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Review
. 2021 Oct:99:107969.
doi: 10.1016/j.intimp.2021.107969. Epub 2021 Jul 10.

Umifenovir in hospitalized moderate to severe COVID-19 patients: A randomized clinical trial

Ilad Alavi Darazam  1 , Shervin Shokouhi  2 , Masoud Mardani  2 , Mohamad Amin Pourhoseingholi  3 , Mohammad Mahdi Rabiei  4 , Firouze Hatami  4 , Minoosh Shabani  2 , Omid Moradi  5 , Farid Javandoust Gharehbagh  6 , Seyed Sina Naghibi Irvani  6 , Mahdi Amirdosara  7 , Mohammadreza Hajiesmaeili  7 , Omidvar Rezaei  8 , Ali Khoshkar  9 , Legha Lotfollahi  10 , Latif Gachkar  4 , Hadiseh Shabanpour Dehbsneh  11 , Negar Khalili  11 , Azam Soleymaninia  11 , Akram Hoseyni Kusha  11 , Maryam Taleb Shoushtari  11 , Parham Torabinavid  12
Affiliations
Review

Umifenovir in hospitalized moderate to severe COVID-19 patients: A randomized clinical trial

Ilad Alavi Darazam et al. Int Immunopharmacol. 2021 Oct.

Abstract

Introduction: The effectiveness of umifenovir against COVID-19 is controversial; therefore, clinical trials are crucial to evaluate its efficacy.

Methods: The study was conducted as a single-center, randomized, open-label clinical trial. Eligible moderate-severe hospitalized patients with confirmed SARS-Cov-2 infection were randomly segregated into intervention and control groups. The intervention group were treated with lopinavir/ritonavir (400 mg/100 mg bid for 10-14 days) + hydroxychloroquine (400 mg single dose) + interferon-β1a (Subcutaneous injections of 44 µg (12,000 IU) on days 1, 3, 5) + umifenovir (200 mg trice daily for 10 days), and the control group received lopinavir/ritonavir (same dose) + hydroxychloroquine (same dose) + interferon-β1a (same dose).

Results: Of 1180 patients with positive RT-PCRs and positive chest CT scans, 101 patients were finally included in the trial; 50 were assigned to receive IFNβ1a + hydroxychloroquine + lopinavir/ritonavir group and 51 were managed to treat with IFNβ1a + hydroxychloroquine + lopinavir/ritonavir + umifenovir. Since all patients received the intended treatment as scheduled, the analysis just included as the ITT population. Time to clinical improvement (TTCI) did not hold a statistically significant difference between intervention and control groups (median, 9 days for intervention group versus 7 days for the control group; P: 0.22). Besides, Hazard Ratio for TTCI in the Cox regression model was 0.75 (95% CI: 0.45-1.23, P:0.25) which also confirmed that there was no statistically significant difference between the treatment group and the control group. The mortality was not statistically significant between the two groups (38% in controls vs 33.3% treatment group).

Conclusions: Our findings shed new lights on the facts that additional umifenovir has not been found to be effective in shortening the duration of SARS-CoV-2 in severe patients and improving the prognosis in non-ICU patients and mortality.

Trial registration: The trial was confirmed by the Ethics in Medical Research Committee of the Shahid Beheshti University of Medical Sciences. signed informed consents were obtained from all the participants or their legally authorized representatives. This trial has been registered as ClinicalTrials.gov, NCT04350684.

Keywords: Arbidol; COVID-19; SARS-CoV-2; Umifenovir.

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Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Trial Flow Diagram.
Fig. 2
Fig. 2
Kaplan–Meier plot depicted the Time to Clinical Improvement in the Intention-to-Treat Population.
See this image and copyright information in PMC

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