Amantadine in unvaccinated patients with early, mild to moderate COVID ‐19: a randomized, placebo‐controlled, double‐blind trial.
Konrad Rejdak, Piotr Fiedor, Robert Bonek, Jacek Łukasiak, Waldemar Chełstowski, Sławomir Kiciak, Piotr Dąbrowski, Agnieszka Gala‐Błądzińska, Mateusz Dec, Ewa Papuć, Adriana Zasybska, Marcin Kaczor, Paweł Grieb, - Neurology (clinical)
- Neurology
Abstract
Background and purpose
Adamantanes were listed as interesting option as an early intervention against COVID‐19. We aimed to evaluate the effectiveness of amantadine in preventing the progression of COVID‐19 and its neurological sequelae.
Methods
Unvaccinated patients with confirmed SARS‐CoV‐2 infection within 5 days were enrolled. Subjects were randomized (50:50) to amantadine (AMD, 100 mg BID) or placebo (PLB), for 14 days. WHO ordinary scale was the primary measure. The secondary endpoints included assessment for: fatigue; depression, disorders of smell and taste and sleepiness on Day 1 and 15.
Results
We enrolled 99 patients (49 AMD and 50 PLB). Disease progression (WHO=4) was observed in 3 patients (6%) in AMD group, and in 4 patients (8%) in PLB (p>0.05). Complete recovery on Day 15 was 60% higher in AMD compared to PLB group (p = 0.025). There was improvement in taste (AMD: p = 0.003; PLB: p = 0.0001) and smell (AMD: p = 0.005; PLB: p = 0.0004) but not in fatigue in both groups. Improvement was observed in AMD (p = 0.010), but not in PLB group (p = 0.058) assessing depression as well as sleepiness (AMD, p = 0.0002; PLB, p = 0.341). There was one death case in the PLB group (2.0%) and none in the AMD group (p>0.05) until Day 210. Overall the drug was well tolerated.
Conclusions
The central effects on the nervous system with reduction of sleepiness and depression might have had a supportive effect on faster recovery in early COVID‐19 patients.