Back to resultsInterferon Gamma Induced Protein 10 (IP-10) in a Clinical Decision Support Protocol in COVID-19 Patients
Primary Purpose
COVID-19
Status
Completed
Phase
Locations
Israel
Study Type
Observational
Intervention
IP-10 in CDS protocol
Sponsored by
About this trial
This is an observational trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- PCR- positive for COVID-19
Exclusion Criteria:
- <18 years of age
Sites / Locations
- Rabin Medical Center
Outcomes
Primary Outcome Measures
IP-10 levels
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04389645
Brief Title
Interferon Gamma Induced Protein 10 (IP-10) in a Clinical Decision Support Protocol in COVID-19 Patients
Official Title
Interferon Gamma Induced Protein 10 (IP-10) in a Clinical Decision Support Protocol in COVID-19 Patients
Study Type
Observational
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 7, 2020 (Actual)
Primary Completion Date
May 12, 2020 (Actual)
Study Completion Date
May 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MeMed Diagnostics Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed project will pilot incorporation of rapid serial measurements of IP-10 into a CDS tool for moderate and severe COVID-19 patients.
The tool was applied to all comers with confirmed COVID-19 diagnosis at a secondary medical center in Israel.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
IP-10 in CDS protocol
Intervention Description
Dynamic IP-10 measurements in hospitalized COVID-19 positive patients
Primary Outcome Measure Information:
Title
IP-10 levels
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PCR- positive for COVID-19
Exclusion Criteria:
<18 years of age
Study Population Description
PCR-positive COVID-19 all comers
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaul Lev, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petach Tikva
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
33434221
Citation
Lev S, Gottesman T, Sahaf Levin G, Lederfein D, Berkov E, Diker D, Zaidman A, Nutman A, Ilan Ber T, Angel A, Kellerman L, Barash E, Navon R, Boico O, Israeli Y, Rosenberg M, Gelman A, Kalfon R, Simon E, Avni N, Hainrichson M, Zarchin O, Gottlieb TM, Oved K, Eden E, Tadmor B. Observational cohort study of IP-10's potential as a biomarker to aid in inflammation regulation within a clinical decision support protocol for patients with severe COVID-19. PLoS One. 2021 Jan 12;16(1):e0245296. doi: 10.1371/journal.pone.0245296. eCollection 2021.
Results Reference
derived
Learn more about this trial
Interferon Gamma Induced Protein 10 (IP-10) in a Clinical Decision Support Protocol in COVID-19 Patients
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