Name (Synonyms) | Correlation | |
---|---|---|
drug235 | CYNK-001 Wiki | 0.71 |
drug505 | Hydroxychloroquine Wiki | 0.08 |
drug850 | Placebo Wiki | 0.06 |
Name (Synonyms) | Correlation | |
---|---|---|
D030341 | Nidovirales Infections NIH | 0.71 |
D003333 | Coronaviridae Infections NIH | 0.41 |
D012327 | RNA Virus Infections NIH | 0.35 |
D008171 | Lung Diseases, NIH | 0.29 |
D012140 | Respiratory Tract Diseases NIH | 0.22 |
D012141 | Respiratory Tract Infections NIH | 0.16 |
D011024 | Pneumonia, Viral NIH | 0.10 |
D014777 | Virus Diseases NIH | 0.10 |
D003141 | Communicable Diseases NIH | 0.07 |
D011014 | Pneumonia NIH | 0.05 |
D007239 | Infection NIH | 0.05 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
D018352 | Coronavirus Infections NIH | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002088 | Abnormal lung morphology HPO | 0.29 |
HP:0011947 | Respiratory tract infection HPO | 0.16 |
HP:0002090 | Pneumonia HPO | 0.05 |
There are 2 clinical trials
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.
Description: Number and severity of adverse events
Measure: Phase 1: Frequency and Severity of Adverse Events (AE) Time: Up to 12 monthsDescription: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR
Measure: Time to Clearance of SARS-CoV-2 Time: Up to 12 monthsDescription: Time from the date of randomization to the first date of clinical improvement of cough.
Measure: Time to Clinical Improvement of cough Time: Up to 28 daysDescription: Time from the date of randomization to the first date of clinical improvement of radiological evaluation of disease related chest x-ray
Measure: Time to Clinical Improvement in radiological evaluation of disease related chest x-ray Time: Up to 28 daysDescription: Proportion of subjects who achieve pulmonary clearance
Measure: Rate of Pulmonary Clearance Time: Up to 28 daysDescription: Proportion of subjects who achieved clinical improvement of radiological evaluation of disease related chest x-ray
Measure: Rate of Clinical Improvement of radiological evaluation of disease related chest x-ray Time: Up to 28 daysDescription: 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: Proportion of subjects who achieved clinical improvement of fever
Measure: Rate of Clinical Improvement of fever Time: Up to 28 daysDescription: Time from the date of randomization to the first date of clinical improvement of fever
Measure: Time to Clinical Improvement of fever 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 monthsSARS-CoV-2 outbreak causes a spectrum of clinical patterns that varies from asymptomatic infection to mildly symptomatic manifestations and more-severe forms that need intensive care. Until now, the immune response to SARS-CoV-2 virus infection has been poorly reported to help decision for immune modulation therapies. As a consequence, trials have been designed to test both anti-inflammatory molecules as steroids or anti-bodies against IL-6, and others proposing to "boost" immunity with interferon beta based on similar inclusion criteria. The immune response to infective agents including viruses may have a complex time evolution with early and late phases corresponding to different patterns, oscillating between pro-inflammation and immune-depression. The potential window to improve outcome in COVID-19 by therapeutic intervention aimed at a fine tuning between immune toxicity and immunodepression requires a longitudinal assessment during the course of illness, especially for the patients who develop acute respiratory failure. Immune monitoring of both innate and adaptive immunity would then be essential to appropriately design clinical trials. The whole blood cells evaluation was recorded according to the time intervals between the onset of symptoms and the sampling after ICU admission. Patients' care was standardized, especially with regard to ventilation, sedation, and antimicrobial treatment. In this study the investigators prospectively perform a longitudinal study of both innate and adaptive immunity on patients admitted to ICU for an COVID-19 related acute respiratory failure. The data will be analyzed in reference to the onset of initial symptoms and also to the admission in ICU. The primary end point is the evolution of the characterization of monocytes and their subsets in term of number and expression of HLA-DR. A similar approach is used for lymphocytes and their subtypes with in addition, an ex vivo testing of their capabilities to be stimulated by SARS-CoV-2 viral proteins in term of TNFalpha, INFgamma, and IL1beta production. The secondary end-point was to test the association with outcomes and other non-specific markers of inflammation as CRP (C reactive protein), PCT (procalcitonin), DDimers and ferritin.
Description: circulating immune cell characterization
Measure: Changes in monocytes HLA-DR expression Time: through ICU stay, an average of 30 daysDescription: circulating immune cell characterization
Measure: Changes in lymphocytes subpopulations numbers Time: through ICU stay, an average of 30 daysDescription: circulating immune cell characterization
Measure: Changes in monocytes number Time: through ICU stay, an average of 30 daysDescription: stimulation by SARS-CoV-2 viral proteins
Measure: TNFalpha level Time: 4 hoursDescription: stimulation by SARS-CoV-2 viral proteins
Measure: INFgamma level Time: 4 hoursDescription: stimulation by SARS-CoV-2 viral proteins
Measure: IL1beta level Time: 4 hoursDescription: Sequential Organ dysfunction assessement, ranging from 0 (better) to 24 (worst) outcome
Measure: SOFA score Time: through ICU stay, an average of 30 daysDescription: mortality
Measure: number of recorded deaths Time: through study completion, an average of 6 monthsDescription: infectious complications
Measure: presence of pneumonia Time: through ICU stay, an average of 30 daysDescription: infectious complications
Measure: presence of bacteremia Time: through ICU stay, an average of 30 daysDescription: infectious complications
Measure: presence of urinary tract infection Time: through ICU stay, an average of 30 daysDescription: inflammation marker
Measure: C reactive protein Time: through ICU stay, an average of 30 daysDescription: inflammation marker
Measure: D Dimers Time: through ICU stay, an average of 30 days