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Pentoxifylline effects on hospitalized patients with COVID19: A randomized, double-blind clinical trial

Azizi et al., International Immunopharmacology, doi:10.1016/j.intimp.2021.108227, IRCT20190804044429N4, Dec 2021
https://c19early.org/azizi2.html
Mortality -540% Improvement Relative Risk Ventilation -60% ICU admission -60% Pentoxifylline  Azizi et al.  LATE TREATMENT  DB RCT Is late treatment with pentoxifylline beneficial for COVID-19? Double-blind RCT 72 patients in Iran (November 2020 - April 2021) Higher mortality with pentoxifylline (not stat. sig., p=0.25) c19early.org Azizi et al., Int. Immunopharmacology, Dec 2021 Favorspentoxifylline Favorscontrol 0 0.5 1 1.5 2+
RCT 72 hospitalized COVID-19 patients showing no significant difference in clinical outcomes with pentoxifylline treatment compared to placebo.
risk of death, 540.0% higher, RR 6.40, p = 0.25, treatment 3 of 40 (7.5%), control 0 of 32 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of mechanical ventilation, 60.0% higher, RR 1.60, p = 1.00, treatment 2 of 40 (5.0%), control 1 of 32 (3.1%).
risk of ICU admission, 60.0% higher, RR 1.60, p = 0.69, treatment 4 of 40 (10.0%), control 2 of 32 (6.2%).
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Azizi et al., 31 Dec 2021, Double Blind Randomized Controlled Trial, placebo-controlled, Iran, peer-reviewed, mean age 58.9, 8 authors, study period November 2020 - April 2021, trial IRCT20190804044429N4. Contact: ghazaeianm@gmail.com.
Pentoxifylline effects on hospitalized patients with COVID19: A randomized, double-blind clinical trial
Hanieh Azizi, Nima Rouhani, Fatemeh Shaki, Elahe Karimpour-Razkenari, Monireh Ghazaeian, Ebrahim Salehifar, Majid Saeedi, Sahar Fallah
International Immunopharmacology, doi:10.1016/j.intimp.2021.108227
A B S T R A C T Pentoxifylline (PTX) has broad-spectrum properties such as anti-inflammatory, anticoagulant, and antiviral effects. The aim of this study was to evaluate the efficacy and safety of PTX in hospitalized patients with COVID-19. This double-blind, placebo-controlled randomized clinical trial was conducted on hospitalized patients with COVID-19. The recruited patients were randomly (1:1) assigned to the PTX group and the placebo group. The intervention group received PTX capsules at a dose of 400 mg three times a day for 10 days along with the national regimen, including interferon plus lopinavir/ritonavir and hydroxychloroquine. The primary outcome was the improvement of clinical scores. The secondary outcomes, on the other hand, were improvement in inflammatory and oxidative stress factors and hospital complications. From a total of 102 patients who met the inclusion criteria, 72 individuals completed the study and were analyzed. No significant differences were shown in demographics and baseline clinical characteristics. Clinical scores was not significant between the two groups (P = 0.31 and 0.07 for day 5 and 11, respectively). Although the mean serum levels of interleukin-6 (IL-6) and glutathione changed significantly after 5 days in the PTX group (P = 0.03 and p = 0.04), ICU admission, intubation, and hospital stay did not differ between the two groups. The results of our study did not show any superiority of PTX over placebo in improving the clinical outcomes of patients with COVID-19. Although PTX had a beneficial effect on IL-6 and showed an acceptable safety profile, it did not offer any clinical benefit for COVID-19 complications.
Ethics approval This study follows the declaration of Helsinki and was approved by the Ethics Committee of Mazandaran University of Medical Sciences (IR. MAZUMS.REC.1399.744). CRediT authorship contribution statement Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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Late treatment
is less effective
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