The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms

Study Overview
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Brief Summary
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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

Official Title
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The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms in Patients Infected With the SARS-CoV-2 Virus

Conditions
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COVID-19, SARS-CoV-2

Intervention / Treatment
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* Drug: Amantadine Hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br> | Drug: Amantadine Hydrochloride<br>* 100 mg, capsule<br>|
| Placebo Comparator: Control group<br> | Drug: Placebo<br>* 100 mg, capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of clinical deterioration | Defined as dyspnoea - physical examination - doctor's assessment | Up to day 15 from randomization | 
| Clinical deterioration occurs | Defined as drop in O2 saturation (<92% with patient exposure to room air) and / or additional oxygen demand to maintain O2 saturation ≥92%) | Up to day 15 from randomization | 
| Clinical deterioration occurs | Defined as achievement of ≥4 points on the WHO [OSCI-WHO] scale (7-point clinical status assessment scale) | Up to day 15 from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Health Scale (PROMIS® Global Health Scale) | 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. | Day 15, 30 complementary visit-optional, 90, 150, 210 | 
| The neurological assessment | will include the assessment of neurological functions based on: scales for fatigue, depression, disorders of smell and taste, sleep disorders, quality of life. | Day 15, 30 complementary visit-optional, 90, 150, 210 | 
| Time to clinical deterioration |  | Day 15, 30 complementary visit-optional, 90, 150, 210 | 
| Survival time |  | Day 15, 30 complementary visit-optional, 90, 150, 210 |