The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms
- Registration Number
- NCT04854759
- Lead Sponsor
- Independent Public Clinical Hospital No. 4 in Lublin
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study group Amantadine Hydrochloride - Control group Placebo -
- Primary Outcome Measures
Name Time Method 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 achievement of ≥4 points on the WHO \[OSCI-WHO\] scale (7-point clinical status assessment scale)
- Secondary Outcome Measures
Name Time Method Time to clinical deterioration Day 15, 30 complementary visit-optional, 90, 150, 210 Survival time Day 15, 30 complementary visit-optional, 90, 150, 210 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.
Trial Locations
- Locations (8)
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
🇵🇱Lublin, Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie
🇵🇱Warszawa, Poland
Oddział Obserwacyjno-Zakaźny SPSz Woj. Im. Jana Bożego Lublin
🇵🇱Lublin, Poland
Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego Oddział Neurologii i Neuroimmunologii Klinicznej
🇵🇱Grudziądz, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kalwarii Zebrzydowskiej
🇵🇱Kalwaria Zebrzydowska, Poland
Klinika Chorób Wewnętrznych Nefrologii i Endokrynologii Klinicznego Szpitala Wojewódzkiego nr 2 im. Św. Jadwigi Królowej
🇵🇱Rzeszów, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus
🇵🇱Warszawa, Poland
Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Wyszkowie
🇵🇱Wyszków, Poland