| CTRI Number |
CTRI/2020/05/025424 [Registered on: 28/05/2020] Trial Registered Prospectively |
| Last Modified On: |
27/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical features and outcome of COVID-19 and non-COVID respiratory infection |
|
Scientific Title of Study
|
Comparison of clinical profile, outcome and peripheral blood cell population data in children with COVID-19 and non-COVID acute severe respiratory infection |
| Trial Acronym |
Pedscovid |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Leni G Mathew |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Pediatrics, Christian Medical College
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9500921016 |
| Fax |
|
| Email |
lenigm@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Leni G Mathew |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Pediatrics, Christian Medical College
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9500921016 |
| Fax |
|
| Email |
lenigm@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Leni G Mathew |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Pediatrics, Christian Medical College
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9500921016 |
| Fax |
|
| Email |
lenigm@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Christian Medical College
Vellore |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Leni G Mathew |
Christian Medical College |
Department of Pediatrics. Christian Medical College Vellore TAMIL NADU |
9500921016
lenigm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review Board, Christian Medical Collge |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J180||Bronchopneumonia, unspecified organism, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
All children from birth to 16 years of age presented with ALRI as per IMNCI criteria |
|
| ExclusionCriteria |
| Details |
Children with ALRI but having asthma, empyema, aspiration pneumonia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mode of oxygen therapy. Other interventions needed. Outcome from illnes- recovery or death |
Baseline, 3rd day, 5th day and at dischargefrom hospital. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Other systemic manifestations: Cardio vascular
Dermatological
Neurological
Musculo-skeletal
Hemato-Lymphoid
gastro-intestinal
Genito-urinary
|
baseline, 3rd day, 5th day , At discharge from hospital |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/06/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background: An outbreak of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 was first detected in Wuhan, Hubei, China. People of all ages are susceptible to SARS-CoV-2 infection. No information on severe pediatric patients with COVID-19 has been reported from India. We aimed to describe the clinical features and outcome of children admitted with acute lower respiratory infection (LARI) in Pediatric wards and to compare cell counter white blood cell data and indices of children with COVID infection with those with non-COVID acute respiratory illness (non-COVID ARI) including pneumonia and very severe disease. Methods: We will collect demographic information and clinical characteristics including exposure history, clinical signs and symptoms, chest computed tomographic (CT) scan or X-ray results, complications, treatments, clinical outcomes, and laboratory findings of children with COVID and non Covid ALRI. COVID-19 was confirmed in all patients by positive results of real-time reverse transcription-polymerase chain reaction (RT-PCR) assay for nasopharyngeal swab specimens. Data on patients with laboratory-confirmed 2019-nCoV infection will be obtained with standardized data collection forms. Researchers also directly communicated with patients or their families to ascertain epidemiological and symptom data. Data on laboratory tests including a complete blood count (leucocytes, neutrophils, lymphocytes, thrombocyte, hemoglobin), serum biochemistry (C-reactive protein, procalcitonin, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin, creatine kinase, creatinine and D-dimer) will be collected. We will also look for other system involvement in children with COVID-19. Outcomes like discharged home or death will be also collected. Analysis: The basic demographic, clinical characteristics, laboratory parameters, and treatment outcome of this cohort at diagnosis will be analyzed. We intend to summarize subject characteristics by median and interquartile range (IQR) for continuous variables and frequency and percentage for categorical variables. |