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Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 EClinicalMedicine 2021 ; 37 (ä): 100959 Nephropedia Template TP
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Antiviral effect of high-dose ivermectin in adults with COVID-19: A proof-of-concept randomized trial #MMPMID34189446
Krolewiecki A; Lifschitz A; Moragas M; Travacio M; Valentini R; Alonso DF; Solari R; Tinelli MA; Cimino RO; Alvarez L; Fleitas PE; Ceballos L; Golemba M; Fernandez F; Fernandez de Oliveira D; Astudillo G; Baeck I; Farina J; Cardama GA; Mangano A; Spitzer E; Gold S; Lanusse C
EClinicalMedicine 2021[Jul]; 37 (ä): 100959 PMID34189446show ga
BACKGROUND: There are limited antiviral options for the treatment of patients with COVID-19. Ivermectin (IVM), a macrocyclic lactone with a wide anti-parasitary spectrum, has shown potent activity against SARS-CoV-2 in vitro. This study aimed at assessing the antiviral effect of IVM on viral load of respiratory secretions and its relationship with drug concentrations in plasma. METHODS: Proof-of-concept, pilot, randomized, controlled, outcome-assessor blinded trial to evaluate antiviral activity of high-dose IVM in 45 COVID-19 hospitalized patients randomized in a 2:1 ratio to standard of care plus oral IVM at 0.6 mg/kg/day for 5 days versus standard of care in 4 hospitals in Argentina. Eligible patients were adults with RT-PCR confirmed SARS-CoV-2 infection within 5 days of symptoms onset. The primary endpoint was the difference in viral load in respiratory secretions between baseline and day-5, by quantitative RT-PCR. Concentrations of IVM in plasma were measured. Study registered at ClinicalTrials.gov: NCT04381884. FINDINGS: 45 participants were recruited (30 to IVM and 15 controls) between May 18 and September 9, 2020. There was no difference in viral load reduction between groups but a significant difference was found in patients with higher median plasma IVM levels (72% IQR 59-77) versus untreated controls (42% IQR 31-73) (p = 0.004). Mean ivermectin plasma concentration levels correlated with viral decay rate (r: 0.47, p = 0.02). Adverse events were similar between groups. No differences in clinical evolution at day-7 and day-30 between groups were observed. INTERPRETATION: A concentration dependent antiviral activity of oral high-dose IVM was identified at a dosing regimen that was well tolerated. Large trials with clinical endpoints are necessary to determine the clinical utility of IVM in COVID-19. FUNDING: This work was supported by grant IP-COVID-19-625, Agencia Nacional de Promocion de la Investigacion, el Desarrollo Tecnologico y la Innovacion, Argentina and Laboratorio ELEA/Phoenix, Argentina.
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EClinicalMedicine 2021 ; 37 (ä): 100959
