Importance of blood investigations in assessing severity and recovery in Covid 19 patients
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2021/01/030432
- Lead Sponsor
- Manipal Academy of Higher Education
- Brief Summary
**1. Title of the project: Laboratory variables and outcome measuresof Covid 19 in patients: A data based retrospective study from Udupi district**
**2. Type ofStudy:** Retrospective
3. Aims &objectives (hypotheses if applicable) :1) To assess thebiochemical and hematological perturbations in confirmed Covid 19 patient
Haematologicalparameters recorded: CBC, ESR, APTT, Peripheral smear.
Biochemicalparameters: FBS, HbA1c, RFT, Total & direct bilirubin, total protein, liverenzymes, electrolytes (Na, K, Ca, P, Mg), CRP, LDH, ferritin, D Dimer, CPK,Trop T, pro BNP, ABG at admission)
2) To correlatethe laboratory findings with the clinical severity of the disease
3) To investigatethe influence of comorbid conditions on the laboratory based and clinicalprogression of the disease
4) To compare thelaboratory findings with the patient outcomes (time to discharge/ recovery andmortality)
4. Justificationfor study (whether of national significance with rationale) : As a lot of evidences continue to be addedand guidelines continue to be modified, there is a relative scarcity of Indianliterature on the hematological, biochemical and inflammatory perturbations inCovid 19 patients, and also the influence of comorbidities on theseperturbations and prognostic value to these disturbances in patient outcomeswhich has to be emphasized.
**5.** **Departmentsinvolved:**
Departmentof Biochemistry, KMC, Manipal
Divisionof Ayurveda, CIMR, Manipal
Departmentof Critical Care, KMC, Manipal
**6****.Study period:** 6 months
7. Sample size:500 patients (Convenience sampling will beused and the sample size is kept towards a lower minimum for the ease ofaccessibility and the absence of prevalence data in the face of the suddenpandemic).
**8. Materials and methods:**
a) Inclusion and exclusion criteria:
i. Inclusion criteria:
All patients with confirmed Covid 19 infectionadmitted (30/05/2020 to 30/08/2020) to Kasturba Hospital, Manipal, ManipalAcademy of Higher Education, Manipal can be enrolled in the study
ii. Exclusion criteria:
Any patient without confirmed Covid 19 or anypatient with non Covid SARI will be excluded from the study.
b) Biologicalmaterials required (type - blood, tissue etc and quantity) :NIL
c)Statistical methods:
i.Quantitative characteristics will be tabulated and presented using descriptivestatistics.
ii.Group differences will be evaluated using ANOVA for quantitativecharacteristics. P value less than 0.05 will be considered statisticallysignificant.
iii.The relationship between the various parameters will be quantified bySpearman’s Rank correlation coefficient test.
iv.ROC curves of various parameters and a combination of different parameters andscores will be calculated. Sensitivity, specificity, AUC, NPV & PPV will bedetermined for the same.
d)Tools used:
Ahigh risk progression RISK CALCULATOR generated inhouse by a team (CovidHackathon) will be used to obtain risk scores from the laboratory reports, andthe generated risk scores will be correlated with the outcome measures.
**9. Detailed description of procedure / processes:**
Patientswith confirmed Covid 19 admitted to Kasturba Hospital, Manipal will be enrolledin the study (male/female)
The participantswill be divided into mild, moderate and severe cases of Covid 19 based onstandard guidelines
Laboratorytest reports (Hematology, Biochemistry and microbiology) will be extracted fromthe Laboratory Information System
A detailedinformation about the past history of the patients will be obtained from thepatient records archived in the Medical Records Department of the Hospital. The datawould be entered in the risk calculator to generate risk scores.
Further,combinations of laboratory and clinical variables would be assessed for theirprognostic and risk stratification potential with respect to each of theoutcome variables
Participantswill be followed for prognostic outcomes (time to recovery/ discharge, durationof admission at ICU/ CCU, duration of oxygenation support required/ mortality
(Note:Haematological parameters recorded: CBC, ESR, APTT, Peripheral smear.
Biochemicalparameters: FBS, HbA1c, RFT, Total & direct bilirubin, total protein, liverenzymes, electrolytes (Na, K, Ca, P, Mg), CRP, LDH, ferritin, D Dimer, CPK,Trop T, pro BNP, ABG at admission)
**10. Outcome measures:**
1)Duration of hospital stay/ time to discharge
2)Mortality
3)Development of secondary severe complications like pulmonary embolism, MI,cardiac arrest etc
4)Need for ICU admission
5)Need & duration of HFNC/ NIV/ Mechanical ventilation support
6)Development of Multisystem inflammatory syndrome
7)Severity of perturbations of laboratory analytes
11. Potentialrisks and benefits: Since it’s a retrospective study, only aminimal risk is involved in the conduct of the study. However, the benefit ofthis study is immense because it could help us arrive at an algorithm to assessrisk/ patient outcome and hence institute rigorous therapy and strict monitoringof patients at a risk of deterioration/ adverse outcome. Also, the study wouldhelp in in-depth validation of a high risk progression RISK CALCULATOR,developed by MAHE and freely available online to the health care workers forthe greater benefit of the medical fraternity.
12. Ethicalconsiderations and methods to address issues: Ethical clearance will be obtained from theInstitutional Ethical Committee. The data will be handled with utmostconfidentiality and will remain accessible only to the key research members, whowould strictly agree upon and adhere to the ethical code of conduct and patientconfidentiality, data would be anonymized while result entry and reporting.
**13. Budget (give details) and proposed funding source:**
Thepresent study does not require any funding support since it’s a retrospectivestudy and uses laboratory and clinical records along with a freely availableonline calculator for the purpose of risk stratification and outcomeassessment.
**14. Review of literature (within 1000 words):**
Coronaviruses belonging to the family of Coronaviridae, long consideredinconsequential pathogens often causing mild cold to severe acute respiratorysyndrome in an extreme few. This has challenged the world and humanity byemergence of a highly pathogenic 2019 novel coronavirus (2019-nCoV) causingSARS in millions across the world [1]. After its emergence, in Wuhan inNovember 2019, the World Health Organization declared Covid 19 a globalpandemic on March 11, 2020 [2]. In March 2020 first case of Covid 19 wasdiagnosed in India [3] following which Ministry of Health, Government of Indiaproposed standard precautions to prevent the spread of this virus by washinghand repeatedly with water, soap or alcohol based solution for 20 seconds [4].Beside the people have been alerted to maintain social distancing, minimize thegathering, to wear mask and avoiding contacts with people with cold, cough andfever. As we witness the outbreak taking exponential trajectories, the ultimatescope of this global pandemic is impossible to predict. To date, ourunderstanding of the disease pathophysiology, clinical manifestations,diagnostic and therapeutic regimens and prognostic indicators continue torapidly evolve and researchers from the globe aid in rapid updation ofhealthcare guidelines.
Whilemost patients infected with SARS-CoV-2 have mild symptoms, the viruses cancause severe lung pneumonia, acute respiratory distress syndrome, multipleorgan failure, and finally death [5]. In severe cases with critical condition,a specialized management at intensive care units is needed [6]. To ourknowledge, however, there is presently a restricted standardised method forpredicting which infected patient may stay moderately symptomatic or progresstowards more serious disease [7]. Extreme pulmonary disease with severealveolar damage and progressive respiratory failure results in fatalconsequences [8,9]. High mortality rates occur in the elderly, and people withdiabetes, co-morbidities and immunosuppressant [10]. Although most publishedpapers explored the clinical features and imaging findings of COVID-19, fewstudies examined the diagnostic and prognostic importance of abnormallaboratory findings [11]. The contribution of laboratories goes far beyondetiological detection and it is now almost undeniable that this branch ofmedical science is effectively involved in prognosis and diagnosisdetermination andpatient monitoring [12]. Although in vitro diagnostics contributeeffectively to early detection of SARS-CoV-2 infection, there is evidence thatlaboratory medicine can also provide critical assistance in distinguishingbetween extreme and non-serious COVID-19.
Although *invitro* diagnostics efficiently contribute to the early identificationof SARS-CoV-2 infection, there is evidence that laboratory medicine may alsoprovide essential assistance to discriminate between severe and non-severeCOVID-19. The broad variations in the clinical characteristics of the disease,ranging from asymptomatic to fatal, require the detection and application ofnew laboratory biomarkers to predict COVID-19 prognosis quickly andeconomically [13].
To gain a better understanding of the role of haematological andbiochemical parameters in predicting COVID-19’s mild to severe progression, itis essential to investigate these results for further updating in order tostudy the virus effect in detail.
**15. References:**
1.Cascella M, Rajnik M, Cuomo A, et al. Features, Evaluation and TreatmentCoronavirus (COVID-19) [Updated 2020 Jul 4]. In: StatPearls [Internet]. Availablefrom: <https://www.ncbi.nlm.nih.gov/books/NBK554776/>
Accessedon 12 August 2020.
2.World Health Organization. Coronavirus disease (COVID-19) pandemic. Copenhagen:WHO Regional Office for Europe. c2020 (Cited on 12 August 2020) Available from:<https://www.euro.who.int/en/health-topics/health-emergencies/coronavirus-covid-19>
3.Devesh Kumar. Half a million COVID-19 cases in India: How we got to where weare. India: The Wire, Covid 19 India timeline. c2020 (Cited on 12 August 2020).Available at: <https://thewire.in/covid-19-india-timeline>
4.<https://www.mohfw.gov.in/pdf/PreventivemeasuresDOPT.pdf>
5. N. Chen,M. Zhou, X. Dong, J. Qu, F. Gong, Y. Han, et al. Epidemiological and clinicalcharacteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan,China: a descriptive study. Lancet. 2020; 395:507-513.
6. Z. Xu,L. Shi, Y. Wang, J. Zhang, L. Huang, C. Zhang, S. Liu, P. Zhao, H. Liu, L. Zhu.Pathological findings of COVID-19 associated with acute respiratory distresssyndrome. Lancet Respiratory Med. 2020; 8(4):420-422.
7. Liu, X.,Zhou, H., Zhou, Y. *et al.* Temporal radiographic changes inCOVID-19 patients: relationship to disease severity and viral clearance. *SciRep*. 2020; 10:10263. doi: <https://doi.org/10.1038/s41598-020-66895-w>
8. Chen, N.et al. Epidemiological and clinical characteristics of 99 cases of 2019 novelcoronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020; 395:507–513.
9. Huang,C. et al. Clinical features of patients infected with 2019 novel coronavirus inWuhan, China. Lancet.2020; 395:497–506.
10. Song,J., Zhang, C., Fan, X. *et al.* Immunological and inflammatoryprofiles in mild and severe cases of COVID-19. *Nat Commun*. 2020; 11:3410. doi: <https://doi.org/10.1038/s41467-020-17240-2>
11. G. Lippi, M. Plebani.Laboratory abnormalities in patientswith COVID-2019 infection. Clin. Chem. Lab. Med. 2020; 58(7):1131-1134.doi: 10.1515/cclm-2020-0198.
12. G.Lippi, M. Plebani. The critical role of laboratory medicine during coronavirusdisease 2019 (COVID-19) and other viral outbreaks. Clin. Chem. Lab. Med. 2020; 58(7):1063-1069.doi: 10.1515/cclm-2020-0240.
13. Pourbagheri-SigaroodiA, Bashash D, Fateh F, Abolghasemi H. Laboratory Findings in COVID-19 Diagnosisand Prognosis. Clinica Chimica Acta. 2020; 510: 475-482.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 500
All adult patients with confirmed Covid 19 infection admitted (30/05/2020 to 30/08/2020) to Kasturba Hospital, Manipal, Manipal Academy of Higher Education, Manipal can be enrolled in the study.
Any patient without confirmed Covid 19 or any patient with non Covid SARI.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Duration of hospital stay/ time to discharge At admission and discharge of each patient 3) Development of secondary severe complications like pulmonary embolism, MI, cardiac arrest etc At admission and discharge of each patient 2) Mortality At admission and discharge of each patient
- Secondary Outcome Measures
Name Time Method 4) Need for ICU admission 5) Need & duration of HFNC/ NIV/ Mechanical ventilation support
Trial Locations
- Locations (1)
Kasturba Medical College and Kasturba Hospital Manipal
🇮🇳Udupi, KARNATAKA, India
Kasturba Medical College and Kasturba Hospital Manipal🇮🇳Udupi, KARNATAKA, IndiaDr Vijetha Shenoy BellePrincipal investigator09844667820vijetha.shenoy@manipal.edu