CASE STUDIES:

COVID 19 Open Cohort Study

COVID 19 Open Cohort Study

About the Study

It is a voluntary online study available in English-language. Some unique features of this study include real-time access to incoming data that can be analysed to inform the situation on the ground as the study is ongoing.

OUR AIM

Through an open cohort study (OCS), the aim of COVID-19 OCS (COCS) is to refine case definitions, establish incidence of the pandemic and to characterise the clinical spectrum and outcomes of the disease among different populations.

SPECIFIC OBJECTIVES

  1. Through a cross sectional survey describe risk factors and enlist study participants for the cohort study.
  2. To characterize the clinical spectrum of COVID-19.
  3. To refine case definitions of COVID-19 using data from different population groups.
  4. To explore in detail, the epidemiology of COVID-19.
  5. To document outcomes associated with COVID-19 in various age groups, populations, and concomitant conditions.
  6. To generate data to inform clinical research on COVID-19.
  7. To generate population specific data for evidence based public health education as a control measure.
  8. Provide a decision tree that has automated feedback that has standard of care including quarantine, call helpline, seek medical attention and avoid spread of the disease.

DURATION OF STUDY

We anticipate that the project will be conducted until end of the COVID-19 pandemic. We have initially arranged to conduct baseline survey in 4 weeks and follow up study for 12 months.

 

Health Workers Covid-19 Exposure Risk

Coronavirus disease (COVID-19) was first detected in Wuhan city, China in December 2019 and on 11 March 2020, the WHO Director General declared COVID-19 a pandemic.

Current available evidence is that the COVID-19 virus is transmitted between people through close contact and droplets. People most at risk of infection are those who are in contact with a COVID-19 patient and/or who care for COVID-19 patients. This inevitably places healthcare workers at an increased risk of infection.

As part of our ethically approved COVID-19 Open Cohort Study, we are doing a survey to determine the risks to COVID-19 infection in the line of duty faced by healthcare workers (HCWS) globally, and challenges to their protection during the pandemic.

This survey is only meant for research purposes. We hope to rapidly share the outputs of this survey very objectively with various audiences globally such as Governments, Ministries of Health, Civil Society, Academia, and Grantors.

Participation in this study is completely voluntary and your responses will be strictly confidential. Data from this research will be reported only in the aggregate. Your information will remain confidential.

 

Covid-19 Economic Impact

Following the sudden outbreak of the coronavirus (COVID-19) all walks of life have been affected including business.

This survey is only meant for research purposes; to seek out the challenges faced by you/your company and hence make recommendations. The recommendations will be discussed with stakeholders such as Government, financial institutions, regulators etc. The information and data are strictly confidential. Any commercial use of these data is prohibited.

It takes approximately 10 minutes to complete this questionnaire. We will publish only aggregated, anonymous results.

This survey is initiated by Mbale Clinical Research Institute, Uganda and University of Exeter, UK (Health Economics Group).

COVID-19 OCS Study Summary

  • Study Type: Voluntary Online Cohort Study
  • Focus: Understanding COVID-19 case definitions, incidence, clinical spectrum, and outcomes across populations.

Objectives:

  • Identify risk factors and incidence rates.
  • Refine case definitions.
  • Explore the epidemiology and outcomes by demographics.
  • Provide automated feedback for COVID-19 care recommendations.

Additional Surveys:

  • Healthcare Workers: Risk assessment of COVID-19 exposure and challenges in the line of duty.
  • Economic Impact: Surveying COVID-19 effects on businesses for policy recommendations.

Duration: Active until the end of the pandemic.

About

Denis Amorut serves as the Study Site Coordinator at the Mbale Clinical Research Institute’s Soroti Site. He is a qualified Registered Nurse with a Bachelor of Science in Health Services Management from the Islamic University in Uganda and a Diploma in Comprehensive Nursing from Soroti School of Registered Comprehensive Nursing. Additionally, he is currently pursuing an Advanced Postgraduate Diploma in Clinical Research & Quality Assurance at James Lind Institute, showcasing his commitment to advancing his expertise in clinical research. Denis has an extensive professional background with 12 years in clinical nursing practice and 11 years dedicated to clinical research. He is registered with the Uganda Midwives and Nurses Council, highlighting his professional standing in the healthcare sector.
 
Throughout his career, Denis has held significant positions such as Trial Manager since November 2021 and previously as Study Site Coordinator at Soroti Regional Referral and Teaching Hospital from 2008 to October 2021. He also serves as a member of the Medicine and Therapeutic Committee at the same hospital since 2018. Denis has enriched his knowledge and skills through numerous online courses and certifications in areas like research ethics, data management for clinical studies, Good Clinical Practice (GCP), and managing health emergencies like Covid-19. His involvement in various research studies, including the TRACT study, and his roles in hospital committees further demonstrate his dedication to both practice and research in healthcare, focusing on improving patient care through evidence-based practices.

About

Ms. Linda Isabirye serves as the Public and Community Engagement Officer at MCRI, where her role encompasses a variety of tasks aimed at enhancing the Institute’s interaction with both internal and external communities. Her work is divided into two primary focuses: public engagement, where she communicates the Institute’s research and ideas to the public, and community engagement, where she assists others in conducting research and achieving their objectives.

In her community engagement efforts, Linda is involved in developing and sustaining a public engagement and involvement framework for the research program. She identifies local opportunities for community collaboration, nurturing relationships with MCRI’s research scientists, staff, and the broader community.

With over two years of experience, she has worked extensively with diverse community stakeholders. Her responsibilities include coordinating activities for the Community Advisory Board (CAB), designing, and overseeing the execution of Community Engagement (CE) initiatives. These initiatives are crucial for identifying, recruiting, and retaining volunteers, engaging community leadership, and supporting the formation and operation of community peer groups. This includes working with study participants, family support groups, and youth and adolescent groups, among others.

About

Rita Muhindo holds a MSc. Molecular Biology from Staffordshire University, UK. She attained her BSc. Biomedical Laboratory Science and Technology degree from Makerere University and an Advanced Diploma in Health Services Management from Islamic University in Uganda. She joined Mbale Clinical Research Institute in July 2011 as a laboratory technologist participating in setting up various laboratory assays for all clinical trials at the MCRI.

She is currently the laboratory manager of MCRI, a role which involves supervision all laboratory research activities at MCRI main and satellite laboratories. She has over twelve years of experience in managing laboratory clinical research and diagnostics service delivery across several key disciplines including molecular, immunology, hematology, microbiology and clinical chemistry.

She has keen interest in understanding the prevalence of red cell polymorphisms present in Ugandan donor populations. Her main focus of her MSc project was on the prevalence of Glucose-6-Phosphate dehydrogenase deficiency, α-thalassaemia and Haemoglobin S among Ugandan donors. Rita is also keen to explore the effects of these polymorphisms on the resolution of severe anaemia.

About

Dr. Charles Benard Okalebo is a highly qualified professional with a B. Pharm, an MPH, and currently a fellow in Infectious Disease and Field Epidemiology under the EDCTP-funded IDEA fellowship. His background as a pharmacist and public health specialist, combined with his role as a Quality Assurance Officer, has provided him with extensive experience in clinical research. This diverse training has honed his skills in assessing healthcare gaps, identifying problems, and designing projects to address these deficiencies. Dr. Okalebo values accuracy, integrity, quality, and career growth above all.
 
He is an experienced and determined professional in conducting clinical trials for both infectious and non-infectious diseases. With eight years in the research field, he has served as a Pharmacist and Quality Assurance Officer at the Mbale Clinical Research Institute, focusing on various types of clinical trials related to infectious diseases. His involvement spans across all phases of clinical trials (I-III), including protocol design, review, and implementation; navigating regulatory approval processes; managing investigational medicinal products (IMP); monitoring studies; establishing and implementing Quality Management processes; pharmacovigilance; and leading training sessions on the ethical conduct of research. The trials he has participated in include TRACT (ISRCTN84086586), GASTROSAM (ISRCTN76149273), PAC (ISRCTN11594437), FLACSAM (ISRCTN18051843), MIMBLE (ISRCTN10309022), and TABS (ISRCTN49726849) studies.
 
Dr. Okalebo is a dedicated researcher with a keen interest in advancing his career in pharmaco-epidemiology, statistics, and pharmacovigilance.

About

Felix Opio joined the Mbale Clinical Research Institute (MCRI) in April 2014 as Data Manager under the REACH (Realizing Effectiveness Across Continents with Hydroxyurea) ClinicalTrials.gov NCT01966731) which is a prospective, Phase I/II open-label trial of hydroxyurea designed to evaluate the feasibility, safety, long-term risks and benefits of hydroxyurea treatment for children with SCA in four sub-Saharan African countries (Mable Uganda,Kilifi Kenya, Luanda Angola and Kinshasa DRC).

He holds a Bachelor of Science in Computer Science from Gulu University, a post graduate diploma in Monitoring and Evaluation from Uganda Management Institute (UMI), Certificate in Project Management Professional from Devimpact Institute Kenya and various other certification in Clinical database development.

He Has 9 years of experience in Clinical Database design and Management, He is Currently overseeing data management work for the REACH study and all the day to day activities of the Project, He is also a member of the internal Clinical Trial Monitoring Unit and A chairperson Procurement Committee for Mbale Clinical Research Institute.

About

Ebitu Caleb Daniel serves as an I.T Support Officer at the Mbale Clinical Research Institute. He is recognized as an accomplished network and systems administrator, who takes pleasure in applying his skills to support and contribute to the technological advancement of research within the institution.
 
Ebitu graduated from Uganda Christian University Mukono with a Bachelor’s degree in Computer Science. Over the years, he has also acquired various certifications including CCNA, Information Security, Google Cloud Developer, PMP (Telecom), and Federated Identity Management.

About

Laban has accumulated over four years of experience in managing research financial processes since joining the Mbale Clinical Research Institute on July 1, 2019, as an Accounts Assistant. This experience complements his extensive background of over ten years in the banking sector, where he has previously worked for two banks in roles involving people management, cash management, internal controls, and accountability.

He holds a Bachelor’s degree in Business Studies, specializing in Accounting, from the Islamic University of Uganda. He is currently pursuing a Certificate of Public Accountants (CPA) from the Institute of Certified Public Accountants of Uganda (ICPAU), with only two papers remaining to complete the course.

Driven by an ambition to advance his career in accounting and expand his experience in research-related accounting managed by well-established systems and processes, he believes that MCRI is the ideal place for his professional growth.