CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D007154: Immune System Diseases NIH

(Synonyms: Immune Sy, Immune System Disease, Immune System Diseases)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug235 CYNK-001 Wiki 0.71
drug505 Hydroxychloroquine Wiki 0.08
drug850 Placebo Wiki 0.06

Correlated MeSH Terms (13)


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

Correlated HPO Terms (3)


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

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: 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 months

Description: 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 days

Description: 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 days

Description: Proportion of subjects who achieve pulmonary clearance

Measure: Rate of Pulmonary Clearance

Time: Up to 28 days

Description: 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 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: Proportion of subjects who achieved clinical improvement of fever

Measure: Rate of Clinical Improvement of fever

Time: Up to 28 days

Description: 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 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

2 Whole Blood Immune Cells Characterization in Critically Ill COVID-19 Patients: A Prospective Study

SARS-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.

NCT04386395 SARS-CoV-2 Immune System Disorder
MeSH:Immune System Diseases

Primary Outcomes

Description: circulating immune cell characterization

Measure: Changes in monocytes HLA-DR expression

Time: through ICU stay, an average of 30 days

Description: circulating immune cell characterization

Measure: Changes in lymphocytes subpopulations numbers

Time: through ICU stay, an average of 30 days

Description: circulating immune cell characterization

Measure: Changes in monocytes number

Time: through ICU stay, an average of 30 days

Secondary Outcomes

Description: stimulation by SARS-CoV-2 viral proteins

Measure: TNFalpha level

Time: 4 hours

Description: stimulation by SARS-CoV-2 viral proteins

Measure: INFgamma level

Time: 4 hours

Description: stimulation by SARS-CoV-2 viral proteins

Measure: IL1beta level

Time: 4 hours

Description: Sequential Organ dysfunction assessement, ranging from 0 (better) to 24 (worst) outcome

Measure: SOFA score

Time: through ICU stay, an average of 30 days

Description: mortality

Measure: number of recorded deaths

Time: through study completion, an average of 6 months

Description: infectious complications

Measure: presence of pneumonia

Time: through ICU stay, an average of 30 days

Description: infectious complications

Measure: presence of bacteremia

Time: through ICU stay, an average of 30 days

Description: infectious complications

Measure: presence of urinary tract infection

Time: through ICU stay, an average of 30 days

Description: inflammation marker

Measure: C reactive protein

Time: through ICU stay, an average of 30 days

Description: inflammation marker

Measure: D Dimers

Time: through ICU stay, an average of 30 days


HPO Nodes