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Use of convalescent plasma therapy in eight individuals with mild COVID-19.

ABSTRACT: Coronavirus disease 2019 (COVID-19) is still a global epidemic. Several studies of individuals with severe COVID-19 regard convalescent plasma (CP) transfusion as an effective therapy. However, no significant improvements are found in randomized clinical trials of CP treatment. Until now, data for individuals with mild COVID-19 transfused CP were lacking. This study recruited eight individuals with mild COVID-19 who received at least one dose of CP transfusion. After CP therapy, the clinical symptoms of all individuals improved. Lymphocyte counts tended to increase, and lactate dehydrogenase, creatine kinase and aspartate aminotransferase tended to decrease. However, C-reactive protein increased transiently in three individuals. The median time for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid test to become negative was 2.5 days after CP transfusion. The study shows the potential benefits of CP. Meanwhile, CP probably enhances the inflammatory response to SARS-CoV-2 temporarily in people with insufficient antiviral immunity. However, the effects of CP are not permanent.

SUBMITTER: Ji F

PROVIDER: S-EPMC7661912 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Use of convalescent plasma therapy in eight individuals with mild COVID-19.

Ji F F Liu W W Hao D-A DA Cheng J J Tong X-C XC Hao J-G JG Wang L-P LP Li C-Y CY Dai M-J MJ Yan X-B XB

New microbes and new infections 20201113

Coronavirus disease 2019 (COVID-19) is still a global epidemic. Several studies of individuals with severe COVID-19 regard convalescent plasma (CP) transfusion as an effective therapy. However, no significant improvements are found in randomized clinical trials of CP treatment. Until now, data for individuals with mild COVID-19 transfused CP were lacking. This study recruited eight individuals with mild COVID-19 who received at least one dose of CP transfusion. After CP therapy, the clinical sym ...[more]

PMID: 33204428

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Project description:BackgroundCOVID-19 convalescent plasma (CCP) is a treatment option for COVID-19. This study investigated the safety and efficacy of early, very high-titre CCP in immunocompromised individuals with mild COVID-19.MethodsThis randomised, controlled, open-label trial assessed CCP in immunocompromised patients (n = 120) with mild COVID-19 in 10 clinical trial centres across Germany, France, and the Netherlands. Patients were randomised 1:1 to receive either standard of care (SoC) alone (SoC group) or SoC and 2 units of CCP. Most patients (89.7%) had received ≥3 SARS-CoV-2 vaccinations. The primary endpoint was hospitalisation for progressive COVID-19 symptoms or death by day 28 after randomisation, analysed on a modified intention-to-treat basis (117 patients). The safety analysis included the full analysis set. The trial is registered with EudraCT 2021-006621-22, and ClinicalTrials.gov, NCT05271929.FindingsBetween April 11, 2022 and November 27, 2023, 120 patients were enrolled. Patients in the CCP group received a median of 559 ml CCP from convalescent, vaccinated donors with very high levels of SARS-CoV-2 antibodies (median 81,810 IU/ml) at a median 4 days after symptom onset. The primary outcome occurred in 5/58 patients (8.6%) in the SoC group and in 0/59 patients (0%) in the CCP group, difference -8.6% (95% confidence interval of difference -19% to -0.80%; p-value 0.027; Fisher's exact test). The course of SARS-CoV-2 antibodies in the patients demonstrated a passive transfer of antibodies by the CCP, in particular neutralising effects against new SARS-CoV-2 variants. Whole genome sequencing of SARS-CoV-2 in patients during follow-up showed significant intra-host viral evolution, but without differences between groups. CCP was well tolerated.InterpretationEarly administration of high-titre CCP can prevent hospitalisation or death in immunocompromised patients with mild COVID-19.FundingSupport-e project (European Union's Horizon 2020 Programme), German Federal Ministry of Education and Research, ZonMw, the Netherlands Organisation for Health Research and Development.

Project description:IntroductionCOVID-19 convalescent plasma (CCP) is a possible treatment option for COVID-19. A comprehensive number of clinical trials on CCP efficacy have already been conducted. However, many aspects of CCP treatment still require investigations: in particular (1) Optimisation of the CCP product, (2) Identification of the patient population in need and most likely to benefit from this treatment approach, (3) Timing of administration and (4) CCP efficacy across viral variants in vivo. We aimed to test whether high-titre CCP, administered early, is efficacious in preventing hospitalisation or death in high-risk patients.Methods and analysisCOVIC-19 is a multicentre, randomised, open-label, adaptive superiority phase III trial comparing CCP with very high neutralising antibody titre administered within 7 days of symptom onset plus standard of care versus standard of care alone. We will enrol patients in two cohorts of vulnerable patients [(1) elderly 70+ years, or younger with comorbidities; (2) immunocompromised patients]. Up to 1020 participants will be enrolled in each cohort (at least 340 with a sample size re-estimation after reaching 102 patients). The primary endpoint is the proportion of participants with (1) Hospitalisation due to progressive COVID-19, or (2) Who died by day 28 after randomisation. Principal analysis will follow the intention-to-treat principle.Ethics and disseminationEthical approval has been granted by the University of Ulm ethics committee (#41/22) (lead ethics committee for Germany), Comité de protection des personnes Sud-Est I (CPP Sud-Est I) (#2022-A01307-36) (ethics committee for France), and ErasmusMC ethics committee (#MEC-2022-0365) (ethics committee for the Netherlands). Signed informed consent will be obtained from all included patients. The findings will be published in peer-reviewed journals and presented at relevant stakeholder conferences and meetings.Trial registrationClinical Trials.gov (NCT05271929), EudraCT (2021-006621-22).

Project description:BackgroundThe long-term effect of coronavirus disease 2019 (COVID-19) acute treatments on postacute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) is unknown. The CONTAIN-Extend study explores the long-term impact of COVID-19 convalescent plasma (CCP) therapy on postacute sequelae of SARS-CoV-2 infection (PASC) symptoms and general health 18 months following hospitalization.MethodsThe CONTAIN-Extend study examined 281 participants from the original CONTAIN COVID-19 trial (CONTAIN-RCT, NCT04364737) at 18 months post-hospitalization for acute COVID-19. Symptom surveys, global health assessments, and biospecimen collection were performed from November 2021 to October 2022. Multivariable logistic and linear regression estimated associations between the randomization arms and self-reported symptoms and Patient-Reported Outcomes Measurement Information System (PROMIS) scores and adjusted for covariables, including age, sex, race/ethnicity, disease severity, and CONTAIN enrollment quarter and sites.ResultsThere were no differences in symptoms or PROMIS scores between CCP and placebo (adjusted odds ratio [aOR] of general symptoms, 0.95; 95% CI, 0.54-1.67). However, females (aOR, 3.01; 95% CI, 1.73-5.34), those 45-64 years (aOR, 2.55; 95% CI, 1.14-6.23), and April-June 2020 enrollees (aOR, 2.39; 95% CI, 1.10-5.19) were more likely to report general symptoms and have poorer PROMIS physical health scores than their respective reference groups. Hispanic participants (difference, -3.05; 95% CI, -5.82 to -0.27) and Black participants (-4.48; 95% CI, -7.94 to -1.02) had poorer PROMIS physical health than White participants.ConclusionsCCP demonstrated no lasting effect on PASC symptoms or overall health in comparison to the placebo. This study underscores the significance of demographic factors, including sex, age, and timing of acute infection, in influencing symptom reporting 18 months after acute hypoxic COVID-19 hospitalization.

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Use of convalescent plasma therapy in eight individuals with mild COVID-19.

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Use of convalescent plasma therapy in eight individuals with mild COVID-19.

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