CLINICAL COVID-19 CONVALESCENT PLASMA RESEARCH
Preprints: Preprints contain research findings that have yet to be certified by the scientific community and published in a medical journal. Since the certification process can be lengthy, authors choose to publish their findings early to facilitate discussions, commentary, and further research by other medical professionals. These articles and the Information therein are provided “AS IS” and may be altered during the peer review process.
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“CAPSID” study of high dose CCP in severely ill patients (Germany)
05/10/2021 | medRxiv
Subgroup analysis showed benefit of CCP in those receiving a larger amount of neutralizing antibodies.
Infection and vaccine-induced neutralizing antibody responses to the SARS-CoV-2 B.1.617.1 variant
05/10/2021 | bioRxiv
Using a live virus assay, the majority of convalescent plasma units from infected individuals and all of the plasma from persons vaccinated with mRNA vaccines were able to neutralize the India-variant of the virus.
Convalescent Plasma Use in the United States was Inversely Correlated with COVID-19 Mortality: Did Plasma Hesitancy Cost Lives?
04/16/2021 | medRxiv
Examining COVID-19 convalescent plasma (CCP) usage and hospitalization data over the course of the COVID-19 pandemic, this study estimates that 141K deaths were prevented by CCP treatments. It also suggest that the decline in CCP usage over recent months may have resulted in 29K excess deaths.
CCP Recovery Trial
03/09/2021 | medrxiv
This is the largest RCT of inpatient use of CCP. Investigators found no improvement in mortality at 28 days in those who received CCP.
Convalescent Plasma and Improved Survival in Patients with Hematologic Malignancies and COVID-19
2/5/2021 | medRxiv
In this multi-institutional study, 143 patients hospitalized with COVID-19 infection who also had hematologic malignancies had improved 30-day mortality after receiving convalescent plasma, compared to similar patients who did not receive convalescent plasma.
Exponential Increase in Neutralizing and Spike Specific Antibodies Following Vaccination of COVID-19 Convalescent Plasma Donors
2/5/2021 | medRxiv
Recovered COVID-19 patients who are vaccinated may make ideal candidates for CCP donation, as antibody levels post vaccination are significantly higher than antibody levels seen post COVID-19 infection alone.
The Effect of Convalescent Plasma Therapy on COVID-19 Patient Mortality: Systematic Review and Meta-Analysis
2/2/2021 | medRxiv
This research summarized the patient outcome data from numerous medical trials and studies and found that COVID-19 patients transfused with CCP exhibited a lower mortality rate compared to patients receiving standard treatments. In particular, this research found that early transfusion (i.e., within 3 days of hospital admission) of higher titer plasma is associated with lower patient mortality.
Development of a Rapid Point-Of-Care Test that Measures Neutralizing Antibodies to SARS-CoV-2
12/16/2020 | medRxiv
This paper details the development of a portable, inexpensive, reliable, and rapid neutralizing antibody assay that could have future use in assessing COVID-19 vaccine immunity.
Mortality rates in matched cohort, pseudo-randomised and randomised trials of convalescent plasma given to COVID-19 patients
11/20/2020 | medRxiv
This meta-analysis of 17 studies with a total of 2,378 CCP treated patients showed that overall mortality reduction benefit for CCP treated hospitalized patients was statistically significant.
Evidence favoring the efficacy of convalescent plasma for COVID-19 therapy
10/29/2020 | medRxiv
This meta-analysis of observational and RCTs of use of CCP for hospitalized from across the world concludes that CCP patients exhibited a lower mortality rate compared to patients receiving standard treatment.
Convalescent Plasma for COVID-19. A randomized clinical trial
7/3/20 | medRxiv
Most COVID-19 patients already have high neutralizing antibody titers at hospital admission. Screening for antibodies and prioritizing convalescent plasma to risk groups with recent symptom onset will be key to identify patients that may benefit from convalescent plasma.
The therapeutic effectiveness of Convalescent plasma therapy on treating COVID-19 patients residing in respiratory care units in hospitals in Baghdad, Iraq
6/30/20 | medRxiv
Patients received convalescent plasma showed reduced duration of infection in about 4 days, and showed less death rate, 1/21 versus 8/28 in control group.
RCT of CCP in patients with severe COVID-19 infection (Bahrain)
05/11/2021 | Nature
In his small study of severe patients, there was no statistically significant difference in CCP vs standard care.
A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19
05/11/2021 | The Journal of Clinical Investigation
Although study endpoints for clinical status improvement were not met, 28-day mortality was significantly lower in CCP patients.
Prevalent, protective and convergent IgG recognition of SARS-CoV-2 non-RBD spike epitopes
05/04/2021 | AAAS
Detailed analysis of CCP from 4 patients shows IgG antibodies to non-RBD sites on the virus are the most prevalent immunoglobulin produced.
Association of Convalescent Plasma Treatment With Clinical Outcomes in Patients with COVID-19: A Systematic Review and Meta-Analysis
2/26/2021 | JAMA
In this meta-analysis of clinical trials for patients with COVID-19, treatment with convalescent plasma compared with control was not associated with improved survival or other positive clinical outcomes.
Early High-Titer Plasma Therapy to Prevent Severe COVID-19 in Older Adults
2/18/2021 | The New England Journal of Medicine
Early administration of high-titer COVID-19 convalescent plasma (CCP) in older adults within 72 hours after the onset of mild symptoms is recommended in reducing the progression of the virus.
Early mortality benefit with COVID-19 convalescent plasma: a matched control study
1/22/2021 | British Journal of Haematology
This study found that COVID-19 patients who received CCP were found to have a significant decrease in risk of death at 7 and 14 day milestones, but not at 28 days post transfusion. To date, this is the largest study (i.e., 526 patients) demonstrating benefit of decreased mortality for the use of CCP in patients with COVID‐19 compared to matched controls.
Convalescent Plasma Antibody Levels and the Risk of Death from Covid-19
1/13/2021 | New England Journal of Medicine
For hospitalized COVID-19 patients not requiring mechanical ventilation, this study found that transfusion of plasma with higher anti–SARS-CoV-2 IgG antibody levels was associated with a lower risk of death than transfusion of plasma with lower antibody levels.
Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults
1/7/2021 | New England Journal of Medicine
In this randomized controlled trial, older adults who received high titer plasma within three days of COVID-19 symptoms were about 50% less likely to progress to severe respiratory disease.
Robust neutralizing antibodies to SARS-CoV-2 infection persist for months
12/24/2020 | Science
COVID-19 survivors of mild to moderate cases were found to have neutralizing antibody titers persisted for at least 5 months after infection, which suggest that the chance of reinfection may be lower than is currently feared.
Mortality reduction in 46 severe Covid-19 patients treated with hyperimmune plasma
12/1/2020 | Haematologica
Hyperimmune plasma in Covid-19 shows promising benefits, to be confirmed in a randomized controlled trial.
A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia
11/24/2020 | New England Journal of Medicine
This randomized trial underscores findings that in patients who are already severely ill with pneumonia, CCP does not provide a mortality benefit. (Argentina: PlasmAR study group)
Serological Analysis of New York City COVID-19 Convalescent Plasma Donors
11/18/2020 | Journal of Clinical Microbiology
This study determined the effectiveness of several commercially available SARS-CoV-2 antibody level tests, showing that a large proportion of convalescent plasma samples have modest antibody levels and that commercially available tests have various degrees of accuracy in predicting antibody levels.
Significantly decreased mortality in a large cohort of COVID-19 patients transfused early with convalescent plasma containing high titer anti-SARS-CoV-2 spike protein IgG
11/4/2020 | National Institutes of Health
Researchers from Houston Methodist Hospital compared 351 patients who received CCP with retrospective propensity matched controls, finding that high-titer CCP delivered soon after hospitalization significantly reduces mortality.
Hospitalized COVID-19 patients treated with Convalescent Plasma in a mid-size city in the midwest
10/12/2020 | Translational Medicine Communications
Results demonstrate that convalescent plasma is associated with reducing ventilatory requirements in patients with both severe and life-threatening disease, but appears to be most beneficial when administered early in the course of disease when patients meet the criteria for severe illness.
Convalescent plasma treatment of severe COVID-19: A matched control study
9/15/2020 | Nature Medicine
Outcomes of 39 hospitalized patients with severe to life-threatening COVID-19 who received convalescent plasma transfusion were compared against a cohort of retrospectively matched controls, concluding convalescent plasma transfusion is a potentially efficacious treatment option; data suggest that non-intubated patients may benefit more than those requiring mechanical ventilation.
Convalescent plasma treatment of severe COVID-19: a propensity score–matched control study
9/15/2020 | Nature Medicine
This U.S. study of patients early in the pandemic identifies "high titer" CCP as the most potentially effective against COVID-19.
Use of Convalescent Plasma in Hospitalized Patients With COVID-19 - Case Series
8/6/20 | American Society of Hematology
Study comprised of 20 COVID-19 patients receiving Convalescent Plasma (CP) suggests CP use in severe and critically ill patients with COVID-19 may improve survival if given early in in the course of disease.
Treatment of Coronavirus Disease 2019 (COVID-19) Patients with Convalescent Plasma
8/1/2020 | Science Direct
Outcomes from this case series of 25 patients indicate that administration of convalescent plasma is a safe treatment option for those with severe COVID-19 disease.
Early Safety Indicators of COVID-19 Convalescent Plasma in 5,000 Patients
6/11/20 | Journal of Clinical Investigation
COVID-19 patients transfused with convalescent plasma provides no signal of toxicity beyond what is expected from plasma use in severely ill patients.
A Randomized Trial of Convalescent Plasma for COVID-19—Potentially Hopeful Signals
6/3/20 | JAMA
The first RCT of CCP, from China, showed no statistically significant benefit in clinical improvement at 28 days but does suggest that high titer antibody may have antiviral efficacy.
Effectiveness of convalescent plasma therapy in severe COVID-19 patients
4/28/20 | National Academy of Sciences
To confirm safety of convalescent plasma (CP) transfusion and its effectiveness as a COVID-19 treatment, 10 adults with confirmed COVID-19 were given one dose of 200 mL of CP derived from recently recovered donors as part of an overall supportive care regimen. Several clinical factors improved post CP transfusion.
Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma
3/27/20 | JAMA
Five critically ill patients with COVID-19 and acute respiratory distress syndrome (ARDS) were administered convalescent plasma containing neutralizing antibody, which resulted in an improvement in clinical status. (China)
mAb FDA EUA Updates
04/16/2021 | FDA
FDA has updated guidance for the use of monoclonal antibodies for treatment of COVID-19.
CoVIg-19 Plasma Alliance announces results of Hyperimmune Globulin Study
04/02/2021 | BusinessWire
NIH-sponsored clinical trial on HI-g did not meet its endpoint to show efficacy in hospitalized adults with COVID-19 infection.
NIH halts trial of COVID-19 convalescent plasma in emergency department patients
03/02/2021 | NIH
The NIH has halted the “C3PO” clinical trial evaluating the safety and effectiveness of CCP in treating emergency department patients who developed mild to moderate symptoms of COVID-19.
Investigational COVID-19 Convalescent Plasma - Guidance for Industry
2/11/2021 | FDA
This guidance updates requirements on CCP donation for patients who have received COVID-19 vaccine. New guidance is that donors who have recovered from COVID-19 and have subsequently received the COVID-19 vaccine should complete their CCP donation within 6 months of infection resolution. This is so their plasma has sufficient antibodies related to their own immune response to COVID-19.
Emergency Use Authorization for CCP
2/4/2021 | FDA
On Feb. 4 the FDA updated the Emergency Use Authorization (EUA) for CCP. High titer plasma is authorized for use as early as possible in the course of disease for hospitalized patients. FDA indicates that in particular, patients with impaired humoral immunity may benefit from CCP. They also expand the lab equipment options used to determine plasma antibody titer.
Letter of Authorization, Reissuance of Convalescent Plasma EUA
11/30/2020 | FDA
This letter is an addenda to the August 2020 CCP EUA, dictating that CCP donations must be tested by registered or licensed blood establishments for anti-SARSCoV-2 antibodies as a manufacturing step to determine suitability before release.
Suggested Criteria for Selecting Best CCP Donors
10/19/2020 | Johns Hopkins Bloomberg School of Public Health
New data collected in this study suggest sex, age, and severity of disease may be useful in identifying COVID-19 survivors who are likely to have high levels of antibodies.
Mayo Clinic launches neutralizing antibody test to advance COVID-19 therapies
6/11/20 | Mayo Clinic
Mayo Clinic has created and launched a new SARS-CoV-2 neutralizing antibody test, which measures a subset of antibodies able to independently inactivate the COVID-19 virus and potentially prevent re-infection. This new test indicates how effective a potential Convalescent Plasma (CP) donor’s antibodies are at neutralizing the virus.
Convalescent Plasma and Monoclonal Antibody Therapies for COVID-19
1/20/21 | COVID-19 Healthcare Coalition Response
Webinar where speakers discussed current research and rapidly evolving clinical advice on the use of CCP and mAb therapies for both pre-hospital and hospital care.
ASU COVID-19 Diagnostic Commons Website
1/7/2021 | ASU College of Health Solutions
Dr. Mara G. Apinsall of Arizona State University (ASU) gave a presentation on ASU College of Health Solutions' COVID-19 Diagnostics Commons website. This website provides up-to-the-minute data related to COVID-19 diagnostic testing in hopes of helping governments make better decisions about when and how to open their economics up.
Clarifying the Emergency Use Authorization Framework for COVID-19 Convalescent Plasma: Considerations for Clinicians
11/18/2020 | Infectious Diseases Society of America and AABB
Joint document by American Assoc. of Blood Banks and the Infectious Disease Society of America indicating that patients who received CCP available evidence indicates that the best outcomes are likely to occur in those who receive a high-titer unit of CCP within 3 days of COVID-19 diagnosis or admission to the hospital.
Convalescent Plasma and Immune Therapies for COVID-19
9/16/2020 | COVID-19 Healthcare Coalition Response
Researchers and clinicians are working hard to develop immune therapies to treat COVID-19—including the use of convalescent plasma and hyperimmune globulin. Dr. Mark McClellan et al. discuss the current studies regarding convalescent plasma effectiveness; Dr. Nigel Paneth discusses the current studies regarding convalescent plasma effectiveness; and Dr. William Mezzanotte discusses the current state of using Hyperimmune Globulin (H-IG) as a potential treatment.
Update on Convalescent Plasma in COVID-19
5/27/20 | Philippe R. Bauer, MD, PhD
This is a presentation provides an overview of the findings presented in a preprint titled Early Safety Indicators of COVID-19 Convalescent Plasma in 5,000 Patients (5/14/2020 MedRxIV) that Dr Bauer co-authored. Note that this article has since been peer reviewed and included in the Journal of Clinical Investigation, dated 6/11/2020.
Deployment of convalescent plasma for the prevention and treatment of COVID-19
4/7/20 | The Journal of Clinical Investigation
This article acts as a guidebook for the healthcare system to use in scaling up Convalescent Plasma availability as a COVID-19 treatment.
AABB COVID-19 Resources
Educational resources for physicians to cover the latest information regarding COVID-19 convalescent plasma's use and efficacy.
The British Medical Journal (BMJ) COVID-19 Research Hub
Clinical Microbiology and Infection (CMI) COVID-19 Collection
Journal of the American Medical Association (JAMA) Coronavirus 19 Portal
The Lancet Latest COVID-19 Content
MedRxIV COVID-19 SARS-CoV-2 Preprints
Microsoft Academic COVID-19 Plasma Publication Portal
National Institutes of Health (NIH) COVID-19 Portal
NIH National Library of Medicine NCBI SARS-CoV-2 Resources
COVID-19 Collaboration Platform
NIH COVID-19 Treatment Guidelines
Infectious Diseases Society of America (IDSA) CCP Portal
Outbreak.info COVID-19 Epidemiology Data and Resources
COVID-19 Variant Case in US (CDC)