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  • HP:0011947: Respiratory tract infection
  • Pneumonia (361) Abnormality of the cardiovascular system (36) Respiratory tract infection (36) Neoplasm (29) Hypoxemia (28) Diabetes mellitus (25) Depressivity (24) Thromboembolism (23) Acute kidney injury (22) Abnormal lung morphology (21) Anosmia (19) Hypertension (18) Abnormality of coagulation (15) Pulmonary embolism (15) Pulmonary fibrosis (15) Stroke (14) Arthritis (14) Interstitial pneumonitis (14) Myocardial infarction (12) Type II diabetes mellitus (12) Deep venous thrombosis (11) Rheumatoid arthritis (10) Leukemia (10) Respiratory distress (10) Low levels of vitamin D (10) Behavioral abnormality (9) Mental deterioration (9) Chronic pain (9) Congestive heart failure (8) Myocarditis (8) Type I diabetes mellitus (8) Sepsis (8) Infertility (7) Abnormality of the liver (7) Lymphopenia (7) Inflammation of the large intestine (7) Pulmonary obstruction (7) Pulmonary insufficiency (7) Immunodeficiency (6) Systemic lupus erythematosus (6) Chronic pulmonary obstruction (6) 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    HP:0011947: Respiratory tract infection

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (94)


    Name (Synonyms) Correlation
    drug3519 VPM1002 Wiki 0.19
    drug539 CAP-1002 Wiki 0.17
    drug2247 Observational measurement of biometric data. No change to health care provided. Wiki 0.17
    Name (Synonyms) Correlation
    drug1096 ELISA Wiki 0.17
    drug773 Cliniporator Wiki 0.17
    drug1071 Drug: NA-831 - 0.10 mg/kg Wiki 0.17
    drug3162 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation Wiki 0.17
    drug379 BNT162c2 Wiki 0.17
    drug1206 Exercise capacity Wiki 0.17
    drug2524 Placebo- 1.00 mg/kg Wiki 0.17
    drug1505 Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets Wiki 0.17
    drug2522 Placebo- 0.10 mg/kg Wiki 0.17
    drug341 Azithromycin Capsule Wiki 0.17
    drug343 Azithromycin and hydroxychloroquine Wiki 0.17
    drug1396 Health-related quality of life Wiki 0.17
    drug3313 Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals Wiki 0.17
    drug1072 Drug: NA-831 - 0.20 mg/kg Wiki 0.17
    drug1550 IL-12 plasmid Wiki 0.17
    drug2523 Placebo- 0.20 mg/kg Wiki 0.17
    drug2525 Placebo- 2.00 mg/kg Wiki 0.17
    drug2466 Placebo 0.20 mg + 2.00 mg/kg Wiki 0.17
    drug3576 Vitamin D supplementation Wiki 0.17
    drug3119 Standard Donor Plasma Wiki 0.17
    drug1777 Levamisole and isoprinosine Wiki 0.17
    drug1075 Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg) Wiki 0.17
    drug946 DAS181 OL Wiki 0.17
    drug2812 Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening Wiki 0.17
    drug1215 Experimental drug Wiki 0.17
    drug938 CytoSorb-Therapy Wiki 0.17
    drug2096 NaCl Solution Wiki 0.17
    drug894 Corn oil (placebo) Wiki 0.17
    drug945 DAS181 COVID-19 Wiki 0.17
    drug1860 Lower-dose prophylactic anticoagulation Wiki 0.17
    drug953 DWJ1248 Wiki 0.17
    drug2465 Placebo 0.10 mg + 1.00 mg/kg Wiki 0.17
    drug1865 Lung Function tests Wiki 0.17
    drug2805 Respiratory infections Wiki 0.17
    drug2072 NA-831 and Atazanavir Wiki 0.17
    drug3575 Vitamin D 1000 IU Wiki 0.17
    drug1065 Drug: GS-5734 - 1.00 mg/kg Wiki 0.17
    drug565 CORVax Wiki 0.17
    drug1052 Dornase Alfa Inhalation Solution Wiki 0.17
    drug2160 Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation Wiki 0.17
    drug3165 Standard therapy recommended by the Ministry of Health of the Russian Federation. Wiki 0.17
    drug1308 Follow-up phone call Wiki 0.17
    drug1236 F-652 Wiki 0.17
    drug1070 Drug: NA-831 Wiki 0.17
    drug535 C3+ Holter Monitor Wiki 0.17
    drug1580 IgM and IgG antibodies assay Wiki 0.17
    drug1170 Enoxaparin Higher Dose Wiki 0.17
    drug1076 Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg) Wiki 0.17
    drug1036 Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care Wiki 0.17
    drug2623 Prophylactic/Intermediate Dose Enoxaparin Wiki 0.17
    drug2683 Querying the INSEE database Wiki 0.17
    drug3970 qRT-PCR and serology Wiki 0.17
    drug375 BNT162a1 Wiki 0.17
    drug2073 NA-831and Dexamethasone Wiki 0.17
    drug641 COVSurf Drug Delivery System Wiki 0.17
    drug1207 Exercise physiology Wiki 0.17
    drug1097 ELISA and Rapid test to detect antibodies against COVID-19 Wiki 0.17
    drug783 Cod liver oil Wiki 0.17
    drug4058 traditional communication tools Wiki 0.17
    drug3164 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation Wiki 0.17
    drug1066 Drug: GS-5734 - 2.00 mg/kg Wiki 0.17
    drug1184 Equipment with smartwatch throughout hospital stay on the general ward Wiki 0.17
    drug4044 telemedicine Wiki 0.17
    drug665 CYNK-001 Wiki 0.17
    drug2747 Rapid Pathogen Detection Wiki 0.17
    drug1816 Lopinavir/ Ritonavir Oral Tablet Wiki 0.17
    drug3163 Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection Wiki 0.17
    drug304 Atazanavir and Dexamethasone Wiki 0.17
    drug864 Convalescent Plasma Wiki 0.13
    drug384 Bacille Calmette-Guérin (BCG) Wiki 0.12
    drug1504 Hydroxychloroquine Sulfate Tablets Wiki 0.12
    drug1219 Exposure Wiki 0.12
    drug1570 Icosapent ethyl Wiki 0.12
    drug376 BNT162b1 Wiki 0.10
    drug68 ACE inhibitor Wiki 0.10
    drug2726 RT-PCR Wiki 0.10
    drug1000 Dexamethasone Wiki 0.10
    drug377 BNT162b2 Wiki 0.08
    drug2448 Placebo Wiki 0.08
    drug969 Data collection Wiki 0.07
    drug944 DAS181 Wiki 0.07
    drug205 Anakinra Wiki 0.05
    drug2938 Saline Wiki 0.05
    drug3574 Vitamin D Wiki 0.05
    drug1995 Methylprednisolone Wiki 0.04
    drug1166 Enoxaparin Wiki 0.04
    drug879 Convalescent plasma Wiki 0.04
    drug3146 Standard of care Wiki 0.03
    drug3375 Tocilizumab Wiki 0.03
    drug3138 Standard of Care Wiki 0.03
    drug1472 Hydroxychloroquine Wiki 0.02

    Correlated MeSH Terms (36)


    Name (Synonyms) Correlation
    D012141 Respiratory Tract Infections NIH 1.00
    D012327 RNA Virus Infections NIH 0.29
    D003141 Communicable Diseases NIH 0.27
    Name (Synonyms) Correlation
    D030341 Nidovirales Infections NIH 0.24
    D007239 Infection NIH 0.19
    D050197 Atherosclerosis NIH 0.17
    D018184 Paramyxoviridae Infections NIH 0.17
    D015163 Superinfection NIH 0.17
    D003139 Common Cold NIH 0.17
    D001424 Bacterial Infections NIH 0.17
    D014777 Virus Diseases NIH 0.16
    D003333 Coronaviridae Infections NIH 0.15
    D012140 Respiratory Tract Diseases NIH 0.13
    D058345 Asymptomatic Infections NIH 0.12
    D009410 Nerve Degeneration NIH 0.12
    D007251 Influenza, Human NIH 0.10
    D045169 Severe Acute Respiratory Syndrome NIH 0.09
    D018352 Coronavirus Infections NIH 0.08
    D007154 Immune System Diseases NIH 0.07
    D029424 Pulmonary Disease, Chronic Obstructive NIH 0.07
    D011665 Pulmonary Valve Insufficiency NIH 0.06
    D008173 Lung Diseases, Obstructive NIH 0.06
    D053717 Pneumonia, Ventilator-Associated NIH 0.06
    D014808 Vitamin D Deficiency NIH 0.05
    D008171 Lung Diseases, NIH 0.04
    D018450 Disease Progression NIH 0.04
    D011014 Pneumonia NIH 0.03
    D000860 Hypoxia NIH 0.03
    D002318 Cardiovascular Diseases NIH 0.03
    D004630 Emergencies NIH 0.03
    D016638 Critical Illness NIH 0.02
    D011024 Pneumonia, Viral NIH 0.02
    D013577 Syndrome NIH 0.02
    D012127 Respiratory Distress Syndrome, Newborn NIH 0.01
    D055371 Acute Lung Injury NIH 0.01
    D012128 Respiratory Distress Syndrome, Adult NIH 0.01

    Correlated HPO Terms (10)


    Name (Synonyms) Correlation
    HP:0002621 Atherosclerosis HPO 0.17
    HP:0002180 Neurodegeneration HPO 0.12
    HP:0006510 Chronic pulmonary obstruction HPO 0.07
    Name (Synonyms) Correlation
    HP:0006536 Pulmonary obstruction HPO 0.06
    HP:0010444 Pulmonary insufficiency HPO 0.06
    HP:0100512 Low levels of vitamin D HPO 0.05
    HP:0002088 Abnormal lung morphology HPO 0.04
    HP:0002090 Pneumonia HPO 0.04
    HP:0012418 Hypoxemia HPO 0.03
    HP:0001626 Abnormality of the cardiovascular system HPO 0.03

    Clinical Trials

    Navigate: Correlations   HPO

    There are 36 clinical trials


    1 An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria, Burkholderia Spp, Aspergillus Spp and Corona-like Viral (Sub-Study) Infections

    Non tuberculous mycobacteria (NTM), Burkholdria spp, Aspergillus in the lung are almost impossible to eradicate with conventional antibiotics. In addition COVID-19 has know current treatment. These patients have few options to treat their lung infection. Nitric oxide has broad bactericidal and virucidal properties. It has been shown that nitric oxide was safe to be inhaled for similar cystic fibrosis patients and reduced drug resistant bacteria in the lungs. Further, research indicates that clinical isolates of NTM, Burkholderia spp, Aspergillus spp and Corona-like viruses can be eradicated by 160ppm NO exposure in the laboratory petri dish. This is not the first time inhaled NO treatment has been used in patients with difficult lung infections. This study will provide more data to see if NO therapy can reduce the bacterial load in the lungs, help the patients breath better; and in the case of COVID-19 act as a anti-viral agent resulting in the reduction of incidence of oxygen therapy, mechanical assistance of BIPAP, CPAP, intubation and mechanical ventilation during the study period.

    NCT03331445
    Conditions
    1. Respiratory Tract Infections
    2. Corona Virus Infection
    Interventions
    1. Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Measure the number of unanticipated adverse events over the duration of the study protocol

    Measure: Measure the safety of 160ppm inhaled nitric oxide delivery in NTM subjects

    Time: 26 Days

    Secondary Outcomes

    Description: Measure the change in absolute FEV1.0 change from baseline during 160 ppm inhalation therapy

    Measure: Measure the effect of 160ppm inhaled nitric oxide delivery on lung spirometry in NTM subjects

    Time: Day 5,12,19 and 26

    Description: Measure the difference from baseline NTM species bacterial load (0 to +4) in sputum during 160ppm nitric oxide inhalation therapy

    Measure: Measure the antimicrobial effect of 160ppm inhaled nitric oxide on lung NTM bacterial load in the sputum

    Time: Day 19 and 26

    Description: Measure the difference from baseline CRISS (0-100) during 160ppm nitric oxide inhalation therapy (lower score represents higher quality of life)

    Measure: Measure the effect of 160ppm inhaled nitric oxide on Quality of Life (CRISS) Score

    Time: Day 19 and 26

    Other Outcomes

    Description: Measuring reduction in the incidence of mechanical assistance including oxygen therapy, BIPAP, CPAP, intubation and mechanical ventilation during the study period.

    Measure: Sub-Study Primary Endpoint(s): Efficacy to reduce respiratory interventions

    Time: Day 26

    Description: Measured by death from all causes

    Measure: Efficacy in reduction of mortality

    Time: Day 26

    Description: Assessed by time to negative conversion of COVID-19 RT-PCR from upper respiratory tract

    Measure: Antiviral effect

    Time: Day 26

    Description: Time to clinical recovery as measured by resolution of clinical signs

    Measure: Efficacy on clinical improvement

    Time: Day 26

    Description: Measured by change in the Modified Jackson Cold Score

    Measure: Efficacy on the respiratory symptoms

    Time: Day 26
    2 A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

    This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.

    NCT03808922
    Conditions
    1. Lower Respiratory Tract Infection
    2. Parainfluenza
    3. Immunocompromised
    4. COVID-19
    Interventions
    1. Drug: DAS181
    2. Drug: Placebo
    3. Drug: DAS181 COVID-19
    4. Drug: DAS181 OL
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Paramyxoviridae Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Removal of all oxygen support (with stable SpO2)

    Measure: Percent of subjects who Return to Room Air (RTRA) (main study)

    Time: by Day 28

    Measure: Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)

    Time: Day 14

    Secondary Outcomes

    Measure: All-cause mortality rate (main study)

    Time: at Day 28

    Measure: Percent of subjects who Return to Room Air (RTRA) (main study)

    Time: by Day 21

    Measure: Time (in days) to RTRA (main study)

    Time: Days 10, 14, 21, 28

    Measure: Percent of subjects who achieve clinical stability (main study)

    Time: by Day 28

    Measure: Percent of subjects discharged (without mortality and hospice) (main study)

    Time: by Days 14, 21, 28 and 35

    Measure: Time (in days) to first hospital discharge (without hospice) (main study)

    Time: through Day 35

    Measure: Total number of inpatient days (main study)

    Time: up to Day 35

    Measure: Baseline SAD-RV infection-related mortality rate (main study)

    Time: at Day 28

    Measure: Baseline SAD-RV infection-related mortality rate (main study)

    Time: at Day 35

    Measure: All-cause mortality rate (main study)

    Time: at Day 35

    Measure: Change in pulmonary function (FEV1% predicted) (main study)

    Time: Day 1, Day 7, Day 14, Day 28

    Measure: Time to improved COVID19 clinical status (Sub-study)

    Time: Day 5, Day 10, Day 21, Day 28

    Measure: Time to RTRA

    Time: Day 10, Day 14, Day 21, Day 28

    Measure: Time to Clinical stability

    Time: Day 14, Day 21, Day 28

    Measure: Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable

    Time: Day 5, Day 10, Day 14, Day 21, Day 28

    Measure: Time to Clinical deterioration

    Time: Day 5, Day 10, Day 14, Day 21, Day 28

    Measure: Time to Discharge from hospital (without readmission before Day 28).

    Time: Day 14, Day 21, Day 28

    Measure: Time to Death (all causes)

    Time: Day 14, Day 21, Day 28
    3 RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study

    Lower Respiratory Tract infections are a common cause of admission to the intensive care unit. Children routinely receive antibiotics until the tests confirm whether the infection is bacterial or viral. The exclusion of bacterial infection may take 48 hours or longer for culture tests on biological samples to be completed. In many cases, the results may be inconclusive or negative if the patient has already received antibiotics prior to the sample being taken. A rapid assay to detect the most likely cause of infection could improve the speed with which antibiotic therapy is rationalised or curtailed. This study aims to assess whether a new genetic testing kit which can identify the presence of bacteria and viruses within hours rather than days is a feasible tool in improving antibiotic prescribing and rationalisation of therapy in critically ill children with suspected lower respiratory tract infection.

    NCT04233268
    Conditions
    1. Lower Respiratory Tract Infection
    2. Ventilator Associated Pneumonia
    3. COVID19
    Interventions
    1. Diagnostic Test: Rapid Pathogen Detection
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Pneumonia, Ventilator-Associated Pneumonia
    HPO:Pneumonia Respiratory tract infection

    Primary Outcomes

    Description: Performance of novel pathogen detection assays compared to standard microbiology, in regard to sensitivity, specificity and likelihood ratios

    Measure: Performance of the novel pathogen detection assay

    Time: 3 years

    Secondary Outcomes

    Description: Time to reportable test results

    Measure: Time to results

    Time: 3 years

    Description: Where routine culture is negative, what proportion of tests have a positive detection using the novel assay?

    Measure: Negative cultures

    Time: 3 years

    Description: Duration of therapy and number of antibiotic classes during paediatric intensive care unit admission

    Measure: Antibiotic therapy

    Time: 3 years

    Description: Number of critically ill children requiring mechanical ventilation with COVID19 compared to those without

    Measure: Prevalence of COVID19 in children admitted to PICU

    Time: 2 years
    4 Impact of Swab Site and Sample Collector on Testing Sensitivity for COVID-19 Virus in Symptomatic Individuals

    Operational project to compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic setting

    NCT04321369
    Conditions
    1. Infections, Respiratory
    2. Fever
    3. Cough
    Interventions
    1. Diagnostic Test: Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals
    MeSH:Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic setting

    Measure: Accuracy of patient administered tests

    Time: 2 weeks
    5 The Use of Angiotensin Converting Enzyme Inhibitors and Incident Respiratory Infections, Are They Harmful or Protective? An Analysis Using UK Based Electronic Health Records of 5.6 Million Individuals.

    The study use UK based linked electronic health records from the Clinical Research Datalink (CALIBER) of 5.6 million individuals to conduct a matched case-control study to investigate the incidence of influenza in individuals prescribed ACEI compared to those not prescribed ACEI.

    NCT04322786
    Conditions
    1. Covid-19, Coronavirus, Angiotensin Converting Enzyme Inhibitors, Influenza, Electronic Health Records, Epidemiology, Comorbidity, Incidence, United Kingdom
    Interventions
    1. Drug: ACE inhibitor
    MeSH:Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Measure: Incidence of influenza

    Time: Jan 1st 1998 - May 31st 2016
    6 Audio Data Collection for Identification and Classification of Coughing

    An open access study that will define and collect digital measures of coughing in multiple populations and public spaces using various means of audio data collection.

    NCT04326309
    Conditions
    1. COVID-19
    2. Coronavirus Infections
    3. Hay Fever
    4. Asthma
    5. Chronic Obstructive Pulmonary Disease
    6. Influenza
    7. Common Cold
    8. Respiratory Tract Infections
    9. Healthy
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Common Cold Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive
    HPO:Chronic pulmonary obstruction Pulmonary obstruction Respiratory tract infection

    Primary Outcomes

    Description: Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.

    Measure: Dataset size

    Time: 14 days

    Secondary Outcomes

    Description: Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity

    Measure: Cough sound identification

    Time: 14 days

    Description: Increase in the sensitivity of the mathematical model to cough sounds to ≥ 70% while retaining the specificity of ≥ 99%

    Measure: Improvement of the existing model

    Time: 14 days

    Description: Determination of the level of acceptance and satisfaction of the solution by patients by means of a Standard Usability Questionnaire to provide feedback. The score ranges from 10 to 50, higher score indicating a better usability.

    Measure: Evaluate the usability of the application

    Time: 14 days
    7 Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease

    ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.

    NCT04332991
    Conditions
    1. Coronavirus
    2. Acute Respiratory Infection
    3. SARS-CoV Infection
    Interventions
    1. Drug: Hydroxychloroquine
    2. Drug: Placebo
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: We will determine the COVID Ordinal Scale for all patients on study day 15 COVID Ordinal Scale defined as: Death Hospitalized on invasive mechanical ventilation or ECMO ( extracorporeal membrane oxygenation) Hospitalized on non-invasive ventilation or high flow nasal cannula Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with limitation in activity (continued symptoms) Not hospitalized without limitation in activity (no symptoms)

    Measure: COVID Ordinal Outcomes Scale on Day 15

    Time: assessed on study day 15

    Secondary Outcomes

    Description: Vital status of the patient on day 15 will be determined using any of the following methods: medical record review, phone calls to patient or proxy

    Measure: all-location, all-cause mortality assessed on day 15

    Time: assessed on study day 15

    Description: Vital status of the patient at day 28 will be determined using any of the following methods: medical record review, phone calls to patient or proxy

    Measure: all-location, all-cause mortality assessed on day 29

    Time: assessed on study day 29

    Description: We will determine the COVID Ordinal Scale for all patients on study day 3

    Measure: COVID Ordinal Outcomes Scale on Study Day 3

    Time: assessed on study day 3

    Description: We will determine the COVID Ordinal Scale on study day 8

    Measure: COVID Ordinal Outcomes Scale on Study Day 8

    Time: assessed on study day 8

    Description: We will determine the COVID Ordinal Scale on study day 29

    Measure: COVID Ordinal Outcomes Scale on Study Day 29

    Time: assessed on study day 29

    Description: We will determine the number of patients who are either dead or on ECMO ( extracorporeal membrane oxygenation) between enrollment and day 28

    Measure: Number of patients dead or with receipt of ECMO between enrollment and Day 28

    Time: Enrollment to Day 28

    Description: The number of calendar days between randomization and 28 days later that the patient is alive and without the use of oxygen therapy. Patients who die prior to day 28 are assigned zero oxygen free days.

    Measure: Oxygen-free days through Day 28

    Time: 28 days after randomization

    Description: Ventilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.

    Measure: Ventilator-free days through Day 28

    Time: 28 days after randomization

    Description: The number of calendar days between randomization and 28 days later that the patient is alive and without the use of vasopressor therapy. Patients who die prior to day 28 are assigned zero vasopressor free days.

    Measure: Vasopressor-free days through Day 28

    Time: 28 days after randomization

    Description: The number of days spent out of the ICU to day 28.

    Measure: ICU-free days to Day 28

    Time: 28 days after randomization

    Description: Defined as 28 days minus the number of days from randomization to discharge home.If a patient has not been discharged home prior to day 28 or dies prior to day 28, hospital free days will be zero.

    Measure: Hospital-free days to Day 28

    Time: 28 days after randomization

    Other Outcomes

    Description: We will determine the number of patients that experience seizure between randomization and day 28

    Measure: Number of patients with seizures to day 28

    Time: 28 days after randomization

    Description: We will determine the number of patients that experience ventricular arrhythmia between randomization and day 28

    Measure: Number of patients with atrial or ventricular arrhythmia to day 28

    Time: 28 days after randomization

    Description: We will determine the number of patients that experience cardiac arrest between randomization and day 28

    Measure: Number of patients with cardiac arrest to day 28

    Time: 28 days after randomization

    Description: We will determine the number of patients that experience elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal between randomization and day 28

    Measure: Number of patients with elevation in aspartate aminotransferase or alanine aminotransferase to twice the local upper limit of normal to day 28

    Time: 28 days after randomization

    Description: We will determine the number of patients that experience acute pancreatitis between randomization and day 28

    Measure: Number of patients with acute pancreatitis arrest to day 28

    Time: 28 days after randomization

    Description: We will determine the number of patients that experience acute kidney injury between randomization and day 28

    Measure: Number of patients with acute kidney injury to day28

    Time: 28 days after randomization

    Description: We will determine the number of patients that experience renal replacement therapy between randomization and day 28

    Measure: Number of patients with receipt of renal replacement therapy to day 28

    Time: 28 days after randomization

    Description: We will determine the number of patients that experience symptomatic hypoglycemia between randomization and day 28

    Measure: Number of patients with symptomatic hypoglycemia to day 28

    Time: 28 days after randomization

    Description: We will determine the number of patients that experience neutropenia, lymphopenia, anemia, or thrombocytopenia between randomization and day 28

    Measure: Number of patients with neutropenia, lymphopenia, anemia, or thrombocytopenia to day 28

    Time: 28 days after randomization

    Description: We will determine the number of patients that experience severe dermatologic reaction between randomization and day 28

    Measure: Number of patients with severe dermatologic reaction to day 28

    Time: 28 days after randomization

    Description: Time to recovery, defined as time to reaching level 5, 6, or 7 on the COVID Outcomes Scale, which is the time to the earlier of final liberation from supplemental oxygen or hospital discharge

    Measure: Time to recovery, defined as time to reaching level 5, 6, or 7 on the COVID Outcomes Scale, which is the time to the earlier of final liberation from supplemental oxygen or hospital discharge

    Time: 28 days after randomization
    8 An Open Randomized Study of the Effectiveness of the Drug Dalargin for the Prevention and Treatment of Symptoms of Pulmonary Complications in Patients With Coronavirus Infection (SARS-COVID-19)

    The purpose of the study is to evaluate an effectiveness of the drug Dalargin for the prevention and treatment of severe pulmonary complications symptoms associated with severe and critical coronavirus infection cases (SARS COVID19, expanded as Severe acute respiratory syndrome Cоrona Virus Disease 2019 ). Test drug that will be administered to patients are: - Dalargin, solution for inhalation administration, - Dalargin, solution for intravenous and intramuscular administration.

    NCT04346693
    Conditions
    1. Acute Respiratory Tract Infection
    2. Acute Respiratory Insufficiency
    3. Pneumonia
    4. Septic Shock
    5. Hypoxemia
    Interventions
    1. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation.
    2. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection
    3. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin inhalation
    4. Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Dalargin intramuscular injection combined with Dalargin inhalation
    MeSH:Infection Respiratory Tract Infections Pneumonia Respiratory Insufficiency Pulmonary Valve Insufficiency Hypoxia
    HPO:Hypoxemia Pneumonia Pulmonary insufficiency Respiratory tract infection

    Primary Outcomes

    Description: Estimated by Polymerase chain reaction (PCR)

    Measure: The change of viral load in patients with SARS-COVID-19.

    Time: Upon patient inclusion in the study, after 96 hours and on the 10day;

    Description: Assessed through the entire patient participation in the study

    Measure: The frequency of development of Acute Respiratory Distress Syndrome (ADRS)

    Time: up to 10 days

    Description: The number of days a patient is hospitalized

    Measure: Duration of hospitalization

    Time: up to 10 days

    Description: Early mortality from all causes will be estimated

    Measure: The frequency of early mortality

    Time: up to 30 days

    Description: Late mortality from all causes will be estimated

    Measure: The frequency of late mortality

    Time: up to 90 days

    Description: Clinical status at the time of completion of participation in the study will be estimated based upon the following criteria: Death; Hospitalization is extended, on invasive mechanical ventilation of the lungs with extracorporeal membrane oxygenation; Hospitalization extended, on non-invasive ventilation; Hospitalization is extended, needs additional oxygen; Hospitalization is extended, additional oxygen is not required; Discharged.

    Measure: Clinical status at the time of completion of participation in the study

    Time: an average of 10 days
    9 suPAR-guided Anakinra Treatment for Validation of the Risk and Early Management of Severe Respiratory Failure by COVID-19: The SAVE Open-label, Non-randomized Single-arm Trial

    In the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure.

    NCT04357366
    Conditions
    1. COVID-19
    2. Virus Diseases
    3. Corona Virus Infection
    4. Lower Respiratory Tract Infection Viral
    Interventions
    1. Drug: Anakinra
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Insufficiency
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: The primary study endpoint is the ratio of patients who will develop serious respiratory failure SRF until day 14. Patients dying before study visit of day 14 are considered achieving the primary endpoint.

    Measure: The ratio of patients who will develop serious respiratory failure (SRF)

    Time: Visit study day 14

    Secondary Outcomes

    Description: Evaluation of clinical data (pO2/FiO2 and need of mechanical ventilation) between baseline and study visit day 14 will be compared with comparators from Hellenic Sepsis Study Group Database

    Measure: Comparison of the rate of patients who will develop serious respiratory failure (SRF) until day 14 with comparators from Hellenic Sepsis Study Group Database receiving standard-of-care treatment

    Time: Visit study day 14

    Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 7

    Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 7

    Time: Visit study day 1, visit study day 7

    Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 14

    Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 14

    Time: Visit study day 1, visit study day 14

    Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 7 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

    Measure: Change of SOFA score in enrolled subjects between days 1 and 7

    Time: Visit study day 1, visit study day 7

    Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 14 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)

    Measure: Change of Sequential organ failure assessment (SOFA) score in enrolled subjects between days 1 and 14

    Time: Visit study day 1, visit study day 14

    Description: Change of peripheral mononuclear blood cells' (PBMCs) functionality of enrolled subjects will be compared between days 1 and 7

    Measure: Change of peripheral mononuclear blood cells' (PBMCs) functionality between days 1 and 7

    Time: Visit study day 1, visit study day 7

    Description: Change of plasma inflammatory mediators measured levels will be compared between days 1 and 7

    Measure: Change of plasma inflammatory mediators levels between days 1 and 7

    Time: Visit study day 1, visit study day 7

    Description: Mortality on day 30

    Measure: Rate of Mortality

    Time: Visit study day 30

    Description: Mortality on day 90

    Measure: Rate of Mortality

    Time: Visit study day 90

    Description: Transcriptional, proteomic and metabolomic change will be compared between days 1 and 7

    Measure: Change of gene expression between days 1 nad 7

    Time: days 1 and 7
    10 A Clinical Trial of Nebulized Surfactant for the Treatment of Moderate to Severe COVID-19

    Lung surfactant is present in the lungs. It covers the alveolar surface where it reduces the work of breathing and prevents the lungs from collapsing. In some respiratory diseases and in patients that require ventilation this substance does not function normally. This study will introduce surfactant to the patients lungs via the COVSurf Drug Delivery System

    NCT04362059
    Conditions
    1. Respiratory Infections
    Interventions
    1. Device: COVSurf Drug Delivery System
    2. Other: Standard of Care
    MeSH:Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: To assess the improvement in oxygenation as determined by the PaO2/FiO2 ratio after treatment with study treatment

    Measure: Oxygenation Improvement

    Time: 3 months

    Description: To assess the improvement in pulmonary ventilation as determined by the Ventilation Index (VI), where VI = [RR x (PIP - PEEP) × PaCO2]/1000 after study treatment.

    Measure: Pulmonary ventilation Improvement

    Time: 3 months

    Secondary Outcomes

    Description: To assess safety as judged by the frequency and severity of adverse events and severe adverse events (SAEs).

    Measure: Safety Assessment of Frequency and Severity of Adverse Events

    Time: 3 months
    11 A Phase I/II Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) for the Treatment of Adults With COVID-19

    This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.

    NCT04365101
    Conditions
    1. Coronavirus
    2. Coronavirus Infection
    3. Severe Acute Respiratory Syndrome Coronavirus 2
    4. Pneumonia
    5. Pneumonia, Viral
    6. Lung Diseases
    7. Respiratory Tract Disease
    8. Respiratory Tract Infections
    9. Coronaviridae Infections
    10. Nidovirales Infections
    11. RNA Virus Infections
    12. Virus Disease
    13. Immunologic Disease
    14. ARDS
    15. Immunologic Factors
    16. Physiological Effects of Drugs
    17. Antiviral Agents
    18. Anti-infective Agents
    19. Analgesics
    20. Antimetabolites, Antineoplastic
    Interventions
    1. Biological: CYNK-001
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Coronavirus I Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral RNA Virus Infections Coronaviridae Infections Nidovirales Infections Pneumonia Lung Diseases Respiratory Tract Diseases Immune System Diseases
    HPO:Abnormal lung morphology Pneumonia Respiratory tract infection

    Primary Outcomes

    Description: Number and severity of adverse events

    Measure: Phase 1: Frequency and Severity of Adverse Events (AE)

    Time: Up to 6 months

    Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR

    Measure: Phase 1: Rate of clearance of SARS-CoV-2

    Time: Up to 6 months

    Description: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score.

    Measure: Phase 1: Rate of clinical improvement

    Time: Up to 6 months

    Description: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR. Negative results will need to be confirmed by a second negative result in the same sample type at least 24 hours after the first negative result.

    Measure: Phase 2: Time to Clearance of SARS-CoV-2

    Time: Up to 28 days

    Description: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by National Early Warning Score 2 (NEWS2) Score.

    Measure: Phase 2: Time to Clinical Improvement by NEWS2 Score

    Time: Up to 28 days

    Secondary Outcomes

    Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR

    Measure: Rate of Clearance of SARS-CoV-2

    Time: Up to 6 months

    Description: Number and severity of adverse events

    Measure: Phase 2: Frequency and Severity of Adverse Events (AE)

    Time: up to 6 months

    Description: Time to medical discharge as an assessment of overall clinical benefit

    Measure: Overall Clinical Benefit by time to medical discharge

    Time: up to 6 months

    Description: Hospital utilization will be measured as an assessment of overall clinical benefit

    Measure: Overall Clinical Benefit by hospital utilization

    Time: up to 6 months

    Description: Mortality rate will be measured as an assessment of overall clinical benefit

    Measure: Overall Clinical Benefit by measuring mortality rate

    Time: up to 6 months

    Description: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.

    Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score

    Time: Up to 28 days

    Description: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).

    Measure: Time to Pulmonary Clearance

    Time: Up to 28 days

    Description: For ventilatory support subjects, the days with supplemental oxygen-free.

    Measure: Supplemental oxygen-free days

    Time: Up to 28 days

    Description: Proportion of subjects who need invasive or non-invasive ventilation

    Measure: Proportion of subjects requiring ventilation

    Time: Up to 28 days
    12 Study of Clinical and Immune Severity Profiles of Patients Infected With SARS-Cov2

    The SARS-CoV2 virus causes severe or even fatal disease in a fraction of infected people. The clinical severity is based on a complicated pneumopathy with acute respiratory distress syndrome that can lead to multi-visceral failure. The underlying mechanism is a cytokinergic storm, an emerging facet of immunological dysregulation. This clinical trial is aimed to understand the mechanisms of this immunological dysregulation in order to identify therapeutic levers. The main objective is to understand the relationships between clinical severity, death or morbidity of resuscitation management, and immune status (i.e., immune pathways activated or not). Immune status will be investigated at many levels of organization (i.e., circulating leukocytes, cytokines and chemokines, transcripts). The secondary objectives are : - to understand what is responsible for clinical severity, viral load, or immune activation; - to highlight the consequences of immunological dysregulation on associated risks (i.e., immunosuppression leading to the emergence of infectious comorbidities) as well as the functioning of neurotransmission through metabolic pathway diversions. The impact of dysimmunity on these biological pathways will be assessed with a metabolomic analysis; - to understand the mechanisms of vulnerability related to the field. Moreover, while co-morbidities are likely to be a risk factor for severe disease progression, there are many situations in which they do not occur. Stress, with its neurovegetative and endocrinological dimensions, modulates the immune response. It is essential to know whether the stress response plays a role in immunological dysregulation. This analysis is a prerequisite for understanding the conditions of treatment with glucocorticoids. Angiotensin converting enzyme type 2 (ACE2) also plays a likely role in host viral infection. It is also thought to play an important role in the emergence of severe syndromes by affecting the quality of vascular response.

    NCT04365166
    Conditions
    1. Respiratory Tract Infections
    2. Respiratory Tract Disease
    MeSH:Respiratory Tract Infections Respiratory Tract Diseases
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Mortality

    Measure: Mortality

    Time: 90 days following the enrollment

    Description: Th1/Th2/Th17/Treg balance, Type I Interferons and inflammation

    Measure: Immune response - Plasma cytokine profile

    Time: Through study completion (90 days following the enrollment)

    Description: T cells (CD3, CD4, CD8, PD1, FAS, CD45RO, CTLA4+, CXCR5, CXCR3, CCR6, CD69, CD95, HLA-DR) and B cells (CD3, CD19, CD27, IgD, CD69) with cell subtypes and memory/naive compartments (CD27, CD38, IgD, IgG1, IgG2, IgG3, CD20, CD24), NK cells (CD14, CD16, CD56, HLA-DR), monocytes (CD14, CD45, HLA-DR, PDL-1)

    Measure: Immune response - Phenotype of circulating cells

    Time: Through study completion (90 days following the enrollment)

    Secondary Outcomes

    Description: Number of days in intensive care unit

    Measure: Severity criteria - Duration of stay in intensive care unit

    Time: 90 days following the enrollment

    Description: Number of days of hospitalization

    Measure: Severity criteria - Duration of hospitalization stay

    Time: 90 days following the enrollment

    Description: Number of days out of hospital

    Measure: Severity criteria - Duration of period out of hospital

    Time: 90 days following the enrollment

    Description: Number of days without mechanical ventilation (invasive/non-invasive)

    Measure: Severity criteria - Duration without mechanical ventilation

    Time: 90 days following the enrollment

    Description: Number of days not being ventilated

    Measure: Severity criteria - Duration without ventilation

    Time: 90 days following the enrollment

    Description: Number of days not being intubated

    Measure: Severity criteria - Duration without intubation

    Time: 90 days following the enrollment

    Description: Number of transfusions

    Measure: Severity criteria - Number of transfusions

    Time: 90 days following the enrollment

    Description: Number of days without cathecholamines

    Measure: Severity criteria - Duration of the period without cathecholamines

    Time: 90 days following the enrollment

    Description: Number of days without dialysis

    Measure: Severity criteria - Duration of the period without dialysis

    Time: 90 days following the enrollment

    Description: Sepsis-related Organ Failure Assessment (SOFA) Score

    Measure: Severity criteria - SOFA

    Time: Through study completion (90 days following the enrollment)

    Description: Lung Injury Score (LIS)

    Measure: Severity criteria - LIS

    Time: Through study completion (90 days following the enrollment)

    Description: SARS-Cov2 viral load will be measured in blood and in broncho-tracheal secretions

    Measure: SARS-Cov2 viral load

    Time: Through study completion (90 days following the enrollment)

    Description: Co-infections and acquired infections (bacterial or fungal) in intensive care unit, in particular based on an all-site positive PCR for EBV and/or CMV and/or HSV

    Measure: Emergence of concomitant infections

    Time: 90 days following the enrollment

    Description: T cells (CD3, CD4, CD8, PD1, FAS, CD45RO, CTLA4+, CXCR5, CXCR3, CCR6, CD69, CD95, HLA-DR) and B cells (CD3, CD19, CD27, IgD, CD69) with cell subtypes and memory/naive compartments (CD27, CD38, IgD, IgG1, IgG2, IgG3, CD20, CD24), NK cells (CD14, CD16, CD56, HLA-DR), monocytes (CD14, CD45, HLA-DR, PDL-1)

    Measure: Emergence of concomitant infections - Phenotype of circulating cells

    Time: Through study completion (90 days following the enrollment)

    Description: Heart rate variability

    Measure: Stress physiological profile - Sympathetic tone

    Time: Through study completion (90 days following the enrollment)

    Description: Core temperature

    Measure: Stress physiological profile - Temperature

    Time: Through study completion (90 days following the enrollment)

    Description: Quantity of glucocorticoids in the urine during 24 hours and at night

    Measure: Stress physiological profile - Glucocorticoids

    Time: Through study completion (90 days following the enrollment)

    Description: ACE Polymorphism

    Measure: Angiotensin converting enzyme type II (ACE2) polymorphism - ACE

    Time: At enrollment

    Description: Protein expression of ACE2 vs. ACE1 and angiotensin II chain proteins

    Measure: Angiotensin converting enzyme type II (ACE2) polymorphism - ACE2/ACE1

    Time: At enrollment

    Description: Diabete diagnosis

    Measure: Comorbidities - diabetes

    Time: At enrollment

    Description: Heart disease diagnosis

    Measure: Comorbidities - Heart disease

    Time: At enrollment

    Description: Organ failure diagnosis

    Measure: Comorbidities - organ failure

    Time: At enrollment

    Description: GABA level in blood and urine

    Measure: Plasma concentrations of several metabolic pathways - GABA

    Time: Through study completion (90 days following the enrollment)

    Description: Glucocorticoid level in blood and urine

    Measure: Plasma concentrations of several metabolic pathways - Glucocorticoid

    Time: Through study completion (90 days following the enrollment)

    Description: Tryptophan in blood and urine

    Measure: Plasma concentrations of several metabolic pathways - Tryptophan

    Time: Through study completion (90 days following the enrollment)

    Description: Serotonin level in blood and urine

    Measure: Plasma concentrations of several metabolic pathways - Serotonin

    Time: Through study completion (90 days following the enrollment)

    Description: Dopamin level in blood and urine

    Measure: Plasma concentrations of several metabolic pathways - Dopamin

    Time: Through study completion (90 days following the enrollment)

    Description: Catecholamines level in blood and urine

    Measure: Plasma concentrations of several metabolic pathways - Cathecholamines

    Time: Through study completion (90 days following the enrollment)

    Description: Arachidonic acid derivatives level in blood and urine

    Measure: Plasma concentrations of several metabolic pathways - Arachidonic acid derivatives

    Time: Through study completion (90 days following the enrollment)

    Description: Endocannabinoids level in blood and urine

    Measure: Plasma concentrations of several metabolic pathways - Endocannabinoids

    Time: Through study completion (90 days following the enrollment)
    13 A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of Four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-2019 Using Different Dosing Regimens in Healthy Adults

    The trial has two parts: Part A is for dose ranging with dose escalation and de-escalation plus the evaluation of interim dose levels. It also includes dose ranging in older subjects. Part B is dedicated to recruit expansion cohorts with dose levels which are selected from data generated in Part A. The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will also be administered using a Single dose (SD) regimen.

    NCT04380701
    Conditions
    1. Infections, Respiratory
    2. Virus Diseases
    3. Infection Viral
    4. Vaccine Adverse Reaction
    5. RNA Virus Infections
    Interventions
    1. Biological: BNT162a1
    2. Biological: BNT162b1
    3. Biological: BNT162b2
    4. Biological: BNT162c2
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases RNA Virus Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Measure: Solicited local reactions at the injection site (pain, tenderness, erythema/redness, induration/swelling) recorded up to 7±1 days after each immunization.

    Time: up to 7 days following each dose administration

    Measure: Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 days after each immunization.

    Time: up to 7 days following each dose administration

    Description: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 21±2 days after the prime immunization.

    Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE):

    Time: 21 days following dose administration

    Description: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 28±4 days after the boost immunization. For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the immunization.

    Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE):

    Time: 28 days following dose administration

    Secondary Outcomes

    Description: Functional antibody responses at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.

    Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):

    Time: up to 162 days following dose administration

    Description: Fold increase in functional antibody titers 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.

    Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):

    Time: up to 162 days following dose administration

    Description: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.

    Measure: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B):

    Time: up to 162 days following dose administration

    Description: Functional antibody responses at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.

    Measure: For BNT162c2 (SD):

    Time: up to 183 days following dose administration

    Description: Fold increase in functional antibody titers at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.

    Measure: For BNT162c2 (SD):

    Time: up to 183 days following dose administration

    Description: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.

    Measure: For BNT162c2 (SD):

    Time: up to 183 days following dose administration
    14 Hypertonic Saline Nasal Irrigation and Gargling for Suspected or Confirmed COVID-19: Pragmatic Web-based Bayesian Adaptive Randomised Controlled Trial (ELVIS COVID-19)

    ELVIS COVID-19 is a pragmatic web-based Bayesian adaptive randomised controlled, parallel group trial of hypertonic saline nasal irrigation and gargling (HSNIG) compared to standard care in participants with clinically suspected or confirmed COVID-19 being managed at home.

    NCT04382131
    Conditions
    1. Upper Respiratory Tract Infections
    2. Virus
    3. COVID
    4. Virus Shedding
    5. Virus Diseases
    Interventions
    1. Other: NaCl Solution
    MeSH:Respiratory Tract Infections Virus Diseases
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Time until participant reports well

    Measure: Time to resolution of symptoms as defined by the single question 'how unwell do you feel today'.

    Time: Maximum of 14 days

    Secondary Outcomes

    Description: Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe)

    Measure: Severity of all symptoms

    Time: 1-14 days or until the participant reports that they are well

    Description: Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe)

    Measure: The length of time for individual symptoms to resolve

    Time: 1-14 days or until the participant reports that they are well

    Description: Recorded using validated Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire and daily diaries. The WURSS-24 questionnaire assesses the interference on daily life and severity of symptoms on a scale of 1 (not at all) to 7 (severe)

    Measure: Severity of individual symptoms

    Time: 1-14 days or until the participant reports that they are well

    Description: Number of participants and frequency of contacts

    Measure: Contacting healthcare (NHS 24, OOH, GP)

    Time: 1-14 days or until the participant reports that they are well

    Description: Number of participants and frequency of contacts

    Measure: Participants needing GP appointments

    Time: 1-14 days or until the participant reports that they are well

    Description: Number of participants

    Measure: Participants attending hospital

    Time: 1-14 days or until the participant reports that they are well

    Description: Number of days

    Measure: Length of stay in hospital if admitted

    Time: 1-14 days or until the participant reports that they are well

    Description: Number of participants

    Measure: Number of participants reporting over the counter medication use

    Time: 1-14 days or until the participant reports that they are well

    Description: Number of people within participant's household who develop symptoms

    Measure: Reduction in transmission to household contacts

    Time: 1-14 days or until the participant reports that they are well

    Description: Number of participants in intervention arm reporting side effects

    Measure: Number of participants reporting side effects of nasal irrigation

    Time: 1-14 days or until the participant reports that they are well

    Description: Participants asked if they have experienced common side effects or other and to rate the severity on a 7 point scale of 'Did not have this side effect' to 'severe'

    Measure: Types and severity of side effects reported

    Time: 1-14 days or until the participant reports that they are well

    Description: Estimated cost requested when participant states over the counter medication used

    Measure: Cost of over the counter medication used

    Time: 1-14 days or until the participant reports that they are well
    15 The Efficacy of Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial

    The use of both levamisole & Isoprinosine has both synergistic and complementary effect in the treatment of COVID 19 infection

    NCT04383717
    Conditions
    1. Respiratory Tract Infections
    Interventions
    1. Drug: Levamisole and isoprinosine
    2. Drug: Azithromycin and hydroxychloroquine
    MeSH:Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Improvement of fever in degrees celsius

    Measure: COVID 19 induced fever in both groups

    Time: 4 weeks

    Description: improvement of dyspnea by normalization of respiratory rate

    Measure: COVID 19 induced dyspnea in both groups

    Time: 4 weeks

    Description: PCR of COVID 19 changes from positive to negative

    Measure: COVID 19 viral load in both groups

    Time: 4 weeks

    Secondary Outcomes

    Description: CRP in mg/dL

    Measure: laboratory clearance in both groups: CRP in mg/dL

    Time: 4 weeks
    16 A Phase III, Double-blind, Randomized, Placebo-controlled Multicentre Clinical Trial to Assess the Efficacy and Safety of VPM1002 in Reducing Healthcare Professionals' Absenteeism in the SARS-CoV-2 Pandemic by Modulating the Immune System

    The aim of this study is to investigate whether vaccination of healthcare professionals with VPM1002 could reduce the number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection). VPM1002 is a vaccine that is a further development of the old Bacillus Calmette-Guérin (BCG) vaccine, which has been used successfully as a vaccine against tuberculosis for about 100 years, especially in developing countries. VPM1002 has been shown in various clinical studies to be significantly safer than the BCG vaccine. VPM1002 strengthens the body's immune defence and vaccination with BCG reduces the frequency of respiratory diseases. It is therefore assumed that a VPM1002 vaccination could also provide (partial) protection against COVID-19 disease caused by the new corona virus "SARS-CoV 2". A total of 1200 health care professionals (doctors, nurses and paramedical staff) with high expected exposure to SARSCoV-2 infected patients will receive a single dose of either VPM1002 or Placebo. All subjects will be requested to enter data regarding absenteeism, adverse events / serious adverse events, hospitalizations, intensive care unit admissions into an online questionnaire.

    NCT04387409
    Conditions
    1. Infection, Respiratory Tract
    Interventions
    1. Biological: VPM1002
    2. Biological: Placebo
    MeSH:Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Measure: Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection)

    Time: From day 0 to day 240

    Secondary Outcomes

    Measure: Cumulative incidence of documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Number of days absent from work due to documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Number of days absent from work due to exposure to person with documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Number of days absent from work due to symptoms of respiratory disease, documented SARS-CoV-2 infection, or fever (≥ 38 °C)

    Time: From day 0 to day 240

    Measure: Number of days of self-reported fever (≥ 38 °C)

    Time: From day 0 to day 240

    Measure: Number of days of self-reported acute respiratory symptoms

    Time: From day 0 to day 240

    Measure: Cumulative incidence of self-reported acute respiratory symptoms

    Time: From day 0 to day 240

    Measure: Cumulative incidence of death for any reason

    Time: From day 0 to day 240

    Measure: Cumulative incidence of death due to documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Cumulative incidence of ICU admission for any reason

    Time: From day 0 to day 240

    Measure: Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Cumulative incidence of hospital admission for any reason

    Time: From day 0 to day 240

    Measure: Cumulative incidence of hospital admission due to documented SARS-CoV-2 infection

    Time: From day 0 to day 240
    17 Hydroxychloroquine and Lopinavir/ Ritonavir for Hospitalization and Mortality Reduction in Patients With COVID-19 and Mild Disease Symptoms: "The Hope Coalition"

    The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.

    NCT04403100
    Conditions
    1. COVID-19
    2. Coronavirus Infection
    3. Virus Disease
    4. Acute Respiratory Infection
    5. SARS-CoV Infection
    Interventions
    1. Drug: Hydroxychloroquine Sulfate Tablets
    2. Drug: Lopinavir/ Ritonavir Oral Tablet
    3. Drug: Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets
    4. Drug: Placebo
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Virus Diseases Severe Acute Respiratory Syndrome
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Hospitalization is defined as at least 24 hours of acute care in a hospital or similar acute care facility (emergency settings, temporary emergency facilities created for acute care of COVID-19 pandemic)

    Measure: Proportion of participants who were hospitalized for progression of COVID-19 disease

    Time: Measuring during 28-day period since randomization (Intention to treat analysis)

    Measure: Proportion of participants who died due to COVID-19 progression and/ or complications

    Time: Measuring during 28-day period since randomization (Intention to treat analysis)

    Secondary Outcomes

    Description: Viral load change on 03, 07, 10 and 14 after randomization (200 patients per arm)

    Measure: Proportion of participants with viral load change on 03, 07, 10 and 14 after randomization

    Time: Measuring during 14-day period since randomization

    Description: Proportion of participants with clinical improvement, defined as normalization of temperature, Respiratory rate, SaO2, and cough relief (> 50% compared to baseline measured on a visual analog scale) in the last 72 hours.

    Measure: Time to clinical improvement

    Time: Measuring during 28-day period since randomization

    Description: Proportion of participants with clinical improvement, defined as as time to need for hospitalization due to dyspnea, death, need for mechanical ventilation, shock and need for vasoactive amines;

    Measure: Time to clinical failure

    Time: Measuring during 28-day period since randomization

    Description: Proportion of participants with hospitalization for any cause

    Measure: Hospitalization for any cause

    Time: Measuring during 28-day period since randomization

    Measure: Proportion of participants who died due to pulmonary complications

    Time: Measuring during 28-day period since randomization

    Measure: Proportion of participants who died due to cardiovascular complications

    Time: Measuring during 28-day period since randomization

    Description: Evaluation of adverse events evaluated as associated to any of study arms

    Measure: Proportion of participants who presented with adverse events

    Time: Measuring during 28-day period since randomization

    Description: Proportion of participants who presented sustained improvement on respiratory scale defined as at least 48 hours of improvement.

    Measure: Time to improvement on respiratory scale symptoms

    Time: Measuring during 28-day period since randomization

    Measure: proportion of non-adherent participants to any of study drugs

    Time: Measuring during 10-day period since randomization
    18 A Phase III, Randomized, Double-blind, Placebo-controlled, Multicentre, Clinical Trial to Assess the Efficacy and Safety of VPM1002 in Reducing Hospital Admissions and/or Severe Respiratory Infectious Diseases in Elderly in the SARS-CoV-2 Pandemic by Modulating the Immune System

    The aim of this study is to investigate whether vaccination of elderly with VPM1002 could reduce hospital admissions and/or severe respiratory infectious diseases in the SARS-CoV-2 pandemic . VPM1002 is a vaccine that is a further development of the old Bacillus Calmette-Guérin (BCG) vaccine, which has been used successfully as a vaccine against tuberculosis for about 100 years, especially in developing countries. VPM1002 has been shown in various clinical studies to be significantly safer than the BCG vaccine. VPM1002 strengthens the body's immune defence and vaccination with BCG reduces the frequency of respiratory diseases. It is therefore assumed that a VPM1002 vaccination could also provide (partial) protection against COVID-19 disease caused by the "new corona virus" SARS-CoV 2.

    NCT04435379
    Conditions
    1. Infection, Respiratory Tract
    Interventions
    1. Biological: VPM1002
    2. Biological: Placebo
    MeSH:Communicable Diseases Infection Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Measure: Number of days with severe respiratory disease at hospital and/or at home

    Time: From day 0 to day 240

    Secondary Outcomes

    Measure: Cumulative incidence of hospital admissions

    Time: From day 0 to day 240

    Measure: Cumulative incidence of documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Number of days with self-reported fever (≥ 38 ºC)

    Time: From day 0 to day 240

    Measure: Number of days with self-reported acute respiratory symptoms

    Time: From day 0 to day 240

    Measure: Cumulative incidence of self-reported acute respiratory symptoms

    Time: From day 0 to day 240

    Measure: Cumulative incidence of death for any reason

    Time: From day 0 to day 240

    Measure: Cumulative incidence of death due to documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Cumulative incidence of ICU admission for any reason

    Time: From day 0 to day 240

    Measure: Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection

    Time: From day 0 to day 240

    Measure: Cumulative incidence of hospital admission due to documented SARSCoV- 2 infection

    Time: From day 0 to day 240
    19 Randomized Controlled Phase 2/3 Clinical Trial of NA-831 Alone or With Atazanavir, or NA-831 With Dexamethasone, or Atazanavir With Dexamethasone in the Treatment of COVID-19 Infection

    This Phase 2/3 trial evaluates four treatment strategies for non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, in which participants will receive NA-831 or Atazanavir with or without Dexamethasone.

    NCT04452565
    Conditions
    1. Coronavirus Infection
    2. Severe Acute Respiratory Infection
    3. Severe Acute Respiratory Syndrome Coronavirus 2
    Interventions
    1. Drug: Drug: NA-831
    2. Combination Product: NA-831 and Atazanavir
    3. Combination Product: NA-831and Dexamethasone
    4. Combination Product: Atazanavir and Dexamethasone
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death

    Measure: 1. Time (Hours) to recovery

    Time: [ Time Frame: 36 days ]

    Secondary Outcomes

    Description: Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications

    Measure: Time fever resolution

    Time: [ Time Frame: 36 days ]
    20 Reducing Asymptomatic Infection With Vitamin D in Coronavirus Disease

    This study is intended to address whether oral daily vitamin D supplementation reduces infection with SARS-CoV-2 in healthy young adults. The primary aim of the study is to demonstrate a reduction in 'silent' seroconversion rates, consistent with asymptomatic transmission of SARS-CoV-2, in a young healthy adult population following 24 weeks of taking oral vitamin D supplemented at a dose of 1000 I.U. daily, versus matching placebo. The secondary aims of this study are to explore: 1. Any effect on symptomatic illness. 2. The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults. 3. The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time. 4. Where salivary Immunoglobulin A (IgA) may be used to provide an alternative/ complementary serological method 5. The effect (if any) of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs and iii) gender.

    NCT04476680
    Conditions
    1. SARS-CoV Infection
    2. Vitamin D Deficiency
    3. Covid19
    4. Acute Respiratory Tract Infection
    Interventions
    1. Dietary Supplement: Vitamin D 1000 IU
    2. Drug: Placebo
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Vitamin D Deficiency Asymptomatic Infections
    HPO:Low levels of vitamin D Respiratory tract infection

    Primary Outcomes

    Description: asymptomatic seroconversion for SARS-CoV-2

    Measure: Seroconversion

    Time: 24 weeks

    Description: asymptomatic seroconversion for SARS-CoV-2

    Measure: Interim analysis - seropositivity at 12 weeks

    Time: 12 weeks

    Secondary Outcomes

    Description: Sensitivity and specificity of dried blood spot assay compared with venous blood serology

    Measure: Dried Blood Spot performance

    Time: 24 weeks

    Description: Sensitivity and specificity of salivary IgA compared with venous blood serology

    Measure: Salivary IgA performance

    Time: 24 weeks

    Description: The background 'point' prevalence and subsequent rate of increase in seropositivity for SARS-CoV-2 in healthy young adults.

    Measure: Prevalence of SARS-CoV-2

    Time: 24 weeks

    Description: The individual reductions in seropositivity to SARS-CoV-2 over time, and changes in seropositivity in a defined young adult population over time

    Measure: Change in seropositivity

    Time: 24 weeks

    Description: The effect of vitamin D supplementation on seroconversion rates stratified by: i) level of baseline vitamin D 'deficiency/ insufficiency/ sufficiency' status; ii) extent of BMI-defined normal/overweight/obesity cut-offs, iii) gender iv) ethnicity

    Measure: Change in seroconversion rate

    Time: 24 weeks
    21 Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19

    The overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab combined with Dexamethasone in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care (including Dexamethasone) treated patients

    NCT04476979
    Conditions
    1. Coronavirus Infection
    2. SARS (Severe Acute Respiratory Syndrome)
    3. Virus Diseases
    4. Coronaviridae Infections
    5. Nidovirales Infections
    6. RNA Virus Infe
    7. RNA Virus Infections
    8. Respiratory Tract Infections
    9. Respiratory Tract Disease
    Interventions
    1. Drug: Tocilizumab
    2. Drug: Dexamethasone
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Coronaviridae Infections Nidovirales Infections Respiratory Tract Diseases
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death.

    Measure: Survival without needs of ventilator utilization at day 14

    Time: day 14

    Secondary Outcomes

    Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

    Measure: WHO progression scale at day 7 and 14

    Time: day 7 and day 14

    Description: Overall survival

    Measure: Overall survival at 14, 28, 60 and 90 days

    Time: 14, 28, 60 and 90 days

    Description: Cumulative incidence of discharge alive

    Measure: Cumulative incidence of discharge alive at 14 and 28 days

    Time: 14 and 28 days

    Description: Survival without needs of mechanical ventilation at day 1. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.

    Measure: Survival without needs of mechanical ventilation at day 1

    Time: day 1

    Description: Cumulative incidence of oxygen supply independency

    Measure: Cumulative incidence of oxygen supply independency at 14 and 28 days

    Time: 14 and 28 days
    22 A Randomized, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and in Combination With NA-831 in Healthy Volunteers

    The clinical study is designed to evaluate the safety, tolerability and pharmacokinetics of inhaled nanoparticle nanoparticle formulation of Remdesivir (GS-5734) alone and in combination with NA-831 in 48 healthy volunteers.

    NCT04480333
    Conditions
    1. Covid19
    2. Corona Virus Infection
    3. Severe Acute Respiratory Syndrome
    4. Severe Acute Respiratory Infection
    5. Severe Acute Respiratory Syndrome (SARS) Pneumonia
    6. Severe Acute Respiratory Syndrome of Upper Respiratory Tract
    7. Neurodegeneration
    8. Neuroinflammatory Response
    Interventions
    1. Drug: Drug: NA-831 - 0.10 mg/kg
    2. Drug: Placebo- 0.10 mg/kg
    3. Drug: Drug: NA-831 - 0.20 mg/kg
    4. Drug: Placebo- 0.20 mg/kg
    5. Drug: Drug: GS-5734 - 1.00 mg/kg
    6. Drug: Placebo- 1.00 mg/kg
    7. Drug: Drug: GS-5734 - 2.00 mg/kg
    8. Drug: Placebo- 2.00 mg/kg
    9. Combination Product: Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg)
    10. Combination Product: Placebo 0.10 mg + 1.00 mg/kg
    11. Combination Product: Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg)
    12. Combination Product: Placebo 0.20 mg + 2.00 mg/kg
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Severe Acute Respiratory Syndrome Coronavirus Infections Pneumonia Syndrome Nerve Degeneration
    HPO:Neurodegeneration Pneumonia Respiratory tract infection

    Primary Outcomes

    Description: AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0

    Measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events

    Time: First dose date up to Day 30 Follow-up Assessment

    Description: This will be assessed at various time points by clinical laboratory tests and vital signs.

    Measure: Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities

    Time: First dose date up to Day 30 Follow-up Assessment

    Secondary Outcomes

    Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the maximum concentration (Cmax) of NA-831 and GS-5734 in human serum.

    Measure: Maximum Concentration (Cmax) - Pharmacokinetic Assessment

    Time: 7 days

    Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the time to maximum concentration (Tmax) of NA-831 and GS-5734 in human serum

    Measure: Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment

    Time: 7 days

    Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve from time of administration to the last measurable of NA-831 and GS-5734

    Measure: AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment

    Time: 7 days

    Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the area under the curve extrapolated to infinity (AUC0-∞) of NA-831 and GS-5734

    Measure: Area Under the Curve Extrapolated to Infinity (AUC0-∞)

    Time: 7 days

    Description: Monitoring of the levels of drugs in subject sera at various time points to elucidate the half-life (t1/2) of NA-831 and GS-5734 in human serum.

    Measure: Half-Life (t1/2) - Pharmacokinetic Assessment

    Time: 7 days

    Description: Monitoring of the levels of drugs in subject sera through various time points to elucidate the volume of distribution (Vd) of NA-831 and GS-5734 in human serum.

    Measure: Volume of Distribution (Vd) - Pharmacokinetic Assessment

    Time: 7 days

    Description: Monitoring of the levels of drugs in subject sera through at various time points to elucidate clearance [CL] of NA-831 and GS-5734 in human serum.

    Measure: Clearance [CL] - Pharmacokinetic Assessment

    Time: 7 days
    23 A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE)

    MITIGATE is a prospective, open-label, parallel-group, randomized, pragmatic clinical trial. The MITIGATE Study has been designed to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (IPE), also known as Vascepa®, compared to usual standard of care to prevent and reduce the sequelae of laboratory-confirmed viral upper respiratory infection (URI)-related (i.e., COVID-19, influenza, and other known viral respiratory pathogens) morbidity and mortality in a high-risk cohort of adults with established atherosclerotic cardiovascular disease (ASCVD).

    NCT04505098
    Conditions
    1. Covid19
    2. Atherosclerosis
    3. Cardiovascular Diseases
    4. Upper Respiratory Tract Infections
    Interventions
    1. Drug: Icosapent ethyl
    MeSH:Respiratory Tract Infections Cardiovascular Diseases Atherosclerosis
    HPO:Abnormality of the cardiovascular system Atherosclerosis Respiratory tract infection Type IV atherosclerotic lesion

    Primary Outcomes

    Description: Confirmed viral URIs (i.e., including recurrent events) (i.e., COVID-19, influenza, and other known viral respiratory pathogens) based on laboratory testing (i.e., FDA or locally-approved testing modalities) with an oxygen saturation <94% on room air and/or requiring any form of supplemental oxygen.

    Measure: Percentage of patients with moderate or severe confirmed viral URIs

    Time: 0-12 months

    Description: At any point in time based on a 7-point ordinal scale (i.e., 1 = death, 2 = mechanically ventilated/extracorporeal membrane oxygenation, 3 = high flow supplemental oxygen, 4 = low flow supplemental oxygen, 5 = hospitalized with no supplemental oxygen requirements, 6 = urgent care or emergency department visit not leading to hospitalization, and 7 = no relevant clinical encounters)

    Measure: Worst clinical status due to a confirmed viral URI

    Time: 0-12 months

    Other Outcomes

    Measure: Percentage of participants who die due to any cause

    Time: 0-12 months

    Description: Death due to any cause, hospitalization for myocardial infarction, or hospitalization for ischemic stroke

    Measure: Percentage of participants experiencing a major adverse cardiovascular event

    Time: 0-12 months

    Description: Major adverse cardiovascular events, hospitalization for acute coronary syndrome, and coronary revascularization (i.e., percutaneous coronary intervention and/or coronary artery bypass graft)

    Measure: Percentage of participants experiencing an expanded major adverse cardiovascular event

    Time: 0-12 months

    Measure: Percentage of participants who are hospitalized for heart failure

    Time: 0-12 months

    Measure: Percentage of participants who are hospitalized for any reason

    Time: 0-12 months

    Measure: Percentage of participants who have an emergency department visit for any reason

    Time: 0-12 months
    24 Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection (PICOV) A Multicentre Academic Prospective Cohort Study in Nursing Home During the Winter Season 2020-2021

    Background: Each Belgian winter season is characterized by a wave of influenza like and respiratory symptoms. Especially, the elderly people are more vulnerable to be infected by influenza, but also RSV. The recent COVID-19 pandemic and eventually a next wave, will increase the prevalence of influenza like and respiratory symptoms. Method: A multicentre non-commercial cohort study will be conducted in nursing home staff and residents during the Winter season 2020-2021. Objectives: Primary objective is the difference in incidence of influenza like and respiratory symptoms between cases (cases have evidence of past infection with SARS-CoV-2, referred to as Covid +) and controls (controls have no evidence of previous infection and are referred to as Covid -). The primary outcome analysis as well as the secondary outcome analyses will use two strata: nursing home staff and nursing home residents. The secondary objectives are the difference in incidence of COVID-19, influenza, RSV infections confirmed by PCR between cases and controls, to define a correlate of protection in the covid + group against re-infection with SARS-CoV-2 based on the study of the pre-existing antibody profile (antigen specificity, antibody type and antibody level) at the time of re-exposure. A multiplex assay will be used to assess the antibody profile. Finally, to study the COVID-19 disease severity (7 point WHO ordinal scale, this includes a.o. hospitalisation, mechanical ventilation need and ICU admission, mortality) based on the presence/absence of pre-existing antibodies and the pre-existing antibody profile. For other respiratory infections we will study the need for hospitalization and mortality.

    NCT04527614
    Conditions
    1. Influenza, Human
    2. SARS Virus
    3. COVID-19
    4. Espiratory Tract Infections
    Interventions
    1. Diagnostic Test: qRT-PCR and serology
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Influenza, Human
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: This study will assess the time to the occurrence of influenza-like illness (ILI) or acute respiratory infection (ARI) in subjects previously COVID+ compared to subjects known as COVID- (controls), more specifically subjects will belong to two subgroups: nursing home residents (65+) and nursing home staff (18-65y). COVID+ is defined as a past SARS-CoV-2 infection.

    Measure: Time to occurrence of ILI and ARI both in participants previously exposed to SARS-COV-2 and controls

    Time: up to 8 months

    Secondary Outcomes

    Measure: Number of patients with ILI or ARI, diagnosed with COVID-19, influenza, RSV

    Time: up to 8 months

    Measure: Validation of (SimplySpiro) to replace nasopharyngeal swabs

    Time: up to 8 months

    Measure: Identify the antibody characteristics in participants with reinfection with SARS-CoV-2

    Time: up to 8 months

    Description: Disease severity will be measured by hospitalization and mortality

    Measure: Correlation of the pre-existing antibody characteristics for COVID-19 with disease severity.

    Time: up to 8 months

    Measure: Correlation of the level of neutralization antibodies against influenza subtypes with protection against influenza reinfection

    Time: up to 8 months
    25 Bacillus Calmette-Guérin Vaccination To Prevent Serious Respiratory Tract Infection And Covid-19 In Vulnerable Elderly - An Adaptive Randomized Controlled Trial

    On March 11 2020 the World Health Organization (WHO) declared the coronavirus (SARS-CoV-2) outbreak a pandemic. Worldwide, the number of confirmed cases continues to rise, leading to significant morbidity and mortality. In the Netherlands, although the incidence is currently low due to social distancing measures, recurrence of infections is expected once measures are going to be lifted. Although individuals of any age can acquire SARS-CoV-2, adults of middle and older age are at highest risk for developing severe COVID-19 disease. Moreover, recent reports demonstrate that mortality rates rise significantly among patients 60 years and older. Therefore, strategies to prevent SARS-CoV-2 infection or to reduce its clinical consequences in vulnerable populations are urgently needed. Bacille Calmette-Guérin (BCG) vaccine not only protects against tuberculosis, but also induces protection against various respiratory infections, including those with a viral etiology. We hypothesize that BCG vaccination reduces clinically relevant respiratory tract infections requiring medical intervention, including COVID-19, in vulnerable elderly. The objective of this trial is to determine the impact of BCG vaccination on the incidence of clinically relevant respiratory infections or COVID-19 in vulnerable elderly. The trial is designed as an adaptive multi-center double-blind randomized placebo-controlled trial. The attempt is to include 5,200 to 7,000 vulnerable elderly, defined as ≥60 years of age being discharged from hospital in the last 6 weeks, or visiting a medical outpatient clinic, thrombosis care services, or chronic renal replacement departments. Patients with contraindications to BCG vaccination as stipulated in the Summary of Product Characteristics (SPC) and patients with a history of COVID-19 will be excluded. Participants will be randomized between intracutaneous administration of BCG vaccine (Danish strain 1331) or placebo (0.1ml 0.9% NaCl) in a 1:1 ratio.The trial has an adaptive primary endpoint. Based on accrual of the two endpoints, the primary endpoint will be either (a) COVID-19 or (b) clinically relevant respiratory tract infection requiring medical intervention, potentially including COVID-19 episodes. The other will be declared secondary endpoint. Other secondary endpoints include: all SARS-CoV-2 infections (including asymptomatic infections), influenza infection, acute respiratory infection (ARI; all infections regardless of medical intervention), ARI-related hospital admission, COVID-19 related hospital admission, pneumonia, mental, physical and social functioning, serious adverse events and adverse events, and death.

    NCT04537663
    Conditions
    1. Respiratory Tract Infections
    2. Covid19
    Interventions
    1. Drug: Bacille Calmette-Guérin (BCG)
    2. Drug: Placebo
    MeSH:Infection Communicable Diseases Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Clinically relevant relevant respiratory tract infection is composed of clinical symptoms in combination with the need for medical intervention. Exact criteria for clinically relevant respiratory tract infection and COVID-19 are described in the protocol. A blinded adjudication committee will determine the status of the primary endpoints of all participants with a potential primary endpoint, based on information provided in a standardized narrative using data reported by the participant and from GP and hospital medical records when relevant. For detection of ARI, symptoms are checked on a weekly (from week 1-4) or bi-weekly basis (from week 4 onward).

    Measure: The trial has an adaptive primary endpoint. Based on predefined objective and quantitative criteria the primary endpoint will be either a clinically relevant respiratory tract infection, or COVID-19.

    Time: 180 days

    Secondary Outcomes

    Description: Cumulative incidence of SARS-CoV-2 infection regardless of symptomatology defined as having had COVID-19 as described under primary endpoints above and/or SARS-CoV-2 positive test in real time as part of the test-and-trace program of the Dutch government and/of documented SARS-CoV-2 seroconversion at 6 months. Seroconversion will be defined as antibody-positive at 6 months but negative at baseline.

    Measure: Cumulative incidence of SARS-CoV-2 infection (irrespective the presence of symptoms)

    Time: 180 days

    Measure: Cumulative incidence of asymptomatic, mild/moderate, and severe (requiring hospitalization) SARS-CoV-2 infection.

    Time: 180 days

    Description: Defined as either of 1) ARI + microbiological evidence of influenza infection, 2) seroconversion of influenza between enrolment and month 6.

    Measure: Influenza infection

    Time: 180 days

    Description: Meeting the definition stated in the primary outcome. Irrespective of requiring an intervention.

    Measure: An acute respiratory tract infection

    Time: 180 days

    Description: Meeting the definition stated in the primary outcome including the requirement of an intervention.

    Measure: Medically attended acute respiratory tract infection

    Time: 180 days

    Description: Meeting the definition stated in the primary outcome including the need of hospitalization.

    Measure: Acute respiratory tract infection related hospital admission

    Time: 180 days

    Measure: Pneumonia diagnosed by a GP or medical specialist

    Time: 180 days

    Description: Using the Katz Activities of Daily Living (ADL) scale, from A (fully independent) to G (dependent in feeding, continence, transferring, going to toilet, dressing, and bathing)

    Measure: Functioning in daily activities

    Time: 180 days

    Measure: Serious adverse events and adverse events.

    Time: 180 days

    Measure: Major cardiovascular events

    Time: 180 days

    Measure: All cause 6-month mortality

    Time: 180 days

    Measure: History of falls

    Time: 180 days

    Description: Using the EQ5D quality of life instrument, with questions on 4 domains (mobility, self-care, usual activities, pain discomfort) and the percepted health of the participant with 100 meaning the best health you can imagine, and 0 meaning the worst health you can imagine

    Measure: Quality of life using the EQ5D quality of life instrument

    Time: 180 days

    Description: Using the 6-item Lawton Activities of Daily Living questionnaire, with scores ranging from 0 (low function, dependent) to 8 (high function, independent) for women (0 through 5 for men)

    Measure: Activities in daily living

    Time: 180 days
    26 A Prospective Analysis of the Quality and Quantity of Antibiotic Prescriptions for Bacterial Respiratory Tract Superinfection in Patients Hospitalized in COVID-19 Wards of a Tertiary University Hospital During the COVID-19 Pandemic

    In this prospective observational study, a quantitative and qualitative analysis of antibiotic prescriptions for presumed respiratory tract (super)infection in patients hospitalized on COVID-19 wards will be made. Drivers of antibiotic prescription for presumed respiratory tract infection in patients suspected of being infected with COVID-19 or with definite COVID-19 infections will be identified.

    NCT04544072
    Conditions
    1. SARS-CoV Infection
    2. Antimicrobial Stewardship
    3. Respiratory Tract Infections
    4. Antibiotic Resistance
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Superinfection Coronavirus Infections Severe Acute Respiratory Syndrome
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: The total antibiotic use, expressed as Daily Defined Doses (DDD) of antibiotics in grams. This will be aggregated with the amount of hospitalizations to arrive at one reported value: DDD/hospitalization (expressed as grams/hospitalization), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

    Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/hospitalization'.

    Time: 7 months

    Description: The total antibiotic use, expressed as Daily Defined Doses (DDD) in grams. This will be aggregated with the total amount of hospitalized patient days to arrive at one reported value: DDD/1000 hospitalization patient days (expressed as grams/1000 hospitalization days), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general. 1000 hospitalised patient days for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

    Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily defined doses/1000 hospitalized patient days'.

    Time: 7 months

    Description: The total antibiotic use, expressed as Daily Doses of Administration (DDA) of antibiotics in grams. This will be aggregated with the amount of hospitalizations to arrive at one reported value: DDA/hospitalization (expressed as grams/hospitalization), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

    Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards with a clinical or PCR-based COVID diagnosis, expressed as 'Daily doses of administration/hospitalization'.

    Time: 7 months

    Description: The total antibiotic use, expressed as Daily Doses of Administration (DDA) in grams. This will be aggregated with the total amount of hospitalized patient days to arrive at one reported value: DDA/1000 hospitalization patient days (expressed as grams/1000 hospitalization days), for every antibiotic and antibiotic formulation (IV or PO) separately but also for all prescribed antibiotics in general.

    Measure: Total antimicrobial consumption for suspicion of secondary bacterial respiratory infections in hospitalized patients in COVID wards, expressed as 'Daily doses of administration (DDA)/1000 hospitalized patient days'.

    Time: 7 months

    Secondary Outcomes

    Description: The degree of appropriateness for each antibiotic (AB) formulation separately but also for all prescribed antibiotics in general, with distinction between 'Appropriate', 'Unnecessary', 'inappropriate' and 'suboptimal' AB choice. Results will be expressed as DDD or DDA of appropriate AB/1000 patient days, DDD or DDA of unnecessary AB/1000 patient days, DDD or DDA of inappropriate AB/1000 patient days and DDD or DDA of suboptimal AB/1000 patient days. Used units: g/1000 hospitalized patients days

    Measure: The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection

    Time: 7 months

    Description: The degree of appropriateness for each antibiotic (AB) formulation separately but also for all prescribed antibiotics in general, with distinction between 'Appropriate', 'Unnecessary', 'inappropriate' and 'suboptimal' AB choice. Results will be expressed as DDD or DDA of appropriate AB/hospitalization, DDD or DDA of unnecessary AB/hospitalization, DDD or DDA of inappropriate AB/hospitalization and DDD or DDA of suboptimal AB/hospitalization. Used units: g/hospitalization

    Measure: The degree of appropriateness of antimicrobial prescriptions for presumed respiratory tract (super)infection, denominator 2

    Time: 7 months

    Description: The number of C. Difficile infections in the inpatient setting

    Measure: Rate of Clostridioides Difficile infections

    Time: 7 months

    Description: median or mean age (number) , comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Measure: Is there a significant difference in age comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: median or mean weight (kg), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Measure: Is there a significant difference in weight comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: rate of comorbidities expressed as mean Charlson Comorbidity Index score, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

    Measure: significant difference in amount of comorbidities comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: rate of chronical pulmonary disease, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

    Measure: significant difference in rate of chronical pulmonary disease as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: rate of haematological or solid neoplasia, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

    Measure: significant difference in rate of haematological or solid neoplasia as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: rate of diabetes mellitus, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

    Measure: significant difference in rate of diabetes mellitus as a comorbidity, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: rate of patients with fever (t°>38°c), dyspnea, cough, runny nose, throat pain, thoracic pain, myalgia, fatigue, anosmia, confusion at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Measure: significant difference in rate of patients with presence or not of at least one suggestive symptom of COVID-19 symptomatology, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: rate of patients rate of patients having received an antibiotic prescription for a suspicion of respiratory tract infection during the 3 weeks before hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 surinfection and the group without antibiotics?

    Measure: significant difference in rate of patients with recent AB prescription, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: rate of patients with significant positive respiratory cultures, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Measure: Is there a significant difference in the rate of patients having had at least one positive significant respiratory germ culture, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: rate of patients with oxygen suppletion need, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Measure: Is there a significant difference in the rate of patients needing oxygen supletion at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: mean duration of hospitalization on a COVID-ward, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Measure: significant difference in the mean duration of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: rate of ICU admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Measure: significant difference in the rate of ICU admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: mean SatO2/FiO2 ratio (number ranging from 50-500), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Measure: Is there a significant difference in the mean value of oxygen saturation percentage over fractional oxygen percentage, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: mean/median qSOFA score at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Measure: Is there a significant difference in qSOFA score level at admission, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: Rate of lymphopenia (<1250/mcl), comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Measure: Is there a significant difference in the rate of lymphopenia, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: mean CRP values (mg/dl) at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

    Measure: significant difference in the mean value of C-reactive protein measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: mean WBC count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

    Measure: significant difference in the mean value of white blood cell count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: mean neutrophil count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

    Measure: significant difference in the mean value of neutrophil count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: mean lymphocyte count (/mcl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 surinfection and the group without antibiotics

    Measure: significant difference in the mean value of lymphocyte count measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: mean creatinine (mg/dl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

    Measure: significant difference in the mean value of creatinine measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: mean LDH (U/L) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

    Measure: significant difference in the mean value of LDH measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: mean bilirubin (mg/dl) values at day 1 of hospitalization, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

    Measure: significant difference in the mean value of bilirubin measured at day 1 of hospitalization on a COVID-ward ,comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: mean ferritin (mcg/l) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

    Measure: significant difference in the mean value of ferritin (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: mean troponin (mcg/l) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

    Measure: significant difference in the mean value of troponins (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months

    Description: mean D-dimer (ng/ml) values, comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics

    Measure: significant difference in the mean value of D-dimers (first value during hospitalization),comparing the group receiving antibiotics for a suspicion of COVID-19 superinfection and the group without antibiotics?

    Time: 7 months
    27 Non-invasive Biometric Monitoring for the Prevention of COVID-19 Transmission and Deaths in Nursing Homes

    Solving the problem of detecting asymptomatic carriers who can transmit infection is key to protecting vulnerable residents of nursing homes and assisted living facilities, to protecting frontline workers who care for them, and to facilitating return to work (including return of nurses and medical assistants). The wearable biometric technology, if widely disseminated among vulnerable populations and the community-at-large, will help avoid the ravages of seasonal flu and other contagious illnesses, and the society will be better prepared for future waves of COVID-19 or other pandemics. Even if a vaccine is developed, due to immune senescence and immunocompromise, elderly people and those with chronic medical conditions may not be well protected by it. Continuous biomonitoring provides another layer of protection for them.

    NCT04548895
    Conditions
    1. Covid19
    2. Community-Acquired Respiratory Tract Infection
    Interventions
    1. Device: Observational measurement of biometric data. No change to health care provided.
    MeSH:Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Feasibility assessment

    Measure: Proportion of quality signals obtained out of all monitoring time for each device

    Time: 8 weeks from first enrollment

    Description: Algorithm development, sensitivity, specificity, positive and negative predictive value at different lead times ahead of symptom onset

    Measure: Predictive characteristics of the algorithm for respiratory tract infection

    Time: 2 months
    28 Phase 3 Randomised Controlled Trial of Vitamin D Supplementation to Reduce Risk and Severity of COVID-19 and Other Acute Respiratory Infections in the UK Population

    CORONAVIT is an open-label, phase 3, randomised clinical trial testing whether implementation of a test-and-treat approach to correction of sub-optimal vitamin D status results in reduced risk and/or severity of COVID-19 and other acute respiratory infections.

    NCT04579640
    Conditions
    1. Covid19
    2. Acute Respiratory Tract Infection
    Interventions
    1. Dietary Supplement: Vitamin D
    MeSH:Infection Communicable Diseases Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Measure: Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause.

    Time: Over 6 months

    Secondary Outcomes

    Description: Secondary efficacy outcome

    Measure: Proportion of participants seroconverting to SARS-CoV-2 (i.e. with test results for antibodies to SARS-CoV-2 transitioning from negative at baseline to positive at follow-up)

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants developing antigen test-positive COVID-19

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants developing 'probable COVID-19', as adjudged using a validated symptom score

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants developing antigen test-positive influenza

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants reporting symptoms of acute respiratory infection

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants who are prescribed one or more courses of antibiotic treatment for acute respiratory infection

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants with asthma who experience one or more exacerbations of asthma requiring treatment with oral corticosteroids and/or requiring hospital treatment

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants with COPD who experience one or more exacerbations of COPD requiring treatment with oral corticosteroids and/or antibiotics, and/or requiring hospital treatment

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection who report symptoms of COVID-19 lasting more than 4 weeks after onset

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Mean MRC dyspnoea score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection

    Time: 6 months

    Description: Secondary efficacy outcome

    Measure: Mean FACIT Fatigue Scale score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection

    Time: 6 months

    Description: Secondary efficacy outcome

    Measure: Mean COVID-19 Recovery Questionnaire score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection

    Time: 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants who experience COVID-19 requiring hospitalisation

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants hospitalised for COVID-19 requiring ventilatory support

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants who experience influenza requiring hospitalisation

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants dying of any cause during participation in the trial

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants dying of acute respiratory infection during participation in the trial

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants dying of COVID-19 during participation in the trial

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: Proportion of participants dying of influenza during participation in the trial • mean end-study 25(OH)D concentrations (sub-set of participants having end-study tests of vitamin D status)

    Time: Over 6 months

    Description: Secondary efficacy outcome

    Measure: mean end-study 25(OH)D concentration (sub-set of participants having end-study tests of vitamin D status) Mean end-study 25(OH)D concentration (sub-set of participants having end-study tests of vitamin D status)

    Time: 6 months

    Description: Secondary safety outcome

    Measure: Proportion of participants experiencing known hypercalcaemia

    Time: Over 6 months

    Description: Secondary safety outcome

    Measure: Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation

    Time: Over 6 months

    Description: Secondary safety outcome

    Measure: Proportion of participants experiencing a serious adverse event of any cause

    Time: Over 6 months
    29 Application of Telemedicine to Optimize Teamwork and Infection Control of Critical Patients in Isolation Rooms in the Emergency Department During Novel Coronavirus Disease 2019 Outbreak

    Since 2000, various emerging infectious diseases have repeatedly caused serious impact on the health of the global population and the healthcare systems. With the growing international transportation and improving accessibility of the healthcare systems, hospitals have been inevitably the first sentinels dealing with emerging infectious diseases. The biological disasters, such as the Severe Acute Respiratory Syndrome (SARS) in 2003, the Middle East Respiratory Syndrome (MERS) outbreak in South Korean in 2015, and the Coronavirus disease 2019 (COVID-19) outbreak this year, challenged our vulnerable healthcare systems and caused great loss of lives. Regarding the ongoing global epidemics and possible community outbreaks of the COVID-19, the management of biological disasters for an overcrowded emergency department should be planned. In the early 2020, the emergency department used a double-triage and telemedicine method to treat non-critical patient with suspected COVID-19. This application reduced the exposure time of the first responders and reserve adequate interview quality. However, for the critical patients treated in the isolated resuscitation rooms, the unique environment limited the teamwork and communication for the resuscitation team. These factors might led to poorer quality of critical care. The investigators designed a telemedicine-teamwork model, which connected the isolation room, prepare room and nursing station by an video-conferencing system in the emergency department. This model try to break the barriers of space between the rooms and facilitate the teamwork communications between each unit. Besides, by providing a more efficient workflow, this model could lower the total exposure time for all workers in the contaminated area. This study was conducted to evaluate the benefits of the telemedicine-teamwork model and provide a practical, safe and effective alternative to critical care of the patients with suspected highly infectious diseases.

    NCT04591873
    Conditions
    1. Critical Illness
    2. Infections, Respiratory
    3. Emergency Service, Hospital
    4. Telemedicine
    Interventions
    1. Other: telemedicine
    2. Other: traditional communication tools
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Emergencies Critical Illness
    HPO:Respiratory tract infection

    Primary Outcomes

    Measure: time to complete intubation

    Time: immediately after intervention

    Secondary Outcomes

    Description: Team Emergency Assessment Measure, minimal score is 0 and the maximal score is 4. Higher score means a better outcome.

    Measure: teamwork score

    Time: immediately after intervention

    Measure: exposure time in isolation rooms

    Time: immediately after intervention
    30 Vitamin D3 Supplementation to Prevent Respiratory Tract Infections in Hospital Workers: a Pragmatic Study

    The Cooper vitamin D3 study is a randomized study investigating whether daily vitamin D3 supplementation can prevent respiratory tract infections in hospital workers.

    NCT04596657
    Conditions
    1. Respiratory Tract Infections
    2. Covid19
    3. Flu Like Illness
    Interventions
    1. Dietary Supplement: Vitamin D supplementation
    MeSH:Infection Communicable Diseases Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Incidence of acute respiratory tract infection

    Measure: Respiratory tract infection

    Time: 9 months
    31 A Randomized, Parallel-group Treatment, Quadruple Masked, Two-arm Study, to Assess the Effectiveness of Cod Liver Oil Compared to Placebo in the Prevention of Covid-19 and Airway Infections in Healthy Adults

    A randomized, parallel-group treatment, quadruple masked, two-arm study to assess the effectiveness of cod liver oil compared to placebo in the prevention of Covid-19 and airway infections in healthy adults. In this study, the investigators will investigate whether daily cod liver oil can prevent Covid-19 infections and reduce the severity of such infections. The investigators will also examine whether cod liver oil prevents other airway infections in healthy adults.

    NCT04609423
    Conditions
    1. Covid-19
    2. Respiratory Tract Infections
    Interventions
    1. Dietary Supplement: Cod liver oil
    2. Dietary Supplement: Corn oil (placebo)
    MeSH:Infection Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: The number of participants with first time SARS-CoV-2 positive nasopharyngeal and or pharyngeal swabs (or any other sample used for detection of current disease) analyzed by reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) nucleic acid amplification test or antigen tests used by accredited Norwegian microbiology laboratories in the period from one week after the start of cod liver oil/placebo taking to the end of this period together with any of the following: A) Self-reported dyspnea and fever concurrent (within four weeks) with the positive test OR B) hospitalization caused by Covid-19 concurrent (within four weeks) with the positive test OR C) death where the Covid-19 infection was wholly or partly responsible as judged by the death certificate (see endpoint in the protocol)

    Measure: Number of participants diagnosed with serious Covid-19

    Time: 6 months

    Description: The number of participants diagnosed with first time SARS-CoV-2 positive nasopharyngeal and or pharyngeal swabs (or any other sample used for detection of current disease) analyzed by reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) nucleic acid amplification test or antigen tests used by accredited Norwegian microbiology laboratories from one week after the start of cod liver oil/placebo taking.

    Measure: Number of participants diagnosed with New Covid-19

    Time: 6 months

    Description: Number of participants with an airway sample positive for a respiratory pathogen* (either PCR or culture). *Influenza virus (A and B), parainfluenzavirus (1,2,3), metapneumovirus, rhinovirus, coronavirus (non-SARS), Respiratory Syncytial virus, Haemophilus Influenzae, Moraxella Catharralis, Streptococcus Pneumonia, Beta-hemolytic streptococci, Mycoplasma pneumonia, Chlamydophila pneumonia, Enterovirus, Bordetella pertussis. The list can be expanded based on the analyses performed in Norwegian Microbiology laboratories.

    Measure: Number of participants with laboratory confirmed respiratory tract infection

    Time: 6 months

    Description: The number of episodes with any two of the following symptoms: fever, cough, nasal congestion or sore throat

    Measure: Number of participants with self-reported airway infection

    Time: 6 months

    Secondary Outcomes

    Description: Number of participants hospitalized wholly or partly caused by Covid-19.

    Measure: Number of participants hospitalized due to Covid-19

    Time: 6 months

    Description: Number of participants with ICU care wholly or partly caused by Covid-19.

    Measure: Number of participants in Intensiv Care Unit (ICU) caused by Covid-19

    Time: 6 months

    Description: Number of participants with any admissions to hospital based on the Norwegian Patient Registry data.

    Measure: Number of participants with any admissions to hospital

    Time: 6 months

    Description: An airway sample positive for a respiratory pathogen* (either PCR or culture) in the period from one week after the start of cod liver oil/placebo taking to the end of this period. *Influenza virus (A and B), parainfluenzavirus (1,2,3), metapneumovirus, rhinovirus, coronavirus (non-SARS), Respiratory Syncytial virus, Haemophilus Influenzae, Moraxella Catharralis, Streptococcus Pneumonia, Beta-hemolytic streptococci, Mycoplasma pneumonia, Chlamydophila pneumonia, Enterovirus, Bordetella pertussis. The list can be expanded based on the analyses performed in Norwegian Microbiology laboratories.

    Measure: Infection with each of the mentioned pathogens

    Time: 6 months

    Description: Based on The Norwegian Reimbursement Database

    Measure: Number of visits at GP for infections

    Time: 6 months

    Description: Based on The Norwegian Reimbursement Database

    Measure: Number of visits at GP

    Time: 6 months

    Other Outcomes

    Description: Based on self-reporting and Norwegian Registries

    Measure: Incidence of Cardiovascular disease

    Time: 6 months

    Description: Based on self-reporting and Norwegian Registries

    Measure: Incidence of Cardiovascular disease

    Time: 30 months

    Description: Based on self-reporting and Norwegian Registries

    Measure: Incidence of cardiovascular mortality

    Time: 6 months

    Description: Based on self-reporting and Norwegian Registries

    Measure: Incidence of cardiovascular mortality

    Time: 30 months

    Description: Based on self-reporting and Norwegian Registries

    Measure: Incidence of cancer

    Time: 6 months

    Description: Based on self-reporting and Norwegian Registries

    Measure: Incidence of cancer

    Time: 30 months

    Description: Based on self-reporting and Norwegian Registries

    Measure: Incidence of cancer mortality

    Time: 6 months

    Description: Based on self-reporting and Norwegian Registries

    Measure: Incidence of cancer mortality

    Time: 30 months

    Description: Based on self-reporting and Norwegian Registries

    Measure: All-cause mortality

    Time: 6 months

    Description: Based on self-reporting and Norwegian Registries

    Measure: All-cause mortality

    Time: 30 months

    Description: Based on self-reporting and Norwegian Registries

    Measure: Incidence of fracture of the hip or forearm

    Time: 6 months

    Description: Based on self-reporting and Norwegian Registries

    Measure: Incidence of fracture of the hip or forearm

    Time: 30 months

    Description: Based on self-reporting and Norwegian Registries

    Measure: Incident dementia

    Time: 6 months

    Description: Based on self-reporting and Norwegian Registries

    Measure: Incident dementia

    Time: 30 months

    Description: The number of participants with first time SARS-CoV-2 positive nasopharyngeal and or pharyngeal swabs (or any other sample used for detection of current disease) analyzed by reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) nucleic acid amplification test or antigen tests used by accredited Norwegian microbiology laboratories in the period from one week after the start of cod liver oil/placebo taking to the end of this period together with any of the following: A) Self-reported dyspnea and fever concurrent (within four weeks) with the positive test OR B) hospitalization caused by Covid-19 concurrent (within four weeks) with the positive test OR C) death where the Covid-19 infection was wholly or partly responsible as judged by the death certificate (see endpoint in the protocol)

    Measure: Number of participants diagnosed with serious Covid-19

    Time: 12 months

    Description: The number of participants diagnosed with first time SARS-CoV-2 positive nasopharyngeal and or pharyngeal swabs (or any other sample used for detection of current disease) analyzed by reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) nucleic acid amplification test or antigen tests used by accredited Norwegian microbiology laboratories from one week after the start of cod liver oil/placebo taking.

    Measure: Number of participants diagnosed with new Covid-19

    Time: 12 months

    Description: An airway sample positive for a respiratory pathogen* (either PCR or culture). *Influenza virus (A and B), parainfluenzavirus (1,2,3), metapneumovirus, rhinovirus, coronavirus (non-SARS), Respiratory Syncytial virus, Haemophilus Influenzae, Moraxella Catharralis, Streptococcus Pneumonia, Beta-hemolytic streptococci, Mycoplasma pneumonia, Chlamydophila pneumonia, Enterovirus, Bordetella pertussis. The list can be expanded based on the analyses performed in Norwegian Microbiology laboratories.

    Measure: Laboratory confirmed respiratory tract infection

    Time: 12 months

    Description: The number of episodes with any two of the following symptoms: fever, cough, nasal congestion or sore throat

    Measure: Self-reported airway infection

    Time: 12 months

    Description: Number of participants with self-reported adverse events

    Measure: Number of participants with self-reported cod liver oil related adverse events

    Time: 12 months

    Description: Number of participants hospitalized for major diseases or death in the cod liver oil versus placebo group in Norwegian registries

    Measure: Number of participants with cod liver oil related adverse events

    Time: 12 months
    32 Prospective Evaluation of the Predictive Criteria of Severity Related to Patient Calling Emergency Centre for Low or High Respiratory Infection With or Without Fever and Suspected to be COVID-19.

    Emergency call centers are very solicited in epidemic situations. It is necessary to detect early Predictive Criteria of Severity in COVID respiratory infection to identify patients at risk of complication or aggravation from an emergency call center in order to adapt their orientation and their medical management.

    NCT04615676
    Conditions
    1. SARS-CoV2
    Interventions
    1. Other: Follow-up phone call
    MeSH:Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Hospitalization declared by the patient 1 month after his call to the emergency call center

    Measure: Hospitalization

    Time: Month 1
    33 Prevalence and Risk Factors of COVID-19 Infection in the Upper Silesian Agglomeration Population in 2020

    Project is designed as a comprehensive population-based epidemiological study in Upper-Silesian Conurbation (Poland) aiming at: 1. analysis of available data on incidence and mortality due to COVID-19 and 2. estimation of the occurrence of viral infection SARS-CoV-2 as revealed by the results of serological test (ELISA: IgM, IgG), with assessment of risk factors. The project's objectives are: to assess incidence and mortality due COVID-19 according to sex, age and coexisting diseases; to determine the level of potential "underdiagnosis" of the magnitude of COVID-19 mortality using vital statistics data for Upper-Silesian Conurbation; to assess the prevalence of SARS-CoV-2 based on the level of seropositivity in Upper-Silesian Conurbation; to identify host-related and environmental risk factors if the infection. Analysis of existing data will include monthly records on incidence and mortality over the period 01.01.2020-31.12.2020 and comparison of the findings with the monthly records of 2018 and 2019, for the same population. Cross-sectional epidemiological study will be located in three towne (Katowice, Sosnowiec, Gliwice). In each town a representative age-stratified sample of 2000 subjects will undergo questionnaire assessment and serological examination performed by serological test. The project corresponds with analogous population-based studies on COVID-19 in a number of countries and responds to the WHO recommendation in that field.

    NCT04627623
    Conditions
    1. Covid19
    2. Respirato
    3. Respiratory Tract Infections
    4. Severe Acute Respiratory Syndrome
    5. Corona Virus Infection
    6. RNA Virus Infections
    7. Virus Disease
    8. Respiratory Tract Disease
    Interventions
    1. Diagnostic Test: IgM and IgG antibodies assay
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Virus Diseases Severe Acute Respiratory Syndrome Coronavirus Infections RNA Virus Infections Respiratory Tract Diseases
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: Estimation of real prevalence of elevated IgM and IgG COVID antibodies in general population will allow to estimate real number of current and past COVID infection in the population.

    Measure: Estimation of prevalence of specific anti-SARS-CoV-2 IgM and IgG antibodies in general population.

    Time: 8 months

    Secondary Outcomes

    Description: Prevalence of asymptomatic cases into seropositive population

    Measure: Frequency of asymptomatic course of COVID in individuals with anti-SARS-CoV2 antibodies

    Time: 8 months
    34 Profiling the Determinants of Recovery to Establish Novel Rehabilitation Guidelines to Improve Clinically Relevant and Patient-reported Outcomes in the Post-COVID-19 Period

    Currently, there are few studies that have been established that consist of a variety of established and coherent approaches that sought to profile the determinants of recovery, nor used interrogative procedures to understand lasting physical impairment. In this context, measurements obtained from an assessment of cardio-respiratory responses to physiological stress could provide an important insight regarding the integrity of the pulmonary-vascular interface and characterisation of any impairment or abnormal cardio-respiratory function [4]. Indeed, current approaches are being developed to support patients using previous knowledge from other acute respiratory infections (e.g. Acute Respiratory Distress Syndrome; ARDS and Middle Eastern Respiratory Syndrome; MERS), approaches that do not consider the novel challenges presented by COVID-19. The knowledge obtained from the proposed research plan will inform the development of COVID-19 specific rehabilitation and clinical management guidelines which can be implemented globally to increase patient wellbeing, physical capacity, and functional status which will be directly related national and international health and wellbeing, economical and societal impacts.

    NCT04649957
    Conditions
    1. Infections, Respiratory
    2. Respiratory Physiology
    3. Respiratory Muscle
    4. Symptoms and General Path
    5. Symptoms and General Pathology
    MeSH:Respiratory Tract Infections
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: The PCFS offers the full spectrum of functional outcomes, and focuses on both limitations in usual duties/activities and changes in lifestyle in six scale grades.

    Measure: Post-COVID-19 Functional Status (PCFS) Scale

    Time: 16 weeks

    Secondary Outcomes

    Description: The EQ-5D-5L is routinely used in the assessment of the quality of life in respiratory research and is available in more than 130 languages (EQ-5D-5L). It comprises five dimensions (previously 3): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.

    Measure: EQ-5D-5L

    Time: 16 weeks
    35 Wide Scale Monitoring for Acute Respiratory Infection Using a Mobile-Based Study Platform

    This is a prospective observational study using a mobile study platform (app) that is designed for use on Android phones. Study participants will provide baseline demographic and medical information and report symptoms of respiratory infection on a weekly basis using the app. Participants will also report use of prevention techniques on the weekly survey. Mobility data will be collected passively using the sensors on the participant's smartphone, if the participant has granted the proper device permissions. The overall goals of the study are to track spread of coronavirus-like illness (CLI), influenza-like illness (ILI) and non-specific respiratory illness (NSRI) on a near-real time basis and identify specific behaviors associated with an increased or decreased risk of developing these conditions.

    NCT04663776
    Conditions
    1. Covid19
    2. Influenza
    3. Respiratory Tract Infections
    4. Acute Respiratory Tract Infection
    5. Acute Respiratory Distress Syndrome
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: The definition of ILI will be adapted from CDC guidelines as a participant reporting fever in addition to cough or sore throat without any other known cause. All study analyses and outcomes will be reported using federated analytics. Federated analytics utilizes aggregated responses, rather than individual subject reports. Due to this, when reporting the final outcome, the total incidence may not add up to exactly 100%.

    Measure: Incidence of influenza-like illness (ILI) and COVID-like illness (CLI) in a study participant.

    Time: 6-month participation period

    Description: CLI will be defined as fever and cough, or shortness of breath, or loss of smell. Incidence will be defined as reporting of the above symptoms in the 7 days prior (and not previously). All study analyses and outcomes will be reported using federated analytics. Federated analytics utilizes aggregated responses, rather than individual subject reports. Due to this, when reporting the final outcome, the total incidence may not add up to exactly 100%.

    Measure: Incidence of COVID-like illness (CLI) in a study participant.

    Time: 6-month participation period

    Secondary Outcomes

    Description: Patterns of mobility (e.g. time away from home, use of public transportation), and reported use of prevention strategies such as wearing a mask and social distancing in participants who do, or don't, develop CIL and/or ILI will be compared. All study analyses and outcomes will be reported using federated analytics. Federated analytics utilizes aggregated responses, rather than individual subject reports. Due to this, when reporting the final outcome, the total prevalence may not add up to exactly 100%.

    Measure: Disease Prevalence

    Time: 1-year study period
    36 Predicting Severity and Disease Progression in Influenza-like Illness

    Respiratory infections such as colds, flu and pneumonia affect millions of people around the world every year. Most cases are mild, but some people become very unwell. Influenza ('flu') is one of the most common causes of lung infection. Seasonal flu affects between 10% and 46% of the population each year and causes around 12 deaths in every 100,000 people infected. In addition, both influenza and coronaviruses have caused pandemics in recent years, leading to severe disease in many people. Although flu vaccines are available, these need to change every year to overcome rapid changes in the virus and are not completely protective. This study aims to find and develop predictive tests to better understand how and when flu-like illness progresses to more severe disease. This may help to decide which people need to be admitted to hospital, and how their treatment needs to be increased or decreased during infection. The aim is to recruit 100 patients admitted to hospital due to a respiratory infection. It is voluntary to take part and participants can choose to withdraw at any time. The study will involve some blood and nose samples. This will be done on Day 0, Day 2 and Discharge from hospital, and an out-patient follow-up visit on Day 28. The data will be used to develop novel diagnostic tools to assist in rational treatment decisions that will benefit both individual patients and resource allocation. It will also establish research preparedness for upcoming pandemics.

    NCT04664075
    Conditions
    1. Influenza
    2. SARS (Severe Acute Respiratory Syndrome)
    3. Respiratory Viral Infection
    4. Respiratory Tract Infections
    5. Infection, Bacterial
    6. Infection Viral
    7. Covid19
    8. RNA Virus Infections
    Interventions
    1. Biological: Respiratory infections
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Bacterial Infections Influenza, Human Virus Diseases Severe Acute Respiratory Syndrome Coronavi Coronavirus Infections RNA Virus Infections Disease Progression
    HPO:Respiratory tract infection

    Primary Outcomes

    Description: The identity of pathological organisms associated with influenza-like illness (including respiratory viruses and bacteria) will be obtained from the patient's medical record

    Measure: Describe the aetiology of influenza-like illness in hospitalised adults

    Time: Day 0 to Day 28

    Description: The following data will be collected from the patient's medical record. At enrolment, data will consist of: past medical history, clinical signs and symptoms relating to this admission, vital signs (pulse rate, blood pressure, temperature, oxygen saturation), demographics, drug history, laboratory results including diagnostic microbiological tests and interventions. Data collection on Day 28 will consist of clinical diagnosis at discharge, any febrile illness in the 7 days preceding the visit, mortality and complications between Day 0 and 28.

    Measure: Describe the clinical outcomes of influenza-like illness in hospitalised adults

    Time: Day 0 to Day 28

    Secondary Outcomes

    Description: Cytokine levels (in pg/mL) will be measured in plasma and nasal lining fluid samples by MesoScale Discovery

    Measure: Identify changes in cytokine levels during influenza-like illness in hospitalised adults

    Time: Day 0 to Day 28

    HPO Nodes


    HP:0011947: Respiratory tract infection
    Genes 816
    KMT2D SMARCB1 ABCA12 TNFSF11 TRAIP MAGEL2 DNAAF1 NFE2L2 NFKB2 LCK MAGEL2 SGCG TECPR2 GTF2IRD1 CHAMP1 OFD1 SCNN1G CD247 MGP SPINK5 CTPS1 NTRK1 NGLY1 RELB ZNF341 RSPH9 FCN3 NELFA MALT1 CFTR OCA2 LETM1 PIK3CD FMO3 USP9X HLA-DPA1 DNAH11 ZAP70 UNC119 WAS SIM1 GNPTAB FOXH1 CFAP221 TARS1 LAMB2 MYO5A CD81 ADNP TNFRSF13B MYH6 TSC1 CYBA HLA-DPB1 GNS FOXH1 LIPN KATNIP TPM2 COL6A1 NIPBL SPAG1 IL17RA GAS1 SLC12A6 EFEMP2 CRLF1 GMNN CTLA4 SLC35A1 ADAMTS3 TAPBP SLC25A24 CXCR4 BLM RNU4ATAC CFAP300 FOXP1 CDON CD79A RAG1 VPS51 DISP1 USB1 NEPRO COL11A2 CR2 LAMTOR2 SNORD115-1 MAP3K20 DNMT3B MKRN3-AS1 LYST PIK3R1 ACADVL TDGF1 RFX5 VPS33A MDM4 TBC1D24 NGLY1 GLI2 FGF8 ODAD4 CCDC40 MCM4 CRELD1 ZBTB24 TINF2 ECM1 LRRC6 CFTR COL11A2 CR2 ELP1 TFRC AGA SMPD1 PWRN1 IPW TCIRG1 BLNK FLI1 UBB KIF20A STAT1 MBTPS2 ELP1 SNRPN DISP1 RMRP STAG2 IRF8 SIX3 KIF1A RYR1 IGHM BTK CYP4F22 CXCR4 RSPH1 CCBE1 DNAH11 ZIC2 CSF2RA POLR3A LAMA2 STAT1 SNX10 FGF8 FOXJ1 AICDA SHH RYR1 ODAD1 SIK1 HACD1 CREBBP TNFRSF13B CITED2 OCA2 NODAL NOTCH2 CFAP298 SELENON ZIC2 ALMS1 ODAD4 IDUA DLL1 SBDS COG6 TBX6 RFXAP PEX13 TCTN3 PTPN22 SFTPC MAGEL2 COG4 EPM2A MESP2 TTC12 TBC1D23 SCNN1B TGFB1 MAN2B1 PTCH1 NPM1 EPG5 UGP2 GLI2 GAS2L2 TSC2 RANBP2 SCN11A CTLA4 MESP2 IL21R IL17RC UMPS SLC18A3 MYSM1 TRPS1 MKRN3 RPGR DSG1 ACP5 JAK3 EXOSC9 MIR140 DNAL1 NCF4 ACTC1 VAMP1 TGFB1 CD3E IDUA FANCF PLCG2 SLC29A3 NDN RAG2 RAG2 SLC46A1 PGM3 GBA IL2RG SULT2B1 DNAJB13 SDR9C7 MSN MYOD1 FCGR3A SHROOM4 PNP ACTA1 ERF MYSM1 LEPR FLNC NCF4 ODAD2 RFXANK KAT6B DNAI1 NEK10 DNAI1 MPLKIP AGA LAMC2 RAG2 LEPR IL17F DCLRE1C LIMK1 PEPD ITGA3 ZBTB24 NCF1 CD3D EP300 IL2RB GLI2 COL6A3 FBLN5 TASP1 DCLRE1C PYROXD1 IL7R TBC1D24 PLCG2 GAA ODAD3 NFKBIA IL17RA KRAS IGLL1 SCNN1A ODAD3 TK2 TPM3 RNF113A IGHM CCDC39 MS4A1 SMN1 SMARCC2 LEP CYBB NEU1 CD3E PTPRC PLG FOXH1 TNNI3 TYK2 ORC6 RNF168 CARD11 CD3G LONP1 GNPTAB IDUA CYBB NBN NRAS DNAAF6 TGIF1 WAC ADA STAT3 SETBP1 CD3D STAT3 RSPH4A HLA-B TSC1 DNMT3B ITCH GAS1 NEK10 CCDC22 SAMD9 CD247 CFI TREX1 ASAH1 INPPL1 MECP2 HYDIN DNAAF2 IL6R LAMB3 NFKB1 RUNX2 KANSL1 PTCH1 TDGF1 RAG1 UBE2A NFKB2 PIK3CD SMN1 TGIF1 HELLS RSPH9 MTHFD1 SMARCD1 OCRL SLC52A3 DZIP1L TDGF1 WDR1 ALB ADA2 DLL1 SHH SIX3 MYL2 STAG2 EFL1 TERC CFAP410 MASP2 GLB1 LIG4 PARN NFKB2 EDARADD DNAAF6 BCR RNF125 TLL1 DCLRE1C SCNN1A ASAH1 SNAP25 NHP2 DNAAF5 DLL1 EXTL3 PRPS1 MAN2B1 ZMYND10 FOXN1 PRKCD BLNK IL2RG IL7R SMPD1 NODAL NECTIN1 LAMTOR2 RAG2 ROR2 ADA IER3IP1 KDM6A TLL1 ALOXE3 TGIF1 PIGN NOS1 NXN DNAH1 MS4A1 NODAL USB1 LRRC56 ATP6V0A2 EPG5 CASP8 PRPS1 IKBKB ARID2 SHH ARID1B EGFR LAMA3 IKZF1 PLOD1 PRKDC JAK3 DNAAF4 BTK PEPD SCNN1B KCNJ6 GAA MCIDAS SOX4 ZMYND10 UNG GATA6 GATA4 SLC26A2 NDN CD81 NKX2-1 PLOD1 PLEC FGF8 GAS1 ABCA12 IGH CLIP2 SCNN1B CYBC1 RAG1 CLEC7A DRC1 TCIRG1 PMM2 PAFAH1B1 TGM1 DLL1 SIX3 TIMM8A ELN FUCA1 SPAG1 ARID1B ABCA3 ARSB CFB SOX11 FOXP3 USP9X P4HTM AP3B1 POLA1 CDON PKHD1 TAF1 COLQ TCF3 TRIP4 STXBP2 CREBBP NPAP1 STK36 DOCK8 DDR2 CD8A CCDC65 INPPL1 TNFRSF13C KNSTRN SELENON LRRC6 SLC5A7 SHH IFIH1 IL7R CIITA ZIC2 FLNA G6PC3 BACH2 ZNHIT3 DNAJC21 SH2D1A CCNO COL13A1 DISP1 IL21 HYDIN MGP IL2RA MED25 GSN FOXH1 SLC35C1 PNP PRTN3 SP110 ARID1A NBN MCIDAS RAG1 TAP1 SNRPN NADK2 ZAP70 MAGT1 FGFR1 GATA2 ALOX12B IFNGR1 NFKB1 DOCK8 AP3D1 STING1 B2M SRP54 TNFRSF13C TTC12 TAP2 KPTN SNRPN DNAI2 CHRM3 CCNO RAC1 ADA TBX20 ODAD2 BCL10 FLNA SLC25A22 RAG2 GATA4 DNAH9 SMARCA4 TNFRSF11A IRAK4 GUSB CD40LG SCNN1G GUSB KIAA0586 NSD2 DPF2 GBA NCF2 GAS2L2 MYH3 TBCD PTPN22 RAC2 PTCH1 DNAI2 TPP2 RAG1 KANSL1 PURA LRRC56 DNAAF1 SCNN1G IL6ST ACP5 XIAP IL2RG IGLL1 AFF4 SCNN1B BTK PCNT CDON COG4 PRKCD LRRC8A PSAP HLA-DQA1 DYNC2I2 SLC35C1 PWAR1 SLC1A4 CR2 TBCE AGRN CTCF FBLN5 TRIP11 NKX2-5 TSC2 GFI1 TNFSF12 GAS8 MAPK1 DNAAF2 SCNN1A ACTA1 NDN IDS PANK2 FGFR1 CHD7 DNAAF3 DNAAF3 DPM2 OCA2 PCGF2 SFTPB MANBA TNNT2 SRP54 CD79B CD19 FOXJ1 LEP NHLRC1 GATA6 SCNN1A SERPINA1 ATM DNAJB13 CLCN7 CACNA1C SPEF2 CREBBP TNFSF12 COL6A2 RAC2 TBL2 CFTR CFAP298 RSPH3 SDCCAG8 DNAH5 WIPF1 NCF2 FOXP1 RFC2 SNORD116-1 POLR2A CCDC103 OFD1 DNAAF5 PDHA1 CD19 SIX3 LTBP3 SMARCD2 CSF2RB PSMB8 CRKL EP300 RSPH1 ATM DCTN4 CLCA4 CTSC STAT3 FCGR2A DNAH5 CDON TRAF3IP2 IDS CD79A PIK3R1 GRHL3 NOP10 HPS6 RPGR SCNN1G CD79B IVNS1ABP ZIC2 AFF4 ITGA7 ERCC2 RAB3GAP2 RTEL1 CYBA SCN9A RASGRP1 FGF8 SNRPN CARD11 POLE ICOS NME8 HLA-DQB1 PGM3 CDCA7 SAMD9L SMC1A ICOS GLI3 SREBF1 CHAT RFX5 TDGF1 CCDC40 SMARCE1 DCLRE1C ALMS1 NCF1 RSPH3 CYBC1 SLC25A1 PTCH1 IL2RG GLI2 GAS1 TNFRSF13B WAS EHMT1 WRAP53 TGIF1 GLUL SH3KBP1 RFXAP CARMIL2 GTF2I TNFRSF1A MAGEL2 HGSNAT MYO9A GTF2H5 TERT RYR1 FAT4 RIPK1 COL13A1 JAGN1 CIITA TBX20 CSPP1 DNAAF4 HK1 NFIX RNU4ATAC BIRC3 IKBKB CD27 NDN TGFB1 PIK3R1 CREBBP ALPL CCDC103 NAGLU ODAD1 CTC1 SNRPN PRPS1 DLL3 LYST GBA NME8 MYPN STX1A TNFRSF13C HERC2 ELANE CORO1A SYT2 CCDC39 CFTR ICOS RFXANK EP300 MAGEL2 WDR19 ALG12 AK2 CD55 GAS8 DKC1 NKX2-1 SCN10A NODAL LRBA ELANE GTF2E2 SGSH BAZ1B PLP1 CACNA1B RSPH4A CCDC65 MID1 NR2F2 ERCC3 WASHC5 NIPAL4 VPS33A CD19 GALNS OSTM1 XIAP ASAH1 DISP1
    Protein Mutations 1
    H275Y
    SNP 0

    HPO

    Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


    HPO Nodes


    HP:0011947: Respiratory tract infection
    Genes 816
    KMT2D SMARCB1 ABCA12 TNFSF11 TRAIP MAGEL2 DNAAF1 NFE2L2 NFKB2 LCK MAGEL2 SGCG TECPR2 GTF2IRD1 CHAMP1 OFD1 SCNN1G CD247 MGP SPINK5 CTPS1 NTRK1 NGLY1 RELB ZNF341 RSPH9 FCN3 NELFA MALT1 CFTR OCA2 LETM1 PIK3CD FMO3 USP9X HLA-DPA1 DNAH11 ZAP70 UNC119 WAS SIM1 GNPTAB FOXH1 CFAP221 TARS1 LAMB2 MYO5A CD81 ADNP TNFRSF13B MYH6 TSC1 CYBA HLA-DPB1 GNS FOXH1 LIPN KATNIP TPM2 COL6A1 NIPBL SPAG1 IL17RA GAS1 SLC12A6 EFEMP2 CRLF1 GMNN CTLA4 SLC35A1 ADAMTS3 TAPBP SLC25A24 CXCR4 BLM RNU4ATAC CFAP300 FOXP1 CDON CD79A RAG1 VPS51 DISP1 USB1 NEPRO COL11A2 CR2 LAMTOR2 SNORD115-1 MAP3K20 DNMT3B MKRN3-AS1 LYST PIK3R1 ACADVL TDGF1 RFX5 VPS33A MDM4 TBC1D24 NGLY1 GLI2 FGF8 ODAD4 CCDC40 MCM4 CRELD1 ZBTB24 TINF2 ECM1 LRRC6 CFTR COL11A2 CR2 ELP1 TFRC AGA SMPD1 PWRN1 IPW TCIRG1 BLNK FLI1 UBB KIF20A STAT1 MBTPS2 ELP1 SNRPN DISP1 RMRP STAG2 IRF8 SIX3 KIF1A RYR1 IGHM BTK CYP4F22 CXCR4 RSPH1 CCBE1 DNAH11 ZIC2 CSF2RA POLR3A LAMA2 STAT1 SNX10 FGF8 FOXJ1 AICDA SHH RYR1 ODAD1 SIK1 HACD1 CREBBP TNFRSF13B CITED2 OCA2 NODAL NOTCH2 CFAP298 SELENON ZIC2 ALMS1 ODAD4 IDUA DLL1 SBDS COG6 TBX6 RFXAP PEX13 TCTN3 PTPN22 SFTPC MAGEL2 COG4 EPM2A MESP2 TTC12 TBC1D23 SCNN1B TGFB1 MAN2B1 PTCH1 NPM1 EPG5 UGP2 GLI2 GAS2L2 TSC2 RANBP2 SCN11A CTLA4 MESP2 IL21R IL17RC UMPS SLC18A3 MYSM1 TRPS1 MKRN3 RPGR DSG1 ACP5 JAK3 EXOSC9 MIR140 DNAL1 NCF4 ACTC1 VAMP1 TGFB1 CD3E IDUA FANCF PLCG2 SLC29A3 NDN RAG2 RAG2 SLC46A1 PGM3 GBA IL2RG SULT2B1 DNAJB13 SDR9C7 MSN MYOD1 FCGR3A SHROOM4 PNP ACTA1 ERF MYSM1 LEPR FLNC NCF4 ODAD2 RFXANK KAT6B DNAI1 NEK10 DNAI1 MPLKIP AGA LAMC2 RAG2 LEPR IL17F DCLRE1C LIMK1 PEPD ITGA3 ZBTB24 NCF1 CD3D EP300 IL2RB GLI2 COL6A3 FBLN5 TASP1 DCLRE1C PYROXD1 IL7R TBC1D24 PLCG2 GAA ODAD3 NFKBIA IL17RA KRAS IGLL1 SCNN1A ODAD3 TK2 TPM3 RNF113A IGHM CCDC39 MS4A1 SMN1 SMARCC2 LEP CYBB NEU1 CD3E PTPRC PLG FOXH1 TNNI3 TYK2 ORC6 RNF168 CARD11 CD3G LONP1 GNPTAB IDUA CYBB NBN NRAS DNAAF6 TGIF1 WAC ADA STAT3 SETBP1 CD3D STAT3 RSPH4A HLA-B TSC1 DNMT3B ITCH GAS1 NEK10 CCDC22 SAMD9 CD247 CFI TREX1 ASAH1 INPPL1 MECP2 HYDIN DNAAF2 IL6R LAMB3 NFKB1 RUNX2 KANSL1 PTCH1 TDGF1 RAG1 UBE2A NFKB2 PIK3CD SMN1 TGIF1 HELLS RSPH9 MTHFD1 SMARCD1 OCRL SLC52A3 DZIP1L TDGF1 WDR1 ALB ADA2 DLL1 SHH SIX3 MYL2 STAG2 EFL1 TERC CFAP410 MASP2 GLB1 LIG4 PARN NFKB2 EDARADD DNAAF6 BCR RNF125 TLL1 DCLRE1C SCNN1A ASAH1 SNAP25 NHP2 DNAAF5 DLL1 EXTL3 PRPS1 MAN2B1 ZMYND10 FOXN1 PRKCD BLNK IL2RG IL7R SMPD1 NODAL NECTIN1 LAMTOR2 RAG2 ROR2 ADA IER3IP1 KDM6A TLL1 ALOXE3 TGIF1 PIGN NOS1 NXN DNAH1 MS4A1 NODAL USB1 LRRC56 ATP6V0A2 EPG5 CASP8 PRPS1 IKBKB ARID2 SHH ARID1B EGFR LAMA3 IKZF1 PLOD1 PRKDC JAK3 DNAAF4 BTK PEPD SCNN1B KCNJ6 GAA MCIDAS SOX4 ZMYND10 UNG GATA6 GATA4 SLC26A2 NDN CD81 NKX2-1 PLOD1 PLEC FGF8 GAS1 ABCA12 IGH CLIP2 SCNN1B CYBC1 RAG1 CLEC7A DRC1 TCIRG1 PMM2 PAFAH1B1 TGM1 DLL1 SIX3 TIMM8A ELN FUCA1 SPAG1 ARID1B ABCA3 ARSB CFB SOX11 FOXP3 USP9X P4HTM AP3B1 POLA1 CDON PKHD1 TAF1 COLQ TCF3 TRIP4 STXBP2 CREBBP NPAP1 STK36 DOCK8 DDR2 CD8A CCDC65 INPPL1 TNFRSF13C KNSTRN SELENON LRRC6 SLC5A7 SHH IFIH1 IL7R CIITA ZIC2 FLNA G6PC3 BACH2 ZNHIT3 DNAJC21 SH2D1A CCNO COL13A1 DISP1 IL21 HYDIN MGP IL2RA MED25 GSN FOXH1 SLC35C1 PNP PRTN3 SP110 ARID1A NBN MCIDAS RAG1 TAP1 SNRPN NADK2 ZAP70 MAGT1 FGFR1 GATA2 ALOX12B IFNGR1 NFKB1 DOCK8 AP3D1 STING1 B2M SRP54 TNFRSF13C TTC12 TAP2 KPTN SNRPN DNAI2 CHRM3 CCNO RAC1 ADA TBX20 ODAD2 BCL10 FLNA SLC25A22 RAG2 GATA4 DNAH9 SMARCA4 TNFRSF11A IRAK4 GUSB CD40LG SCNN1G GUSB KIAA0586 NSD2 DPF2 GBA NCF2 GAS2L2 MYH3 TBCD PTPN22 RAC2 PTCH1 DNAI2 TPP2 RAG1 KANSL1 PURA LRRC56 DNAAF1 SCNN1G IL6ST ACP5 XIAP IL2RG IGLL1 AFF4 SCNN1B BTK PCNT CDON COG4 PRKCD LRRC8A PSAP HLA-DQA1 DYNC2I2 SLC35C1 PWAR1 SLC1A4 CR2 TBCE AGRN CTCF FBLN5 TRIP11 NKX2-5 TSC2 GFI1 TNFSF12 GAS8 MAPK1 DNAAF2 SCNN1A ACTA1 NDN IDS PANK2 FGFR1 CHD7 DNAAF3 DNAAF3 DPM2 OCA2 PCGF2 SFTPB MANBA TNNT2 SRP54 CD79B CD19 FOXJ1 LEP NHLRC1 GATA6 SCNN1A SERPINA1 ATM DNAJB13 CLCN7 CACNA1C SPEF2 CREBBP TNFSF12 COL6A2 RAC2 TBL2 CFTR CFAP298 RSPH3 SDCCAG8 DNAH5 WIPF1 NCF2 FOXP1 RFC2 SNORD116-1 POLR2A CCDC103 OFD1 DNAAF5 PDHA1 CD19 SIX3 LTBP3 SMARCD2 CSF2RB PSMB8 CRKL EP300 RSPH1 ATM DCTN4 CLCA4 CTSC STAT3 FCGR2A DNAH5 CDON TRAF3IP2 IDS CD79A PIK3R1 GRHL3 NOP10 HPS6 RPGR SCNN1G CD79B IVNS1ABP ZIC2 AFF4 ITGA7 ERCC2 RAB3GAP2 RTEL1 CYBA SCN9A RASGRP1 FGF8 SNRPN CARD11 POLE ICOS NME8 HLA-DQB1 PGM3 CDCA7 SAMD9L SMC1A ICOS GLI3 SREBF1 CHAT RFX5 TDGF1 CCDC40 SMARCE1 DCLRE1C ALMS1 NCF1 RSPH3 CYBC1 SLC25A1 PTCH1 IL2RG GLI2 GAS1 TNFRSF13B WAS EHMT1 WRAP53 TGIF1 GLUL SH3KBP1 RFXAP CARMIL2 GTF2I TNFRSF1A MAGEL2 HGSNAT MYO9A GTF2H5 TERT RYR1 FAT4 RIPK1 COL13A1 JAGN1 CIITA TBX20 CSPP1 DNAAF4 HK1 NFIX RNU4ATAC BIRC3 IKBKB CD27 NDN TGFB1 PIK3R1 CREBBP ALPL CCDC103 NAGLU ODAD1 CTC1 SNRPN PRPS1 DLL3 LYST GBA NME8 MYPN STX1A TNFRSF13C HERC2 ELANE CORO1A SYT2 CCDC39 CFTR ICOS RFXANK EP300 MAGEL2 WDR19 ALG12 AK2 CD55 GAS8 DKC1 NKX2-1 SCN10A NODAL LRBA ELANE GTF2E2 SGSH BAZ1B PLP1 CACNA1B RSPH4A CCDC65 MID1 NR2F2 ERCC3 WASHC5 NIPAL4 VPS33A CD19 GALNS OSTM1 XIAP ASAH1 DISP1
    Protein Mutations 1
    H275Y
    SNP 0

    Reports

    Data processed on December 13, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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