Amantadine for COVID-19 (ACT)
Covid19
About this trial
This is an interventional treatment trial for Covid19
Eligibility 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
Sites / Locations
- Copenhagen University Hospital, HvidovreRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Amantadine
Placebo
The intervention group will receive a dose at day 1 of amantadine 100 mg followed by 100 mg amantadine after 6 hours. The following 4 consecutive days, study participants will receive a daily dose of 200mg amantadine, 100 mg (1 capsule) morning and 100 mg (1 capsule) evening, yielding 5 days of treatment in total (10 capsules in total).
The control group will receive placebo treatment with lactose monohydrate; 1 capsule, followed by 1 capsule after 6 hours on day 1. The following 4 consecutive days, study participants will receive 1 capsule morning and 1 capsule evening, yielding 5 days of treatment in total (10 capsules in total).