NCT04389645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

May 13, 2020

Last Update Submit

May 14, 2020

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • IP-10 levels

    up to 24 months

Interventions

IP-10 in CDS protocolDIAGNOSTIC_TEST

Dynamic IP-10 measurements in hospitalized COVID-19 positive patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PCR-positive COVID-19 all comers

You may qualify if:

  • PCR- positive for COVID-19

You may not qualify if:

  • \<18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

Location

Related Publications (1)

  • 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.

    PMID: 33434221DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Shaul Lev, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 15, 2020

Study Start

April 7, 2020

Primary Completion

May 12, 2020

Study Completion

May 12, 2020

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations

IL(1)