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Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial
Wesley H Self1,2, Thomas G Stewart3, Allison P Wheeler4
1Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, 1313 21st Ave South, 312 Oxford House, Nashville, TN, 37232, USA. wesley.self@vumc.org.
Insights
The Passive Immunity Trial for Our Nation (PassITON) investigated if convalescent plasma effectively treats hospitalized COVID-19 patients. Results will clarify plasma therapy
Area of Science:
- Clinical Medicine
- Infectious Diseases
- Immunology
Background:
- Convalescent plasma is widely used for treating coronavirus disease 2019 (COVID-19).
- The clinical efficacy of COVID-19 convalescent plasma remains unclear.
- This study addresses the need for high-quality evidence on plasma therapy.
Purpose of the Study:
- To evaluate the efficacy of COVID-19 convalescent plasma in hospitalized adults with symptomatic disease.
- To provide robust data guiding COVID-19 treatment strategies.
- To inform decisions on future pandemic preparedness for plasma collection and distribution.
Main Methods:
- A multicenter, placebo-controlled, blinded, randomized clinical trial (PassITON) in the USA.
- Adults hospitalized with COVID-19 and respiratory symptoms within 14 days were eligible.
- Patients received 1 unit of neutralizing antibody-confirmed COVID-19 convalescent plasma or placebo, randomized 1:1.
- Primary outcome: clinical status at 14 days post-treatment on a 7-category ordinal scale.
- Secondary outcomes: mortality and oxygen-free days.
- Trial projected to enroll 1000 patients.
Main Results:
- Primary outcome data on clinical status at 14 days will be analyzed.
- Secondary outcomes including mortality and oxygen-free days will be assessed.
- The trial is designed to detect a significant difference in clinical outcomes.
Conclusions:
- The PassITON trial will provide robust evidence on COVID-19 convalescent plasma efficacy.
- Findings will guide current COVID-19 treatment and future pandemic preparedness.
- Results will inform the development of standardized plasma collection and dissemination infrastructure.
Background:
Convalescent plasma is being used widely as a treatment for coronavirus disease 2019 (COVID-19). However, the clinical efficacy of COVID-19 convalescent plasma is unclear.
Methods:
The Passive Immunity Trial for Our Nation (PassITON) is a multicenter, placebo-controlled, blinded, randomized clinical trial being conducted in the USA to provide high-quality evidence on the efficacy of COVID-19 convalescent plasma as a treatment for adults hospitalized with symptomatic disease. Adults hospitalized with COVID-19 with respiratory symptoms for less than 14 days are eligible. Enrolled patients are randomized in a 1:1 ratio to 1 unit (200-399 mL) of COVID-19 convalescent plasma that has demonstrated neutralizing function using a SARS-CoV-2 chimeric virus neutralization assay. Study treatments are administered in a blinded fashion and patients are followed for 28 days. The primary outcome is clinical status 14 days after study treatment as measured on a 7-category ordinal scale assessing mortality, respiratory support, and return to normal activities of daily living. Key secondary outcomes include mortality and oxygen-free days. The trial is projected to enroll 1000 patients and is designed to detect an odds ratio ≤ 0.73 for the primary outcome.
Discussion:
This trial will provide the most robust data available to date on the efficacy of COVID-19 convalescent plasma for the treatment of adults hospitalized with acute moderate to severe COVID-19. These data will be useful to guide the treatment of COVID-19 patients in the current pandemic and for informing decisions about whether developing a standardized infrastructure for collecting and disseminating convalescent plasma to prepare for future viral pandemics is indicated.
Trial Registration:
ClinicalTrials.gov NCT04362176 . Registered on 24 April 2020.
