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

NCT04854759 | Unknown Phase 3

• 1 other identifier: LUB-COV-2021-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 8

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

Outcome Measures

Primary Outcomes (3)

• Development of clinical deterioration

  Defined as dyspnoea - physical examination - doctor's assessment

  Up to day 15 from randomization

• Clinical deterioration occurs

  Defined as drop in O2 saturation (\<92% with patient exposure to room air) and / or additional oxygen demand to maintain O2 saturation ≥92%)

  Up to day 15 from randomization

• Clinical deterioration occurs

  Defined as achievement of ≥4 points on the WHO \[OSCI-WHO\] scale (7-point clinical status assessment scale)

  Up to day 15 from randomization

Secondary Outcomes (4)

• General Health Scale (PROMIS® Global Health Scale)

  Day 15, 30 complementary visit-optional, 90, 150, 210

• The neurological assessment

  Day 15, 30 complementary visit-optional, 90, 150, 210

• Time to clinical deterioration

  Day 15, 30 complementary visit-optional, 90, 150, 210

• Survival time

  Day 15, 30 complementary visit-optional, 90, 150, 210

Study Arms (2)

Study group

EXPERIMENTAL

Drug: Amantadine Hydrochloride

Control group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Amantadine Hydrochloride DRUG

100 mg, capsule

Study group

Placebo DRUG

100 mg, capsule

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Independent Public Clinical Hospital No. 4 in Lublin: lead

Study Sites (8)

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

Grudziądz, 86-300, Poland

RECRUITING

Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kalwarii Zebrzydowskiej

Kalwaria Zebrzydowska, 34-130, Poland

RECRUITING

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

Lublin, 20-089, Poland

RECRUITING

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, 20-954, Poland

RECRUITING

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

Rzeszów, 35-301, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus

Warsaw, 02-005, Poland

RECRUITING

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie

Warsaw, 02-507, Poland

RECRUITING

Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Wyszkowie

Wyszków, 07-200, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 35390511 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Konrad Rejdak, Professor, PhD, MD

  Independent Public Clinical Hospital No. 4 in Lublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konrad Rejdak, Professor, PhD, MD

CONTACT

81 72 44 720; konradrejdak@umlub.pl

Paweł Pinkosz

CONTACT

81 72 44 484; pawel.pinkosz@spsk4.lublin.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2021
• First Posted: April 22, 2021
• Study Start: March 15, 2021
• Primary Completion: March 31, 2022
• Study Completion: May 31, 2022
• Last Updated: August 13, 2021

Record last verified: 2021-08

Locations

PL (8)