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FDA gave emergency use approval to COVID-19 convalescent plasma on 08/24/2020
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The investigators hypothesize that use of convalescent plasma donated from individuals recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals with active, severe COVID-19 infection.
The purpose of this research study is to see if convalescent plasma is safe and effective for the treatment of patients acutely ill with COVID-19. The researchers want to confirm the right dose levels of immunoglobulins/antibodies (immune proteins) and find out what therapeutic effects plasma donated by recovered individuals has on people severely sick with COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion | Experimental | Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent plasma transfusion | Biological | Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome. |
| Measure | Description | Time Frame |
|---|---|---|
| Change is Clinical Status | Change is clinical status as captured by 7-point ordinal scale to include
| Time of plasma infusion (day 0) compared to day 7 |
| Transfusion Related Events Due to Administration of CCP | Number of participants with Transfusion Related Adverse Events | Within 6 hours of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Change is Clinical Status | Change in 7-point ordinal scale score from time of plasma infusion (day 0-prior to first infusion) to days 7, 14, 21, and 28. 7 point ordinal scale:
|
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Phase 1 Inclusion Criteria:
Inclusion Criteria for Convalescent Plasma Donors:
- Outpatients 18 years old and older who have recovered from COVID-19:
Phase 1 Exclusion Criteria:
Exclusion criteria:
PHASE 2: Inclusion Criteria for Recipients of COVID-19 Convalescent Plasma:
Patients in the Inova Health System with confirmed COVID-19 by PCR testing
Age ≥ 13 years
Currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome as follows:
Severe COVID-19: (three or more of the following)
Life-threatening disease is defined as: (one of the following)
Patient must provide informed consent or have health care power of attorney/next of kin provide consent if he/she cannot.
PHASE 2 Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Brown, M.D. | Inova Health Care Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26674811 | Background | Marano G, Vaglio S, Pupella S, Facco G, Catalano L, Liumbruno GM, Grazzini G. Convalescent plasma: new evidence for an old therapeutic tool? Blood Transfus. 2016 Mar;14(2):152-7. doi: 10.2450/2015.0131-15. Epub 2015 Nov 6. | |
| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | COVID-19 Convalescent Plasma (CCP) Donors | Patients recovered from COVID-19 and donated CCP through the study. |
| FG001 | COVID-19 Convalescent Plasma (CCP Recipients) | Patients who were hospitalized with COVID-19 and received CCP infusions through the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion | Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria Convalescent plasma transfusion: Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome. |
| 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 | Change is Clinical Status | Change is clinical status as captured by 7-point ordinal scale to include
| Patients that were hospitalized with COVID-19 and received CCP were evaluated using the 7-point ordinal scale. The worse oxygenation status was used for day 0 and day 7. | Posted | Mean | Full Range | units on a scale | Time of plasma infusion (day 0) compared to day 7 |
|
Patients were monitored for up to 67 days
Only serious adverse events were recorded.
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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 | Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion | Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria Convalescent plasma transfusion: Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome. Adverse Events only monitored/assessed in Convalescent Plasma Recipients. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | 14 patients died during the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Whitney Brown, MD | Inova Health Systems | 7037763067 | anne.brown@inova.org |
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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 | Jun 19, 2020 | Dec 14, 2021 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Phase 1 will be recruitment and enrollment of plasma donors. Phase 2 will be continued recruitment and enrollment of plasma donors, with the addition of recruitment and enrollment of plasma recipients.
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| Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28 |
| Length of Hospital Stay | Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death (up to an average of 67 days) | Total Index Hospitalization |
| Mechanical Ventilation | Number of participants that required mechanical ventilation that were not on mechanical ventilation at that time point. | Days 7, 14, 21, 28 |
| Change in Mechanical Ventilation Status | Number of participants who required a change in the mechanical ventilation status | Day 0 (date of CCP transfusion) to Day 28 |
| Mortality | All-cause Mortality | From Day of Transfusion (Day 0) to Day 28 post-transfusion for patients who received CCP. Patients who donated CCP were not followed for a defined time period after CCP donation. |
| 92624 | Background | Maiztegui JI, Fernandez NJ, de Damilano AJ. Efficacy of immune plasma in treatment of Argentine haemorrhagic fever and association between treatment and a late neurological syndrome. Lancet. 1979 Dec 8;2(8154):1216-7. doi: 10.1016/s0140-6736(79)92335-3. |
| 15214887 | Background | Soo YO, Cheng Y, Wong R, Hui DS, Lee CK, Tsang KK, Ng MH, Chan P, Cheng G, Sung JJ. Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients. Clin Microbiol Infect. 2004 Jul;10(7):676-8. doi: 10.1111/j.1469-0691.2004.00956.x. |
| 21248066 | Background | Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19. |
| 26618098 | Background | Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4(1):709. doi: 10.1186/s40064-015-1490-9. eCollection 2015. |
| 27959686 | Background | van Griensven J, Edwards T, Baize S; Ebola-Tx Consortium. Efficacy of Convalescent Plasma in Relation to Dose of Ebola Virus Antibodies. N Engl J Med. 2016 Dec 8;375(23):2307-2309. doi: 10.1056/NEJMc1609116. Epub 2016 Nov 14. No abstract available. |
| Background | WHO. Use of convalescent whole blood or plasma collected from patients recovered from Ebola virus disease for transfusion, as an empirical treatment during outbreaks. 2014 http://apps.who.int/iris/rest/bitstreams/604045/retrieve (accessed 3/27/2020). |
| Background | WHO. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected 2020. https://www.who.int/docs/default-source/coronaviruse/clinical-management-of-novel-cov.pdf (accessed 3/27/20). |
| 32113510 | Background | Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available. |
| 32150748 | Background | Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, Azman AS, Reich NG, Lessler J. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020 May 5;172(9):577-582. doi: 10.7326/M20-0504. Epub 2020 Mar 10. |
| 32398876 | Background | Amanat F, Stadlbauer D, Strohmeier S, Nguyen THO, Chromikova V, McMahon M, Jiang K, Arunkumar GA, Jurczyszak D, Polanco J, Bermudez-Gonzalez M, Kleiner G, Aydillo T, Miorin L, Fierer DS, Lugo LA, Kojic EM, Stoever J, Liu STH, Cunningham-Rundles C, Felgner PL, Moran T, Garcia-Sastre A, Caplivski D, Cheng AC, Kedzierska K, Vapalahti O, Hepojoki JM, Simon V, Krammer F. A serological assay to detect SARS-CoV-2 seroconversion in humans. Nat Med. 2020 Jul;26(7):1033-1036. doi: 10.1038/s41591-020-0913-5. Epub 2020 May 12. |
| 32319102 | Background | Epstein J, Burnouf T. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma. Vox Sang. 2020 Aug;115(6):485-487. doi: 10.1111/vox.12939. Epub 2020 May 14. No abstract available. |
| 28522352 | Background | Beigel JH, Tebas P, Elie-Turenne MC, Bajwa E, Bell TE, Cairns CB, Shoham S, Deville JG, Feucht E, Feinberg J, Luke T, Raviprakash K, Danko J, O'Neil D, Metcalf JA, King K, Burgess TH, Aga E, Lane HC, Hughes MD, Davey RT; IRC002 Study Team. Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study. Lancet Respir Med. 2017 Jun;5(6):500-511. doi: 10.1016/S2213-2600(17)30174-1. Epub 2017 May 15. |
| 30895200 | Background | Wang Y, Fan G, Horby P, Hayden F, Li Q, Wu Q, Zou X, Li H, Zhan Q, Wang C, Cao B; CAP-China Network. Comparative Outcomes of Adults Hospitalized With Seasonal Influenza A or B Virus Infection: Application of the 7-Category Ordinal Scale. Open Forum Infect Dis. 2019 Feb 15;6(3):ofz053. doi: 10.1093/ofid/ofz053. eCollection 2019 Mar. |
| 8844239 | Background | Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available. |
| Background | Woelfel R, Corman VM, Guggemos W, et al. Clinical presentation and virological assessment of hospitalized cases of coronavirus disease 2019 in a travel-associated transmission cluster. BMJ Yale 2020. https://doi.org/10.1101/2020.03.05.20030502 |
| 22578374 | Background | Pandey S, Vyas GN. Adverse effects of plasma transfusion. Transfusion. 2012 May;52 Suppl 1(Suppl 1):65S-79S. doi: 10.1111/j.1537-2995.2012.03663.x. |
| BG001 | Donor of COVID-19 Convalescent Plasma (CCP) | Patients who recovered from COVID-19 infection and test negative for COVID-19 by nasopharyngeal swab. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
| Primary | Transfusion Related Events Due to Administration of CCP | Number of participants with Transfusion Related Adverse Events | Transfusion related events were only measured in the convalescent plasma recipient arm. 48 patients were enrolled in the study. 45 received CCP. 3 patients received CCP through individual INDs. This outcome measure was only for patients who were hospitalized with COVID-19 and received CCP through the study. | Posted | Count of Participants | Participants | Within 6 hours of infusion |
|
|
|
| Secondary | Change is Clinical Status | Change in 7-point ordinal scale score from time of plasma infusion (day 0-prior to first infusion) to days 7, 14, 21, and 28. 7 point ordinal scale:
| Patients ts that were hospitalized with COVID-19 and received CCP were evaluated using the 7-point ordinal scale. The worse oxygenation status was used for days 7, 14, 21, and 28 | Posted | Count of Participants | Participants | Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28 |
|
|
|
| Secondary | Length of Hospital Stay | Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death (up to an average of 67 days) | Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death | Posted | Mean | Full Range | days | Total Index Hospitalization |
|
|
|
| Secondary | Mechanical Ventilation | Number of participants that required mechanical ventilation that were not on mechanical ventilation at that time point. | The count of participants below shows the total number of participants needing mechanical ventilation for that time point. | Posted | Count of Participants | Participants | Days 7, 14, 21, 28 |
|
|
|
| Secondary | Change in Mechanical Ventilation Status | Number of participants who required a change in the mechanical ventilation status | Patients that were hospitalized with COVID-19 and received CCP through the study | Posted | Count of Participants | Participants | Day 0 (date of CCP transfusion) to Day 28 |
|
|
|
| Secondary | Mortality | All-cause Mortality | Posted | Count of Participants | Participants | From Day of Transfusion (Day 0) to Day 28 post-transfusion for patients who received CCP. Patients who donated CCP were not followed for a defined time period after CCP donation. |
|
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| 14 |
| 45 |
| 21 |
| 45 |
| 0 |
| 0 |
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| transfusion reaction | Blood and lymphatic system disorders | Systematic Assessment | 3 patients had a transfusion reaction due to CCP. |
|
| Intubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | 4 patients were intubated during the course of the study that recovered. |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Ordinal Scale 5 out of 7 |
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| Ordinal Scale 6 out of 7 |
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| Ordinal Scale 7 out of 7 |
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| Ordinal Scale 1 out of 7 |
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| Ordinal Scale Day 7 |
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| Ordinal Scale Day 14 |
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| Ordinal Scale Day 21 |
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| Ordinal Scale Day 28 |
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| Patients discharged |
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| Day 14 |
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| Day 21 |
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| Day 28 |
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