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| Name | Class |
|---|---|
| New York Blood Center | OTHER |
| Amazon, Inc. | INDUSTRY |
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This randomized blinded multi-center phase 2 trial will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma among adults with severe COVID-19. Adults ≥18 years of age may participate. A total of 219 eligible subjects will be randomized in a 2:1 ratio to receive either high-titer anti-SARS-CoV-2 plasma or non-convalescent fresh frozen plasma (control plasma).
There are few effective therapies for coronavirus disease 2019 (COVID-19) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Exposure to viruses results in an adaptive immune response that commonly include antibodies with neutralization activity. Plasma from subjects who have recovered from viral infections has been used to both prevent or treat disease. Notable examples of the successful use of convalescent plasma (CP) include influenza, measles, Argentine hemorrhagic fever, Middle East respiratory syndrome (MERS), Ebola and severe acute respiratory syndrome (SARS-CoV). Small clinical trials and observational studies of CP therapy in patients with COVID-19 have suggested a possible clinical benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convalescent Plasma (anti-SARS-CoV-2 plasma) | Experimental | Convalescent plasma (1 unit; ~200-250 mL) collected from a volunteer who recovered from COVID-19 disease |
|
| Non-convalescent Plasma (control plasma) | Active Comparator | Non-convalescent plasma (1 unit; ~200-250 mL) of standard plasma collected prior to December 2019 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent Plasma (anti-SARS-CoV-2 plasma) | Biological | Convalescent Plasma that contains antibody titers against SARS-CoV-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Day 28 Severity Outcomes Using a 7-point Ordinal Scale of Clinical Status | Compare the day 28 severity outcome amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups using a 7-point ordinal scale of clinical status. Seven-point ordinal scale for clinical assessment ranges from 1 and 2: Not hospitalized 3: Hospitalized, not requiring supplemental oxygen 4: Hospitalized, requiring supplemental oxygen 5: Hospitalized, requiring high-flow oxygen therapy or noninvasive mechanical ventilation 6: Hospitalized, requiring IMV, ECMO, or both 7: Dead Higher number means worse outcome | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of SARS-CoV-2 PCR Positivity | Compare the proportion and duration of SARS-CoV-2 PCR positivity (via RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups at days 0, 7, and 14. | Up to 14 days |
| Levels of SARS-CoV-2 RNA |
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Inclusion Criteria:
Exclusion Criteria:
Participation in another clinical trial of anti-viral agent(s) for COVID-19
Receipt of any anti-viral agent(s) with possible activity against SARS-CoV-2 <24 hours prior to study drug administration [1]
Mechanically ventilated (including veno-venous (VV)-ECMO) ≥ 5 days
Severe multi-organ failure
History of prior reactions to transfusion blood products meeting definitive case definition criteria, at least severe severity, and probable or definite imputability per National Healthcare Safety Network (NHSN)/Centers for Disease Control and Prevention (CDC) criteria
Known Immunoglobulin A (IgA) deficiency
Females who are pregnant
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| Name | Affiliation | Role |
|---|---|---|
| Max O'Donnell, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center/NYP | New York | New York | 10032 | United States | ||
| Hospital Federal dos Servidores do Estado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27532807 | Background | Arabi 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. | |
| 28913837 |
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The data-sharing plans for this study will be made available at a later date.
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| ID | Title | Description |
|---|---|---|
| FG000 | Convalescent Plasma (Anti-SARS-CoV-2 Plasma) | Convalescent plasma (1 unit; ~200-250 mL) collected from a volunteer who recovered from COVID-19 disease Convalescent Plasma (anti-SARS-CoV-2 plasma): Convalescent Plasma that contains antibody titers against SARS-CoV-2 |
| FG001 | Non-convalescent Plasma (Control Plasma) | Non-convalescent plasma (1 unit; ~200-250 mL) of standard plasma collected prior to December 2019 Non-convalescent Plasma (control plasma): Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Convalescent Plasma (Anti-SARS-CoV-2 Plasma) | Convalescent plasma (1 unit; ~200-250 mL) collected from a volunteer who recovered from COVID-19 disease Convalescent Plasma (anti-SARS-CoV-2 plasma): Convalescent Plasma that contains antibody titers against SARS-CoV-2 |
| BG001 | Non-convalescent Plasma (Control Plasma) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Day 28 Severity Outcomes Using a 7-point Ordinal Scale of Clinical Status | Compare the day 28 severity outcome amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups using a 7-point ordinal scale of clinical status. Seven-point ordinal scale for clinical assessment ranges from 1 and 2: Not hospitalized 3: Hospitalized, not requiring supplemental oxygen 4: Hospitalized, requiring supplemental oxygen 5: Hospitalized, requiring high-flow oxygen therapy or noninvasive mechanical ventilation 6: Hospitalized, requiring IMV, ECMO, or both 7: Dead Higher number means worse outcome | Posted | Count of Participants | Participants | No | Up to 28 days |
|
Up to 28 days
Adverse events and serious adverse events were monitored/assessed for a different population of participants (147 out of 150 Convalescent Plasma, and 72 out of 73 Non-convalescent Plasma).
Adverse Events and serious adverse events were monitored/assessed without regard to the specific Adverse Event Term, given the circumstances surrounding the pandemic.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Convalescent Plasma (Anti-SARS-CoV-2 Plasma) | Convalescent plasma (1 unit; ~200-250 mL) collected from a volunteer who recovered from COVID-19 disease Convalescent Plasma (anti-SARS-CoV-2 plasma): Convalescent Plasma that contains antibody titers against SARS-CoV-2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular event | Vascular disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia, worsening | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Max O'Donnell, MD | Columbia University Irving Medical Center | 212-305-5794 | mo2130@columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2020 | Nov 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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A total of 219 eligible subjects will be randomized in a 2:1 ratio to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody (anti-SARS-CoV-2 plasma) or non-convalescent fresh frozen plasma (control plasma).
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| Non-convalescent Plasma (control plasma) | Biological | Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2) |
|
Compare levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups at days 0, 7, and 14. |
| Up to 14 days |
| Duration of Need for Supplemental Oxygen | Compare duration of need for supplemental oxygen and/or mechanical ventilation amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups. | Up to 28 days |
| Duration of Hospitalization | Compare duration of hospitalization amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups. | Up to 28 days |
| 28-day Mortality | Compare up to 28-day mortality amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups. | Up to 28 days |
| Time-to-clinical Improvement In-hospital | Compare time-to-clinical improvement in-hospital amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups, defined as the time to either an improvement of clinical status or alive discharge from the hospital, whichever comes first. | Up to 28 days |
| Host Genetic Differences at Day 0 | To assess for host genetic differences at Day 0 amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups. | Day 0 |
| Host Transcriptomic Differences at Days 0,7,14 | To assess for host transcriptomic differences at Day 0,7,14 amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups. | Up to 14 days |
| Rio de Janeiro |
| Brazil |
| Hospital Geral de Nova Iguaçu | Rio de Janeiro | Brazil |
| Instituto Nacional de Infectologia Evandro Chagas | Rio de Janeiro | Brazil |
| Background |
| Austin PC, Fine JP. Practical recommendations for reporting Fine-Gray model analyses for competing risk data. Stat Med. 2017 Nov 30;36(27):4391-4400. doi: 10.1002/sim.7501. Epub 2017 Sep 15. |
| 7985997 | Background | Casadevall A, Scharff MD. Serum therapy revisited: animal models of infection and development of passive antibody therapy. Antimicrob Agents Chemother. 1994 Aug;38(8):1695-702. doi: 10.1128/AAC.38.8.1695. No abstract available. |
| 15616839 | Background | Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9. |
| 32492084 | Background | Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, Kong Y, Ren L, Wei Q, Mei H, Hu C, Tao C, Yang R, Wang J, Yu Y, Guo Y, Wu X, Xu Z, Zeng L, Xiong N, Chen L, Wang J, Man N, Liu Y, Xu H, Deng E, Zhang X, Li C, Wang C, Su S, Zhang L, Wang J, Wu Y, Liu Z. Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial. JAMA. 2020 Aug 4;324(5):460-470. doi: 10.1001/jama.2020.10044. |
| 32219428 | Background | Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783. |
| 32934372 | Background | Liu STH, Lin HM, Baine I, Wajnberg A, Gumprecht JP, Rahman F, Rodriguez D, Tandon P, Bassily-Marcus A, Bander J, Sanky C, Dupper A, Zheng A, Nguyen FT, Amanat F, Stadlbauer D, Altman DR, Chen BK, Krammer F, Mendu DR, Firpo-Betancourt A, Levin MA, Bagiella E, Casadevall A, Cordon-Cardo C, Jhang JS, Arinsburg SA, Reich DL, Aberg JA, Bouvier NM. Convalescent plasma treatment of severe COVID-19: a propensity score-matched control study. Nat Med. 2020 Nov;26(11):1708-1713. doi: 10.1038/s41591-020-1088-9. Epub 2020 Sep 15. |
| 37162745 | Derived | Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6. |
| 36734509 | Derived | Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5. |
| 34013969 | Derived | Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4. |
| 33974559 | Derived | O'Donnell MR, Grinsztejn B, Cummings MJ, Justman JE, Lamb MR, Eckhardt CM, Philip NM, Cheung YK, Gupta V, Joao E, Pilotto JH, Diniz MP, Cardoso SW, Abrams D, Rajagopalan KN, Borden SE, Wolf A, Sidi LC, Vizzoni A, Veloso VG, Bitan ZC, Scotto DE, Meyer BJ, Jacobson SD, Kantor A, Mishra N, Chauhan LV, Stone EF, Dei Zotti F, La Carpia F, Hudson KE, Ferrara SA, Schwartz J, Stotler BA, Lin WW, Wontakal SN, Shaz B, Briese T, Hod EA, Spitalnik SL, Eisenberger A, Lipkin WI. A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19. J Clin Invest. 2021 Jul 1;131(13):e150646. doi: 10.1172/JCI150646. |
| 32513308 | Derived | Eckhardt CM, Cummings MJ, Rajagopalan KN, Borden S, Bitan ZC, Wolf A, Kantor A, Briese T, Meyer BJ, Jacobson SD, Scotto D, Mishra N, Philip NM, Stotler BA, Schwartz J, Shaz B, Spitalnik SL, Eisenberger A, Hod EA, Justman J, Cheung K, Lipkin WI, O'Donnell MR. Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Jun 8;21(1):499. doi: 10.1186/s13063-020-04422-y. |
Non-convalescent plasma (1 unit; ~200-250 mL) of standard plasma collected prior to December 2019 Non-convalescent Plasma (control plasma): Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Non-convalescent Plasma (Control Plasma) | Non-convalescent plasma (1 unit; ~200-250 mL) of standard plasma collected prior to December 2019 Non-convalescent Plasma (control plasma): Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2) |
|
|
| Secondary | Proportion of SARS-CoV-2 PCR Positivity | Compare the proportion and duration of SARS-CoV-2 PCR positivity (via RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups at days 0, 7, and 14. | Data was not collected or analyzed. | Posted | Up to 14 days |
|
|
| Secondary | Levels of SARS-CoV-2 RNA | Compare levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups at days 0, 7, and 14. | Data was not collected or analyzed. | Posted | Up to 14 days |
|
|
| Secondary | Duration of Need for Supplemental Oxygen | Compare duration of need for supplemental oxygen and/or mechanical ventilation amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups. | Posted | Median | Inter-Quartile Range | days | Up to 28 days |
|
|
|
| Secondary | Duration of Hospitalization | Compare duration of hospitalization amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups. | Posted | Median | Inter-Quartile Range | days | Up to 28 days |
|
|
|
| Secondary | 28-day Mortality | Compare up to 28-day mortality amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups. | Posted | Count of Participants | Participants | Up to 28 days |
|
|
|
| Secondary | Time-to-clinical Improvement In-hospital | Compare time-to-clinical improvement in-hospital amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups, defined as the time to either an improvement of clinical status or alive discharge from the hospital, whichever comes first. | Posted | Median | Inter-Quartile Range | days | Up to 28 days |
|
|
|
| Secondary | Host Genetic Differences at Day 0 | To assess for host genetic differences at Day 0 amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups. | Data was not collected or analyzed. | Posted | Day 0 |
|
|
| Secondary | Host Transcriptomic Differences at Days 0,7,14 | To assess for host transcriptomic differences at Day 0,7,14 amongst the anti-SARS-CoV-2 convalescent plasma and non-convalescent plasma groups. | Data was not collected or analyzed. | Posted | Up to 14 days |
|
|
| 19 |
| 150 |
| 39 |
| 147 |
| 4 |
| 147 |
| EG001 | Non-convalescent Plasma (Control Plasma) | Non-convalescent plasma (1 unit; ~200-250 mL) of standard plasma collected prior to December 2019 Non-convalescent Plasma (control plasma): Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2) | 18 | 73 | 26 | 72 | 3 | 72 |
| Pulmonary adverse event | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Renal/metabolic adverse event | Renal and urinary disorders | Non-systematic Assessment |
|
| Infectious adverse event | Infections and infestations | Non-systematic Assessment |
|
| Hematologic adverse event | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Inflammatory adverse event | Immune system disorders | Non-systematic Assessment |
|
| Gastrointestinal/hepatic adverse event | Gastrointestinal disorders | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Transfusion-related circulatory overload | Vascular disorders | Non-systematic Assessment |
|
| Possible febrile non-hemolytic transfusion reaction | General disorders | Non-systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |