SARS-CoV-2 infection with one or more of the following symptoms: fever, cough, muscle aches, mild breathlessness, chest pain, diarrhea, nausea, vomiting, anosmia, lack of taste, sore throat, nasal congestion MedDRA version: 23.1 Level: LLT Classification code 10084355 Term: COVID-19 virus test positive System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Viregyt-K
Product Name: Amantadine (Amantadini hydrochloridum)
Pharmaceutical Form: Capsule
INN or Proposed INN: Amantadine
Other descriptive name: AMANTADINE HYDROCHLORIDE
Concentration u
Sponsors
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 18 and over. 2. Can give informed consent. 3. Confirmed positive result for SARS-CoV-2 within 5 days from the date the result was issued (according to the laboratory report). 4. Patient presently symptomatic with one or more of the following symptoms: fever, cough, myalgia, mild dyspnoea, chest pain, diarrhea, nausea, vomiting, anosmia, lack of taste, sore throat, nasal congestion. 5. At initial screening, the subject will report at least one and no more than 3 of the following risk factors for clinical worsening: age =40, obesity, hypertension, diabetes, pulmonary disease (e.g., asthma, COPD), and immune disorders (e.g. rheumatoid arthritis, lupus), neurological diseases: e.g. after a distant stroke or trauma to the brain, multiple sclerosis, dementia and other neurodegenerative diseases). 6. Outpatients or hospitalized patientsdue to meeting the above criteria and requiring observation in a hospital or outpatient. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Disease severe enough to meet the study's primary endpoint of clinical worsening (eg, current O2 saturation 20 mg prednisone daily). 4. Hypersensitivity to any component of the preparation, severe congestive heart failure, cardiomyopathy, myocarditis, II-III degree AV block, bradycardia, clinically significant prolongation of the QT interval, or a family history of congenital long QT syndrome, severe ventricular arrhythmias (including torsade de pointes), concomitant use of drugs that prolong the QT interval, hypokalaemia, hypomagnesaemia, 5. Pregnancy, the period of breastfeeding. 6. Parallel intake of memantine or other drugs acting on the CNS (neuroleptics, anxiolytics, antiepileptic drugs, antidepressants). 7. Other neurological conditions with agitation or confusion, delirium syndromes or psychoses. 8. Receipt of a partial or full vaccination schedule against SARS-CoV-2 is also an exclusion criterion from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the project is to determine whether oral intake of amantadine in the early phase of COVID-19 can prevent the development of the disease towards acute respiratory failure and multiple organ failure, reducing the need for oxygen therapy, intubation and respiratory therapy as well as delayed neurological complications.;Secondary Objective: Not applicable;Primary end point(s): Clinical deterioration occurs. Defined as one of the following: a. Dyspnoea - physical examination - doctor's assessment b. Drop in O2 saturation (<92% with patient exposure to room air) and / or additional oxygen demand to maintain O2 saturation =92%) and / or c. Achievement of =4 points on the WHO [OSCI-WHO] scale (7-point clinical status assessment scale). Meeting the above criteria qualifies the patient for further treatment in hospital, in accordance with the current recommendations.;Timepoint(s) of evaluation of this end point: Up to day 15 from randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. General Health Scale (PROMIS Global Health Scale); 2. The neurological assessment will include the assessment of neurological functions based on: a.scales for fatigue, b. depression, c. disorders of smell and taste, d. sleep disorders, e. quality of life. 3. Time to clinical deterioration; 4. Survival time.;Timepoint(s) of evaluation of this end point: Day 15, 30 complementary visit-optional, 90, 150, 210 | — |
Countries
Poland
Contacts
Public ContactKatedra i Klinika Neurologii
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Outcome results
None listed