: Overall change in disease severity over 14 days among those who are symptomatic at baseline Time: 14 daysThe therapeutic hypothesis for the use of losmapimod in COVID-19 disease is that increased mortality and severe disease is caused by p38 mitogen-activated protein kinase (MAPK)-mediated exaggerated acute inflammatory response resulting from SARS-CoV-2 infection. The study Sponsor hypothesize's that the early initiation of p38α/β inhibitor therapy in patients hospitalized with moderate COVID-19 who are at increased risk of a poor prognosis based on older age and elevated systemic inflammation will reduce clinical deterioration including progression to respiratory failure and death. To address this hypothesis, Fulcrum Therapeutics is conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that will evaluate the safety and efficacy of losmapimod versus placebo in subjects 50 and older who are hospitalized with moderate COVID-19 disease.
Description: The efficacy of Losmapimod will be assessed by the development of progression to critical disease as evidence of mortality or development of respiratory failure by Day 28.
Measure: Day 28 Mortality Time: Day 28Description: The change from baseline in clinical disease status will be evaluated using the 9-point World Health Organization (WHO) ordinal scale: 0 indicating, no clinical evidence of SARS-CoV-2 infection and 8 indicating death.
Measure: Clinical Status Assessment Time: Day 7 and Day 14Description: The response to treatment with Losmapimod in COVID-19 patients will be assessed by the total number of study days not requiring oxygen supplementation.
Measure: Respiratory Failure Assessment Time: Day 28Description: To assess the effect on survival following treatment with Losmapimod, mortality will be evaluated by the number of days alive by Day 28.
Measure: Treatment Survival Time: Day 28Description: To evaluate the safety and tolerability of Losmapimod, the incidence of treatment-emergent adverse events will be assessed by clinically significant changes in laboratory test results and vital signs.
Measure: Treatment-Emergent Adverse Events Time: Screening, Date of enrollment and Days 2-14 and 7 and 14 days after the last dose of study drugDescription: To characterize changes in SARS-CoV-2 infection following treatment with losmapimod versus placebo.
Measure: Treatment-Emergent Adverse Events Time: Day 7Description: The change from baseline in levels of C-reactive protein (CRP), a biomarker of systemic inflammatory response to infection with the SARS-CoV-2 virus will be evaluated in serum by immunoturbidimetric assay.
Measure: Changes in C-Reactive Protein Time: Days 1, 4, 7 and 14Description: The change from baseline in the levels of cytokines (IFNγ, IL-2, IL-10 in normalized protein expression (NPX)) in response to the SARS-CoV-2 virus in serum will be evaluated using the Olink immunoassay panel.
Measure: Changes in Levels of Cytokines Time: Days 1, 4, 7 and 14Description: The change from baseline in the levels of chemokines (CXCL10, CXCL9 in normalized protein expression (NPX)) in response to the SARS-CoV-2 virus in serum will be evaluated using the Olink immunoassay panel.
Measure: Changes in Levels of Chemokines Time: Days 1, 4, 7 and 14Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports