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

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ClinicalTrials.gov Identifier: NCT04854759
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Independent Public Clinical Hospital No. 4 in Lublin

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

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Drug: Amantadine Hydrochloride Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study group Drug: Amantadine Hydrochloride
100 mg, capsule

Placebo Comparator: Control group Drug: Placebo
100 mg, capsule




Primary Outcome Measures :
  1. Development of clinical deterioration [ Time Frame: Up to day 15 from randomization ]
    Defined as dyspnoea - physical examination - doctor's assessment

  2. Clinical deterioration occurs [ Time Frame: Up to day 15 from randomization ]
    Defined as drop in O2 saturation (<92% with patient exposure to room air) and / or additional oxygen demand to maintain O2 saturation ≥92%)

  3. Clinical deterioration occurs [ Time Frame: Up to day 15 from randomization ]
    Defined as achievement of ≥4 points on the WHO [OSCI-WHO] scale (7-point clinical status assessment scale)


Secondary Outcome Measures :
  1. General Health Scale (PROMIS® Global Health Scale) [ Time Frame: Day 15, 30 complementary visit-optional, 90, 150, 210 ]
    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.

  2. The neurological assessment [ Time Frame: Day 15, 30 complementary visit-optional, 90, 150, 210 ]

    will include the assessment of neurological functions based on:

    1. scales for fatigue,
    2. depression,
    3. disorders of smell and taste,
    4. sleep disorders,
    5. quality of life.

  3. Time to clinical deterioration [ Time Frame: Day 15, 30 complementary visit-optional, 90, 150, 210 ]
  4. Survival time [ Time Frame: Day 15, 30 complementary visit-optional, 90, 150, 210 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04854759


Contacts
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Contact: Konrad Rejdak, Professor, PhD, MD 81 72 44 720 ext 0048 konradrejdak@umlub.pl
Contact: Paweł Pinkosz 81 72 44 484 ext 0048 pawel.pinkosz@spsk4.lublin.pl

Locations
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Poland
Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego Oddział Neurologii i Neuroimmunologii Klinicznej Recruiting
Grudziądz, Poland, 86-300
Contact: Robert Bonek, PhD, MD         
Oddział Obserwacyjno-Zakaźny SPSz Woj. Im. Jana Bożego Lublin Recruiting
Lublin, Poland, 20-089
Contact: Slawomir Kiciak, PhD, MD         
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Recruiting
Lublin, Poland, 20-954
Contact: Konrad Rejdak, Professor, PhD, MD         
Oddział Hematologii MSWiA w Poznaniu Not yet recruiting
Poznań, Poland, 60-631
Contact: Tomasz Woźny, PhD, MD         
Klinika Chorób Wewnętrznych Nefrologii i Endokrynologii Klinicznego Szpitala Wojewódzkiego nr 2 im. Św. Jadwigi Królowej Recruiting
Rzeszów, Poland, 35-301
Contact: Agnieszka Gala- Błądzińska, PhD, MD         
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus Recruiting
Warszawa, Poland, 02-005
Contact: Piotr Fiedor, Professor, PhD, MD         
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie Recruiting
Warszawa, Poland, 02-507
Contact: Zbigniew J. Król, PhD, MD         
Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Wyszkowie Recruiting
Wyszków, Poland, 07-200
Contact: Waldemar Chełstowski, MD         
Sponsors and Collaborators
Independent Public Clinical Hospital No. 4 in Lublin
Investigators
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Principal Investigator: Konrad Rejdak, Professor, PhD, MD Independent Public Clinical Hospital No. 4 in Lublin
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Responsible Party: Independent Public Clinical Hospital No. 4 in Lublin
ClinicalTrials.gov Identifier: NCT04854759    
Other Study ID Numbers: LUB-COV-2021-01
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes
Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents