COVID-19Phase 3PassItOnNCT04362176
Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults
A Phase 3 study testing pathogen reduced SARS-CoV-2 convalescent plasma in people with COVID-19 and Coronavirus, run by Vanderbilt University Medical Center at 26 sites in United States.
Trial summary
The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Coronavirus, SARS-CoV-2
- What is being tested?
- pathogen reduced SARS-CoV-2 convalescent plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 974 participants
- Where
- 26 sitesUnited States
- Study dates
- 24 Apr 2020to 6 Aug 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Currently hospitalized or in an emergency department with anticipated hospitalization
- Symptoms of acute respiratory infection, defined as one or more of the following:
- Cough
- Chills, or a fever (greater than 37.5° C or 99.5° F)
- Shortness of breath, operationalized as a patient having any of the following:
- Subjective shortness of breath reported by a patient or surrogate. ii. Tachypnea with respiratory rate of greater than 22 breaths per minute iii. Hypoxemia, defined as SpO2 less than 92% on room air, new receipt of supplemental oxygen to maintain SpO2 greater than or equal to 92%, or increased supplemental oxygen to maintain SpO2 greater than or equal to 92% for a patient on chronic oxygen therapy
- Laboratory-confirmed SARS-CoV-2 infection within the past 14 days
Who cannot join
- Prisoner
- Unable to randomize within 14 days after onset of acute respiratory infection symptoms
- Patient, legal representative, or physician not committed to full support (Exception: a patient who will receive all supportive care except for attempts at resuscitation from cardiac arrest will not be excluded.)
- Inability to be contacted on Day 29-36 for clinical outcome assessment
- Receipt of any SARS-CoV-2 passive immunity therapy, such as convalescent plasma, monoclonal antibodies, or pooled immunoglobulin, in the past 30 days
- Contraindications to transfusion or history of prior reactions to transfused blood products
Show all 11Show fewer
- Plan for hospital discharge within 24 hours of enrollment
- Previous enrollment in this trial
- Previous laboratory-confirmed SARS-CoV-2 infection before the current illness
- Enrollment in another clinical trial evaluating monoclonal antibodies, convalescent plasma, or another passive immunity therapy
- Prior receipt of SARS-CoV-2 vaccine
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
University of Colorado Denver
Aurora, Colorado, 80045
University of Maryland, Baltimore (University of Maryland Medical Center)
Baltimore, Maryland, 21201
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University at Buffalo/Buffalo General Medical Center
Buffalo, New York, 14203
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Ohio
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center and James Cancer Hospital
Columbus, Ohio, 43210
University of Mississippi Medical Center
Jackson, Mississippi, 39216
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Scripps Health
La Jolla, California, 92037
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Loyola University Medical Center
Maywood, Illinois, 60153
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Meharry Medical College
Nashville, Tennessee, 37208
Newton-Wellelsey Hospital
Newton, Massachusetts, 012462
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Utah Valley Hospital
Provo, Utah, 84604
Virginia Commonwealth University
Richmond, Virginia, 23298
Rochester General Hospital
Rochester, New York, 14621
University of Utah Health
Salt Lake City, Utah, 84132
University of Washington
Seattle, Washington, 98104
MedStar Health Research Institute/MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Official title: Passive Immunity Trial for Our Nation (PassItOn)
The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.
Read the detailed description
After being informed about the study and potential risks, participants confirmed to meet all eligibility criteria who have provided informed consent will be randomized 1:1 to convalescent plasma versus placebo. Transfusion of convalescent plasma or placebo will be administered by clinical or research personnel while the patient is hospitalized on Study Day 1. On Study Days 1-7, participants will be monitored for adverse reactions to the transfusion. Research personnel will also assess patients at Day 14 and Day 28; these assessments will be completed by phone if the participant has been discharged from the hospital.
- Conditions
- COVID-19, Coronavirus, SARS-CoV-2
- Being tested
- pathogen reduced SARS-CoV-2 convalescent plasma, Placebo
- Keywords
- COVID-19 drug treatment, convalescent plasma
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pathogen reduced SARS-CoV-2 convalescent plasmaBiological
Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
PlaceboBiological
Lactated Ringer's solution with multivitamins
| Study group | Role | What they receive |
|---|---|---|
| pathogen reduced SARS-CoV-2 convalescent plasma | Experimental | Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization. Receives: Biological: pathogen reduced SARS-CoV-2 convalescent plasma |
| Placebo | Placebo comparator | Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows:
- Not hospitalized with resumption of normal activities.
- Not hospitalized, but unable to resume normal activities.
- Hospitalized, not on supplemental oxygen.
- Hospitalized, on supplemental oxygen.
- Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
- Hospitalized, on ECMO, invasive mechanical ventilation, or both.
- Death
Measured: Study Day 15
Secondary outcomes (11)
All-location, All-cause 14-day Mortality
All-location, all-cause 14-day mortality; mortality was assessed via EHR review, phone call, social media review
Measured: Baseline to Study Day 14
All-location, All-cause 28-day Mortality
All-location, all-cause 28-day mortality
Measured: Baseline to Study Day 28
Survival Through 28 Days
Number of participants survived through Day 28
Measured: Baseline to Day 28 (assessed on Study Day 29)
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows:
- Not hospitalized with resumption of normal activities.
- Not hospitalized, but unable to resume normal activities.
- Hospitalized, not on supplemental oxygen.
- Hospitalized, on supplemental oxygen.
- Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
- Hospitalized, on ECMO, invasive mechanical ventilation, or both.
- Death
Measured: Baseline to Study Day 3
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows:
- Not hospitalized with resumption of normal activities.
- Not hospitalized, but unable to resume normal activities.
- Hospitalized, not on supplemental oxygen.
- Hospitalized, on supplemental oxygen.
- Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
- Hospitalized, on ECMO, invasive mechanical ventilation, or both.
- Death
Measured: Study Day 8
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows:
- Not hospitalized with resumption of normal activities.
- Not hospitalized, but unable to resume normal activities.
- Hospitalized, not on supplemental oxygen.
- Hospitalized, on supplemental oxygen.
- Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
- Hospitalized, on ECMO, invasive mechanical ventilation, or both.
- Death
Measured: Study Day 29
Oxygen-free Days Through Day 28
Number of days without use of oxygen
Measured: Baseline to Day 28
Ventilator-free Days Through Day 28
Number of days without use of a ventilator
Measured: Baseline to Day 28
Vasopressor-free Days Through Day 28
Number of days without use of vasopressors
Measured: Baseline to Day 28
ICU-free Days Through Day 28
Number of days outside of ICU
Measured: Baseline to Day 28
Hospital-free Days Through Day 28
Number of days outside of the hospital
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start24 Apr 2020
- Primary completion6 Jul 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomized 1:1 to convalescent plasma versus lactated Ringer's solution with multivitamins. Randomization will be completed in permuted blocks and stratified by site, gender, and age. Participants, treating clinicians and outcomes assessors will all be blinded to study group assignment. Study personnel will not be blinded to the study group assignment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 974 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dolly Parton, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Todd Rice, Vanderbilt University Medical Center
- Investigators
- Todd Rice, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362176
- Sponsor's protocol ID
- 200738
- Other IDs
- 3UL1TR002243-04S3
- Acronym
- PassItOn
- Status last verified
- Oct 2022
- First submitted
- 21 Apr 2020
- Last updated
- 3 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Del Rio C, Malani PN. COVID-19-New Insights on a Rapidly Changing Epidemic. JAMA. 2020 Apr 14;323(14):1339-1340. doi: 10.1001/jama.2020.3072. No abstract available.
PubMed 32108857Fauci AS, Lane HC, Redfield RR. Covid-19 - Navigating the Uncharted. N Engl J Med. 2020 Mar 26;382(13):1268-1269. doi: 10.1056/NEJMe2002387. Epub 2020 Feb 28. No abstract available.
PubMed 32109011Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.
PubMed 32187464Casadevall A, Scharff MD. Return to the past: the case for antibody-based therapies in infectious diseases. Clin Infect Dis. 1995 Jul;21(1):150-61. doi: 10.1093/clinids/21.1.150.
PubMed 7578724Casadevall A, Dadachova E, Pirofski LA. Passive antibody therapy for infectious diseases. Nat Rev Microbiol. 2004 Sep;2(9):695-703. doi: 10.1038/nrmicro974.
PubMed 15372080Sahr F, Ansumana R, Massaquoi TA, Idriss BR, Sesay FR, Lamin JM, Baker S, Nicol S, Conton B, Johnson W, Abiri OT, Kargbo O, Kamara P, Goba A, Russell JB, Gevao SM. Evaluation of convalescent whole blood for treating Ebola Virus Disease in Freetown, Sierra Leone. J Infect. 2017 Mar;74(3):302-309. doi: 10.1016/j.jinf.2016.11.009. Epub 2016 Nov 17.
PubMed 27867062Arabi YM, Hajeer AH, Luke T, Raviprakash K, Balkhy H, Johani S, Al-Dawood A, Al-Qahtani S, Al-Omari A, Al-Hameed F, Hayden FG, Fowler R, Bouchama A, Shindo N, Al-Khairy K, Carson G, Taha Y, Sadat M, Alahmadi M. Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia. Emerg Infect Dis. 2016 Sep;22(9):1554-61. doi: 10.3201/eid2209.151164.
PubMed 27532807Zhang JS, Chen JT, Liu YX, Zhang ZS, Gao H, Liu Y, Wang X, Ning Y, Liu YF, Gao Q, Xu JG, Qin C, Dong XP, Yin WD. A serological survey on neutralizing antibody titer of SARS convalescent sera. J Med Virol. 2005 Oct;77(2):147-50. doi: 10.1002/jmv.20431.
PubMed 16121363Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
PubMed 31995857Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
PubMed 31978945Perlman S. Another Decade, Another Coronavirus. N Engl J Med. 2020 Feb 20;382(8):760-762. doi: 10.1056/NEJMe2001126. Epub 2020 Jan 24. No abstract available.
PubMed 31978944Su S, Wong G, Shi W, Liu J, Lai ACK, Zhou J, Liu W, Bi Y, Gao GF. Epidemiology, Genetic Recombination, and Pathogenesis of Coronaviruses. Trends Microbiol. 2016 Jun;24(6):490-502. doi: 10.1016/j.tim.2016.03.003. Epub 2016 Mar 21.
PubMed 27012512Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol. 2019 Mar;17(3):181-192. doi: 10.1038/s41579-018-0118-9.
PubMed 30531947Cheng PK, Wong DA, Tong LK, Ip SM, Lo AC, Lau CS, Yeung EY, Lim WW. Viral shedding patterns of coronavirus in patients with probable severe acute respiratory syndrome. Lancet. 2004 May 22;363(9422):1699-700. doi: 10.1016/S0140-6736(04)16255-7.
PubMed 15158632Hui DS, Azhar EI, Kim YJ, Memish ZA, Oh MD, Zumla A. Middle East respiratory syndrome coronavirus: risk factors and determinants of primary, household, and nosocomial transmission. Lancet Infect Dis. 2018 Aug;18(8):e217-e227. doi: 10.1016/S1473-3099(18)30127-0. Epub 2018 Apr 18.
PubMed 29680581
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Immunity Trial for Our Nation (PassItOn)
- ClinicalTrials.gov ID
- NCT04362176
- Acronym / sponsor ID
- PassItOn / 200738
- Conditions
- COVID-19, Coronavirus, SARS-CoV-2
- Keywords
- COVID-19 drug treatment, convalescent plasma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 974 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Dolly Parton, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 6 Jul 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Posted 3 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.
Detailed description
After being informed about the study and potential risks, participants confirmed to meet all eligibility criteria who have provided informed consent will be randomized 1:1 to convalescent plasma versus placebo. Transfusion of convalescent plasma or placebo will be administered by clinical or research personnel while the patient is hospitalized on Study Day 1. On Study Days 1-7, participants will be monitored for adverse reactions to the transfusion. Research personnel will also assess patients at Day 14 and Day 28; these assessments will be completed by phone if the participant has been discharged from the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomized 1:1 to convalescent plasma versus lactated Ringer's solution with multivitamins. Randomization will be completed in permuted blocks and stratified by site, gender, and age. Participants, treating clinicians and outcomes assessors will all be blinded to study group assignment. Study personnel will not be blinded to the study group assignment.
| Arm | Type | Receives |
|---|---|---|
| pathogen reduced SARS-CoV-2 convalescent plasma | Experimental | Biological: pathogen reduced SARS-CoV-2 convalescent plasmaTransfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age greater than or equal to 18 years
- Currently hospitalized or in an emergency department with anticipated hospitalization
- Symptoms of acute respiratory infection, defined as one or more of the following:
- Laboratory-confirmed SARS-CoV-2 infection within the past 14 days
Key exclusion criteria (11 listed)
- Prisoner
- Unable to randomize within 14 days after onset of acute respiratory infection symptoms
- Patient, legal representative, or physician not committed to full support (Exception: a patient who will receive all supportive care except for attempts at resuscitation from cardiac arrest will not be excluded.)
- Inability to be contacted on Day 29-36 for clinical outcome assessment
- Receipt of any SARS-CoV-2 passive immunity therapy, such as convalescent plasma, monoclonal antibodies, or pooled immunoglobulin, in the past 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pathogen reduced SARS-CoV-2 convalescent plasmaConvalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection. | Biological | pathogen reduced SARS-CoV-2 convalescent plasma |
| PlaceboLactated Ringer's solution with multivitamins | Biological | Placebo |
Primary outcome
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
Time frame: Study Day 15
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
11 secondary outcomes
All-location, All-cause 14-day Mortality
Time frame: Baseline to Study Day 14
All-location, All-cause 28-day Mortality
Time frame: Baseline to Study Day 28
Survival Through 28 Days
Time frame: Baseline to Day 28 (assessed on Study Day 29)
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3
Time frame: Baseline to Study Day 3
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8
Time frame: Study Day 8
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29
Time frame: Study Day 29
Oxygen-free Days Through Day 28
Time frame: Baseline to Day 28
Ventilator-free Days Through Day 28
Time frame: Baseline to Day 28
Vasopressor-free Days Through Day 28
Time frame: Baseline to Day 28
ICU-free Days Through Day 28
Time frame: Baseline to Day 28
Hospital-free Days Through Day 28
Time frame: Baseline to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32108857Del Rio C, Malani PN. COVID-19-New Insights on a Rapidly Changing Epidemic. JAMA. 2020 Apr 14;323(14):1339-1340. doi: 10.1001/jama.2020.3072. No abstract available.
- Background: PubMed 32109011Fauci AS, Lane HC, Redfield RR. Covid-19 - Navigating the Uncharted. N Engl J Med. 2020 Mar 26;382(13):1268-1269. doi: 10.1056/NEJMe2002387. Epub 2020 Feb 28. No abstract available.
- Background: PubMed 32187464Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.
- Background: PubMed 7578724Casadevall A, Scharff MD. Return to the past: the case for antibody-based therapies in infectious diseases. Clin Infect Dis. 1995 Jul;21(1):150-61. doi: 10.1093/clinids/21.1.150.
- Background: PubMed 15372080Casadevall A, Dadachova E, Pirofski LA. Passive antibody therapy for infectious diseases. Nat Rev Microbiol. 2004 Sep;2(9):695-703. doi: 10.1038/nrmicro974.
- Background: PubMed 27867062Sahr F, Ansumana R, Massaquoi TA, Idriss BR, Sesay FR, Lamin JM, Baker S, Nicol S, Conton B, Johnson W, Abiri OT, Kargbo O, Kamara P, Goba A, Russell JB, Gevao SM. Evaluation of convalescent whole blood for treating Ebola Virus Disease in Freetown, Sierra Leone. J Infect. 2017 Mar;74(3):302-309. doi: 10.1016/j.jinf.2016.11.009. Epub 2016 Nov 17.
- Background: PubMed 27532807Arabi YM, Hajeer AH, Luke T, Raviprakash K, Balkhy H, Johani S, Al-Dawood A, Al-Qahtani S, Al-Omari A, Al-Hameed F, Hayden FG, Fowler R, Bouchama A, Shindo N, Al-Khairy K, Carson G, Taha Y, Sadat M, Alahmadi M. Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia. Emerg Infect Dis. 2016 Sep;22(9):1554-61. doi: 10.3201/eid2209.151164.
- Background: PubMed 16121363Zhang JS, Chen JT, Liu YX, Zhang ZS, Gao H, Liu Y, Wang X, Ning Y, Liu YF, Gao Q, Xu JG, Qin C, Dong XP, Yin WD. A serological survey on neutralizing antibody titer of SARS convalescent sera. J Med Virol. 2005 Oct;77(2):147-50. doi: 10.1002/jmv.20431.
- Background: PubMed 31995857Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.
- Background: PubMed 31978945Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
- Background: PubMed 31978944Perlman S. Another Decade, Another Coronavirus. N Engl J Med. 2020 Feb 20;382(8):760-762. doi: 10.1056/NEJMe2001126. Epub 2020 Jan 24. No abstract available.
- Background: PubMed 27012512Su S, Wong G, Shi W, Liu J, Lai ACK, Zhou J, Liu W, Bi Y, Gao GF. Epidemiology, Genetic Recombination, and Pathogenesis of Coronaviruses. Trends Microbiol. 2016 Jun;24(6):490-502. doi: 10.1016/j.tim.2016.03.003. Epub 2016 Mar 21.
- Discovery of a novel coronavirus associated with the recent pneumonia outbreak in humans and its potential bat originLink provided by the sponsor.
- China puts 245 COVID-19 patients on convalescent plasma therapy - XinhuaLink provided by the sponsor.
- WHO \| Coronavirus disease (COVID-2019) R\&DLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Rice, MD principal investigator
Vanderbilt University Medical Center
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pathogen reduced SARS-CoV-2 convalescent plasma in people with COVID-19 and Coronavirus, run by Vanderbilt University Medical Center at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score (time frame: Study Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04362176, which also lists 53 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.