Covid 19 Research using Clinical Trials (Home Page)
Report for D030341: Nidovirales Infections NIH
(Synonyms: Nidovir, Nidovirales Infections)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug276 | CYNK-001 Wiki | 1.00 |
| drug591 | Hydroxychloroquine Wiki | 0.11 |
| drug1016 | Placebo Wiki | 0.08 |
Correlated MeSH Terms (13)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D007154 | Immune System Diseases NIH | 0.71 |
| D003333 | Coronaviridae Infections NIH | 0.50 |
| D012327 | RNA Virus Infections NIH | 0.50 |
| D008171 | Lung Diseases, NIH | 0.38 |
| D012140 | Respiratory Tract Diseases NIH | 0.30 |
| D012141 | Respiratory Tract Infections NIH | 0.22 |
| D011024 | Pneumonia, Viral NIH | 0.14 |
| D014777 | Virus Diseases NIH | 0.13 |
| D003141 | Communicable Diseases NIH | 0.10 |
| D011014 | Pneumonia NIH | 0.07 |
| D007239 | Infection NIH | 0.07 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.06 |
| D018352 | Coronavirus Infections NIH | 0.05 |
Correlated HPO Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002088 | Abnormal lung morphology HPO | 0.41 |
| HP:0011947 | Respiratory tract infection HPO | 0.23 |
| HP:0002090 | Pneumonia HPO | 0.07 |
There is one clinical trial.
Clinical Trials
1 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 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 or radiologic evaluation as measured by protocol-defined radiologic evaluation 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
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 Radiologic Evaluation Score.
Measure: Phase 2: Time to Clinical Improvement by radiologic evaluation score Time: Up to 28 days
Secondary Outcomes
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: Proportion of subjects who achieved clinical improvement of cough
Measure: Rate of Clinical Improvement of cough 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
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
HPO Nodes
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 or radiologic evaluation as measured by protocol-defined radiologic evaluation 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 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 Radiologic Evaluation Score.
Measure: Phase 2: Time to Clinical Improvement by radiologic evaluation score Time: Up to 28 daysSecondary Outcomes
Description: 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: Proportion of subjects who achieved clinical improvement of cough
Measure: Rate of Clinical Improvement of cough 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 daysDescription: 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