COVID-19, SARS-CoV-2
Conditions
Brief summary
The use of amantadine in the prevention of progression and treatment of COVID-19 symptoms in patients infected with the SARS-CoV-2 virus. Multicenter randomized, double-blind, placebo-controlled, non-commercial clinical trial
Interventions
100 mg, capsule
DRUGPlacebo
100 mg, capsule
Sponsors
Independent Public Clinical Hospital No. 4 in Lublin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women aged 18 and over * Can give informed consent * Confirmed positive result for SARS-CoV-2 within 72 hours from the date the result was issued (according to the laboratory report) * 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 * 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) * Patients hospitalized due to meeting the above criteria and requiring observation in a hospital or outpatient setting.
Exclusion criteria
* Disease severe enough to meet the study's primary endpoint of clinical worsening (eg, current O2 saturation \<92% with patient exposure to room air, current use of supplemental oxygen to maintain O2 saturation ≥ 92%). * WHO score ≥4 (requires oxygen therapy during hospitalization) * Concomitant diseases which, in the opinion of the attending physician, prevent the patient from participating in the study, such as: decompensated cirrhosis, active ulcer disease, epilepsy and symptomatic convulsions, untreated angle-closure glaucoma determined on the basis of the patient's interview and / or medical documentation . In addition, immunocompromised patients (solid organ transplant, BMT, AIDS, renal failure (patients with renal impairment may develop drug poisoning) or other diseases not mentioned and other diseases treated with biological, immunological and / or steroids in high doses will not be eligible for the study. doses (\> 20 mg prednisone daily). * 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, * Pregnancy, the period of breastfeeding. * Parallel intake of memantine or other drugs acting on the CNS (neuroleptics, anxiolytics, antiepileptic drugs, antidepressants). * Other neurological conditions with agitation or confusion, delirium syndromes or psychoses. * 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 | Description |
|---|---|---|
| Development of clinical deterioration | Up to day 15 from randomization | Defined as dyspnoea - physical examination - doctor's assessment |
| Clinical deterioration occurs | Up to day 15 from randomization | Defined as drop in O2 saturation (\<92% with patient exposure to room air) and / or additional oxygen demand to maintain O2 saturation ≥92%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Health Scale (PROMIS® Global Health Scale) | Day 15, 30 complementary visit-optional, 90, 150, 210 | Mean Global Health scores for each arm at day 15, 30 complementary visit-optional, 90, 150, 210. PROMIS® instruments are scored using item-level calibrations. This method of scoring uses response pattern scoring, which uses responses to each item for each participant. |
| The neurological assessment | Day 15, 30 complementary visit-optional, 90, 150, 210 | will include the assessment of neurological functions based on: 1. scales for fatigue, 2. depression, 3. disorders of smell and taste, 4. sleep disorders, 5. quality of life. |
| Time to clinical deterioration | Day 15, 30 complementary visit-optional, 90, 150, 210 | — |
| Survival time | Day 15, 30 complementary visit-optional, 90, 150, 210 | — |
Countries
Poland
Contacts
Primary ContactKonrad Rejdak, Professor, PhD, MD
Backup ContactPaweł Pinkosz
Outcome results
None listed