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Evaluation of adalimumab effects in managing severe cases of COVID-19: A randomized controlled trial
Atefeh Fakharian1, Saghar Barati2, Maryam Mirenayat1
1Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Insights
Adalimumab did not improve outcomes for severe COVID-19 patients when combined with remdesivir and dexamethasone. This combination therapy showed no significant difference in mortality, ventilation needs, or hospital stay compared to standard care.
Area of Science:
- Immunology
- Infectious Diseases
- Pharmacology
Background:
- COVID-19, caused by SARS-CoV-2, has seen associations between elevated TNF-α levels and severe disease.
- TNF-α blocking agents, like adalimumab, were explored as potential interventions.
- Adalimumab's role in managing COVID-19 pneumonia alongside standard treatments was investigated.
Purpose of the Study:
- To evaluate the efficacy of adalimumab as an add-on therapy for severe COVID-19.
- To assess the impact of adalimumab combined with remdesivir and dexamethasone on patient outcomes.
Main Methods:
- A randomized controlled trial involving 68 severe COVID-19 patients.
- 34 patients received adalimumab (40 mg subcutaneous) plus remdesivir, dexamethasone, and supportive care.
- 34 patients received a placebo with remdesivir, dexamethasone, and supportive care.
Main Results:
- No significant differences were observed between the adalimumab and control groups regarding mortality rates (P=1).
- Mechanical ventilation requirements (P=1), hospital length of stay (P=1), ICU stay (P=0.27), and radiologic changes (P=0.53) were also not significantly affected.
- Adalimumab did not demonstrate a statistically significant benefit in the studied parameters.
Conclusions:
- The combination of adalimumab with remdesivir and dexamethasone did not show efficacy in treating severe COVID-19.
- Findings do not support the use of adalimumab in this therapeutic context.
- Further research may be needed to explore other anti-TNF agents or different patient populations.
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.
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