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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  
No funding required  
 
Primary Sponsor  
Name  Christian Medical College 
Address  Christian Medical College Vellore 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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.

 
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