The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms (COV-PREVENT)

The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms in Patients Infected With the SARS-CoV-2 Virus

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

Study Overview

• Status: Recruiting
• Conditions: COVID-19; SARS-CoV-2
• Intervention / Treatment: Drug: Amantadine Hydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Konrad Rejdak, Professor, PhD, MD; Phone Number: 0048 81 72 44 720; Email: konradrejdak@umlub.pl
• Study Contact Backup: Name: Paweł Pinkosz; Phone Number: 0048 81 72 44 484; Email: pawel.pinkosz@spsk4.lublin.pl

Study Locations

• Poland
  • Grudziądz, Poland, 86-300
    • Recruiting
    • Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego Oddział Neurologii i Neuroimmunologii Klinicznej
    • Contact: Robert Bonek, PhD, MD
  • Kalwaria Zebrzydowska, Poland, 34-130
    • Recruiting
    • Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kalwarii Zebrzydowskiej
    • Contact: Mateusz Dec, MD
  • Lublin, Poland, 20-089
    • Recruiting
    • Oddział Obserwacyjno-Zakaźny SPSz Woj. Im. Jana Bożego Lublin
    • Contact: Slawomir Kiciak, PhD, MD
  • Lublin, Poland, 20-954
    • Recruiting
    • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
    • Contact: Konrad Rejdak, Professor, PhD, MD
  • Rzeszów, Poland, 35-301
    • Recruiting
    • Klinika Chorób Wewnętrznych Nefrologii i Endokrynologii Klinicznego Szpitala Wojewódzkiego nr 2 im. Św. Jadwigi Królowej
    • Contact: Agnieszka Gala- Błądzińska, PhD, MD
  • Warszawa, Poland, 02-005
    • Recruiting
    • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus
    • Contact: Piotr Fiedor, Professor, PhD, MD
  • Warszawa, Poland, 02-507
    • Recruiting
    • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
    • Contact: Zbigniew J. Król, PhD, MD
  • Wyszków, Poland, 07-200
    • Recruiting
    • Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Wyszkowie
    • Contact: Waldemar Chełstowski, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group	Drug: Placebo; 100 mg, capsule
Experimental: Study group	Drug: Amantadine Hydrochloride; 100 mg, capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Health Scale (PROMIS® Global Health Scale)	Mean Global Health scores for each arm at day 15, 30 complementary visit-optional, 90, 150, 210. PROMIS® instruments are scored using item-level calibrations. This method of scoring uses "response pattern scoring," which uses responses to each item for each participant.	Day 15, 30 complementary visit-optional, 90, 150, 210
The neurological assessment	will include the assessment of neurological functions based on: scales for fatigue,; depression,; disorders of smell and taste,; sleep disorders,; quality of life.	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

Collaborators and Investigators

• Sponsor: Independent Public Clinical Hospital No. 4 in Lublin
• Investigators: Principal Investigator: Konrad Rejdak, Professor, PhD, MD, Independent Public Clinical Hospital No. 4 in Lublin

Publications and helpful links

General Publications

• Rejdak K, Fiedor P, Bonek R, Goch A, Gala-Błądzińska A, Chełstowski W, Łukasiak J, Kiciak S, Dąbrowski P, Dec M, Król ZJ, Papuć 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: April 17, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 13, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Amantadine
• Other Study ID Numbers: LUB-COV-2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No