Prioritizing COVID-19 Clinical Research Needs in Low-Resource Settings
Since the beginning of the COVID-19 pandemic, there has been a limited focus on the needs of low-resource settings, including of clinical research priorities. The “global” research response has largely been conducted by stakeholders from or based in the Global North in response to their own needs.
With few exceptions, funding and prioritization of the clinical research priorities in low-resource settings has been inadequate.
Important work has been done by other organizations to identify global or region-specific research priorities, including by the World Health Organization, the Africa CDC, the African Academy of Sciences, and others.
One of the challenges has been to reduce longer priority lists or less detailed priority areas to just a few specific “top” priorities. Several working groups of topic-specific experts in the COVID-19 Clinical Research Coalition have worked together to identify the top 5 research priorities in their respective domains, from clinical epidemiology to virology, immunology and diagnostics.
Working group members undertook a collaborative exercise, referring to existing research priority lists (see links above) and brainstorming, holding consensus-based meetings, and in some cases running multi-language surveys and using a Delphi-like process to finalize lists of questions that had not yet been adequately addressed in current research, as well as questions for which available evidence was insufficient. In this exercise, coalition members adopted a bottom-up approach to identify the challenges most relevant in low-resource settings without being regional-specific.
Clinical Epidemiology Working Group
- What signs and symptoms can confirm the clinical diagnosis of COVID-19?
- What clinical findings (signs, symptoms, biomarkers, and imaging) are associated with a worse prognosis in COVID-19?
- What is the best strategy to achieve treatment goals in patients with non-communicable diseases (NCDs) during the COVID-19 pandemic?
- What are the short, mid-, and long-term post-infectious sequelae of COVID-19?
- What is the COVID-19 Infection Fatality Rate in low and middle countries, including stratification by age?
- What is the excess mortality of non-COVID-19 in low- and middle-income countries (LMIC) during the pandemic?
PICO format of these questions will be available soon.
Maternal, Newborn and Child Health Working Group
Access to healthcare, treatment and vaccination trials for women and children during the COVID-19 pandemic
- What are the effects of the pandemic response on availability of and access to maternal, sexual and reproductive health, child and adolescent health services?
- What is the safety and efficacy of treatment for SARS-COV2 in pregnant women and children? What are the ethical considerations that would enable women and children to be included in COVID19 treatment and vaccination clinical trials?
- Are women in LMICs able to access antenatal care? If access is reduced, what are the main barriers and how can they be overcome?
Direct effects of the SARS-CoV-2 virus on pregnant and breastfeeding women and children
- Are pregnant women with COVID-19 at increased risk of hospitalisation, intensive care unit admission and death compared to non-pregnant women? What is the immunopathological basis for these outcomes?
- What is the pathophysiology of severe COVID-19 infection in children?
- What is the immunopathological mechanism of PIMS-TS?
Indirect effects of the COVID-19 pandemic on pregnant and breastfeeding women and children
- What is the effect of the pandemic on maternal and child mental health?
- What are the main social drivers in the rise in sexual and gender-based violence during the COVID-19 pandemic?
- What are the long-term effects of the COVID-19 restrictions on early childhood development?
- How has the disruption of routine childhood disease prevention and surveillance affected future rates of vaccine preventable diseases?
Transmission of the SARS-CoV-2 virus and protection from infection
- Do antibodies against the SARS-CoV-2 virus expressed in breastmilk confer protective immunity against the SARS-CoV-2 virus in infants?
- What are the neurodevelopmental effects of SARS-CoV-2 exposure in utero?
- What proportion of SARS-CoV-2 community transmission is by children?
Social Science Working Group
- How are COVID-19 public health decisions and the trajectory of the epidemic affected by each country’s political-economic context?
- How are political actors using COVID-19 to leverage political agendas? How has the COVID-19 pandemic and response been shaped by political priorities? What reactions have we seen to this?
- How does the political-economic context affect public trust in the response? How does this impact uptake of public health guidance or trust in health and medical providers?
Clinical trials and vaccine deployment
- How can governments and COVID-19 country coordinating bodies improve public trust, acceptability, effectiveness, and uptake of COVID-19 vaccines and therapeutics? How have rumors and misinformation affected these processes?
- What forms of community engagement have been ongoing in COVID-19 clinical trials? How might community engagement be increased or systematized for COVID-19 clinical trials?
- With increasing nationalism, how might countries in the Global South access COVID-19 vaccines and therapeutics once available?
- How are issues of social justice reflected in competition over and access to COVID-19 therapeutics and vaccines?
- How are borders being settled or re-affirmed conceptually? What are challenges related to transnational or regional collaboration and how is this affected by the hardening of national borders?
- How are transnational populations (border communities, transnational migrants) affected by dynamics of the pandemic, nationalism, and national-level public health response? How are transnational populations affected by and represented in COVID-19 policymaking?
Preventative and health-seeking behavior
- How does trust in various public health actors affect health-seeking behavior? How might multiple uncertainties around the pandemic, including prevention and treatment, affect how and when individuals engage in preventative or treatment-seeking behavior?
- How do individuals understand the social construction of risk and how does this drive when and how to seek health care for COVID-19? How does the general population perceive, understand, construct, COVID-19 risk and how does it affect their practices?
- How is COVID-19 stigma and other forms of social stigma affecting health-seeking behavior?
- How are vulnerabilities and social difference manifesting in health care access and ability to engage in health-seeking behavior?
- What are the secondary health impacts of COVID-19? How is a vertical COVID-19 response affecting health-seeking behavior for other non-COVID medical needs?
Virology, Immunology, and Diagnostics Working Group
- What is the feasibility and performance of “alternative” samples (nasal/saliva/oropharyngeal) for self-administered collection?
- What is the impact on serological test performance of different disease backgrounds (e.g., malaria, HIV, TB)?
- What is the role of antigen tests in different populations and settings?
- Are PCR testing results (e.g., cycle threshold) associated with infectivity?
- What are the various approaches to setting up biobanks of COVID-19 samples?
PICO format of these questions will be available soon.