Not provided
Not provided
Not provided
Not provided
Not provided
Lack of eligible patients due to change in standard therapy
Not provided
Not provided
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Overall study design
Number of subjects
• Up to 36 patients in track 2, and 19 patients in track 3 as described in the statistical section 8.
Overall study duration
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convalescent Plasma | Experimental | Fresh or frozen plasma will be infused one time to patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent Plasma | Biological | Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Hospitalized for COVID-19 But Not Intubated | Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients | 7 Days |
| Primary Objective for Patients With COVID-19 Already Intubated | Mortality rate at 30 days from starting treatment for patients with COVID-19 | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospitalization | The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death. Patients who are not discharged, are alive and still in the hospital on the date of closing follow-up, or lost follow-up on the date of closing follow-up will be considered censored on that date. | 60 Days |
Not provided
Donor Eligibility Criteria:
Recipient Eligibility Criteria:
Recipients age >18 years old, are assigned to one of two clinical tracks, track 2 or 3, based on COVID-19 disease severity. Onset of first symptoms < 9 days.
Track 2:
Track 3:
Recipient exclusion criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Michele L Donato, MD | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32192578 | Background | Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available. | |
| 7985997 | Background |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Convalescent Plasma | Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Convalescent Plasma | Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 Hospitalized for COVID-19 But Not Intubated | Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients | Of the 52 participants enrolled, 36 were not intubated at time of enrollment. | Posted | Count of Participants | Participants | 7 Days |
|
|
Safety assessment performed on post infusion day 0,3,10, 30, and 60 days
Not provided
Not provided
| 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 | Fresh or frozen plasma will be infused one time to patients Convalescent Plasma: Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aneurysm | Investigations | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Zenreich | Hackensack Meridian Health | 15519964248 | joshua.zenreich@hmhn.org |
Not provided
| 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 | Dec 15, 2020 | Jun 9, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
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| Duration of Mechanical Ventilation | The duration of mechanical ventilation is defined as the time in days from the first day of using mechanical ventilation to the last day of using mechanical ventilation. All evaluable patients will be included and no censoring for this analysis. | 60 Days |
| Time to Symptoms Resolution | The time to symptom resolution is defined as the time in days from new therapy initiation to the first documented symptom resolution as assessed by local site. Patients whose symptom are not resolved, who are dead, or lost follow-up on the designed follow-up date will be censored on that date. | 60 Days |
| Overall Survival | Overall survival rate at 60 days from starting treatment for patients with COVID-19 | 60 Days |
| Rate of Virologic Clearance by Nasopharyngeal Swab at Day 10 | 10 Days |
| Rate of Virologic Clearance by Nasopharyngeal Swab at Day 30 | 30 Days |
| Impact of Donor Titers Level on Efficacy | 60 Days |
| Impact of Donor Titers Level on Safety | 60 Days |
| Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion) | 0 Days (pre-infusion) |
| Recipient Anti-SARS-CoV2 Titer Assessment on Days 3 | 3 Days |
| Recipient Anti-SARS-CoV2 Titer Assessment on Day 10 | 10 Days |
| Recipient Anti-SARS-CoV2 Titer Assessment on Day 30 | 30 Days |
| Recipient Anti-SARS-CoV2 Titer Assessment on Day 60 | 60 Days |
| 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. |
| 7578724 | Background | Casadevall 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. |
| 12967670 | Background | Casadevall A, Pirofski LA. Antibody-mediated regulation of cellular immunity and the inflammatory response. Trends Immunol. 2003 Sep;24(9):474-8. doi: 10.1016/s1471-4906(03)00228-x. No abstract available. |
| 15372080 | Background | Casadevall A, Dadachova E, Pirofski LA. Passive antibody therapy for infectious diseases. Nat Rev Microbiol. 2004 Sep;2(9):695-703. doi: 10.1038/nrmicro974. |
| 32167489 | Background | Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available. |
| 16121363 | Background | Zhang 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. |
| 27867062 | Background | Sahr 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. |
| 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. |
| 16183666 | Background | Yeh KM, Chiueh TS, Siu LK, Lin JC, Chan PK, Peng MY, Wan HL, Chen JH, Hu BS, Perng CL, Lu JJ, Chang FY. Experience of using convalescent plasma for severe acute respiratory syndrome among healthcare workers in a Taiwan hospital. J Antimicrob Chemother. 2005 Nov;56(5):919-22. doi: 10.1093/jac/dki346. Epub 2005 Sep 23. |
| 29923831 | Background | Ko JH, Seok H, Cho SY, Ha YE, Baek JY, Kim SH, Kim YJ, Park JK, Chung CR, Kang ES, Cho D, Muller MA, Drosten C, Kang CI, Chung DR, Song JH, Peck KR. Challenges of convalescent plasma infusion therapy in Middle East respiratory coronavirus infection: a single centre experience. Antivir Ther. 2018;23(7):617-622. doi: 10.3851/IMP3243. Epub 2018 Jun 20. |
| 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. |
| 30092199 | Background | Gunn BM, Yu WH, Karim MM, Brannan JM, Herbert AS, Wec AZ, Halfmann PJ, Fusco ML, Schendel SL, Gangavarapu K, Krause T, Qiu X, He S, Das J, Suscovich TJ, Lai J, Chandran K, Zeitlin L, Crowe JE Jr, Lauffenburger D, Kawaoka Y, Kobinger GP, Andersen KG, Dye JM, Saphire EO, Alter G. A Role for Fc Function in Therapeutic Monoclonal Antibody-Mediated Protection against Ebola Virus. Cell Host Microbe. 2018 Aug 8;24(2):221-233.e5. doi: 10.1016/j.chom.2018.07.009. |
| 31826992 | Background | Wan Y, Shang J, Sun S, Tai W, Chen J, Geng Q, He L, Chen Y, Wu J, Shi Z, Zhou Y, Du L, Li F. Molecular Mechanism for Antibody-Dependent Enhancement of Coronavirus Entry. J Virol. 2020 Feb 14;94(5):e02015-19. doi: 10.1128/JVI.02015-19. Print 2020 Feb 14. |
| 25030060 | Background | Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16. |
| 11564809 | Background | Crowe JE Jr, Firestone CY, Murphy BR. Passively acquired antibodies suppress humoral but not cell-mediated immunity in mice immunized with live attenuated respiratory syncytial virus vaccines. J Immunol. 2001 Oct 1;167(7):3910-8. doi: 10.4049/jimmunol.167.7.3910. |
| 8896138 | Background | Tan M, Xiong X. Continuous and group sequential conditional probability ratio tests for phase II clinical trials. Stat Med. 1996 Oct 15;15(19):2037-51. doi: 10.1002/(SICI)1097-0258(19961015)15:193.0.CO;2-Z. |
| 22328328 | Background | Tan MT, Xiong X. A flexible multi-stage design for phase II oncology trials. Pharm Stat. 2011 Jul-Aug;10(4):369-73. doi: 10.1002/pst.478. Epub 2010 Dec 8. |
| 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. |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Primary Objective for Patients With COVID-19 Already Intubated | Mortality rate at 30 days from starting treatment for patients with COVID-19 | Posted | Count of Participants | Participants | 30 Days |
|
|
|
| Secondary | Duration of Hospitalization | The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death. Patients who are not discharged, are alive and still in the hospital on the date of closing follow-up, or lost follow-up on the date of closing follow-up will be considered censored on that date. | The study was terminated early due to rapid change in standard therapy. This information was not collected or analyzed due to early termination. | Posted | 60 Days |
|
|
| Secondary | Duration of Mechanical Ventilation | The duration of mechanical ventilation is defined as the time in days from the first day of using mechanical ventilation to the last day of using mechanical ventilation. All evaluable patients will be included and no censoring for this analysis. | The study was terminated early due to rapid change in standard therapy. This information was not collected or analyzed due to early termination. | Posted | 60 Days |
|
|
| Secondary | Time to Symptoms Resolution | The time to symptom resolution is defined as the time in days from new therapy initiation to the first documented symptom resolution as assessed by local site. Patients whose symptom are not resolved, who are dead, or lost follow-up on the designed follow-up date will be censored on that date. | Due to the early termination of the trial, data regarding this outcome were not collected. | Posted | 60 Days |
|
|
| Secondary | Overall Survival | Overall survival rate at 60 days from starting treatment for patients with COVID-19 | Posted | Count of Participants | Participants | 60 Days |
|
|
|
| Secondary | Rate of Virologic Clearance by Nasopharyngeal Swab at Day 10 | Posted | Count of Participants | Participants | 10 Days |
|
|
|
| Secondary | Rate of Virologic Clearance by Nasopharyngeal Swab at Day 30 | Posted | Count of Participants | Participants | 30 Days |
|
|
|
| Secondary | Impact of Donor Titers Level on Efficacy | The study was terminated early due to rapid change in standard therapy. This information was not collected or analyzed due to early termination. | Posted | 60 Days |
|
|
| Secondary | Impact of Donor Titers Level on Safety | The study was terminated early due to rapid change in standard therapy. This information was not collected or analyzed due to early termination. | Posted | 60 Days |
|
|
| Secondary | Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion) | Posted | Count of Participants | Participants | 0 Days (pre-infusion) |
|
|
|
| Secondary | Recipient Anti-SARS-CoV2 Titer Assessment on Days 3 | Posted | Count of Participants | Participants | 3 Days |
|
|
|
| Secondary | Recipient Anti-SARS-CoV2 Titer Assessment on Day 10 | Posted | Count of Participants | Participants | 10 Days |
|
|
|
| Secondary | Recipient Anti-SARS-CoV2 Titer Assessment on Day 30 | Posted | Count of Participants | Participants | 30 Days |
|
|
|
| Secondary | Recipient Anti-SARS-CoV2 Titer Assessment on Day 60 | Posted | Count of Participants | Participants | 60 Days |
|
|
|
| 11 |
| 52 |
| 24 |
| 52 |
| 0 |
| 52 |
| Appendicitis | Gastrointestinal disorders | Systematic Assessment |
|
| Cerebral Edema | Nervous system disorders | Systematic Assessment |
|
| Death | Infections and infestations | Systematic Assessment |
|
| Readmission | Infections and infestations | Systematic Assessment |
|
| Worsening Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Worsening Condition Intubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| IgG Levels 100-500 |
|
| IgG Levels BLQ |
|