Status:
UNKNOWN
The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms
Lead Sponsor:
Independent Public Clinical Hospital No. 4 in Lublin
Conditions:
COVID-19
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04854759
Start Date
March 15 2021
End Date
May 31 2022
Last Update
August 13 2021
Active Locations (8)
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1
Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego Oddział Neurologii i Neuroimmunologii Klinicznej
Grudziądz, Poland, 86-300
2
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kalwarii Zebrzydowskiej
Kalwaria Zebrzydowska, Poland, 34-130
3
Oddział Obserwacyjno-Zakaźny SPSz Woj. Im. Jana Bożego Lublin
Lublin, Poland, 20-089
4
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Poland, 20-954