COVID-19NCT04389645
Interferon Gamma Induced Protein 10 (IP-10) in a Clinical Decision Support Protocol in COVID-19 Patients
An observational study of COVID-19, run by MeMed Diagnostics Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- IP-10 in CDS protocol
- How many people
- 52 participants
- Where
- 1 siteIsrael
- Study dates
- 7 Apr 2020to 12 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PCR-positive COVID-19 all comers
Who may be able to join
- PCR- positive for COVID-19
Who cannot join
- <18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- COVID-19
- Being tested
- IP-10 in CDS protocol
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IP-10 in CDS protocolDiagnostic test
Dynamic IP-10 measurements in hospitalized COVID-19 positive patients
What is being measured
The primary outcome is the main question the study is designed to answer.
IP-10 levels
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start7 Apr 2020
- Primary completion12 May 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeMed Diagnostics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaul Lev, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389645
- Sponsor's protocol ID
- MM-5000-BV
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33434221
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon Gamma Induced Protein 10 (IP-10) in a Clinical Decision Support Protocol in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04389645
- Acronym / sponsor ID
- MM-5000-BV
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- MeMed Diagnostics Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PCR-positive COVID-19 all comers
Key inclusion criteria (1 listed)
- PCR- positive for COVID-19
Key exclusion criteria (1 listed)
- <18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IP-10 in CDS protocolDynamic IP-10 measurements in hospitalized COVID-19 positive patients | Diagnostic test | – |
Primary outcome
IP-10 levels
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Derived from this study: PubMed 33434221Lev 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaul Lev, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by MeMed Diagnostics Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IP-10 levels (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04389645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.