Covid19NCT04534712
Lymphocyte - Monocyte Ratio As An Independent Predictor For Progression Of Illness In Patients With Covid-19
An observational study of Covid19, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Corona virus disease 2019 (COVID 19), first identified in December 2019 in a cluster of population in a Chinese province, soon emerged as a pandemic, causing a huge strain on healthcare system and mortality all over the world. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- LYMPHOCYTE MONOCYTE RATIO
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2020to 1 Oct 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients who are tested positive for COVID 19 and presented within 7 days of symptom onset will be included
Who may be able to join
- All adults of age 18-80 years tested positive for SARS-CoV-2 reverse-transcriptase - polymerase chain reaction (rt-PCR) and presented within 7 days of symptom(s) onset
Who cannot join
- Pregnancy
- Sepsis
- Malignancy
- Patients on immunosuppressant therapy
- Chronic inflammatory conditions
- Cases lost to follow up
Trial locations and contacts
1 site in 1 country.
India1 site
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
About this study
Corona virus disease 2019 (COVID 19), first identified in December 2019 in a cluster of population in a Chinese province, soon emerged as a pandemic, causing a huge strain on healthcare system and mortality all over the world. An ideal marker for predicting course of this illness should be easily available and reproducible; as the disease burden has spread to third world countries whose healthcare system is resource limited. Our study is aimed to study the utility of lymphocyte- monocyte ratio in the early stages to predict the progression of COVID 19 pneumonia.
- Conditions
- Covid19
- Being tested
- LYMPHOCYTE MONOCYTE RATIO
- Keywords
- LYMPHOCYTE MONOCYTE RATIO, COVID-19, DISEASE PROGRESSION
- Medical subject headings
- COVID-19, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYMPHOCYTE MONOCYTE RATIODiagnostic test
Absolute lymphicyte and absolute monocyte counts are recorded on admission of COVID -19 positive patient and ratio is derived. the patients are followed up for any progression of disease stage.
| Study group | Role | What they receive |
|---|---|---|
| PROGRESSION | Cohort A with patients who progressed to next stage of illness or continue to remain in the same stage Receives: Diagnostic Test: LYMPHOCYTE MONOCYTE RATIO | |
| NON PROGRESSION | Cohort B with those who improved by two points on the ordinal scale without any further progression Receives: Diagnostic Test: LYMPHOCYTE MONOCYTE RATIO |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression
disease progression equal or more than 2 stages
Measured: 28 days
Secondary outcomes (1)
mortality
end outcome of the patients diagnosed of COVID-19 infection
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Sep 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Ganga Ram Hospital
- Responsible party
- Principal investigator, VAMSIDHAR, Sir Ganga Ram Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534712
- Sponsor's protocol ID
- yet to be assigned
- Status last verified
- Mar 2023
- First submitted
- 30 Aug 2020
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD data shall be shared on request basis.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphocyte - Monocyte Ratio As An Independent Predictor For Progression Of Illness In Patients With Covid-19
- ClinicalTrials.gov ID
- NCT04534712
- Acronym / sponsor ID
- yet to be assigned
- Conditions
- Covid19
- Keywords
- LYMPHOCYTE MONOCYTE RATIO, COVID-19, DISEASE PROGRESSION
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Collaborators
- Sir Ganga Ram Hospital
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 1 Sep 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.
Corona virus disease 2019 (COVID 19), first identified in December 2019 in a cluster of population in a Chinese province, soon emerged as a pandemic, causing a huge strain on healthcare system and mortality all over the world. An ideal marker for predicting course of this illness should be easily available and reproducible; as the disease burden has spread to third world countries whose healthcare system is resource limited. Our study is aimed to study the utility of lymphocyte- monocyte ratio in the early stages to predict the progression of COVID 19 pneumonia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROGRESSION | – | Diagnostic Test: LYMPHOCYTE MONOCYTE RATIOCohort A with patients who progressed to next stage of illness or continue to remain in the same stage |
| NON PROGRESSION | – | Diagnostic Test: LYMPHOCYTE MONOCYTE RATIOCohort B with those who improved by two points on the ordinal scale without any further progression |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients who are tested positive for COVID 19 and presented within 7 days of symptom onset will be included
Key inclusion criteria (1 listed)
- All adults of age 18-80 years tested positive for SARS-CoV-2 reverse-transcriptase - polymerase chain reaction (rt-PCR) and presented within 7 days of symptom(s) onset
Key exclusion criteria (6 listed)
- Pregnancy
- Sepsis
- Malignancy
- Patients on immunosuppressant therapy
- Chronic inflammatory conditions
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 |
|---|---|---|
| LYMPHOCYTE MONOCYTE RATIOAbsolute lymphicyte and absolute monocyte counts are recorded on admission of COVID -19 positive patient and ratio is derived. the patients are followed up for any progression of disease stage. | Diagnostic test | NON PROGRESSION, PROGRESSION |
Primary outcome
progression
Time frame: 28 days
disease progression equal or more than 2 stages
1 secondary outcome
mortality
Time frame: 28 days
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 3 Apr 2023.
- Individual participant dataSharing planned: Yes. IPD data shall be shared on request basis.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 6 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 3 Apr 2023. 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 India. 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?
progression (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2023.