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

NCT ID: NCT04854759

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2022-05-31

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

Conditions

COVID-19; SARS-CoV-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study group

Group Type: EXPERIMENTAL

Amantadine Hydrochloride

Intervention Type: DRUG

100 mg, capsule

Control group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

100 mg, capsule

Interventions

Amantadine Hydrochloride

100 mg, capsule

Intervention Type: DRUG

Placebo

100 mg, capsule

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Independent Public Clinical Hospital No. 4 in Lublin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Konrad Rejdak, Professor, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Independent Public Clinical Hospital No. 4 in Lublin

Locations

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

Grudziądz, , Poland

Site Status: RECRUITING

Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kalwarii Zebrzydowskiej

Kalwaria Zebrzydowska, , Poland

Site Status: RECRUITING

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

Lublin, , Poland

Site Status: RECRUITING

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, , Poland

Site Status: RECRUITING

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

Rzeszów, , Poland

Site Status: RECRUITING

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus

Warsaw, , Poland

Site Status: RECRUITING

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie

Warsaw, , Poland

Site Status: RECRUITING

Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Wyszkowie

Wyszków, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Konrad Rejdak, Professor, PhD, MD

Role: CONTACT

konradrejdak@umlub.pl

81 72 44 720 ext. 0048

Paweł Pinkosz

Role: CONTACT

pawel.pinkosz@spsk4.lublin.pl

81 72 44 484 ext. 0048

Facility Contacts

Robert Bonek, PhD, MD

Role: primary

Mateusz Dec, MD

Role: primary

Slawomir Kiciak, PhD, MD

Role: primary

Konrad Rejdak, Professor, PhD, MD

Role: primary

Agnieszka Gala- Błądzińska, PhD, MD

Role: primary

Piotr Fiedor, Professor, PhD, MD

Role: primary

Zbigniew J. Król, PhD, MD

Role: primary

Waldemar Chełstowski, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 35390511 (View on PubMed)

Other Identifiers

LUB-COV-2021-01

Identifier Type: -

Identifier Source: org_study_id