COVID-19 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10070255 Term: Coronavirus test positive System Organ Class: 10022891 - Investigations MedDRA version: 23.0 Level: LLT Classification code 10084382 Term: Coronavirus disease 2019 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Dinetrel
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: AMANTADINE
CAS Number: 768-94-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Ph
Sponsors
Copenhagen University Hospital, Hvidovre , Capital Region
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Population at risk of developing severe COVID-19, defined as either: Age = 40 years of age Age = 18 years of age and at least one known comorbidity Age = 18 years of age and a BMI = 30 ? 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 121 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 121
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to investigate if early preemptive therapy with amantadine in non-hospitalized high-risk individuals with symptomatic COVID-19 disease can prevent disease progression.;Secondary Objective: Not applicable;Primary end point(s): The primary outcome is clinical status on day 14 assessed by the ordinal scale suggested by WHO. 1)Ambulatory with no limitations to activities. 2) Ambulatory with limitations to activities. 3) Hospitalized without oxygen therapy. 4) Hopitalized and oxygen therapy by mask or nasal prongs. 5) Hospitalized and non-invasive ventilation or high flow oxygen. 6) Intubation and mechanical ventilation. 7) Ventilation + additional organ support -pressors, ECMO. 8) Death ;Timepoint(s) of evaluation of this end point: Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Mortality rate on day 7, 14, 28 and 90 ? Incidence of invasive mechanical ventilation at day 7, 14, 28 and 90 ? Hospitalization at day 7, 14, 28 and 90 ? Duration of hospitalization ? Proportion of patients with PCR virus negativity on day 7, as collected by oropharyngeal swab ? Frequency of adverse events ? Frequency of severe adverse events ;Timepoint(s) of evaluation of this end point: Day 7, 14, 28 and 90. | — |
Countries
Denmark
Contacts
Public ContactDepartment of Infectious diseases
Copenhagen University Hospital, Hvidovre
Outcome results
None listed