Colchicine with Infliximab Compared to Infliximab in Hospitalized Patients with COVID-19 Pneumonia: An Open-label Randomized Trial

Mahdi Yadollahzadeh; Somayyeh Nasiripour; Najmeh Moradi Shahrbabak; Nader Rezaie; Mohsen Farrokhpour; Mehdi Azimi; Shirin Izadi; Farhad Zamani; Maryam Farasatinasab; Hootan Diba

Mahdi Yadollahzadeh, Somayyeh Nasiripour, Najmeh Moradi Shahrbabak, Nader Rezaie, Mohsen Farrokhpour, Mehdi Azimi, Shirin Izadi, Farhad Zamani, Maryam Farasatinasab, Hootan Diba

Coronaviruses, doi:10.2174/0126667975271636231109051950

Background: Anti-inflammatory agents have been proposed to improve oxygenation and mortality rates in severe COVID-19 pneumonia. This study has assessed the impact of colchicine as a coadjuvant inflammatory agent to infliximab in adults hospitalized with severe COVID-19 pneumonia. Method: In this randomized, open-label clinical trial, 63 severe COVID-19 pneumonia patients according to the criteria of the National Institutes of Health, 18 to 85 years old, with an increase in TNF-α and IL-6 levels, were randomized to receive colchicine 1 mg for 7 days and infliximab as a single dose of 300 mg on the first day of treatment or infliximab as a single dose of 300 mg on the first day. The primary outcomes assessed were oxygenation parameters (PaO2/FiO2 ratio and lung infiltrate) after seven days, ICU and hospital length of stay, and in-hospital mortality rates. Secondary outcomes included laboratory data and drug safety after 7 days. Result: 52 patients with similar baseline characteristics completed the study. There were no significant differences in oxygenation parameters (PaO2/FiO2 ratio and lung infiltrate) after seven days, median ICU and hospital length of stay, and in-hospital mortality rates between the two groups. Laboratory data showed no differences between both the groups seven days after the treatment. Also, no serious side effects were observed during the study among the two groups, except for one patient, who experienced diarrhea. Conclusion: Our results cannot support the addition of colchicine to promote the improvement of clinical outcomes in severe COVID-19 pneumonia.

CONFLICT OF INTEREST The authors declare no conflict of interest, financial or otherwise.

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DOI record: { "DOI": "10.2174/0126667975271636231109051950", "ISSN": [ "2666-7967" ], "URL": "http://dx.doi.org/10.2174/0126667975271636231109051950", "abstract": "\nBackground:\nAnti-inflammatory agents have been proposed to improve oxygenation and\nmortality rates in severe COVID-19 pneumonia. This study has assessed the impact of colchicine as\na coadjuvant inflammatory agent to infliximab in adults hospitalized with severe COVID-19 pneumonia.\n\n\nMethod:\nIn this randomized, open-label clinical trial, 63 severe COVID-19 pneumonia patients according\nto the criteria of the National Institutes of Health, 18 to 85 years old, with an increase in\nTNF-α and IL-6 levels, were randomized to receive colchicine 1 mg for 7 days and infliximab as a\nsingle dose of 300 mg on the first day of treatment or infliximab as a single dose of 300 mg on the\nfirst day. The primary outcomes assessed were oxygenation parameters (PaO2/FiO2 ratio and lung\ninfiltrate) after seven days, ICU and hospital length of stay, and in-hospital mortality rates. Secondary\noutcomes included laboratory data and drug safety after 7 days.\n\n\nResult:\n52 patients with similar baseline characteristics completed the study. There were no significant\ndifferences in oxygenation parameters (PaO2/FiO2 ratio and lung infiltrate) after seven days,\nmedian ICU and hospital length of stay, and in-hospital mortality rates between the two groups. Laboratory\ndata showed no differences between both the groups seven days after the treatment. Also,\nno serious side effects were observed during the study among the two groups, except for one patient,\nwho experienced diarrhea.\n\n\nConclusion:\nOur results cannot support the addition of colchicine to promote the improvement of\nclinical outcomes in severe COVID-19 pneumonia.\n", "alternative-id": [ "LiveAll1" ], "assertion": [ { "group": { "label": "Peer Review Details", "name": "peer_review_details" }, "label": "Review Status", "name": "review_status", "order": 0, "value": "Peer Reviewed" }, { "group": { "label": "Peer Review Details", "name": "peer_review_details" }, "label": "Review Process", "name": "review_process", "order": 1, "value": "Single blind" }, { "group": { "label": "Plagiarism Screening", "name": "plagiarism_screening" }, "label": "Screening Status", "name": "screening_status", "order": 0, "value": "Checked with iThenticate" }, { "group": { "label": "Publication History", "name": "publication_history" }, "label": "Received", "name": "received", "order": 0, 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