Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults

For the Passive Immunity Trial for Our Nation (PassITON) Investigators

doi:10.1186/s13063-021-05171-2

Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults

For the Passive Immunity Trial for Our Nation (PassITON) Investigators

Research output: Contribution to journal › Article › peer-review

11 Scopus citations

Abstract

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.

Original language	English (US)
Article number	221
Journal	Trials
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s13063-021-05171-2
State	Published - Dec 2021

Bibliographical note

Funding Information:
Primary funding for this work was provided by the NCATS award 3UL1TR002243-04S3. Funding for REDCap, trial innovation work, and the other tools was provided by NCATS award No. UL1TR002243. Funding for pilot work was provided by the Dolly Parton COVID-19 Research Fund.

Funding Information:
The PassITON trial launched in April 2020 as a single-center study at Vanderbilt University Medical Center with funding from the Dolly Parton COVID-19 Research Fund. The trial expanded to a multicenter study in August 2020 with funding from the NCATS of the National Institutes of Health (NIH). Prior to expansion to the multicenter format, 66 participants had been enrolled at Vanderbilt. Interim analyses conducted by the independent DSMB after enrollment and completion of the primary outcome by 151 and 469 study participants resulted in recommendations to continue the study without modification. PassITON is currently enrolling under protocol version 5.0 dated September 15, 2020. Trial completion is expected by May 31, 2021. Acknowledgements Disclaimer

Publisher Copyright:
© 2021, The Author(s).

Keywords

COVID-19
Clinical trials
Neutralizing antibodies
Passive immunity
Randomized controlled trial
SARS-CoV-2: convalescent plasma

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1186/s13063-021-05171-2

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title = "Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults",

abstract = "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.",

keywords = "COVID-19, Clinical trials, Neutralizing antibodies, Passive immunity, Randomized controlled trial, SARS-CoV-2: convalescent plasma",

author = "{For the Passive Immunity Trial for Our Nation (PassITON) Investigators} and Self, {Wesley H.} and Stewart, {Thomas G.} and Wheeler, {Allison P.} and {El Atrouni}, Wissam and Bistran-Hall, {Amanda J.} and Casey, {Jonathan D.} and Cataldo, {Vince D.} and Chappell, {James D.} and Cohn, {Claudia S.} and Collins, {Jessica B.} and Denison, {Mark R.} and {de Wit}, Marjolein and Dixon, {Sheri L.} and Abhijit Duggal and Edwards, {Terri L.} and Fontaine, {Magali J.} and Ginde, {Adit A.} and Harkins, {Michelle S.} and Thelma Harrington and Harris, {Estelle S.} and Daanish Hoda and Ipe, {Tina S.} and Jaiswal, {Stuti J.} and Johnson, {Nicholas J.} and Jones, {Alan E.} and Maryrose Laguio-Vila and Lindsell, {Christopher J.} and Jason Mallada and Mammen, {Manoj J.} and Metcalf, {Ryan A.} and Middleton, {Elizabeth A.} and Simon Mucha and O{\textquoteright}Neal, {Hollis R.} and Pannu, {Sonal R.} and Pulley, {Jill M.} and Xian Qiao and Raval, {Jay S.} and Rhoads, {Jillian P.} and Harry Schrager and Carl Shanholtz and Shapiro, {Nathan I.} and Schrantz, {Stephen J.} and Isaac Thomsen and Vermillion, {Krista K.} and Bernard, {Gordon R.} and Rice, {Todd W.}",

note = "Funding Information: Primary funding for this work was provided by the NCATS award 3UL1TR002243-04S3. Funding for REDCap, trial innovation work, and the other tools was provided by NCATS award No. UL1TR002243. Funding for pilot work was provided by the Dolly Parton COVID-19 Research Fund. Funding Information: The PassITON trial launched in April 2020 as a single-center study at Vanderbilt University Medical Center with funding from the Dolly Parton COVID-19 Research Fund. The trial expanded to a multicenter study in August 2020 with funding from the NCATS of the National Institutes of Health (NIH). Prior to expansion to the multicenter format, 66 participants had been enrolled at Vanderbilt. Interim analyses conducted by the independent DSMB after enrollment and completion of the primary outcome by 151 and 469 study participants resulted in recommendations to continue the study without modification. PassITON is currently enrolling under protocol version 5.0 dated September 15, 2020. Trial completion is expected by May 31, 2021. Acknowledgements Disclaimer Publisher Copyright: {\textcopyright} 2021, The Author(s).",

year = "2021",

month = dec,

doi = "10.1186/s13063-021-05171-2",

language = "English (US)",

volume = "22",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

number = "1",

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TY - JOUR

T1 - Passive Immunity Trial for Our Nation (PassITON)

T2 - study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults

AU - For the Passive Immunity Trial for Our Nation (PassITON) Investigators

AU - Self, Wesley H.

AU - Stewart, Thomas G.

AU - Wheeler, Allison P.

AU - El Atrouni, Wissam

AU - Bistran-Hall, Amanda J.

AU - Casey, Jonathan D.

AU - Cataldo, Vince D.

AU - Chappell, James D.

AU - Cohn, Claudia S.

AU - Collins, Jessica B.

AU - Denison, Mark R.

AU - de Wit, Marjolein

AU - Dixon, Sheri L.

AU - Duggal, Abhijit

AU - Edwards, Terri L.

AU - Fontaine, Magali J.

AU - Ginde, Adit A.

AU - Harkins, Michelle S.

AU - Harrington, Thelma

AU - Harris, Estelle S.

AU - Hoda, Daanish

AU - Ipe, Tina S.

AU - Jaiswal, Stuti J.

AU - Johnson, Nicholas J.

AU - Jones, Alan E.

AU - Laguio-Vila, Maryrose

AU - Lindsell, Christopher J.

AU - Mallada, Jason

AU - Mammen, Manoj J.

AU - Metcalf, Ryan A.

AU - Middleton, Elizabeth A.

AU - Mucha, Simon

AU - O’Neal, Hollis R.

AU - Pannu, Sonal R.

AU - Pulley, Jill M.

AU - Qiao, Xian

AU - Raval, Jay S.

AU - Rhoads, Jillian P.

AU - Schrager, Harry

AU - Shanholtz, Carl

AU - Shapiro, Nathan I.

AU - Schrantz, Stephen J.

AU - Thomsen, Isaac

AU - Vermillion, Krista K.

AU - Bernard, Gordon R.

AU - Rice, Todd W.

N1 - Funding Information: Primary funding for this work was provided by the NCATS award 3UL1TR002243-04S3. Funding for REDCap, trial innovation work, and the other tools was provided by NCATS award No. UL1TR002243. Funding for pilot work was provided by the Dolly Parton COVID-19 Research Fund. Funding Information: The PassITON trial launched in April 2020 as a single-center study at Vanderbilt University Medical Center with funding from the Dolly Parton COVID-19 Research Fund. The trial expanded to a multicenter study in August 2020 with funding from the NCATS of the National Institutes of Health (NIH). Prior to expansion to the multicenter format, 66 participants had been enrolled at Vanderbilt. Interim analyses conducted by the independent DSMB after enrollment and completion of the primary outcome by 151 and 469 study participants resulted in recommendations to continue the study without modification. PassITON is currently enrolling under protocol version 5.0 dated September 15, 2020. Trial completion is expected by May 31, 2021. Acknowledgements Disclaimer Publisher Copyright: © 2021, The Author(s).

PY - 2021/12

Y1 - 2021/12

N2 - 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.

AB - 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.

KW - COVID-19

KW - Clinical trials

KW - Neutralizing antibodies

KW - Passive immunity

KW - Randomized controlled trial

KW - SARS-CoV-2: convalescent plasma

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U2 - 10.1186/s13063-021-05171-2

DO - 10.1186/s13063-021-05171-2

M3 - Article

C2 - 33743799

AN - SCOPUS:85103230362

SN - 1745-6215

VL - 22

JO - Trials

JF - Trials

IS - 1

M1 - 221

ER -

Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults

Abstract

Bibliographical note

Keywords

UN SDGs

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