Convalescent Plasma for COVID19
On March 24, 2020, FDA approved the investigational use of convalescent plasma, which contains antibodies to SARS-CoV-2, for patients with serious or life threatening COVID19 disease. COVID19 convalescent plasma (CCP) is a potentially safe and effective, but unproven, therapeutic modality for COVID19 disease.
FDA requires the clinical application of COVID19 convalescent plasma to be conducted under one of three defined pathways. The first is under an emergency use investigational new drug (eIND) application allowing compassionate use in an individual patient with severe or immediately life-threatening COVID19. The second pathway is to apply for an IND to support research, which is the traditional approach for clinical trials. The third pathway is a government-led initiative providing expanded access program (EAP) IND to participating institutions under a master treatment protocol with modest data reporting requirements. Mayo Clinic is the lead institution in the EAP IND for hospitalized patients with defined severe or life-threatening COVID19.
Several trials have been proposed to evaluate CCP for:
- Post-exposure prophylaxis among adults who had close contact exposure to COVID19 but not yet manifested symptoms
- Treatment of patients with confirmed mild disease
- Treatment of moderately ill hospitalized patients who have not been admitted to the intensive care unit admission or required mechanical ventilation
- Rescue therapy for patients requiring mechanical ventilation
- Safety and pharmacokinetics in high-risk pediatric patients.
Convalescent plasma is collected from patients who have recovered from COVID19. Donors must meet the following criteria:
- Documented evidence of COVID19 diagnosis by PCR at the time of illness or positive SARS-CoV-2 antibody after recovery if PCR was not performed
- Symptom free for at least 28 days prior to donation or at least 14 days prior to donation and a negative nasopharyngeal swab by PCR
- Compliance with all blood donor eligibility requirements
Donors are tested for infectious diseases, and ABO and Rh type. Females who have ever been pregnant are tested for HLA antibodies. If present, their plasma will not be used for transfusion. CCP units can be frozen and stored for one year. CCP is for investigational use only and is labeled with a tag stating: “Caution: New Drug--Limited by Federal (or United States) law to investigational use.
Each unit of CCP contains approximately 200 mL and should be ABO compatible with the recipient. The dose is one to two units per patient. Transfusion rate is 100 to 250mL per hour or per hospital policy. After thawing, CCP may be stored for up to five days at 1 to 6 ○C. Possible adverse events are the same as other plasma components.
References
Van Buren, N, et al. COVID-19 Convalescent Plasma-a Potentially Effective Therapeutic Modality, America’s Blood Centers Blood Bulletin 20, No. 2, May 2020.
Dzik S. COVID-19 Convalescent Plasma: Now is the time for better science. Transfusion Medicine Reviews https://doi. org/10.1016/j.tmrv.2020.04.002
Bloch EM, et al. Deployment of convalescent plasma for the prevention and treatment of COVID-19. J Clin Invest 2020. https://doi.org/10.1172/JCI138745.
