COVID Convalescent Plasma (CCP) and Its Compassionate Use

Background. COVID Convalescent Plasma (CCP) has been used worldwide to treat hospitalized patients with moderate/severe COVID-19 since the beginning of SARS-CoV-2 pandemia with encouraging results in non randomized trials and evidence of little or no benefit on outcome in randomized controlled trials. Although in Italy CCP use is restricted to clinical trials a compassionate use is randomly requested and approved by Ethical Committees (ECs). In our Hospital EC approved compassionate use based on initially supposed benefits in some subgroup of patients. This subset of patients is represented by pharmacologically B depleted subjects, patients with severe immunosuppression due to haematological malignancies treatments (HMT) or with congenital immune deficiency (CID). Methods. In our hospital from October 2020 to May 2021 CCP compassionate use was approved for 14 patients with demonstrated SARS-CoV-2 infection resulted negative to anti-SARS-CoV-2 antibodies screening at time of EC approval. They were 10 males and 4 females, mean age 63,6 yrs (range 25-82). 7 pts in B cell depletion therapy for NHL, 3 pts with immune suppression due to HMT, 2 pts with CID and 2 patients for ingravescent worsening of respiratory failure. All patients signed a written consent and were treated with the 3 highest available titre units of ABO compatible CCP on day 1,3 and 5 after EC approval. SARS-CoV-2-RNA was measured on plasma samples on day 0,2,4,6 as well as anti-SARS-CoV-2 antibodies titre. Results. 5 out of 14 pts died during hospitalization (35,7%): the 2 patients treated for worsening of COVID-19 (100%) and 3 out 12 severe immune suppressed subjects (25%) 2 of whom were treated very late during the course of infection when an ARDS was already developed. 9 patients severely immune deficient cleared the infection and were discharged from the hospital. Conclusions. Mortality rate amongst haematological patients with SARS-CoV-2 infection are high because of comorbidities and results of multiple chemotherapy cicles. There are some evidences that early treatment of immune compromised patients with CCP could be of help in clearing the infection before compromission of lung function develope. Nevertheless no conclusion will be possible until also this subset of patients will be submitted to randomized controlled trials. For this reason compassionate use should be discouraged.