A Clinical Evaluation of the Safety and Efficacy of Randomized Placebo Versus the 8-aminoquinoline Tafenoquine for Early Symptom Resolution in Patients With Mild to Moderate COVID 19 Disease and Low Risk of Disease Progression

Summary

A clinical study to assess the efficacy and safety of oral tafenoquine compared to placebo in patients with mild to moderate COVID 19 disease and low risk of disease progression (the "ACLR8-LR" study).

Timeline

Start

2023-08-01

Primary completion

2024-04-27

Completion

2024-04-27

Outcome

Missed primary endpoint

paper 8/45 v 10/42 not recovered in the tafenoquine and placebo arms, P = 0.60 PMID 35668841 ↗

Publications

• Results 60º Pharmaceuticals LLC. Clinical Study Report, TQ 2020_06. A double-blind placebo-controlled study to assess the efficacy and safety of oral tafenoquine versus placebo in patients with mild to moderate COVID-19 disease. 14 July 2022
• Results Bobrowski T, Chen L, Eastman RT, Itkin Z, Shinn P, Chen CZ, Guo H, Zheng W, Michael S, Simeonov A, Hall MD, Zakharov AV, Muratov EN. Synergistic and Antagonistic Drug Combinations against SARS-CoV-2. Mol Ther. 2021 Feb 3;29(2):873-885. doi: 10.1016/j.ymthe.2020.12.016. Epub 2020 Dec 15.
• Results Brueckner RP, Lasseter KC, Lin ET, Schuster BG. First-time-in-humans safety and pharmacokinetics of WR 238605, a new antimalarial. Am J Trop Med Hyg. 1998 May;58(5):645-9. doi: 10.4269/ajtmh.1998.58.645.
• Results Chen Y, Yang WH, Chen HF, Huang LM, Gao JY, Lin CW, Wang YC, Yang CS, Liu YL, Hou MH, Tsai CL, Chou YZ, Huang BY, Hung CF, Hung YL, Wang WJ, Su WC, Kumar V, Wu YC, Chao SW, Chang CS, Chen JS, Chiang YP, Cho DY, Jeng LB, Tsai CH, Hung MC. Tafenoquine and its derivatives as inhibitors for the severe acute respiratory syndrome coronavirus 2. J Biol Chem. 2022 Mar;298(3):101658. doi: 10.1016/j.jbc.2022.101658. Epub 2022 Jan 29.
• Results Dow GS, Luttick A, Fenner J, Wesche D, Yeo KR, Rayner C. Tafenoquine inhibits replication of SARS-CoV-2 at pharmacologically relevant cincentrations in vitro. Biorxiv; Tafenoquine inhibits replication of SARS-Cov-2 at pharmacologically relevant concentrations in vitro. bioRxiv.2020. https://doi.org/10.1101/2020.07.12.199059
• Results Dow GS, Smith BL. A phase II, double blind, placebo-controlled, randomized evaluation of the safety and efficacy of tafenoquine in patients with mild-moderate COVID-19 disease. New Microbes New Infect. 2022 Jun 1;47:100986. doi: 10.1016/j.nmni.2022.100986. eCollection 2022 Apr-May.
• Results Grassin-Delyle S, Salvator H, Brollo M, Catherinot E, Sage E, Couderc LJ, Naline E, Devillier P. Chloroquine Inhibits the Release of Inflammatory Cytokines by Human Lung Explants. Clin Infect Dis. 2020 Nov 19;71(16):2265-2268. doi: 10.1093/cid/ciaa546.
• Results Sato R, Imaizumi T, Aizawa T, Watanabe S, Tsugawa K, Kawaguchi S, Seya K, Matsumiya T, Tanaka H. Inhibitory effect of anti-malarial agents on the expression of proinflammatory chemokines via Toll-like receptor 3 signaling in human glomerular endothelial cells. Ren Fail. 2021 Dec;43(1):643-650. doi: 10.1080/0886022X.2021.1908901.
• Results Shivakumar S, Panigrahi T, Shetty R, Subramani M, Ghosh A, Jeyabalan N. Chloroquine Protects Human Corneal Epithelial Cells from Desiccation Stress Induced Inflammation without Altering the Autophagy Flux. Biomed Res Int. 2018 Nov 1;2018:7627329. doi: 10.1155/2018/7627329. eCollection 2018.
• Results Song Y, Zhang H, Zhu Y, Zhao X, Lei Y, Zhou W, Yu J, Dong X, Wang X, Du M, Yan H. Lysozyme Protects Against Severe Acute Respiratory Syndrome Coronavirus 2 Infection and Inflammation in Human Corneal Epithelial Cells. Invest Ophthalmol Vis Sci. 2022 Jun 1;63(6):16. doi: 10.1167/iovs.63.6.16.
• Results United States Centers for Disease Control. Daily update of COVID-19 cases. Accessed on 19 February 2023 at https://covid.cdc.gov/covid-data-tracker/#datatracker-home.

Drugs

Indications