-
Seminars in Nuclear Medicine Jan 2022SARS-CoV-2 virus may cause COVID-19 disease, which causes mild-to-moderate disease in 80% of laboratory-confirmed cases which may be community-managed. A considerable... (Review)
Review
SARS-CoV-2 virus may cause COVID-19 disease, which causes mild-to-moderate disease in 80% of laboratory-confirmed cases which may be community-managed. A considerable age-dependent mortality is seen among elderly and other at-risk populations but among young and healthy individuals it is < 0.5%. Long-term health issues have been reported following severe COVID-19 requiring hospitalization as well as after cases of mild COVID-19 without hospitalization. Upon receiving COVID-19 suspected patients at hospitals, patients should be isolated and PPE should be worn by all health staff when in contact with the patients. Additionally, patients are tested for the presence of SARS-CoV-2 RNA by PCR, and blood samples are drawn. Imaging is not pivotal for the diagnosis, but chest X-ray is a relevant examination for all and is used to determine severity and treatment need Abnormal findings on CT scans are found in most patients, most frequently peripheral ground-glass opacity and bilateral patchy shadowing are present. Patients are, according to their needs and risks, treated with oxygen therapy, anticoagulation therapy, steroids, antivirals, or immunosupressive drugs on special indications. Convalescent plasma therapy and monoclonal antibodies have a limited role in the treatment, mostly in severely immunocompromised patients. Patients with long-term sequelae should be evaluated in a post-COVID outpatient clinic. The most frequent reported symptoms include cognitive impairment, dyspnea, loss of smell and taste, and mental and physical fatigue although a wide spectrum of symptoms from other organ systems are also reported. The current treatment is based on symptom relief and rehabilitation as there is no documented specific medical treatment.
Topics: Aged; COVID-19; Humans; Immunization, Passive; RNA, Viral; SARS-CoV-2; COVID-19 Serotherapy
PubMed: 34243904
DOI: 10.1053/j.semnuclmed.2021.06.004 -
European Journal of Medical Research Jan 2022SARS-CoV-2, a novel coronavirus, is the agent responsible for the COVID-19 pandemic and is a major public health concern nowadays. The rapid and global spread of this... (Review)
Review
SARS-CoV-2, a novel coronavirus, is the agent responsible for the COVID-19 pandemic and is a major public health concern nowadays. The rapid and global spread of this coronavirus leads to an increase in hospitalizations and thousands of deaths in many countries. To date, great efforts have been made worldwide for the efficient management of this crisis, but there is still no effective and specific treatment for COVID-19. The primary therapies to treat the disease are antivirals, anti-inflammatories and respiratory therapy. In addition, antibody therapies currently have been a many active and essential part of SARS-CoV-2 infection treatment. Ongoing trials are proposed different therapeutic options including various drugs, convalescent plasma therapy, monoclonal antibodies, immunoglobulin therapy, and cell therapy. The present study summarized current evidence of these therapeutic approaches to assess their efficacy and safety for COVID-19 treatment. We tried to provide comprehensive information about the available potential therapeutic approaches against COVID-19 to support researchers and physicians in any current and future progress in treating COVID-19 patients.
Topics: Antibodies, Monoclonal; Antibodies, Neutralizing; Antiviral Agents; COVID-19; Clinical Trials as Topic; Dietary Supplements; Humans; Immunization, Passive; Immunoglobulins, Intravenous; Pandemics; SARS-CoV-2; Treatment Outcome; COVID-19 Drug Treatment; COVID-19 Serotherapy
PubMed: 35027080
DOI: 10.1186/s40001-021-00626-3 -
Viral Immunology Oct 2022COVID-19 is a life-threatening respiratory disease triggered by severe acute respiratory syndrome coronavirus 2 (). It has been considered a pandemic viral infection... (Review)
Review
COVID-19 is a life-threatening respiratory disease triggered by severe acute respiratory syndrome coronavirus 2 (). It has been considered a pandemic viral infection since December 2019. The investigation of the effective prophylaxis or therapeutic strategies for emergency management of the current condition has become a priority for medical research centers and pharmaceutical companies. This article provides a comprehensive review of antibody therapy and its different categories with their advantages and disadvantages for COVID-19 over the last few years of the current pandemic. Antibodies can be generated by active immunization, including natural infection with a pathogen and vaccination, or by the passive immunization method such as convalescent plasma therapy (CPT) and antibody synthesis in laboratories. Each of these ways has its characteristics. Arming the immune system with antibodies is the main aim of antiviral therapeutic procedures toward SARS-CoV-2. Collecting and discussing various aspects of available data in this field can give researchers a better perspective for the production of antibody-based products or selection of the most appropriate approach of antibody therapies to improve different cases of COVID-19. Moreover, it can help them control similar viral pandemics that may happen in the future appropriately.
Topics: Antibodies, Viral; Antiviral Agents; COVID-19; Humans; Immunization, Passive; Pharmaceutical Preparations; SARS-CoV-2; COVID-19 Serotherapy
PubMed: 36201297
DOI: 10.1089/vim.2021.0160 -
Blood Reviews Mar 2018Immunoglobulins are used to prevent or reduce infection risk in primary immune deficiencies and in settings which exploit its anti-inflammatory and immune-modulatory... (Review)
Review
Immunoglobulins are used to prevent or reduce infection risk in primary immune deficiencies and in settings which exploit its anti-inflammatory and immune-modulatory effects. Rigorous proof of immunoglobulin efficacy in persons with lympho-proliferative neoplasms, plasma cell myeloma, and persons receiving hematopoietic cell transplants is lacking despite many clinical trials. Further, there are few consensus guidelines or algorithms for use in these conditions. Rapid development of new therapies targeting B-cell signaling and survival pathways and increased use of chimeric antigen receptor T-cell (CAR-T) therapy will likely result in more acquired deficiencies of humoral immunity and infections in persons with cancer. We review immunoglobulin formulations and discuss efficacy and potential adverse effects in the context of preventing infections and in graft-versus-host disease. We suggest an algorithm for evaluating acquired deficiencies of humoral immunity in persons with hematologic neoplasms and recommend appropriate use of immunoglobulin therapy.
Topics: Antineoplastic Agents, Immunological; Autoimmune Diseases; Hematologic Neoplasms; Hematopoietic Stem Cell Transplantation; Humans; Immunization, Passive; Immunotherapy; Treatment Outcome
PubMed: 28958644
DOI: 10.1016/j.blre.2017.09.003 -
Transfusion Medicine (Oxford, England) Feb 2023Faced with an evolving pandemic and a lack of clarity of the role of convalescent plasma for patients with COVID-19, the CONCOR-1 trial was launched. In 14 months the...
Faced with an evolving pandemic and a lack of clarity of the role of convalescent plasma for patients with COVID-19, the CONCOR-1 trial was launched. In 14 months the trial was designed, launched, completed, and submitted for publication. In total, 72 sites in three countries served by four blood suppliers randomised 940 patients. Many enablers facilitated the trial including: three study principal investigators to distribute the trial workload, diverse steering committee members, an international data safety monitoring committee, multiple statisticians and methodologists, virtual meeting platforms, REDCap data platform, pausing of non-COVID-19 trials, rapid approval pathways for institutional review boards and regulators, centralised institutional review boards in many locations, restriction of use of convalescent plasma to trial participants and the incredible dedication by research personnel. In future pandemics, we need to be prepared for rapid launch of trials. The protocols, consent forms, data collection tools, and procedures need to be in draft form ready for use at all times. We were well-prepared for blood shortages but should have anticipated the need to conduct trials with convalescent plasma. In this short article, we detail our lessons learned to inform researchers faced with the next pandemic pathogen.
Topics: Humans; COVID-19; SARS-CoV-2; Bisoprolol; Immunization, Passive; COVID-19 Serotherapy
PubMed: 35633145
DOI: 10.1111/tme.12882 -
The New England Journal of Medicine Sep 2022
Topics: Ambulatory Care; COVID-19; Humans; Immunization, Passive; Outpatients; Plasma; COVID-19 Serotherapy
PubMed: 36069882
DOI: 10.1056/NEJMc2208338 -
The New England Journal of Medicine Sep 2022
Topics: Ambulatory Care; COVID-19; Humans; Immunization, Passive; Outpatients; Plasma; COVID-19 Serotherapy
PubMed: 36069883
DOI: 10.1056/NEJMc2208338 -
The New England Journal of Medicine May 2022Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain.
METHODS
In this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (≥18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion.
RESULTS
Participants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized.
CONCLUSIONS
In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.).
Topics: Adult; Ambulatory Care; COVID-19; Disease Progression; Double-Blind Method; Hospitalization; Humans; Immunization, Passive; Treatment Outcome; United States; COVID-19 Serotherapy
PubMed: 35353960
DOI: 10.1056/NEJMoa2119657 -
Expert Review of Clinical Pharmacology 2016Immunoglobulin therapy has not only served as a lifesaving approach for the prevention and treatment of infections in primary and secondary immunodeficiency diseases,... (Review)
Review
Immunoglobulin therapy has not only served as a lifesaving approach for the prevention and treatment of infections in primary and secondary immunodeficiency diseases, but has also been used as an immunomodulatory agent for autoimmune and inflammatory disorders and to provide passive immunity for some infectious diseases. Most of the adverse effects associated with immunoglobulin therapy are mild, transient and self-limiting. However, serious side effects also occur. Therefore, to minimize the adverse events of immunoglobulin therapy, specialist review of patient clinical status and immunoglobulin products, in addition to selection of appropriate treatment strategy for the management of patients with associated side effects and adverse events, are crucial.
Topics: Autoimmune Diseases; Humans; Immunization, Passive; Immunoglobulins; Immunologic Deficiency Syndromes; Immunologic Factors; Inflammation
PubMed: 26496172
DOI: 10.1586/17512433.2016.1105131 -
Indian Journal of Medical Microbiology 2020The world is challenged with the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) pandemic. Although preventive measures such as social distancing, personal... (Review)
Review
The world is challenged with the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) pandemic. Although preventive measures such as social distancing, personal protective equipment and isolation would decrease the spread of the infection, a definitive treatment is still under way. Antivirals, immunisation, convalescent plasma (CP) and many more modalities are under trial, and there has been no definite answer to the management of COVID-19 infection. All patients so far have received the standard and symptomatic care. It is shown that the SARS-CoV 2 is a respiratory pathogen, and 80% of the infected patients would recover from the illness and it is the 20% of the infected patients require hospitalisation and even critical care. CP has been used to treat recent epidemic respiratory infections such as Middle East respiratory syndrome and severe acute respiratory syndrome (SARS) infections with promising results. The CP of a recovered individual contains antibodies which neutralise the virus and decrease the viral replication in the patient. It is a classic adaptive immunotherapy and has been applied in the prevention and treatment of many infectious diseases. CP is plasma taken from a person who has recovered from an infection, which contains neutralising antibodies against the said infection. Giving CP to susceptible individuals or infected patients is a form of passive antibody therapy and in the case of SARS-CoV-2, is expected to provide protection by viral neutralisation and antibody-dependent cytotoxicity and phagocytosis. The adaptive response is to a specific antigen-binding array of molecules that are foreign to the host. The human response to viruses uses both the innate and the adaptive arms in its attempt to rid the host of the invading pathogen. The humoral response is a component of the adaptive immune response that allows for antibodies to bind to foreign invading pathogens, marks the pathogens and their toxins for phagocytosis and recruits further phagocytic cells to the site via the activation of the complement system and eventually prevents the pathogen from infecting target cells. Studies from Wuhan from various institutions during the research on COVID-19 infections during December 2019 have also shown promising results. Till date, randomised controlled studies for the use of CP in SARS-CoV-2 infection are lacking, and many countries have invited institutions to participate in clinical trials. The Indian Council of Medical research and the Central Drugs Standard Control Organisation, Government of India, have allowed the use of CP as an investigational drug under a trial basis. Internationally, agencies such as the USFDA, American Association of Blood Banks, European Blood Safety and British Blood Transfusion Society have also come out with various guidelines for the use of CP in COVID-19 infection. This article will review the current guidelines for the use of CP and compare the various guidelines of different agencies.
Topics: Antibodies, Neutralizing; Antibodies, Viral; Antiviral Agents; Betacoronavirus; COVID-19; Coronavirus Infections; Female; Guidelines as Topic; Humans; Immunization, Passive; Immunotherapy; Male; Neutralization Tests; Pandemics; Pneumonia, Viral; SARS-CoV-2; Spike Glycoprotein, Coronavirus; COVID-19 Serotherapy
PubMed: 33154232
DOI: 10.4103/ijmm.IJMM_20_358