Introduction:
Corona virus disease 19 (COVID-19) is a devastating pandemic. By early February 2021, more
than 102 million people were infected globally with more than 2.2 million reported deaths.
Current treatments are approved for hospitalized patients with severe COVID-19 only. No
treatment is approved to prevent progression to severe COVID-19 in the early stages of
disease. Previous studies have indicated that amantadine is effective against severe acute
respiratory syndrome corona virus 1 (SARS-CoV-1). Trials are needed to determine if this
translates to a beneficial effect in patients with COVID-19. We hypothesize that preemptive
therapy with amantadine of non-hospitalized high-risk adults with SARS-CoV-2 infection
disease will prevent disease progression and hospitalization.
Methods and analysis:
The study is a randomized, double-blinded, placebo-controlled, single center study with two
treatment arms; oral amantadine or placebo. Individuals with confirmed SARS-CoV-2 infection
and one of following; i) age ≥ 40 years or ii) ≥ 18 years of age with at least one
comorbidity or iii) ≥ 18 years of age with a body mass index (BMI) above 30 will be enrolled
in the study. We plan to enroll 121 persons in each arm, with a total of 242 participants.
Follow up period is 90 days. The primary outcome is disease severity on day 14 assessed by
the 8-point COVID outcome scale proposed by the world health organization.
Ethics and dissemination:
Approvals by the Ethics Committee and National Competent Authorities will be obtained prior
to study initiation. Results will be submitted for publication in a peer-reviewed journal and
presented at international conferences.
Impact:
The results of the study will contribute with important knowledge on the efficacy and safety
of oral amantadine in the treatment of non-hospitalized high-risk individuals with SARS-CoV-2
infection.