Proposal Summary


Investigator(s)

WHO Technical Officer Mohammad Ahmad
WHO country office, India- NPO (Research)
Mohammad Ahmad Mail
Principal Investigator Kiran Goswami
Center for Community Medicine, AIIMS Delhi
Kiran Goswami Mail


Title(s) and abstract

Scientific title Evolving Epidemiology of Long Haul COVID in Rajasthan- A Cohort Study
Public title Long term implications of Covid infection
 
Background The first case of COVID-19 in Rajasthan was reported in March 2020. The infections peaked in November 2020. The second wave of COVID-19 started in March 2021 with peak in May 2021. The Omicron wave struck in January 2022. After recovering from acute phase, patients are experiencing a wide range of symptoms collectively termed as Long Haul COVID or post COVID-19 sequalae, the implications of which are a growing concern. Long COVID significantly impacts the morbidity and mortality as it often involves multiple organ systems. Studies have shown that patients continued to experience symptoms like fatigue, malaise, abnormal breathing, headache, chest pain, palpitations, abdominal-pain and cognitive dysfunction. As most people do not seek hospital-based care for their symptoms, relatively little is known about post covid sequalae symptoms, its progression, severity, impact on daily functioning and return to baseline health. WHO is working with researchers to urgently streamline data collection and reporting on Post COVID-19 condition. In view of this it becomes imperative to know the extent of involvement of organ systems and the severity of symptoms in India.
Objectives Primary Objectives: 1. To estimate the proportion of COVID patients developing Long Haul COVID 2. To characterize the clinical features of Long Haul covid 3. To assess the association of risk factors like co-morbidities, disease severity etc. on Long Haul COVID 4. To compare the occurrence of Long Haul COVID in different time periods (Delta wave and Omicron wave) Secondary Objectives: 5. To study the association between Long Haul COVID with time from diagnosis 6. To analyze the serological and clinical parameters in Long Haul COVID patients 7. To study the association of vaccination on Long Haul COVID 8. To describe the current management practices for Long Haul COVID 9. To assess the re-infection rate and breakthrough infection rate among study participants
Study Methods The study is a retrospective-prospective cohort study in all 33 districts of Rajasthan state in India, conducted in community settings. All cases of COVID-19 after a specified date of diagnosis- will be considered for retrospective enrollment. Cases which are diagnosed COVID-19 positive after the study start date will be considered for prospective enrolment till the study end period. This design will allow enrolment of cases from both the Delta wave and Omicron wave in India. A total of 5775 subjects to be enrolled in the whole state (175 subjects in each district). A simple random technique would be followed for selection of study subjects in each district from the linelist of COVID-19 confirmed cases since the beginning of the pandemic. The subjects will be selected by systematic random sampling from the district linelist of covid positive patients. If the subject/parent agree to participate, a written consent would be obtained. Selected subjects will be interviewed and investigated at the time of enrollment as per the Case Record Form of the World Health Organization, modified as per the local requirement. Study participation criteria includes 1- History of COVID-19 positive by the RT-PCR or rapid antigen or CT between a specified period. 2- Subjects of all age groups, 3-Subjects who are the resident of the district and 4- Subjects/parents who provide consent for the study. The first interview would be done at the time of enrollment. Subsequently, the subjects who suffered during the Delta wave would be followed for 3, 6, 12, 18 and 22-24 months from the date of COVID-19 diagnosis, and those who suffered during Omicron wave would be followed for 3, 6 and 12 months from the date of results. Cases with impaired lab tests will be subjected to further investigations.
Expected outcomes and use of results The study is expected to generate data on proportion of COVID patients developing Long Haul COVID, which is expected to guide long-term policy on Long Haul COVID in India. The study will characterize the clinical features of Long Haul COVID and assess the association of risk factors like co-morbidities, disease severity etc. This is expected to help in future preparedness and response to the emerging issue. Comparing the occurrence of Long Haul COVID in different time periods would also help understand the burden of the problem by different variants of concerns. Analysis of serological and clinical parameters in Long Haul COVID patients could provide some flagging conditions more prone to Long Haul COVID; as also the association of vaccination on Long Haul COVID. The data and inferences from the study is expected to refine the current management practices for Long Haul COVID but also operational preparedness in the future.
 
Keywords Long Haul Covid Rajasthan WHO AIIMS Delhi


Research Details

Student research No
Start Date 01-Jul-2022
End Date 31-Dec-2023
Key Implementing Institution All India Institute of Medical Sciences, New Delhi
Multi-country research No
Nationwide research No
  India
Research Domain(s) Communicable Disease Research
Research field(s) COVID-19
Involves human subjects Yes
  Population-Based Survey,
Data Collection Primary and secondary data
Proposal reviewed by other Committee Under Review