Covid19NCT04670328
Role of Hematological Parameters in the Stratification of COVID-19 Disease Severity
An observational study of Covid19, run by FMH College of Medicine and Dentistry at 1 site in Pakistan.
Trial summary
The hemostatic abnormalities in COVID-19 are related with disease progression, severity and mortality. The Objective of our study is to evaluate the role of hematological parameters in determination of COVID-19 disease severity. Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Covid19
- What is being tested?
- not required
- How many people
- 101 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2020to 31 Jul 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 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: diagnosed cases of covid-19
Who may be able to join
- diagnosed cases of covid-19 disease
- Both genders
- 17 to 75 year age
Who cannot join
- known case of chronic liver disease
- known hematological diseases were excluded
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
FMH college of medicine and dentistry
Lahore, Punjab Province, 54000
About this study
The hemostatic abnormalities in COVID-19 are related with disease progression, severity and mortality. The Objective of our study is to evaluate the role of hematological parameters in determination of COVID-19 disease severity.
Read the detailed description
Objective:
COVID-19 virus involves respiratory as well as other body systems including cardiovascular, gastrointestinal, neurological, immunological and hematopoietic system. Patient of covid-19 pneumonia presents with wide range of hemostatic abnormalities. These hemostatic abnormalities in COVID-19 are related with disease progression, severity and mortality. The Objective of our study is to evaluate the role of hematological parameters in determination of COVID-19 disease severity.
Material and Method:
This was a retrospective study, conducted in Department of Pathology and Department of medicine, FMH college of Medicine and Dentistry from May 2020 to July 2020. Total of 101, confirmed cases of covid-19 disease, both genders between 17 to 75-year age were included. Hematological parameters were compared in mild, moderate, severe and critical disease group. Continuous variables were analyzed by using non parametric, Kruskal Wallis test while categorical variables were analyzed by chi-square test.
- Conditions
- Covid19
- Being tested
- not required
- Keywords
- Covid-19 disease, Neutrophil to Lymphocyte ratio, hematological manifestations
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not requiredDiagnostic test
Diagnostic tests( hematological parameters) were assessed.
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 disease severity | Mild, moderate, severe and critical disease Receives: Diagnostic Test: not required |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete blood count- Hemoglobin. White blood count, platelet count, Neutrophil to lymphocyte ratio
disease severity was assessed on basis of hematological parameters.
Measured: 3 months
Secondary outcomes (1)
PT, APTT and D-dimer
improvement in PT, APTT and D-dimer levels were assessed
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 May 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- FMH College of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadia Taj, FMH College of Medicine and Dentistry
- Investigators
- Ayaz Lone, MBBS,FCPS, Study chair, FMH College of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670328
- Sponsor's protocol ID
- FMHCMD
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Hematological Parameters in the Stratification of COVID-19 Disease Severity
- ClinicalTrials.gov ID
- NCT04670328
- Acronym / sponsor ID
- FMHCMD
- Conditions
- Covid19
- Keywords
- Covid-19 disease, Neutrophil to Lymphocyte ratio, hematological manifestations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- FMH College of Medicine and DentistryUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 17 Dec 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 hemostatic abnormalities in COVID-19 are related with disease progression, severity and mortality. The Objective of our study is to evaluate the role of hematological parameters in determination of COVID-19 disease severity.
Detailed description
Objective:
COVID-19 virus involves respiratory as well as other body systems including cardiovascular, gastrointestinal, neurological, immunological and hematopoietic system. Patient of covid-19 pneumonia presents with wide range of hemostatic abnormalities. These hemostatic abnormalities in COVID-19 are related with disease progression, severity and mortality. The Objective of our study is to evaluate the role of hematological parameters in determination of COVID-19 disease severity.
Material and Method:
This was a retrospective study, conducted in Department of Pathology and Department of medicine, FMH college of Medicine and Dentistry from May 2020 to July 2020. Total of 101, confirmed cases of covid-19 disease, both genders between 17 to 75-year age were included. Hematological parameters were compared in mild, moderate, severe and critical disease group. Continuous variables were analyzed by using non parametric, Kruskal Wallis test while categorical variables were analyzed by chi-square test.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid-19 disease severity | – | Diagnostic Test: not requiredMild, moderate, severe and critical disease |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- diagnosed cases of covid-19
Key inclusion criteria (3 listed)
- diagnosed cases of covid-19 disease
- Both genders
- 17 to 75 year age
Key exclusion criteria (2 listed)
- known case of chronic liver disease
- known hematological diseases were excluded
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 |
|---|---|---|
| not requiredDiagnostic tests( hematological parameters) were assessed. | Diagnostic test | Covid-19 disease severity |
Primary outcome
complete blood count- Hemoglobin. White blood count, platelet count, Neutrophil to lymphocyte ratio
Time frame: 3 months
disease severity was assessed on basis of hematological parameters.
1 secondary outcome
PT, APTT and D-dimer
Time frame: 3 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 17 Dec 2020.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
Ayaz Lone, MBBS,FCPS study chair
FMH College of Medicine and Dentistry
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 FMH College of Medicine and Dentistry at 1 site in Pakistan.
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 3 inclusion and 2 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 17 Dec 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 Pakistan. 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?
complete blood count- Hemoglobin. White blood count, platelet count, Neutrophil to lymphocyte ratio (time frame: 3 months). 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 17 Dec 2020.