Amantadine for COVID-19

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Copenhagen University Hospital, Hvidovre
• Collaborator: University of Copenhagen
• Treatments: Amantadine

Criteria

Inclusion Criteria:

• Population at risk of developing severe COVID-19, defined as either:

• Age ≥ 40 years

• Age ≥ 18 years and at least one of the following comorbidities: Chronic heart disease without heart failure or proarrhythmic conditions or ventricular arrythmias, diabetes, chronic lung disease, hypertension, chronic kidney disease estimated glomerula filtration rate (GFR)<60 ml/minute, BMI

• 30 kg/m2.

• COVID-19 disease confirmed by the presence of SARS-CoV-2 nucleic acid by polymerase chain reaction (PCR) within 5 days prior to inclusion.

• For women of childbearing age (defined as non-sterile premenopausal women):

Negative pregnancy test and willingness to use contraceptive during the study period (90 days)

● Provision of informed consent.

Exclusion Criteria:

• Current hospitalization

• Allergy to amantadine hydrochloride, rimantadine or inactive ingredients.

• Known history of:

• Untreated narrow-angle glaucoma

• Kidney disease with eGFR < 35 ml/min

• Heart failure, proarrhythmic conditions, ventricular arrhythmias.

• Seizures

• Parkinson's disease

• Gastric ulcer

• Liver Disease

• Hereditary galactose intolerance, lactose intolerance or glucose/galactose malabsorption

• Current use of:

• Neuroleptics/antipsychotics/ levodopa

• Anticholinergics

• Thiazides

• Concurrent malignancy requiring chemotherapy

• Pregnancy and breastfeeding