Efficacy of Amantadine Treatment in COVID-19 Patients

Phase 3 Terminated 193 enrolled Noblewell Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice, Poland · collab Medical Research Agency, Poland · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

Demonstration of the efficacy of amantadine over placebo in the population of patients with moderate or severe COVID-19 in the initial stage of the disease treated in the hospital

Timeline

Start: 2021-03-30
Primary completion: 2022-03-10
Completion: 2022-03-10

Outcome

Missed primary endpoint

Stopped: “The annual analysis did not show the efficacy of the investigational medicinal product in this application, therefore the study was not continued.”

paper INTERPRETATION: Adding amantadine to standard care in patients hospitalised with COVID-19 did not increase the likelihood of recovery. PMID 36931576 ↗

Publications

Barczyk A, Czajkowska-Malinowska M, Farnik M, Barczyk M, Boda L, Cofta S, Dulawa J, Dyrbus M, Harat R, Huk M, Kotecka S, Nahorecki A, Nasilowski J, Naumnik W, Przybylski G, Slabon-Willand M, Skoczynski S, Wita K, Ziolo G, Kuna P. Efficacy of oral amantadine among patients hospitalised with COVID-19: A randomised, double-blind, placebo-controlled, multicentre study. Respir Med. 2023 Jun;212:107198. doi: 10.1016/j.rmed.2023.107198. Epub 2023 Mar 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amantadine	Unknown	—	Oral

Indications

No indication recorded.