Ivermectin Treatment Efficacy in Covid-19 High Risk Patients

NCT04920942 ↗

Phase 3 Completed 500 enrolled Clinical Research Centre, Malaysia

RandomizedParallel-groupSingle-blindTreatment

Summary

This is a multicenter study, which is aimed to investigate the efficacy of the Ivermectin drug in high risk COVID-19 patients. This study will compare Ivermectin treatment efficacy with standard of care alone. Target cohort is mild to moderate symptomatic Covid-19 (Stage 2-3), high risk patients aged 50 years and above with comorbidity, who presented to hospitals within first 7 days of illness.

Timeline

Start: 2021-05-31
Primary completion: 2021-10-31
Completion: 2021-10-31

Outcome

Missed primary endpoint

paper ivermectin treatment during early illness did not prevent progression to severe disease. PMID 35179551 ↗

paper 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk [RR], 1.25; 95% CI, 0.87-1.80; P = .25). PMID 35179551 ↗

Publications

Lim SCL, Hor CP, Tay KH, Mat Jelani A, Tan WH, Ker HB, Chow TS, Zaid M, Cheah WK, Lim HH, Khalid KE, Cheng JT, Mohd Unit H, An N, Nasruddin AB, Low LL, Khoo SWR, Loh JH, Zaidan NZ, Ab Wahab S, Song LH, Koh HM, King TL, Lai NM, Chidambaram SK, Peariasamy KM; I-TECH Study Group. Efficacy of Ivermectin Treatment on Disease Progression Among Adults With Mild to Moderate COVID-19 and Comorbidities: The I-TECH Randomized Clinical Trial. JAMA Intern Med. 2022 Apr 1;182(4):426-435. doi: 10.1001/jamainternmed.2022.0189.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ivermectin	Small molecule	0.4 mg/kg	Oral