Clinical trial NCT04854759: The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms
Official title: The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms in Patients Infected With the SARS-CoV-2 Virus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
SARS-CoV-2
Lead sponsor: Independent Public Clinical Hospital No. 4 in Lublin
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Development of clinical deterioration
timeFrame: Up to day 15 from randomization
measure: Clinical deterioration occurs
timeFrame: Up to day 15 from randomization
measure: Clinical deterioration occurs
timeFrame: Up to day 15 from randomization
Secondary outcomes:
measure: General Health Scale (PROMIS® Global Health Scale)
timeFrame: Day 15, 30 complementary visit-optional, 90, 150, 210
measure: The neurological assessment
timeFrame: Day 15, 30 complementary visit-optional, 90, 150, 210
measure: Time to clinical deterioration
timeFrame: Day 15, 30 complementary visit-optional, 90, 150, 210
measure: Survival time
timeFrame: Day 15, 30 complementary visit-optional, 90, 150, 210
Other outcomes:
Locations:
city: Grudziądz
country: Poland
facility: Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego Oddział Neurologii i Neuroimmunologii Klinicznej
city: Kalwaria Zebrzydowska
country: Poland
facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kalwarii Zebrzydowskiej
city: Lublin
country: Poland
facility: Oddział Obserwacyjno-Zakaźny SPSz Woj. Im. Jana Bożego Lublin
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
city: Rzeszów
country: Poland
facility: Klinika Chorób Wewnętrznych Nefrologii i Endokrynologii Klinicznego Szpitala Wojewódzkiego nr 2 im. Św. Jadwigi Królowej
city: Warszawa
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie
city: Wyszków
country: Poland
facility: Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Wyszkowie
Study officials:
affiliation: Independent Public Clinical Hospital No. 4 in Lublin
name: Konrad Rejdak, Professor, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rejdak K, Fiedor P, Bonek R, Goch A, Gala-Bladzinska A, Chelstowski W, Lukasiak J, Kiciak S, Dabrowski P, Dec M, Krol ZJ, Papuc E, Zasybska A, Segiet A, Grieb P. The use of amantadine in the prevention of progression and treatment of COVID-19 symptoms in patients infected with the SARS-CoV-2 virus (COV-PREVENT): Study rationale and design. Contemp Clin Trials. 2022 May;116:106755. doi: 10.1016/j.cct.2022.106755. Epub 2022 Apr 4.