Convalescent Plasma as Adjunctive Therapy for Hospitalized Patients with COVID-19: The Co-CLARITY Trial
Deonne Thaddeus, MD V Gauiran, MD Teresita E Dumagay, MD, MoS Mark Angelo C Ang, MD Cecile C Dungog, Monica M Fresthel, MD Climacosa, MD Sandy Chiong Maganito, MD Rachelle N Alfonso, MD Anne Kristine H Quero, MD Josephine Anne C Lucero, MD Carlo Francisco N Cortez, MD Agnes Lorrainne M Evasan, Ruby Anne, MD Natividad King, PhD Francisco M Heralde III, MD Lynn B Bonifacio, MD German J Castillo Jr, MD Ivy Mae S Escasa, Maria Clariza, MD M Santos, MD Anna Flor G Malundo, MD Alric V Mondragon, Saubel Ezreal, MSc A Salamat, MD Januario D Veloso, MD Jose M Carnate Jr, MD Pedrito Y Tagayuna, MD Jodor A Lim, MD Marissa M Alejandria, Ma Angelina, MD L Mirasol
Acta Medica Philippina, doi:10.47895/amp.vi0.4903
Background and Objective. Convalescent plasma therapy (CPT) may reduce the risk of disease progression among patients with COVID-19. This study was undertaken to evaluate the efficacy and safety of CPT in preventing ICU admission among hospitalized COVID-19 patients.
Methods. In this open-label randomized controlled trial, we randomly assigned hospitalized adult patients with COVID-19 in a 1:1 ratio to receive convalescent plasma as an adjunct to standard of care or standard of care alone. The primary endpoint was ICU admission within first 28 days of enrolment. Primary safety endpoints include rapid deterioration of respiratory or clinical status within four hours of convalescent plasma transfusion and cumulative incidence of serious adverse events during the study period including transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO), severe allergic reactions, and transfusion-related infections. Results. A total of 22 patients were assigned to receive convalescent plasma as an adjunct to standard of care and 22 to receive standard of care alone. The median time from onset of COVID-19 symptoms to study enrolment was eight days (IQR, 4 to 10). Two patients (9.1%) in the CPT group and one patient (4.5%) in the control group were admitted to the ICU. The primary outcome measure, ICU admission, was not different between the two groups (q-value >0.9). No patient who received convalescent plasma had rapid deterioration of respiratory/clinical status within four hours of transfusion and none developed TRALI, TACO, anaphylaxis, severe allergic reactions, or transfusion-related infections. There was also no significant difference in the secondary outcomes of 28-day mortality (two patients in the CPT group and none in the control group, q-value >0.90), dialysis-free days, vasopressor-free days, and ICU-free days.
Statement of Authorship DTVG, TED, MACA and FMMC contributed in the conceptualization of work, acquisition and analysis of data, drafting and revising of manuscript, and final approval of the version to be published. CDD contributed in the conceptualization of work, acquisition and analysis of data, and final approval of the version to be published. SCM, RNA, AKHQ, JACL, CFNC, ALME, RANK, FMH, LBB, GJCJ, IMSE, MCMS, AFGM, AVM, JDV, JMCJ, PYT, JAL, MMA and MALM contributed in the conceptualization of work, acquisition of data, and final approval of the version to be published. SEAS contributed in the acquisition and analysis of data, and final approval of the version to be published.
Author Disclosure All authors declared no conflicts of interest.
APPENDIx
Study Participant and Convalescent Plasma Donor Recruitment For the last quarter of 2020, there was also a decreasing number of COVID-19 hospitalizations in UP-PGH. By March 2021, there was a surge in number of COVID-19 admissions, however, these patients were already too toxic to be eligible for the trial. The UP-PGH is home to a lot of ongoing clinical trials (e.g., Solidarity, favipiravir, VCO, tocilizumab, etc.) and non-intervention studies. With the limited number of COVID-19 patients in UP-PGH, these could account for the decreasing number of patients allocated/ referred to our clinical trial. All patients admitted in UP-PGH are invited to join these trials and most of them will consent to join. However, once..
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