The CONCOVID clinical trial is currently one of the largest randomized clinical trial that treats patients that are sick with severe COVID-19 with immune plasma from patients that recovered from COVID-19
The study will include 400 patients from multiple clinical centers in the Netherlands.
Principal investigator: Bart Rijnders, M.D., Ph.D.
Sponsor: Erasmus University Medical Center (Erasmus MC)
Immunization with immunoglobulins is occasionally used as therapy for the treatment of viral infectious disease. For example, CMV disease, VZV disease, rabies and hepatitis B. Neutralizing antibodies have been found against SARS-CoV-2 present in patients who have been infected with SARS-CoV-2. During the 2003 SARS outbreak, convalescent plasma from SARS recovered donors was shown to increase the discharge rate. With no proven effective therapy against COVID-19, this protocol will evaluate the therapeutic potential of therapy with convalescent plasma (convP) from COVID-19 recovered donors.
Study objectives Primary objectives
- Decrease overall mortality in patients within COVID-19 disease
Secondary (exploratory) objectives
- Evaluate the safety of convP in COVID-19 patients
- Investigate the effect of convP on mortality in patients admitted to the ICU
- Evaluate the effect of convP on hospital stay of COVID-19 patients in the ICU and in the non-ICU hospital departments
- Long-term effects of convP therapy on daily functioning and lung function of COVID-19 patients
- Evaluate the impact of plasma therapy on the shedding and spreading of SARS-CoV2 in the airways
Tertiary Immunology research questions
The trial will also enable us to investigate important questions relating to the immune response in patients and donors. We will investigate the impact of SARS-CoV-2 infection on the immune system. How does the virus impact immunity against the virus, can changes in the immune system inform us on the course of the disease and suggest better treatments, can we predict who will benefit from convP treatment.
This trial is a randomized comparative trial. Patients will be randomized between the infusion of 300mL of convP with standard of care.
Patients with PCR confirmed COVID-19 disease, age >18 years.
Donors will be included with a PCR confirmed history of COVID-19 and who have been asymptomatic for at least 24 hours.