Convalescent Plasma Coupled With Medications for the Treatment of a Severe COVID-19 Patient: Drugs Analysis and Pharmaceutical Care Based on the Newly Established Guidelines for COVID-19 Remedy

Ying, Wang; Zhang, Yang; Yu, Qian; Zhu, Kun

doi:10.3389/fphar.2020.00966

Cited by 7 publications

(2 citation statements)

References 35 publications

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“…Coronavirus disease 2019 (COVID-19) has spread globally at a rapid pace since its inception in December 2019 in Wuhan, China and was declared a pandemic by the World Health Organization on March 11, 2020. 1,2 As of August 1, 2020, over 17 million cases and over 675,000 deaths due to COVID-19 have been reported around the world, 3 caused by the novel coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 4,5 NVX-CoV2373 is a recombinant nanoparticle vaccine constructed from the full-length, wild-type SARS-CoV-2 spike glycoprotein, which mediates viral attachment to the human angiotensin-converting enzyme 2 (hACE2) receptor of host cells for cellular entry and serves as a key target for development of antibodies and vaccines.…”

Section: Introductionmentioning

confidence: 99%

First-in-Human Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine

Keech

Albert

Reed

et al. 2020

Preprint

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Background NVX-CoV2373 is a recombinant nanoparticle vaccine composed of trimeric full-length SARS-CoV-2 spike glycoproteins. We present the Day 35 primary analysis of our trial of NVX-CoV2373 with or without the saponin-based Matrix-M1 adjuvant in healthy adults. Methods This is a randomized, observer-blinded, placebo-controlled, phase 1 trial in 131 healthy adults. Trial vaccination comprised two intramuscular injections, 21 days apart. Primary outcomes were reactogenicity, safety labs, and immunoglobulin G (IgG) anti-spike protein response. Secondary outcomes included adverse events, wild-type virus neutralizing antibody, and T-cell responses. Results Participants received NVX-CoV2373 with or without Matrix-M1 (n=106) or placebo (n=25). There were no serious adverse events. Reactogenicity was mainly mild in severity and of short duration (mean ≥ 2 days), with second vaccinations inducing greater local and systemic reactogenicity. The adjuvant significantly enhanced immune responses and was antigen dose-sparing, and the two-dose 5μg NVX-CoV2373/Matrix-M1 vaccine induced mean anti-spike IgG and neutralizing antibody responses that exceeded the mean responses in convalescent sera from COVID-19 patients with clinically significant illnesses. The vaccine also induced antigen-specific T cells with a largely T helper 1 (Th1) phenotype. Conclusions NVX-CoV2373/Matrix-M1 was well tolerated and elicited robust immune responses (IgG and neutralization) four-fold higher than the mean observed in COVID-19 convalescent serum from participants with clinical symptoms requiring medical care and induced CD4+ T-cell responses biased toward a Th1 phenotype. These findings suggest that the vaccine may confer protection and support transition to efficacy evaluations to test this hypothesis. (Funded by the Coalition for Epidemic Preparedness Innovations; ClinicalTrials.gov number, NCT04368988).

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Section: Introductionmentioning

confidence: 99%

First-in-Human Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine

Keech

Albert

Reed

et al. 2020

Preprint

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“…[173][174][175] Subsequently, the transfusion of CP to infected patients had a high possibility of providing additional clinical benefits through immunomodulation by inhibiting the severe inflammatory process. [176][177][178][179] The mechanism of action CP in the management of COVID-19 has been categorized into two major groups: 1) immune, and 2) non-immune mechanism. 180 Multiple reports documented that CP's most important immunerelated mode of action is by minimizing viral load through antibodies developed in recovered COVID-19 patients.…”

Section: Effects Of Convalescent Plasma On the Coagulopathy Of Covid-19mentioning

confidence: 99%

<p>Convalescent Plasma Therapy for Management of COVID-19: Perspectives and Deployment in the Current Global Pandemic</p>

Samad¹,

Sodunke²,

Banna³

et al. 2020

RMHP

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The world is striving against the severe crisis of the COVID-19 pandemic. Healthcare professionals are struggling to treat their patients based on nonspecific therapies. Amidst this uncertainty, convalescent plasma therapy (CPT) has appeared to be an interim adjuvant therapy for severely ill patients of COVID-19 until long-term clinical trial treatment options are available. Considering the transfusion-related hazards, especially lung injuries and microbial transmission, where sensitivity is not ensured, rigorous trials should be conducted to determine this therapy's efficacy. Moreover, the ratio of recovered cases to plasma donors is not satisfying, which questioning this therapy's availability and accessibility. Although some countries are making the treatment free, the attributable cost mandates a justification for its suitability and sustainability. Our article aimed to review the published facts and findings of CPT's effectiveness in lowering the mortality rate of COVID-19. This pandemic showed that healthcare systems worldwide need core reform. A unified global collaboration must align and coordinate to face the current pandemic and enhance world readiness for future outbreaks based on health equity and equality.

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Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review

Chai

Valk

Piechotta

et al. 2020

Cochrane Database of Systematic Reviews

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Convalescent Plasma Coupled With Medications for the Treatment of a Severe COVID-19 Patient: Drugs Analysis and Pharmaceutical Care Based on the Newly Established Guidelines for COVID-19 Remedy

Cited by 7 publications

References 35 publications

First-in-Human Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine

First-in-Human Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine

<p>Convalescent Plasma Therapy for Management of COVID-19: Perspectives and Deployment in the Current Global Pandemic</p>

Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review

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