Covid 19 Research using Clinical Trials (Home Page)
Report for D003333: Coronaviridae Infections NIH
(Synonyms: Coronaviridae Infections)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (13)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1324 | Hydroxychloroquine sulfate &Azithromycin Wiki | 0.45 |
| drug2904 | There is no intervention in this study Wiki | 0.45 |
| drug1220 | HOPE intervention Wiki | 0.45 |
| drug1932 | Nutrition Wiki | 0.45 |
| drug2926 | To assess for development of IgG antibodies against SARS-CoV2 Wiki | 0.45 |
| drug592 | CYNK-001 Wiki | 0.45 |
| drug2269 | Psychological and Behaviour Change Support Wiki | 0.45 |
| drug564 | COVID-19 patients Wiki | 0.32 |
| drug1035 | Exercise Wiki | 0.32 |
| drug870 | Dexamethasone Wiki | 0.18 |
| drug2928 | Tocilizumab Wiki | 0.08 |
| drug1284 | Hydroxychloroquine Wiki | 0.04 |
| drug2122 | Placebo Wiki | 0.02 |
Correlated MeSH Terms (14)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D030341 | Nidovirales Infections NIH | 0.63 |
| D012327 | RNA Virus Infections NIH | 0.60 |
| D058070 | Asymptomatic Diseases NIH | 0.26 |
| D014777 | Virus Diseases NIH | 0.21 |
| D012140 | Respiratory Tract Diseases NIH | 0.19 |
| D007154 | Immune System Diseases NIH | 0.18 |
| D003141 | Communicable Diseases NIH | 0.18 |
| D012141 | Respiratory Tract Infections NIH | 0.17 |
| D007239 | Infection NIH | 0.12 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.11 |
| D008171 | Lung Diseases, NIH | 0.11 |
| D018352 | Coronavirus Infections NIH | 0.09 |
| D011024 | Pneumonia, Viral NIH | 0.05 |
| D011014 | Pneumonia NIH | 0.03 |
Correlated HPO Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0011947 | Respiratory tract infection HPO | 0.17 |
| HP:0002088 | Abnormal lung morphology HPO | 0.11 |
| HP:0002090 | Pneumonia HPO | 0.03 |
There are 5 clinical trials
Clinical Trials
1 A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection
This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.
NCT04359836 Gut Microbiome Gastrointestinal Microbiome COVID COVID-19 Corona Virus Infection Coronavirus Coronaviridae Infections Coronavirus 19 Coronavirus-19 COVID 19 Other: There is no intervention in this study MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Coronaviridae Infections
Primary Outcomes
Description: Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types.
Measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing Time: One yearSecondary Outcomes
Description: To validate the methods used to sequence samples
Measure: Validation of Sequencing Methods Time: One year2 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 hospitalized patients with moderate COVID-19 disease.
NCT04365101 Coronavirus Coronavirus Infection Severe Acute Respiratory Syndrome Coronavirus 2 Pneumonia Pneumonia, Viral Lung Diseases Respiratory Tract Disease Respiratory Tract Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Disease Immunologic Disease ARDS Immunologic Factors Physiological Effects of Drugs Antiviral Agents Anti-infective Agents Analgesics Antimetabolites, Antineoplastic Biological: CYNK-001 MeSH:Infection Communicable Dis Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Pneumonia, Viral Coronaviridae Infections Nidovirales Infections Pneumonia Lung Diseases Virus 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 12 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 12 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 12 months
Description: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR in nasal and/or lower respiratory tract samples. 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 12 months
Description: Number and severity of adverse events
Measure: Phase 2: Frequency and Severity of Adverse Events (AE) Time: up to 12 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 12 months
Description: Hospital utilization will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by hospital utilization Time: up to 12 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 12 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
3 ScreenNC: A Study to Determine the Number of Asymptomatic Individuals Who Have Antibodies to the SARS-CoV-2 Infection
Primary Outcomes
Description: Number and severity of adverse events
Measure: Phase 1: Frequency and Severity of Adverse Events (AE) Time: Up to 12 monthsDescription: 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 12 monthsDescription: 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 12 monthsDescription: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR in nasal and/or lower respiratory tract samples. 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 daysDescription: 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 daysSecondary 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 12 monthsDescription: Number and severity of adverse events
Measure: Phase 2: Frequency and Severity of Adverse Events (AE) Time: up to 12 monthsDescription: Time to medical discharge as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by time to medical discharge Time: up to 12 monthsDescription: Hospital utilization will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by hospital utilization Time: up to 12 monthsDescription: Mortality rate will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by measuring mortality rate Time: up to 12 monthsDescription: 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 daysDescription: 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 daysDescription: For ventilatory support subjects, the days with supplemental oxygen-free.
Measure: Supplemental oxygen-free days Time: Up to 28 daysDescription: Proportion of subjects who need invasive or non-invasive ventilation
Measure: Proportion of subjects requiring ventilation Time: Up to 28 daysPurpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19
NCT04367740 Asymptomatic Condition Infection Viral Coronavirus Infections Severe Acute Respiratory Syndrome Coronavirus 2 Coronaviridae Infections RNA Virus Infections Virus Diseases Communicable Disease Diagnostic Test: To assess for development of IgG antibodies against SARS-CoV2 MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Coronaviridae Infections Asymptomatic Diseases Virus Diseases
Primary Outcomes
Description: Presence or absence of IgG antibodies to SARS-CoV2
Measure: Percentage of Asymptomatic patients with an IgG response from SARS-CoV-2 infection. Time: at enrollmentSecondary Outcomes
Description: swab for presence of SARS-CoV-2 virus
Measure: Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection. Time: at enrollment4 Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19
This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.
NCT04412551 Corona Virus Infection Virus Diseases Coronaviridae Infections MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Coronaviridae Infections Virus Diseases
Primary Outcomes
Description: Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU
Measure: Identification of requirement of mechanical ventilation Time: 3 weeksSecondary Outcomes
Description: Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU
Measure: Prediction of requirement of mechanical ventilation Time: 3 weeksDescription: Descriptive assessment of clinical parameters and LUS-score over time
Measure: Association of LUS to clinical parameters Time: 3 weeksDescription: Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19
Measure: Description of findings on LUS Time: 3 weeks5 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 Coronavirus Infection SARS (Severe Acute Respiratory Syndrome) Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Respiratory Tract Infections Respiratory Tract Disease Drug: Tocilizumab Drug: Dexamethasone MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Coronaviridae Infections Nidovirales Infections Virus Diseases 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
HPO Nodes
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 14Secondary 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 14Description: Overall survival
Measure: Overall survival at 14, 28, 60 and 90 days Time: 14, 28, 60 and 90 daysDescription: Cumulative incidence of discharge alive
Measure: Cumulative incidence of discharge alive at 14 and 28 days Time: 14 and 28 daysDescription: 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 1Description: Cumulative incidence of oxygen supply independency
Measure: Cumulative incidence of oxygen supply independency at 14 and 28 days Time: 14 and 28 days