Single Dose of Ivermectin is not Useful in Patients with Hematological Disorders and COVID-19 Illness: A Phase II B Open Labelled Randomized Controlled Trial
Biju George, Mahesh Moorthy, Uday Kulkarni, Sushil Selvarajan, Priscilla Rupali, D J Christopher, T Balamugesh, Winsley Rose, Kavitha M Lakshmi, Anup J Devasia, N A Fouzia, Anu Korula, Sharon Lionel, Aby Abraham, Vikram Mathews
Indian Journal of Hematology and Blood Transfusion, doi:10.1007/s12288-022-01546-w
Repurposed drugs may reduce morbidity and mortality in patients with hematological disorders who develop COVID-19 illness. 112 patients with predominantly hematological illnesses were randomized to receive standard of care, ivermectin 12 mg [Iv 12] or 24 mg [Iv24] for asymptomatic, mild, or moderate COVID 19 illness. Serial respiratory samples for rRT-PCR samples were sent on Day 3, 5 and 7. rRT-PCR negativity and C 2 log 10 reduction in viral loads on day 3, 5 and 7 were similar between the 3 treatment groups across all disease categories. Symptom progression occurred in 26 patients [21.6%] with no difference across 3 treatment groups. Twenty-two patients [18.3%] have expired while 98 [81.7%] survived. Survival rates were similar across treatment groups [controls-80.5%, Iv12-77.5%, Iv24-87.2% respectively]. Overall, poorer survival was seen with moderate illness compared to others [51.6% vs 92.1%; p = 0.000] and was the only significant risk factor identified on multivariate analysis. In this Phase II randomised trial, single dose of 12 or 24 mg of ivermectin did not reduce viral loads, prevent symptom progression, or reduce mortality in patients with predominantly haematological illnesses who develop mild to moderate COVID 19 illness.
Author Contributions BG, UK designed the study, interpreted the data and drafted the paper. MM designed the study, acquired of laboratory data and drafted the paper. KML analysed the data, provided critical revision of the paper and approved the final version. SS, PR, DJC, BT, WR, AJD, FNA, AK, SL, AA and VM helped in acquiring the clinical data, interpretation of data and revising the manuscript critically. All authors have approved the final submitted version of the manuscript.
Declarations Conflict of interest No conflicts of interest to declare for any of the authors.
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