Cargando…
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
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...
Autores principales: | , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer India
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9135993/ https://www.ncbi.nlm.nih.gov/pubmed/35669353 http://dx.doi.org/10.1007/s12288-022-01546-w |
_version_ | 1784714077122068480 |
---|---|
author | George, Biju Moorthy, Mahesh Kulkarni, Uday Selvarajan, Sushil Rupali, Priscilla Christopher, D. J. Balamugesh, T. Rose, Winsley Lakshmi, Kavitha M. Devasia, Anup J. Fouzia, N. A. Korula, Anu Lionel, Sharon Abraham, Aby Mathews, Vikram |
author_facet | George, Biju Moorthy, Mahesh Kulkarni, Uday Selvarajan, Sushil Rupali, Priscilla Christopher, D. J. Balamugesh, T. Rose, Winsley Lakshmi, Kavitha M. Devasia, Anup J. Fouzia, N. A. Korula, Anu Lionel, Sharon Abraham, Aby Mathews, Vikram |
author_sort | George, Biju |
collection | PubMed |
description | 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 ≥ 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. |
format | Online Article Text |
id | pubmed-9135993 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer India |
record_format | MEDLINE/PubMed |
spelling | pubmed-91359932022-06-02 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 George, Biju Moorthy, Mahesh Kulkarni, Uday Selvarajan, Sushil Rupali, Priscilla Christopher, D. J. Balamugesh, T. Rose, Winsley Lakshmi, Kavitha M. Devasia, Anup J. Fouzia, N. A. Korula, Anu Lionel, Sharon Abraham, Aby Mathews, Vikram Indian J Hematol Blood Transfus Original Article 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 ≥ 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. Springer India 2022-05-27 2022-10 /pmc/articles/PMC9135993/ /pubmed/35669353 http://dx.doi.org/10.1007/s12288-022-01546-w Text en © The Author(s), under exclusive licence to Indian Society of Hematology and Blood Transfusion 2022 |
spellingShingle | Original Article George, Biju Moorthy, Mahesh Kulkarni, Uday Selvarajan, Sushil Rupali, Priscilla Christopher, D. J. Balamugesh, T. Rose, Winsley Lakshmi, Kavitha M. Devasia, Anup J. Fouzia, N. A. Korula, Anu Lionel, Sharon Abraham, Aby Mathews, Vikram 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9135993/ https://www.ncbi.nlm.nih.gov/pubmed/35669353 http://dx.doi.org/10.1007/s12288-022-01546-w |
work_keys_str_mv | AT georgebiju singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial AT moorthymahesh singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial AT kulkarniuday singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial AT selvarajansushil singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial AT rupalipriscilla singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial AT christopherdj singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial AT balamugesht singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial AT rosewinsley singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial AT lakshmikavitham singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial AT devasiaanupj singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial AT fouziana singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial AT korulaanu singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial AT lionelsharon singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial AT abrahamaby singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial AT mathewsvikram singledoseofivermectinisnotusefulinpatientswithhematologicaldisordersandcovid19illnessaphaseiibopenlabelledrandomizedcontrolledtrial |