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

Last updated: August 12, 2021
Sponsor: Independent Public Clinical Hospital No. 4 in Lublin
Overall Status: Active - Recruiting

Phase

3

Condition

Sars-cov-2

Covid-19

Treatment

N/A

Clinical Study ID

NCT04854759
LUB-COV-2021-01
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 wasissued (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, lackof taste, sore throat, nasal congestion
  • At initial screening, the subject will report at least one and no more than 3 of thefollowing 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 ortrauma to the brain, multiple sclerosis, dementia and other neurodegenerativediseases)
  • Patients hospitalized due to meeting the above criteria and requiring observation in ahospital or outpatient setting.

Exclusion

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 ofsupplemental 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 thepatient from participating in the study, such as: decompensated cirrhosis, activeulcer disease, epilepsy and symptomatic convulsions, untreated angle-closure glaucomadetermined on the basis of the patient's interview and / or medical documentation . Inaddition, immunocompromised patients (solid organ transplant, BMT, AIDS, renal failure (patients with renal impairment may develop drug poisoning) or other diseases notmentioned and other diseases treated with biological, immunological and / or steroidsin 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, clinicallysignificant prolongation of the QT interval, or a family history of congenital long QTsyndrome, severe ventricular arrhythmias (including torsade de pointes), concomitantuse 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 orpsychoses.
  • Receipt of a partial or full vaccination schedule against SARS-CoV-2 is also anexclusion criterion from the study.

Study Design

Total Participants: 200
Study Start date:
March 15, 2021
Estimated Completion Date:
May 31, 2022

Connect with a study center

  • Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego Oddział Neurologii i Neuroimmunologii Klinicznej

    Grudziądz, 86-300
    Poland

    Active - Recruiting

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kalwarii Zebrzydowskiej

    Kalwaria Zebrzydowska, 34-130
    Poland

    Active - Recruiting

  • Oddział Obserwacyjno-Zakaźny SPSz Woj. Im. Jana Bożego Lublin

    Lublin, 20-089
    Poland

    Active - Recruiting

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-954
    Poland

    Active - Recruiting

  • Oddział Hematologii MSWiA w Poznaniu

    Poznań, 60-631
    Poland

    Site Not Available

  • Klinika Chorób Wewnętrznych Nefrologii i Endokrynologii Klinicznego Szpitala Wojewódzkiego nr 2 im. Św. Jadwigi Królowej

    Rzeszów, 35-301
    Poland

    Active - Recruiting

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie

    Warszawa, 02-507
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus

    Warszawa, 02-005
    Poland

    Active - Recruiting

  • Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Wyszkowie

    Wyszków, 07-200
    Poland

    Active - Recruiting

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