What are the sequelae of COVID-19? Join our COVID-19 clinical trial study and help find the consequences of this disease!
Collaborate and participate with us!
Sites are welcome to download the open-access patient data collection and consent form as well as the protocol to contribute to combined analysis to forward knowledge into COVID-19.
Description of the Study:
- Title: ISARIC Global COVID-19 Long term Follow up Study.
- Principal Investigator: Louise Sigfrid.
- Co-Investigators: John Amuasi, Fernando Bozza, Ibrahim Richard Bangura, Anders Benjamin Kildal, Jan Cato Holter, Antonia Ho, Lance Turtle, Clark Russell, Jordi Rello, Daniel Munblit, Anne Margarita Dyrholt-Riise, Carlo Palmieri, Edwin Jesudason, Wei Shen Lim, Muge Cevik, Tom Drake, Katrina Hann, Anna Beltrame, Madiha Hashmi, Sulaiman Lakoh, Jo McPeake, Colin Berry, David Lowe, Natalie Elkheir and Janet Scott.
- Center of Implementation: Multicentric.
- Study Population: It will enroll patients following a diagnosis of COVID-19.
- Study Type: International prospective and observational multi-site study.
- Design: Patients diagnosed with COVID-19. They will be separated into two different groups:
- Level 1, which will be developed follow up patients day 28 post-discharge (0/2-3 months). Additionally, depending on need and resources, they will also be followed up at 3 to 6 months intervals up to 3 to 5 years, depending on need and resources. Modules of this level can serve to identify subsets of patients experiencing specific symptomatology or syndromes for further follow-up.
- Level 2 modules, will be developed for further in-clinic, in-depth follow-up of a subset of patients experiencing persistent symptomatology.
Objectives of the Study:
Principal Objective: Characterise physical and psychosocial consequences in patients post-COVID-19.
Secondary Objective: Stimate the frequency and risk factors for post-COVID-19 medical sequelae, psychosocial consequences, and post-COVID-19 mortality. A subset of patients will have sampling to characterize longer-term antibody and cell-mediated immune responses to SARS-CoV-2.
More about this Study:
Scientific Context: Very little is known about possible clinical sequelae that may persist after resolution of the acute COVID-19.
However, a recent longitudinal cohort from Italy, including 143 patients who recovered after hospitalization with COVID-19, reported that 87% had at least one ongoing symptom at 60-day follow-up.
In fact, early indications suggest that patients with COVID-19 may need even more psychological support than typical ICU patients. Nevertheless, the assessment of risk factors for longer-term consequences requires a longitudinal study linked to data on pre-existing conditions and care received during the acute phase of the illness.
Hence, the ISARIC Global COVID-19 follow-up working group has, in collaboration with a range of experts, developed a protocol and a patient survey to assess the long-term health and psychosocial consequences of COVID-19.
Don’t hesitate to join this covid-19 clinical trial study and help find out the consequences of this disease!