COVID-19NCT04470557
Relation Between Lab Finding and COVID-19 Severity
An observational study of COVID-19, run by Assiut University.
Trial summary
Severe acute respiratory syndrome coronavirus 2 (COVID-19) poses substantial challenges for health care systems. With a vastly expanding amount of publications on COVID-19, clinicians need evidence synthesis to produce guidance for handling patients with COVID-19. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- D-dimer,CBC.ESR,CRP, and Liver function tests ,serum ferritin and PCR for COVID-19 .
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2020to 1 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will be conducted on 100 patients with COVID-19 patients of all age groups and both sexes.
Who may be able to join
- Age: all ages.
- Sex: Males and females.
- COVID-19 patients approved by positive PCR.
Who cannot join
- Patients with known chronic chest disease preceding the infection.
Trial locations and contacts
No sites are listed yet.
Ghydaa A. Shehata, Doctorate contact
About this study
Official title: The Relationship Between Lab Finding and COVID-19 Severity: Multicenter Study
Severe acute respiratory syndrome coronavirus 2 (COVID-19) poses substantial challenges for health care systems. With a vastly expanding amount of publications on COVID-19, clinicians need evidence synthesis to produce guidance for handling patients with COVID-19.
Read the detailed description
. Conavirus belongs to the subfamily of Ortho-coronavirinae in the family of Coronaviridae and the Order Nidovirales. In 2003, a SARS-CoV had caused the out- break of severe acute respiratory syndrome. In December 2019, an "unknown viral pneumonia" out- break has been reported. Finally, a novel coronavirus was detected, isolated virus was termed as SARS-CoV2, characterized as highly contagious and deadly. By the end of February 2020, more than 78,631 cases infected with SARS-CoV-2, and more than 2747 deaths were confrmed in China, and the COVID-19 has been declared a pan- demic by World Health Organization. For those infected by SARS-CoV-2, some of the patients didnot show hypoxemia or respiratory stress during the course of COVID-19, indicating a multifaceted disease of SARS-CoV-2 infection. Therefore, one reliable and convenient biomarker is needed to predict the severity of COVID-19 pneumonia. Recently, several studies have reported that C-reactive protein (CRP) is positively asso-ciated with severe dengue infection, and patients with higher plasma CRP in the initial period of dengue, are at higher risk to develop plasma leakage. We examined which routine laboratory tests are associated with severe COVID-19 disease, and the relation between the laboratory results and the security of COVID19 diasease, in two of large Upper Egypt medical centers, which are Aswan University and assiut university hospitals.
- Conditions
- COVID-19
- Being tested
- D-dimer,CBC.ESR,CRP,, Liver function tests ,serum ferritin and PCR for COVID-19 .
- Keywords
- Laboratory, Severity, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-dimer,CBC.ESR,CRP,Diagnostic test
Complete blood count (for patients and control subjects): was done on CELL-DYN 3700 (Abbott-Germany) and blood film was stained by leishman staining, the morphology of red blood cells. CRP titre estimation by latix method .ESR erythrocyte sedimentation rate estimation (1:5) by Westerngreen tube method.
Liver function tests ,serum ferritin and PCR for COVID-19 .Diagnostic test
Serum ferritin was performed for all subjects on Modular P auto analyzer (Roche Diagnostics, Mannheim, Germany),
- Liver function tests ( aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase) and kidney funcrion were performed for all subjects on Modular P auto analyzer (Roche Diagnostics, Mannheim, G ermany),
| Study group | Role | What they receive |
|---|---|---|
| Patients with COVID-19 | The patients will be subjected to to laboratory analyses, a number of hematological, immunological and biochemical parameters like total leucocytic count and differential count of CBC, ESR, D- dimer levels in plasma, CRP, serum urea and creatinine levels, serum levels of AST, ALT liver enzymes, serum ferritin levels Also, CT scan of chest, clinical assessment and the severity and course of the disease. Receives: Diagnostic Test: D-dimer,CBC.ESR,CRP,; Diagnostic Test: Liver function tests ,serum ferritin and PCR for COVID-19 . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of severity of patients with COVID-19 in relation to Laboratory findings.
with successful completion of the aim, the investigators will establish the correlation between laboratory findings and severity of COVID-19 patients according to WHO classification.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start15 Jul 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anwar Mohamed Ali, Assiut University
- Investigators
- Esam_eldeen M. Abdalla, Doctorate, Study chair, Assiut UniversityHeba Abdellatif, Doctorate, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470557
- Sponsor's protocol ID
- RLCS
- Status last verified
- Jul 2020
- First submitted
- 11 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang W, Du RH, Li B, Zheng XS, Yang XL, Hu B, Wang YY, Xiao GF, Yan B, Shi ZL, Zhou P. Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020 Feb 17;9(1):386-389. doi: 10.1080/22221751.2020.1729071. eCollection 2020.
PubMed 32065057Chen CC, Lee IK, Liu JW, Huang SY, Wang L. Utility of C-Reactive Protein Levels for Early Prediction of Dengue Severity in Adults. Biomed Res Int. 2015;2015:936062. doi: 10.1155/2015/936062. Epub 2015 Jul 12.
PubMed 26247033Alnor A, Sandberg MB, Gils C, Vinholt PJ. Laboratory Tests and Outcome for Patients with Coronavirus Disease 2019: A Systematic Review and Meta-Analysis. J Appl Lab Med. 2020 Sep 1;5(5):1038-1049. doi: 10.1093/jalm/jfaa098.
PubMed 32573713
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Lab Finding and COVID-19 Severity: Multicenter Study
- ClinicalTrials.gov ID
- NCT04470557
- Acronym / sponsor ID
- RLCS
- Conditions
- COVID-19
- Keywords
- Laboratory, Severity, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 14 Jul 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.
Severe acute respiratory syndrome coronavirus 2 (COVID-19) poses substantial challenges for health care systems. With a vastly expanding amount of publications on COVID-19, clinicians need evidence synthesis to produce guidance for handling patients with COVID-19.
Detailed description
. Conavirus belongs to the subfamily of Ortho-coronavirinae in the family of Coronaviridae and the Order Nidovirales. In 2003, a SARS-CoV had caused the out- break of severe acute respiratory syndrome. In December 2019, an "unknown viral pneumonia" out- break has been reported. Finally, a novel coronavirus was detected, isolated virus was termed as SARS-CoV2, characterized as highly contagious and deadly. By the end of February 2020, more than 78,631 cases infected with SARS-CoV-2, and more than 2747 deaths were confrmed in China, and the COVID-19 has been declared a pan- demic by World Health Organization. For those infected by SARS-CoV-2, some of the patients didnot show hypoxemia or respiratory stress during the course of COVID-19, indicating a multifaceted disease of SARS-CoV-2 infection. Therefore, one reliable and convenient biomarker is needed to predict the severity of COVID-19 pneumonia. Recently, several studies have reported that C-reactive protein (CRP) is positively asso-ciated with severe dengue infection, and patients with higher plasma CRP in the initial period of dengue, are at higher risk to develop plasma leakage. We examined which routine laboratory tests are associated with severe COVID-19 disease, and the relation between the laboratory results and the security of COVID19 diasease, in two of large Upper Egypt medical centers, which are Aswan University and assiut university hospitals.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with COVID-19 | – | Diagnostic Test: D-dimer,CBC.ESR,CRP,, Diagnostic Test: Liver function tests ,serum ferritin and PCR for COVID-19 .The patients will be subjected to to laboratory analyses, a number of hematological, immunological and biochemical parameters like total leucocytic count and differential count of CBC, ESR, D- dimer levels in plasma, CRP, serum urea and creatinine levels, serum levels of AST, ALT liver enzymes, serum ferritin levels Also, CT scan of chest, clinical assessment and the severity and course of the disease. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted on 100 patients with COVID-19 patients of all age groups and both sexes.
Key inclusion criteria (3 listed)
- Age: all ages.
- Sex: Males and females.
- COVID-19 patients approved by positive PCR.
Key exclusion criteria (1 listed)
- Patients with known chronic chest disease preceding the infection.
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 |
|---|---|---|
| D-dimer,CBC.ESR,CRP,Complete blood count (for patients and control subjects): was done on CELL-DYN 3700 (Abbott-Germany) and blood film was stained by leishman staining, the morphology of red blood cells. CRP titre estimation by latix method .ESR erythrocyte sedimentation rate estimation (1:5) by Westerngreen tube method. | Diagnostic test | Patients with COVID-19 |
| Liver function tests ,serum ferritin and PCR for COVID-19 .Serum ferritin was performed for all subjects on Modular P auto analyzer (Roche Diagnostics, Mannheim, Germany), • Liver function tests ( aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase) and kidney funcrion were performed for all subjects on Modular P auto analyzer (Roche Diagnostics, Mannheim, G ermany), | Diagnostic test | Patients with COVID-19 |
Primary outcome
Estimation of severity of patients with COVID-19 in relation to Laboratory findings.
Time frame: up to 1 month
with successful completion of the aim, the investigators will establish the correlation between laboratory findings and severity of COVID-19 patients according to WHO classification.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Background: PubMed 32065057Zhang W, Du RH, Li B, Zheng XS, Yang XL, Hu B, Wang YY, Xiao GF, Yan B, Shi ZL, Zhou P. Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020 Feb 17;9(1):386-389. doi: 10.1080/22221751.2020.1729071. eCollection 2020.
- Background: PubMed 26247033Chen CC, Lee IK, Liu JW, Huang SY, Wang L. Utility of C-Reactive Protein Levels for Early Prediction of Dengue Severity in Adults. Biomed Res Int. 2015;2015:936062. doi: 10.1155/2015/936062. Epub 2015 Jul 12.
- Results publication: PubMed 32573713Alnor A, Sandberg MB, Gils C, Vinholt PJ. Laboratory Tests and Outcome for Patients with Coronavirus Disease 2019: A Systematic Review and Meta-Analysis. J Appl Lab Med. 2020 Sep 1;5(5):1038-1049. doi: 10.1093/jalm/jfaa098.
- Individual participant dataSharing planned: No
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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.
Ghydaa A. Shehata, Doctorate contact
Esam_eldeen M. Abdalla, Doctorate study chair
Assiut University
Heba Abdellatif, Doctorate study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Assiut University.
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 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: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anwar M. Ali, Doctorate (01030361010, anwarmoha2006@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of severity of patients with COVID-19 in relation to Laboratory findings. (time frame: up to 1 month). 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 NCT04470557, which also lists 3 linked publications.
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 14 Jul 2020.