The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms (COV-PREVENT)
Primary Purpose
COVID-19, SARS-CoV-2
Status
Unknown status
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Amantadine Hydrochloride
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
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.
Sites / Locations
- Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego Oddział Neurologii i Neuroimmunologii KlinicznejRecruiting
- Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kalwarii ZebrzydowskiejRecruiting
- Oddział Obserwacyjno-Zakaźny SPSz Woj. Im. Jana Bożego LublinRecruiting
- Samodzielny Publiczny Szpital Kliniczny Nr 4 w LublinieRecruiting
- Klinika Chorób Wewnętrznych Nefrologii i Endokrynologii Klinicznego Szpitala Wojewódzkiego nr 2 im. Św. Jadwigi KrólowejRecruiting
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka JezusRecruiting
- Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w WarszawieRecruiting
- Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w WyszkowieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Study group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Development of clinical deterioration
Defined as dyspnoea - physical examination - doctor's assessment
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%)
Clinical deterioration occurs
Defined as achievement of ≥4 points on the WHO [OSCI-WHO] scale (7-point clinical status assessment scale)
Secondary Outcome Measures
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.
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.
Time to clinical deterioration
Survival time
Full Information
NCT ID
NCT04854759
First Posted
April 17, 2021
Last Updated
August 12, 2021
Sponsor
Independent Public Clinical Hospital No. 4 in Lublin
1. Study Identification
Unique Protocol Identification Number
NCT04854759
Brief Title
The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms
Acronym
COV-PREVENT
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Independent Public Clinical Hospital No. 4 in Lublin
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Amantadine Hydrochloride
Intervention Description
100 mg, capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
100 mg, capsule
Primary Outcome Measure Information:
Title
Development of clinical deterioration
Description
Defined as dyspnoea - physical examination - doctor's assessment
Time Frame
Up to day 15 from randomization
Title
Clinical deterioration occurs
Description
Defined as drop in O2 saturation (<92% with patient exposure to room air) and / or additional oxygen demand to maintain O2 saturation ≥92%)
Time Frame
Up to day 15 from randomization
Title
Clinical deterioration occurs
Description
Defined as achievement of ≥4 points on the WHO [OSCI-WHO] scale (7-point clinical status assessment scale)
Time Frame
Up to day 15 from randomization
Secondary Outcome Measure Information:
Title
General Health Scale (PROMIS® Global Health Scale)
Description
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.
Time Frame
Day 15, 30 complementary visit-optional, 90, 150, 210
Title
The neurological assessment
Description
will include the assessment of neurological functions based on:
scales for fatigue,
depression,
disorders of smell and taste,
sleep disorders,
quality of life.
Time Frame
Day 15, 30 complementary visit-optional, 90, 150, 210
Title
Time to clinical deterioration
Time Frame
Day 15, 30 complementary visit-optional, 90, 150, 210
Title
Survival time
Time Frame
Day 15, 30 complementary visit-optional, 90, 150, 210
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konrad Rejdak, Professor, PhD, MD
Phone
81 72 44 720
Ext
0048
Email
konradrejdak@umlub.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Paweł Pinkosz
Phone
81 72 44 484
Ext
0048
Email
pawel.pinkosz@spsk4.lublin.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad Rejdak, Professor, PhD, MD
Organizational Affiliation
Independent Public Clinical Hospital No. 4 in Lublin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego Oddział Neurologii i Neuroimmunologii Klinicznej
City
Grudziądz
ZIP/Postal Code
86-300
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Bonek, PhD, MD
Facility Name
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kalwarii Zebrzydowskiej
City
Kalwaria Zebrzydowska
ZIP/Postal Code
34-130
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mateusz Dec, MD
Facility Name
Oddział Obserwacyjno-Zakaźny SPSz Woj. Im. Jana Bożego Lublin
City
Lublin
ZIP/Postal Code
20-089
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Slawomir Kiciak, PhD, MD
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konrad Rejdak, Professor, PhD, MD
Facility Name
Klinika Chorób Wewnętrznych Nefrologii i Endokrynologii Klinicznego Szpitala Wojewódzkiego nr 2 im. Św. Jadwigi Królowej
City
Rzeszów
ZIP/Postal Code
35-301
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnieszka Gala- Błądzińska, PhD, MD
Facility Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus
City
Warszawa
ZIP/Postal Code
02-005
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Fiedor, Professor, PhD, MD
Facility Name
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zbigniew J. Król, PhD, MD
Facility Name
Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Wyszkowie
City
Wyszków
ZIP/Postal Code
07-200
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waldemar Chełstowski, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35390511
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.
Results Reference
derived
Learn more about this trial
The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms
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