convalescent plasma
Jump to navigation
Jump to search
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]
More general terms
Additional terms
References
- ↑ 1.0 1.1 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 - ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/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 - ↑ 3.0 3.1 3.2 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/33093056 https://www.bmj.com/content/371/bmj.m3939
Pathak EB Convalescent plasma is ineffective for covid-19 BMJ 2020;371:m4072 PMID: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/33232588 https://www.nejm.org/doi/full/10.1056/NEJMoa2031304 - ↑ 4.0 4.1 Miller J WHO Cautious on COVID-19 Plasma as US Issues Emergency Authorization Medscape - Aug 24, 2020. https://www.medscape.com/viewarticle/936230
- ↑ 5.0 5.1 Ault A. Convalescent Plasma Actions Spark Trial Recruitment Concerns. Medscape - Aug 26, 2020. https://www.medscape.com/viewarticle/936370
- ↑ 6.0 6.1 6.2 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/33523609 PMCID: PMC7821984 Free PMC article https://www.nejm.org/doi/full/10.1056/NEJMoa2031893 - ↑ 7.0 7.1 7.2 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: https://www.ncbi.nlm.nih.gov/pubmed/33635310 https://jamanetwork.com/journals/jama/fullarticle/2777060
- ↑ 8.0 8.1 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: https://www.ncbi.nlm.nih.gov/pubmed/34000257 PMCID: PMC8121538 Free PMC article https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00897-7/fulltext
- ↑ 9.0 9.1 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: https://www.ncbi.nlm.nih.gov/pubmed/34606578 https://jamanetwork.com/journals/jama/fullarticle/2784914
- ↑ 10.0 10.1 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: https://www.ncbi.nlm.nih.gov/pubmed/35076699 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2788377
- ↑ 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
- ↑ 12.0 12.1 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: https://www.ncbi.nlm.nih.gov/pubmed/35076698 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2788376
Convalescent Plasma Benefit Index Calculator Results https://covid-convalescentplasma-tbi-calc.org/calculator/ - ↑ 13.0 13.1 Rubin R Once Viewed as a Promising COVID-19 Treatment, Convalescent Plasma Falls Out of Favor. JAMA 2022. March 9 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35262639 https://jamanetwork.com/journals/jama/fullarticle/2790074
- ↑ 14.0 14.1 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: https://www.ncbi.nlm.nih.gov/pubmed/35353960 https://www.nejm.org/doi/full/10.1056/NEJMoa2119657 - ↑ 15.0 15.1 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: https://www.ncbi.nlm.nih.gov/pubmed/36633846 Free article https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2800275
- ↑ 16.0 16.1 Harris E Convalescent Plasma Lowered Risk of Death in COVID-19 ARDS. JAMA. Published online November 8, 2023. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37938859 https://jamanetwork.com/journals/jama/fullarticle/2811885