Long COVID Syndrome Program

Soon after the onset of the pandemic, it was evident that a percentage of patients continued to experience long-term health issues. Prolonged symptoms impact some 10-25% of COVID patients, often referred to as long haulers, with a condition called Long COVID Syndrome. These patients experience a wide spectrum of symptoms, from fatigue and difficulty concentrating to loss of smell and taste, making clear the necessity of a multi-disciplinary approach to treatment and research. 

To that end, Parexel has brought together experts across therapeutic specialties to create the Parexel Long COVID Syndrome Program. These specialties span infectious disease, pulmonary, cardiology, endocrinology, neurology, genomic medicine, epidemiology and vaccines, covering all age groups including those with co-morbidities. With a holistic approach to networking and sharing, this program serves as a place of reference for customers, sites, and patients. While so much about this syndrome is still unknown, Parexel is committed to addressing the challenges and improving the quality of life for those suffering the long-term consequences of this disease.

Our Regulatory & Access consulting team can help with all aspects of commercial and development strategy. The team includes ~100 former regulators and payers who use their first-hand experience to help you create a development strategy that will foresee and address regulatory and access hurdles to advance your therapies to patients faster.

Parexel has been working with customers on developing COVID-19 treatments since January 2020, contributing to more than 170 COVID-19 trials. Drawing upon years of wide-ranging experience, long-standing alliances and cutting-edge solutions, we can respond quickly, iterating as we go in real-time to a situation that is still extremely fluid.

Patients First

At Parexel, our expertise is focused on supporting customers in developing effective treatments, from Early Phase to Phase IV through regulatory and market access. Essential to this work is understanding the patient’s journey. No one experiences the challenges of Long COVID more than the patients themselves. Alone at home, suddenly untethered from a high-intensity medical environment, they are often anxious and fearful about their long-term recovery. It is imperative that their voices be heard to inform trial design, with an empathetic understanding of their unmet needs and the burden of disease. 

Our Patient Engagement team uses Patient-Centric Protocol Optimization (PCPO) to incorporate patient and caregiver needs, views and experiences into trial planning. This helps create a more patient-friendly study design in areas where patient burden can be eased. This can reduce the practical, geographical and financial barriers to participation and make trial experiences more positive to keep patients motivated and engaged.

Tailored Trial Design

Making it easy for patients to participate in trials is paramount, especially in an uncertain and ever-changing healthcare environment. Parexel has deep expertise in use of technology for in-home visits: decentralized trials, remote monitoring, remote source data verification, tele-health and direct-to-patient delivery of investigational products. Central to this expertise is our Clinical Trial Supply & Logistics services.

Yet in-home care options must be judiciously applied to avoid exacerbating anxieties and leaving ill patients feeling overwhelmed. A hybrid approach enabling the right amount of human contact with caregivers, using dedicated transportation or mobile units, for example, can be the best solution. We work with you to understand your trial requirements, customizing our comprehensive technology solutions to best meet the needs of the study and the patient. 

COVID-19 has disproportionately impacted underserved communities without ready access to medical care opportunities. Participation in clinical trials can bring healthcare that is typically out of their reach. Technology can make their participation possible via design of tailored protocols leveraging solutions such as mobile hotspots. 

Site Alliances and Patient Recruitment

Biopharma currently developing treatments for Long COVID must respond to a fluid environment with few answers and different rules of engagement with patients, healthcare providers and sites. Parexel is the ideal partner under these challenging circumstances. Parexel has long-term strategic alliances with more than 500 of the world’s most experienced research and healthcare institutions, representing a network of more than 20,000 principal investigators. We are in an excellent position to help customers identify, screen and recruit patients for Long COVID.

Further, we can support by nominating institutions that are most capable of handling different protocols for several indications. Acting as a trusted partner with customers, sites, and investigators, we leverage long-standing, trusting relationships and open dialog to ensure effective engagement and clear lines of communication.

Predictive Analysis

By using machine learning-based predictive models and heat maps, our sophisticated data analysis tools can help facilitate optimal clinical site selection based on the prevalence of cases and uncover the impact and implications of public health and decision-making in specific geolocations. Even as new strains of the COVID-19 virus (i.e. SARS-CoV-2) present, Parexel can draw upon months of retrospective data analyses across multiple dynamics and domains to effectively position studies to the correct locations. Incidence patterns and baseline characteristics of patients relative to their response to treatment can be analyzed and heat mapped on an ongoing basis to ensure the most optimal approach. 

The heatmaps below show current and predicted COVID-19 incidence per 100,000 population. Predictions at 28 days are obtained via cross-validated machine learning algorithms, combining population-level data with state-level policies and COVID-19 public health statistics and time series.

We continue to learn more every day, with the aim of understanding how to address the unmet needs of patients with Long COVID Syndrome. Indeed, this is our commitment to putting patients at the heart of everything we do.