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Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Int+Immunopharmacol 2021 ; 99 (ä): 107969 Nephropedia Template TP
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Umifenovir in hospitalized moderate to severe COVID-19 patients: A randomized clinical trial #MMPMID34273635
Alavi Darazam I; Shokouhi S; Mardani M; Pourhoseingholi MA; Rabiei MM; Hatami F; Shabani M; Moradi O; Gharehbagh FJ; Irvani SSN; Amirdosara M; Hajiesmaeili M; Rezaei O; Khoshkar A; Lotfollahi L; Gachkar L; Dehbsneh HS; Khalili N; Soleymaninia A; Kusha AH; Shoushtari MT; Torabinavid P
Int Immunopharmacol 2021[Oct]; 99 (ä): 107969 PMID34273635show ga
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-beta1a (Subcutaneous injections of 44 microg (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-beta1a (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 IFNbeta1a + hydroxychloroquine + lopinavir/ritonavir group and 51 were managed to treat with IFNbeta1a + 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.