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

Sponsor
Independent Public Clinical Hospital No. 4 in Lublin (Other)
Overall Status
Recruiting
CT.gov ID
NCT04854759
Collaborator
(none)
200
Enrollment
8
Locations
2
Arms
14.5
Anticipated Duration (Months)
25
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

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

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Amantadine Hydrochloride
  • Drug: Placebo
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 15, 2021
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Study group

Drug: Amantadine Hydrochloride
100 mg, capsule

Placebo Comparator: Control group

Drug: Placebo
100 mg, capsule

Outcome Measures

Primary Outcome Measures

  1. Development of clinical deterioration [Up to day 15 from randomization]

    Defined as dyspnoea - physical examination - doctor's assessment

  2. Clinical deterioration occurs [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 [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) [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 [Day 15, 30 complementary visit-optional, 90, 150, 210]

    will include the assessment of neurological functions based on: scales for fatigue, depression, disorders of smell and taste, sleep disorders, quality of life.

  3. Time to clinical deterioration [Day 15, 30 complementary visit-optional, 90, 150, 210]

  4. Survival time [Day 15, 30 complementary visit-optional, 90, 150, 210]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego Oddział Neurologii i Neuroimmunologii KlinicznejGrudziądzPoland86-300
2Oddział Obserwacyjno-Zakaźny SPSz Woj. Im. Jana Bożego LublinLublinPoland20-089
3Samodzielny Publiczny Szpital Kliniczny Nr 4 w LublinieLublinPoland20-954
4Oddział Hematologii MSWiA w PoznaniuPoznańPoland60-631
5Klinika Chorób Wewnętrznych Nefrologii i Endokrynologii Klinicznego Szpitala Wojewódzkiego nr 2 im. Św. Jadwigi KrólowejRzeszówPoland35-301
6Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka JezusWarszawaPoland02-005
7Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w WarszawieWarszawaPoland02-507
8Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w WyszkowieWyszkówPoland07-200

Sponsors and Collaborators

  • Independent Public Clinical Hospital No. 4 in Lublin

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Independent Public Clinical Hospital No. 4 in Lublin
ClinicalTrials.gov Identifier:
NCT04854759
Other Study ID Numbers:
  • LUB-COV-2021-01
First Posted:
Apr 22, 2021
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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:

Study Results

No Results Posted as of Apr 27, 2021