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A randomized clinical trial evaluating the immunomodulatory effect of convalescent plasma on COVID-19-related cytokine storm

Pouladzadeh et al., Internal and Emergency Medicine, doi:10.1007/s11739-021-02734-8, IRCT20200310046736N1
Apr 2021  
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Mortality 40% Improvement Relative Risk Hospitalization time -30% Conv. Plasma  Pouladzadeh et al.  LATE TREATMENT  RCT Is late treatment with convalescent plasma beneficial for COVID-19? RCT 60 patients in multiple countries (March - May 2020) Longer hospitalization with convalescent plasma (not stat. sig., p=0.06) c19early.org Pouladzadeh et al., Internal and Emerg.., Apr 2021 Favorsconv. plasma Favorscontrol 0 0.5 1 1.5 2+
RCT 62 hospitalized patients in Iran, showing no significant difference in mortality and length of stay with convalescent plasma.
risk of death, 40.0% lower, RR 0.60, p = 0.71, treatment 3 of 30 (10.0%), control 5 of 30 (16.7%), NNT 15.
hospitalization time, 30.0% higher, relative time 1.30, p = 0.06, treatment 30, control 30.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Pouladzadeh et al., 10 Apr 2021, Single Blind Randomized Controlled Trial, multiple countries, peer-reviewed, mean age 53.5, 17 authors, study period March 2020 - May 2020, trial IRCT20200310046736N1. Contact: msafdaryan@gmail.com, parastoomoradi40@yahoo.com.
This PaperConv. PlasmaAll
A randomized clinical trial evaluating the immunomodulatory effect of convalescent plasma on COVID-19-related cytokine storm
Mandana Pouladzadeh, Mehdi Safdarian, Peyman Eshghi, Hassan Abolghasemi, Alireza Ghorbani Bavani, Behnam Sheibani, Parastoo Moradi Choghakabodi, Abdolaziz Feghhi, Mehri Ghafourian Boroujerdnia, Arash Forouzan, Mohammad Ali Jalali Far, Gholam Abbas Kaydani, Elham Rajaei, Mansour Amin, Mehdi Torabizadeh, Farid Yousefi, Reza Hadaddezfuli
Internal and Emergency Medicine, doi:10.1007/s11739-021-02734-8
Evaluating the effect of convalescent plasma (CP) on some cytokine storm indices in severe COVID-19 patients. Totally, 62 patients were randomly assigned into two groups for this clinical trial. Patients in the intervention group received one unit (500 mL) plasma on the admission day plus standard drugs while the controls merely received standard treatments. Eventually, primary and secondary outcomes were evaluated. In the CP group, compared with controls, the mean levels of lymphocytes and IL-10 significantly increased while the levels of IL-6, TNF-α, and IFN-γ decreased (p < 0.05). The length of in-hospital stay, and mortality rate did not significantly reduce in the CP group compared with controls (p > 0.05) while WHO severity scores remarkably improved (p = 0.01), despite the higher frequency of underlying diseases among the CP group (66.7%) vs. controls (33.3%). Although CP has a remarkable immunomodulatory and antiviral potential to improve the cytokine storm and disease severity in COVID-19 patients, it did not considerably affect the mortality rate.
Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1007/ s11739-021-02734-8. Author contributions MP conceptualization, supervision, investigation, and funding acquisition; MS supervision, project administration, methodology, and writing-review and editing; PE and HA methodology and resources; AGB and BS investigation; PMC investigation, data curation, writing-original draft, and writing-review and editing; AF resources and coordination of plasma donation plan; MGB and AF resources; MAJF, GAK, and MA laboratory consultation; ER, MT and FY clinical consultation; RH coordination for blood plasma separation device. Declarations Ethical approval All the procedures performed in studies involving human participants were in accordance with the ethical standards of the national research committee and with the 2008 Helsinki Declaration and its later amendments or comparable ethical standards. This hospital-based, parallel-group and randomized controlled trial was approved by the Ethics Committee of Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran with Ethical Code: IR.AJUMS.REC.1399.003 and IRCT20200310046736N1. Authors and Affiliations Mandana Pouladzadeh 1 • Mehdi Safdarian 2 • Peyman Eshghi
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Coagul role Med Hypotheses 142:109829', 'journal-title': 'Coagul role Med Hypotheses'}], 'container-title': 'Internal and Emergency Medicine', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1007/s11739-021-02734-8.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1007/s11739-021-02734-8/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1007/s11739-021-02734-8.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2021, 11, 2]], 'date-time': '2021-11-02T07:19:18Z', 'timestamp': 1635837558000}, 'score': 1, 'resource': {'primary': {'URL': 'https://link.springer.com/10.1007/s11739-021-02734-8'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 4, 10]]}, 'references-count': 40, 'journal-issue': {'issue': '8', 'published-print': {'date-parts': [[2021, 11]]}}, 'alternative-id': ['2734'], 'URL': 'http://dx.doi.org/10.1007/s11739-021-02734-8', 'relation': {}, 'ISSN': ['1828-0447', '1970-9366'], 'subject': ['Emergency Medicine', 'Internal Medicine'], 'container-title-short': 'Intern Emerg Med', 'published': {'date-parts': [[2021, 4, 10]]}, 'assertion': [ { 'value': '11 December 2020', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '30 March 2021', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '10 April 2021', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'All the procedures performed in studies involving human participants were in ' 'accordance with the ethical standards of the national research committee and ' 'with the 2008 Helsinki Declaration and its later amendments or comparable ' 'ethical standards. 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Late treatment
is less effective
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