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Evaluation of adalimumab effects in managing severe cases of COVID-19: A randomized controlled trial

Fakharian et al., International Immunopharmacology, doi:10.1016/j.intimp.2021.107961, IRCT20151227025726N23, Oct 2021
https://c19early.org/fakharian.html
Mortality 0% Improvement Relative Risk Ventilation -33% ICU admission 0% Adalimumab  Fakharian et al.  LATE TREATMENT  RCT Is late treatment with adalimumab beneficial for COVID-19? RCT 68 patients in Iran Trial underpowered to detect differences c19early.org Fakharian et al., Int. Immunopharmacol.., Oct 2021 Favorsadalimumab Favorscontrol 0 0.5 1 1.5 2+
RCT 68 hospitalized patients with severe COVID-19 showing no significant differences with adalimumab treatment.
risk of death, no change, RR 1.00, p = 1.00, treatment 4 of 34 (11.8%), control 4 of 34 (11.8%).
risk of mechanical ventilation, 33.3% higher, RR 1.33, p = 1.00, treatment 4 of 34 (11.8%), control 3 of 34 (8.8%).
risk of ICU admission, no change, RR 1.00, p = 1.00, treatment 5 of 34 (14.7%), control 5 of 34 (14.7%).
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Fakharian et al., 31 Oct 2021, Randomized Controlled Trial, Iran, peer-reviewed, 10 authors, trial IRCT20151227025726N23. Contact: fzh.dastan@gmail.com.
Evaluation of adalimumab effects in managing severe cases of COVID-19: A randomized controlled trial
Atefeh Fakharian, Saghar Barati, Maryam Mirenayat, Mitra Rezaei, Sara Haseli, Pooria Torkaman, Sahar Yousefian, Alireza Dastan, Hamidreza Jamaati, Farzaneh Dastan
International Immunopharmacology, doi:10.1016/j.intimp.2021.107961
Background: COVID-19, which is a disease caused by the SARS-CoV-2 virus, has spread around the world since late 2019. Studies have found associations between the rising levels of TNF-α and severe COVID-19 cases. Hence, TNF-α blocking can possibly be a favorable intervention in modifying COVID-19. To this end, in order to manage pneumonia caused by COVID-19, adalimumab may potentially be considered as a potential therapeutic agent. The present study aimed to investigate the potential therapeutic role of adalimumab in treating COVID-19 cases in combination therapy with remdesivir and dexamethasone. Methods: Among the 68 patients who were included in the current randomized controlled trial, 34 were assigned to the adalimumab group and the remaining 34 were assigned to the control group. Adalimumab at a dose of 40 mg, subcutaneous for once, was used for the intervention group. Both the intervention and control groups received remdesivir, dexamethasone, and supportive care. The data gathered to make comparisons of the groups included demographic information, the rate of mortality, mechanical ventilation requirement, length of stay in hospital and Intensive Care Unit (ICU), and imaging findings. Results: There was no significant difference between the two groups in the terms of mortality rate (P-value = 1) and mechanical ventilation requirement (P-value = 1). The length of hospital and ICU stay as well as radiologic changes were not affected either (P-value = 1, 0.27, and 0.53, respectively). Conclusions: Our findings did not support the use of adalimumab in combination with remdesivir and dexamethasone in the treatment of severe COVID-19 cases.
References
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Conti, Evolution of COVID-19 infection in 4 psoriatic patients treated with biological drugs, Journal of the European Academy of Dermatology and Venereology
Dastan, Promising effects of tocilizumab in COVID-19: A non-controlled, prospective clinical trial, International immunopharmacology
Del, Valle, An inflammatory cytokine signature predicts COVID-19 severity and survival, Nat Med
Fakharian, Successful Management of COVID-19 With Adalimumab in a Post-Coronary Artery Bypass Graft Surgery Patient, J Cardiothorac Vasc Anesth
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Late treatment
is less effective
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