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convalescent plasma

Clinical significance: - treatment of COVID-19 ARDS with convalescent plasma - may improve outcome [1,2] - of no benefit [3,10] - a calculator has been published to identify hospitalized patients that might benefit from Covid-19 convalescent plasma [12] - symptom resolution or improvement in 1-3 days - clearance of detectable virus within 7 days [2] - convalescent plasma with high IgG titers within 72 hours after onset of mild Covid-19 symptoms may prevent severe COVID-19 [6] - among hospitalized Covid-19 patients not receiving mechanical ventilation, high titer IgG convalescent plasma diminishes mortality [6] - of no benefit in Chinese trial or trial in India [3] - among hospitalized patients with COVID-19, convalescent plasma does not improve survival vs usual care [8] - among critically ill adults, 2 units of high-titer, ABO-compatible convalescent plasma unlikely to improve organ support-free days [9] - FDA is encouraging those who have recovered from COVID-19 to donate plasma [2] - survivors who have been symptom-free for > 2 weeks may donate plasma [2] - FDA emergency authorization for convalescent plasma as a treatment for COVID-19 is now on hold (August 19, 2020) citing weak data [2] - FDA issues emergency use authorization for convalescent plasma to treat COVID-19 (August 23, 2020) [2] - FDA revises emergency use authorization for convalescent plasma for COVID-19 limited to high-antibody-titer convalescent plasma, for use in hospitalized patients with COVID-19 early in the disease course & in those hospitalized with impaired humoral immunity - WHO cautious on COVID-19 plasma [4] - investigators express concern regarding impact of emergency authorization for convalescent plasma on trial recruitment [5] - treatment of COVID-19 with convalescent plasma compared with placebo or standard of care was not significantly associated with a decrease in all-cause mortality or with any benefit for other clinical outcomes [7] - certainty of evidence low to moderate [7] - early promise of convalescent plasma not confirmed in randomized clinical trials [13] - administration of convalescent plasma within 9 days after the onset of Covid-19 symptoms reduces the risk of hospitalization in unvaccinated [14] - COVID-19 convalescent plasma may benefit immunocompromised patients susceptible to refractory infection [15] - patients with Covid-19 ARDS treated with convalescent plasma between September 2020 & March 2022 had a lower 28 day risk of death vs standard treatment 35% vs 45% [16]

Related

SARS Cov2 management severe acute respiratory syndrome coronavirus 2; SARS-CoV2; Wuhan coronavirus

General

plasma

References

  1. JAMA Morning Rounds. March 25, 2020 FDA to allow physicians to use plasma donated by coronavirus survivors to treat critically ill patients. - NBC News. March 24, 2020 FDA will allow doctors to treat critically ill coronavirus patients with blood from survivors https://www.n bcnews.com/news/us-news/fda-will-allow-doctors-treat-critically-ill-coronavirus-patients-blood-n1167831
  2. Shen C, Wang Z, Zhao F et al Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma JAMA. 2020;323(16):1582-1589. PMID: 32219428 https://jamanetwork.com/journals/jama/fullarticle/2763983 - Roback JD, Guarner J. Convalescent Plasma to Treat COVID-19. Possibilities and Challenges. JAMA. Published online March 27, 2020 PMID: 32219429 https://jamanetwork.com/journals/jama/fullarticle/2763982 - FDA - Investigational New Drug (IND). March 24, 2020 Investigational COVID-19 Convalescent Plasma - Emergency INDs - FDA News Release Coronavirus (COVID-19) Update: Daily Roundup April 3, 2020 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-3-2020 - Duab K, Liu B, Li C et al Effectiveness of convalescent plasma therapy in severe COVID-19 patients. PNAS first published April 6, 2020 PMID: 32253318 https://www.pnas.org/content/early/2020/04/02/2004168117 - U.S. Department of Health and Human Services. Food and Drug Administration. Center for Biologics Evaluation and Research. April 2020 Investigational COVID-19 Convalescent Plasma Guidance for Industry. https://www.fda.gov/media/136798/download - Duan K, Liu B, Li C et al. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A 2020 Apr 6; PMID: 32253318 https://www.pnas.org/content/early/2020/04/02/2004168117 - FDA Statement. April 16, 2020 Coronavirus (COVID-19) Update: FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-encourages-recovered-patients-donate-plasma-development-blood - Weiland N, LaFraniere S, Fink S F.D.A's Emergency Approval of Blood Plasma Is Now on Hold. New York Times. August 19, 2020 https://www.nytimes.com/2020/08/19/us/politics/blood-plasma-covid-19.html FDA. August 23, 2020 Recommendations for Investigational COVID-19 Convalescent Plasma https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds - Joyner MJ, Senefeld JW, Klassen SA Effect of Convalescent Plasma on Mortality among Hospitalized Patients with COVID-19: Initial Three-Month Experience. medRxiv. August 12, 2020 https://www.medrxiv.org/content/10.1101/2020.08.12.20169359v1 - National Institutes of Health. Sept 1, 2020 The COVID-19 Treatment Guidelines Panel's Statement on the Emergency Use Authorization of Convalescent Plasma for the Treatment of COVID-19. https://www.covid19treatmentguidelines.nih.gov/statement-on-convalescent-plasma-eua/ - FDA Letter to Nikki Bratcher-Bowman, Acting Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services. from RADM Denise M. Hinton, Feb 4, 2021 https://www.fda.gov/media/141477/download
  3. Li L, Zhang W, Hu Y et al Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19. A Randomized Clinical Trial. JAMA. Published online June 3, 2020. PMID: 32492084 https://jamanetwork.com/journals/jama/fullarticle/2766943 - Casadevall A, Joyner MJ, Pirofski LA A Randomized Trial of Convalescent Plasma for COVID-19 - Potentially Hopeful Signals. JAMA. Published online June 3, 2020 PMID: 32492105 https://jamanetwork.com/journals/jama/fullarticle/2766940 - Agarwal A, Mukherjee A, Kumar G et al Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial). BMJ 2020;371:m3939 PMID: 33093056 https://www.bmj.com/content/371/bmj.m3939 - Pathak EB Convalescent plasma is ineffective for covid-19 BMJ 2020;371:m4072 PMID: 33093025 https://www.bmj.com/content/371/bmj.m4072 - Walker M Convalescent Plasma Flops for Severe COVID-19 - Randomized trial finds no benefit in clinical status or mortality vs placebo. MedPage Today November 24, 2020 https://www.medpagetoday.com/infectiousdisease/covid19/89878 - Simonovich VA, Burgos Pratx LD, Scibona P et al A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia. N Engl J Med. 2020. Nov 24. PMID: 33232588 https://www.nejm.org/doi/full/10.1056/NEJMoa2031304
  4. Miller J WHO Cautious on COVID-19 Plasma as US Issues Emergency Authorization Medscape - Aug 24, 2020. https://www.medscape.com/viewarticle/936230
  5. Ault A. Convalescent Plasma Actions Spark Trial Recruitment Concerns. Medscape - Aug 26, 2020. https://www.medscape.com/viewarticle/936370
  6. Libster R, Perez Marc G, Wappner D et al Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults. N Engl J Med 2021. Jan 6 PMID: 33406353 https://www.nejm.org/doi/full/10.1056/NEJMoa2033700 - Joyner MJ, Carter RE, Senefeld JW et al Convalescent Plasma Antibody Levels and the Risk of Death from Covid-19. N Engl J Med 2021 Jan 13. PMID: 33523609 PMCID: PMC7821984 Free PMC article https://www.nejm.org/doi/full/10.1056/NEJMoa2031893
  7. Janiaud P, Axfors C, Schmitt AM et al Association of Convalescent Plasma Treatment With Clinical Outcomes in Patients With COVID-19A Systematic Review and Meta-analysis. JAMA. Published online February 26, 2021 PMID: 33635310 https://jamanetwork.com/journals/jama/fullarticle/2777060
  8. RECOVERY Collaborative Group. Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): A randomised controlled, open-label, platform trial. Lancet 2021 May 29; 397:2049. PMID: 34000257 PMCID: PMC8121538 Free PMC article https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00897-7/fulltext
  9. Writing Committee for the REMAP-CAP Investigators Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19. A Randomized Clinical Trial. JAMA. Published online October 4, 2021. PMID: 34606578 https://jamanetwork.com/journals/jama/fullarticle/2784914
  10. Troxel AB, Petkova E, Goldfeld K et al Association of Convalescent Plasma Treatment With Clinical Status in Patients Hospitalized With COVID-19. A Meta-analysis. JAMA Netw Open. 2022;5(1):e2147331 PMID: 35076699 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2788377
  11. Walker M Tool Pinpoints Who May Benefit From COVID Convalescent Plasma. Allows a more individualized approach to convalescent plasma use. MedPage Today January 26, 2022 https://www.medpagetoday.com/infectiousdisease/covid19/96883
  12. Park H, Tarpey T, Liu M et al Development and validation of a treatment benefit index to identify hospitalized patients with COVID-19 who may benefit from convalescent plasma. JAMA Netw Open. 2022;5(1):e2147375. PMID: 35076698 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2788376 - Convalescent Plasma Benefit Index Calculator Results https://covid-convalescentplasma-tbi-calc.org/calculator/
  13. Rubin R Once Viewed as a Promising COVID-19 Treatment, Convalescent Plasma Falls Out of Favor. JAMA 2022. March 9 PMID: 35262639 https://jamanetwork.com/journals/jama/fullarticle/2790074
  14. Phend C Early Use of High-Titer Plasma Reduced COVID Hospitalizations. Randomized trial that influenced indication shows benefits in a mostly unvaccinated population. MedPage Today March 30, 2022 https://www.medpagetoday.com/infectiousdisease/covid19/97954 - Sullivan DJ, Gebo KA, Shoham S et al Early Outpatient Treatment for Covid-19 with Convalescent Plasma. N Engl J Med 2022. March 30 PMID: 35353960 https://www.nejm.org/doi/full/10.1056/NEJMoa2119657
  15. Senefeld JW, Franchini M, Mengoli C et al COVID-19 Convalescent Plasma for the Treatment of Immunocompromised Patients: A Systematic Review and Meta-analysis. JAMA Netw Open. 2023;6(1):e2250647 PMID: 36633846 Free article https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2800275
  16. Harris E Convalescent Plasma Lowered Risk of Death in COVID-19 ARDS. JAMA. Published online November 8, 2023. PMID: 37938859 https://jamanetwork.com/journals/jama/fullarticle/2811885