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CTRI Number  CTRI/2022/12/048428 [Registered on: 23/12/2022] Trial Registered Prospectively
Last Modified On: 21/12/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Influenza and COVID study in pregnant women and their newborn  
Scientific Title of Study   Influenza & COVID Obstetric and Perinatal Epidemiology (ICOPE) Study in India  
Trial Acronym  ICOPE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Archana Patel 
Designation  Program Director and CFO 
Affiliation  Lata Medical Research Foundation 
Address  Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S
Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S
Nagpur
MAHARASHTRA
440022
India 
Phone  07122249569  
Fax    
Email  dr_apatel@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Archana Patel 
Designation  Program Director and CFO, PI 
Affiliation  Lata Medical Research Foundation 
Address  Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S
Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S
Nagpur
MAHARASHTRA
440022
India 
Phone  07122249569  
Fax    
Email  dr_apatel@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Archana Patel 
Designation  Program Director and CFO 
Affiliation  Lata Medical Research Foundation 
Address  Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S
Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S
Nagpur
MAHARASHTRA
440022
India 
Phone  07122249569  
Fax    
Email  dr_apatel@yahoo.com  
 
Source of Monetary or Material Support  
BOSTON UNIVERSITY MEDICAL CAMPUS 85 East Newton Street, M-921 BOSTON, MA, 021182841  
 
Primary Sponsor  
Name  National Institute of Health 
Address  EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT, USA, (240) 276-5588 
Type of Sponsor  Government funding agency 
 
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 
Archana Patel  Lata Medical Research Foundation  Research Unit 1, 1st Floor, Kinkine Kutir, Vasant Nagar,
Nagpur
MAHARASHTRA 		 09823350019

dr_apatel@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lata Medical Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: J100||Influenza due to other identifiedinfluenza virus with pneumonia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Eligibility Criteria :

1. Women ages 18 to 50 years registering for ANC at GMC Hospital Nagpur;
2. Intending to be followed throughout pregnancy, labor and delivery and neonatal care at GMC;
3. Living within the city limits of Nagpur to facilitate access to GMC for evaluation of ILI and COVID symptoms;
4. Estimated Gestational Age at registration <13 weeks based on ultrasound at 1st ANC visit
5. Willing to be contacted two times per week by call or text for ILI/COVID symptom screening and return to GMC for an NP swab/evaluation if symptoms are reported;
6. Willing to take temperature with the provided digital thermometer, after training;
7. Willing to provide information on pregnancy and neonatal outcomes if care occurs outside GMC;
8. Willing to permit blood draws or finger sticks for DBS at all ANC visits and if symptoms occur through day 7 postpartum and during visits to GMC or admission for respiratory illness;
9. Willing to consent. 
 
ExclusionCriteria 
Details  1. All those do not meet eligibility criteria and not willing to consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence, incidence and maximal severity of symptomatic or asymptomatic COVID-19 in pregnant women   Day 7, post-partum 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of maternal COVID-19 infection on the fetus and/or neonate   Day 7, Post-partum  
Characterize patterns and trajectories of host response/inflammatory biomarkers as
potential mediators of COVID-19±ORV infection on progression to severe illness in pregnant women/mothers
admitted with COVID-19  		 Endline 
 
Target Sample Size   Total Sample Size="10000"
Sample Size from India="10000" 
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)   01/02/2023 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet published  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Study Objectives

AIM 1: Determine the prevalence, incidence and maximal severity of symptomatic or asymptomatic COVID-19 in pregnant women to day 7 postpartum on maternal outcomes. We hypothesize that a composite maternal outcome (preterm labor, preeclampsia with severe features and/or mortality) will be higher among those with COVID-19 infection vs. those with no COVID infection. Secondary analysis will evaluate whether influenza/ORV infection or vaccination modifies and pre-term birth mediates this risk. Public Health Outcome: Data for public health preparedness.

 

AIM 2: Determine the effect of maternal COVID-19 infection on the fetus and/or neonate through day 7 of life. We hypothesize that a composite fetal/neonatal primary outcome (preterm birth, newborn critical illness and/or perinatal mortality) will be higher among mothers with COVID-19 infection vs. No COVID infection. Secondary analysis will focus on whether influenza/ORV or vaccination modifies and pre-term birth mediates this risk. Public Health Outcome: Data on at risk pregnancies and effect of vaccines on outcomes.

 

AIM 3: (EXPLORATORY) Characterize patterns and trajectories of host response/inflammatory biomarkers as potential mediators of COVID-19±ORV infection on progression to severe illness in pregnant women/mothers admitted with COVID-19. Modifiers include vaccination. Public Health Outcome: Potential targets for treatment/prevention.


Study Process

 

 
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