Convalescent Plasma to Limit Coronavirus Associated Complications: A Proof of Concept Phase-2 Clinical Study at a designated COVID-19 hospital in Mumbai city

Abstract

Objective: With few treatment options available to manage coronavirus disease 2019 (COVID-19), health systems devised strategies to manage covid-19 using repurposed drugs and revisiting older strategies, such as convalescent plasma. This study was planned to evaluate safety and efficacy of Anti-SARS-CoV-2 convalescent plasma in hospitalized subjects with COVID-19.
 Method: An open label, single centre, two arm, prospective, randomised, controlled exploratory phase 2 study was conducted at a covid-19 designated center. 20 subjects (≥18 years) were admitted to hospital (screened 15 June to 27 July 2020) with confirmed moderate covid-19 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen (PaO2/FiO2) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24/min with oxygen saturation 93% or less on room air): 10 subjects were assigned to convalescent plasma with standard treatment (test arm) and 10 subjects to standard treatment only (control arm). Subjects in the test arm received either single or two doses of convalescent plasma 24 hours apart based on their clinical condition as per investigator’s discretion.
 Results: Subjects in test arm showed earlier resolution of symptoms of fever, shortness of breath and cough and the mean duration for RT-PCR test turning negative was better in the test arm. One subject in the control arm progressed to severe ARDS, while none in test arm progressed to severe ARDS. There was no difference in the use of respiratory support (invasive and non-invasive ventilation) between the 2 arms. There was no mortality observed in the study and no serious adverse reaction observed with the transfusion of convalescent plasma in the study.
 Conclusion: This was an exploratory proof of concept study to explore the effectiveness of convalescent plasma in COVID-19 subjects and sample size was not large enough to detect a statistically significant difference however subjects in test arm of this study showed better outcomes in few of the efficacy parameters as compared to subjects in control arm. The use of convalescent plasma transfusion was also observed to be safe.

Effectiveness of COVID-19 Convalescent Plasma (CCP) During the Pandemic Era: A Literature Review

“…Recently, a mechanism on forecasting the potential benefit of CCP based on patient attributes was also revealed, and which may assist in identifying individuals who will benefit most from the CCP infusion, 105 and as per the findings on 7 recently published RCTs, on treatment of CCP appears to be associated with improved outcomes, among 20 COVID-19 patients. 106 As per the data on CP use for MERS, 107 , 108 was limited, and studies in a small number of SARS patients suggested that CP may improve clinical outcomes when administered early in the illness or in those with severe disease. 41 , 109 , 110 However, CCP treatment was initiated early in pandemic as a short-term strategy of providing immediate passive immunization to susceptible people and managing the disease until an effective and targeted drug could be discovered.…”