The effectiveness of convalescent plasma administered on the first day of admission for COVID-19 patients: an open-label randomized controlled trial
et al., Infectious Diseases & Immunity, doi:10.1097/id9.0000000000000145, IRCT20200310046736N1, Nov 2024
RCT 232 hospitalized COVID-19 patients showing no significant reduction in mortality or length of hospitalization with early convalescent plasma treatment.
This trial has several significant issues:
Baseline randomization failure: despite being a randomized trial, the treatment group had significantly worse baseline pulmonary involvement (CT severity scores) than the control group (p < 0.001), indicating a critical failure in the randomization process or severe selection bias.
Conflicting mortality HR: the reported hazard ratios for mortality in Table 2 (HR 1.600 and 1.740) conflict with the raw mortality counts reported in the text.
Co-intervention bias: authors explicitly admit that the open-label design led physicians to administer "more aggressive treatment" to the treatment group due to their higher baseline severity, however details of co-interventions are not provided.
Baseline D-dimer imbalance: higher proportion of elevated D-dimer in the control group (p = 0.035).
Unexplained publication delay: there was a four-year gap between the end of the trial's data collection in July 2020 and the manuscript's submission in June 2024.
Implausible data variance: the reported standard deviation for body temperature in the treatment group on Day 4 (37.5 ± 5.2 °C) is physiologically impossible for a living cohort.
Major differential missing data on secondary labs: By day 7, labs were available in well under half of patients (e.g., CRP in ~42% of the treatment arm, D-dimer in ~36 patients/arm), and more deaths were removed from the control arm before day 7 (16 vs. 5). The secondary CRP/LDH/RR "improvements" rest on these shrunken, non-random subsamples. Sicker control patients dying early plausibly creates the apparent between-group differences.
Mohammadi et al., 21 Nov 2024, Randomized Controlled Trial, Iran, peer-reviewed, 13 authors, study period 1 March, 2020 - 30 July, 2020, trial IRCT20200310046736N1.
Contact: p.eshghi@ibto.ir, parastoomoradi40@yahoo.com.
Abstract:
The effectiveness of convalescent plasma administered on the first day of admission for COVID-19 patients: an open-label randomized controlled trial
Saeed Mohammadi 1,2,3 , Mandana Pouladzadeh 4 , Hamidreza Kouhpayeh 5 , Shamsi Okati 3 , Mehdi Safdarian 6 , Peyman Eshghi 3,7, * , Parastoo Moradi Choghakabodi 8, * , Shahabeddin Mashaei 5 , Sharareh Sanei Sistani 5 , Yalda Khani 5 , Soheila Nasizadeh 3 , Ahmad Reza Shamshiri 9,10 , Amir Teimourpour 3
1 Hematology-Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sciences, Tehran 14166-34793, Iran;
2 Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran 14166-34793, Iran;
3 Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran 14166-51157, Iran;
4 Emergency Medicine Department, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 61357-15794, Iran;
5 Tropical and Infectious Diseases Department, Zahedan University of Medical, Zahedan 98167-43463, Iran;
6 Nanotechnology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 61357-15794, Iran;
7 Pediatric Congenital Hematologic Disorders Research Center, Research Institute for Children's Health, Shahid Beheshti University of Medical Sciences, Tehran 19839-69411, Iran;
8 School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz 61357-15794, Iran;
9 Dental Research Center, Dentistry Research Institute, School of Dentistry, Tehran University of Medical Sciences, Tehran 14166-34793, Iran;
10 Department of Epidemiology and Biostatistics School of Public Health, Tehran University of Medical Sciences, Tehran 14166-34793, Iran.
Abstract
Background: Given the controversial reports on the effect of convalescent plasma (CP) on coronavirus disease 2019 (COVID-19) patients, this study aimed to clarify the efficacy of early CP administration, improve the understanding of its impact on clinical outcomes, guide future research, address safety concerns, and inform public health policies.
Methods: In this prospective, multicenter, randomized controlled trial conducted at Razi Hospital (Ahvaz) and Bouali Hospital (Zahedan) in Iran, 232 confirmed COVID-19 patients were randomly assigned into two groups using a computer-generated randomization method. The treatment group ( n = 116) received CP with anti-severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) IgG titer ≥1/160 on the first day of admission, along with routine antiviral medications, while the control group received only routine medications ( n = 116). Recruitment occurred from 1 March to 30 July 2020, with two months of post-intervention follow-up. The primary outcome was two-month mortality, and secondary outcomes included CP-related side effects and various clinical and laboratory parameters.
Results: No significant differences were observed between the groups in terms of age ( P = 0.119), sex ( P = 0.418), comorbidities ( P > 0.05), or pre- and post-treatment changes in temperature, lymphocyte count, erythrocyte sedimentation rate, or platelet count (all P > 0.05). Despite a higher CT severity score at admission in the treatment group ( P < 0.001), improvements in respiratory rate, C-reactive protein, and lactate dehydrogenase occurred earlier and were more pronounced compared to the control group ( P < 0.05). No side effects related to CP therapy were observed..
DOI record:
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"abstract": "<jats:title>Abstract</jats:title>\n <jats:sec>\n <jats:title>Background:</jats:title>\n <jats:p>Given the controversial reports on the effect of convalescent plasma (CP) on coronavirus disease 2019 (COVID-19) patients, this study aimed to clarify the efficacy of early CP administration, improve the understanding of its impact on clinical outcomes, guide future research, address safety concerns, and inform public health policies.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Methods:</jats:title>\n <jats:p>In this prospective, multicenter, randomized controlled trial conducted at Razi Hospital (Ahvaz) and Bouali Hospital (Zahedan) in Iran, 232 confirmed COVID-19 patients were randomly assigned into two groups using a computer-generated randomization method. The treatment group (<jats:italic toggle=\"yes\">n</jats:italic> = 116) received CP with anti-severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) IgG titer ≥1/160 on the first day of admission, along with routine antiviral medications, while the control group received only routine medications (<jats:italic toggle=\"yes\">n</jats:italic> = 116). Recruitment occurred from 1 March to 30 July 2020, with two months of post-intervention follow-up. The primary outcome was two-month mortality, and secondary outcomes included CP-related side effects and various clinical and laboratory parameters.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Results:</jats:title>\n <jats:p>No significant differences were observed between the groups in terms of age (<jats:italic toggle=\"yes\">P</jats:italic> = 0.119), sex (<jats:italic toggle=\"yes\">P</jats:italic> = 0.418), comorbidities (<jats:italic toggle=\"yes\">P</jats:italic> > 0.05), or pre- and post-treatment changes in temperature, lymphocyte count, erythrocyte sedimentation rate, or platelet count (all <jats:italic toggle=\"yes\">P</jats:italic> > 0.05). Despite a higher CT severity score at admission in the treatment group (<jats:italic toggle=\"yes\">P</jats:italic> < 0.001), improvements in respiratory rate, C-reactive protein, and lactate dehydrogenase occurred earlier and were more pronounced compared to the control group (<jats:italic toggle=\"yes\">P</jats:italic> < 0.05). No side effects related to CP therapy were observed during infusion or follow-up. However, no significant differences were observed between the groups in the mortality rate or length of hospitalization. The mortality rate in the treatment group was 11.2% (13/116), compared to 17.2% (20/116) in the control group (<jats:italic toggle=\"yes\">P</jats:italic> = 0.130). The median hospital stay was 7 days (95% <jats:italic toggle=\"yes\">CI</jats:italic>: 6–8 days) for the treatment group and 6 days (95% <jats:italic toggle=\"yes\">CI</jats:italic>: 5–7 days) for the control group (<jats:italic toggle=\"yes\">P</jats:italic> = 0.560).</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Conclusion:</jats:title>\n <jats:p>While administering CP with a high titer of anti-SARS-CoV-2 IgG early in infection may improve vital signs and laboratory parameters in COVID-19 patients, it does not significantly reduce mortality risk or length of hospitalization compared to routine medications. Overall, the treatment appears to have few side effects, suggesting it may be a safe option for further evaluation in managing early COVID-19 symptoms.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Trial registration:</jats:title>\n <jats:p>This prospective, multicenter, two-parallel randomized controlled trial was prospectively registered in the Iranian Clinical Trials Registry (IRCT20200310046736N1).</jats:p>\n </jats:sec>",
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Late treatment
is less effective
is less effective
