Last Review Performed on: April 10th, 2020
If it is feasible to obtain CP through either current eIND or pending expanded access IND, would consider use if approved by ID (??). Ideally, CP would be used earlier in the course of disease, however, current FDA approval applies only to patients with severe/critical illness.
Convalescent Plasma is not currently being studied at the U of M. The FDA is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications (eINDs).
Eligible patients:
Must have laboratory confirmed COVID-19
Must have severe or immediately life-threatening COVID-19, for example:1
Severe disease is defined as:
dyspnea,
respiratory frequency ≥ 30/min,
blood oxygen saturation ≤ 93%,
partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or
lung infiltrates > 50% within 24 to 48 hours
Life-threatening disease is defined as:
respiratory failure,
septic shock, and/or
multiple organ dysfunction or failure
M Health may get access to CP through an expanded FDA IND protocol out of Mayo Clinic (currently under review).
Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Mar 27. PMID: 32219428. Small case series.
Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005;24(1):44–46. PMID: 15616839. Case series describing 80 patients with SARS-CoV1 treated with convalescent sera.
Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011;52(4):447–456. PMID:21248066. Prospective cohort study of 93 patients; 20 pts received CP.
The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. PMID: 25030060. Meta-analysis of 32 studies of SARS-CoV1 and severe influenza.
Neutralizing antibodies in patients with severe acute respiratory syndrome-associated coronavirus infection. J Infect Dis. 2004 Sep 15;190(6):1119-26. Epub 2004 Aug 2. PMID: 15319862. Serologic survey of Nab titer in survivors of SARS-CoV1.