Status:
UNKNOWN
Amantadine for COVID-19
Lead Sponsor:
Copenhagen University Hospital, Hvidovre
Collaborating Sponsors:
University of Copenhagen
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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. Cur...
Detailed Description
BACKGROUND Globally, Corona virus disease 19 (COVID-19) has caused more than 2.2 million deaths. Most infected cases present with mild respiratory symptoms and fever, and spontaneously recover withi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT04894617
Start Date
June 1 2021
End Date
April 1 2022
Last Update
October 6 2021
Active Locations (1)
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1
Copenhagen University Hospital, Hvidovre
Hvidovre, Denmark, 2650