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COVID-19 - Cytokine Storm

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ClinicalTrials.gov Identifier: NCT04474067
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : August 13, 2020
Sponsor:
Collaborators:
Barzilai Medical Center
The Chaim Sheba Medical Center
Information provided by (Responsible Party):
Mevorach Dror, Hadassah Medical Organization

Brief Summary:
This is a multi-center study comparing clinical outcomes in patients with COVID-19 in subjects hospitalized at Hadassah and other hospitals for PCR or serology confirmed COVID-19 and compare the outcomes to the presence of different degrees of a cytokine storm. The patients will be subdivided into a mild, moderate, and severe course according to NEWS2.

Condition or disease Intervention/treatment
COVID-19 Other: No intervention

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Multi-Center Study Evaluating Clinical Course in Patients With COVID-19 and Its Relationship to Cytokine Storm
Actual Study Start Date : June 28, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Group/Cohort Intervention/treatment
• Asymptomatic or Pre-symptomatic Infection
Individuals who test positive for SARS-CoV-2 by virologic testing using a molecular diagnostic (e.g., polymerase chain reaction) or antigen test, but have no symptoms.
Other: No intervention
This is an observational study, with no intervention.

Mild COVID-19

Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain) without shortness of breath, dyspnea, or abnormal chest imaging.

According to NIH classification

Other: No intervention
This is an observational study, with no intervention.

Moderate COVID-19
COVID-19 patients who have evidence of lower respiratory disease by clinical assessment or imaging and a saturation of oxygen (SpO2) ≥94% on room air at sea level.
Other: No intervention
This is an observational study, with no intervention.

Severe COVID-19
COVID-19 patients who have respiratory frequency >30 breaths per minute, SpO2 <94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mmHg, or lung infiltrates >50%
Other: No intervention
This is an observational study, with no intervention.

Critical COVID-19
COVID-19 patients who have respiratory failure, septic shock, and/or multiple organ dysfunction.
Other: No intervention
This is an observational study, with no intervention.

Sepsis
A control group of patients with sepsis-related cytokine storm
Other: No intervention
This is an observational study, with no intervention.

CAR-T CRS
A control group of patients with cytokine release syndrome due to CAR-T therapy
Other: No intervention
This is an observational study, with no intervention.




Primary Outcome Measures :
  1. Clinical Outcomes of Patients with COVID-19 using the National Early Warning Score 2 (NEWS2) system [ Time Frame: 6 months ]

    To compare the clinical outcomes of patients with COVID-19 to Sepsis and CAR-T-related cytokine storm.

    This will be done by assessment of acute-illness severity using the NEWS2 scoring system (Higher scores mean more severe illness)


  2. Clinical Outcomes of Patients with COVID-19 using the new NIH Patient Classification of severity of illness [ Time Frame: 6 months ]

    To compare the clinical outcomes of patients with COVID-19 to Sepsis and CAR-T-related cytokine storm.

    This will be done by assessment of acute-illness severity using the new NIH Patient Classification to (1) Asymptomatic or Pre-symptomatic Infection; (2) Mild Illness; (3) Moderate Illness; (4) Severe Illness; (5) Critical Illness As detailed in the Study design section.


  3. Mortality [ Time Frame: 6 months ]
    Incidence rate of Mortality from any cause

  4. Cytokine/Chemokine/Hematopoietic Growth Factors/ Complement and Other Immune Modulators in Patients with COVID-19 [ Time Frame: 6 months ]
    To assess cytokine/chemokine/hematopoietic growth factors/ Complement and other immune modulators in patients with COVID-19 by measuring the serum concentrations of these factors in COVID-19 patients and compare those the levels of patients with sepsis and CAR T cytokine release syndrome.


Biospecimen Retention:   Samples With DNA
Blood samples obtained from patients with COVID-19, sepsis, or CAR T and cytokine storm following a consent, for a total amount of up to 10 ml of blood. Also, Blood leftover samples obtained from Hadassah biological blood bank, or from any routine blood examination, or a total amount of up to 10 ml of blood from hospitalized COVID-19 patients is retained.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients that were hospitalized at Hadassah Medical Center and other hospitals in Israel, with the diagnosis of COVID-19 (as specified in the inclusion criteria).
Criteria

Inclusion Criteria:

Patients, male or female of any age diagnosed with COVID-19, as defined below:

  1. Laboratory confirmation of SARS-CoV-2 infection by reverse transcription-polymerase chain reaction (RT-PCR) from any diagnostic sampling source.

    OR

  2. Serological evidence of SARS-CoV-2 infection

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474067


Contacts
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Contact: Dror Mevorach, MD 972-2- 6777317 mevorachd@hadassah.org.il

Locations
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Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel, 91120
Contact: Dror Mevorach, MD    972-2- 6777317    mevorachd@hadassah.org.il   
Principal Investigator: Dror Mevorach, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Barzilai Medical Center
The Chaim Sheba Medical Center
Investigators
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Principal Investigator: Dror Mevorach, MD Hadassah Medical Organization
Publications:
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Responsible Party: Mevorach Dror, Professor & Head, Department of Internal Medicine B; Head, Rheumatology Research Center, Hadassah and the Hebrew University Medical School, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT04474067    
Other Study ID Numbers: DM002
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No