COVID-19 - Cytokine Storm

NCT04474067 | Unknown

• 1 other identifier: DM002
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

• Clinical Outcomes of Patients with COVID-19 using the National Early Warning Score 2 (NEWS2) system

  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)

  6 months

• Clinical Outcomes of Patients with COVID-19 using the new NIH Patient Classification of severity of illness

  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.

  6 months

• Mortality

  Incidence rate of Mortality from any cause

  6 months

• Cytokine/Chemokine/Hematopoietic Growth Factors/ Complement and Other Immune Modulators in Patients with COVID-19

  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.

  6 months

Study Arms (7)

• 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

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

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

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

Critical COVID-19

COVID-19 patients who have respiratory failure, septic shock, and/or multiple organ dysfunction.

Other: No intervention

Sepsis

A control group of patients with sepsis-related cytokine storm

Other: No intervention

CAR-T CRS

A control group of patients with cytokine release syndrome due to CAR-T therapy

Other: No intervention

Interventions

No intervention OTHER

This is an observational study, with no intervention.

CAR-T CRS; Critical COVID-19; Mild COVID-19; Moderate COVID-19; Sepsis; Severe COVID-19; • Asymptomatic or Pre-symptomatic Infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patients, male or female of any age diagnosed with COVID-19, as defined below:
• Laboratory confirmation of SARS-CoV-2 infection by reverse transcription-polymerase chain reaction (RT-PCR) from any diagnostic sampling source.
• Serological evidence of SARS-CoV-2 infection

You may not qualify if:

• None

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Barzilai Medical Center: collaborator
• The Chaim Sheba Medical Center: collaborator

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91120, Israel

RECRUITING

Related Publications (3)

• Siddiqi HK, Mehra MR. COVID-19 illness in native and immunosuppressed states: A clinical-therapeutic staging proposal. J Heart Lung Transplant. 2020 May;39(5):405-407. doi: 10.1016/j.healun.2020.03.012. Epub 2020 Mar 20. No abstract available.

  PMID: 32362390 BACKGROUND

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 BACKGROUND

• Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

  PMID: 32192578 BACKGROUND

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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dror Mevorach, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dror Mevorach, MD

CONTACT

972-2- 6777317; mevorachd@hadassah.org.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Head, Department of Internal Medicine B; Head, Rheumatology Research Center, Hadassah and the Hebrew University Medical School

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 16, 2020
• Study Start: June 28, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

IL (1)