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

Independent Public Clinical Hospital No. 4 in Lublin (Other)
Overall Status
Recruiting ID

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 Disease Intervention/Treatment Phase
  • Drug: Amantadine Hydrochloride
  • Drug: Placebo
Phase 3

Study Design

Study Type:
Anticipated Enrollment :
200 participants
Intervention Model:
Parallel Assignment
Double (Participant, Investigator)
Primary Purpose:
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

Arm Intervention/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


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego Oddział Neurologii i Neuroimmunologii Klinicznej Grudziądz Poland 86-300
2 Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kalwarii Zebrzydowskiej Kalwaria Zebrzydowska Poland 34-130
3 Oddział Obserwacyjno-Zakaźny SPSz Woj. Im. Jana Bożego Lublin Lublin Poland 20-089
4 Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Lublin Poland 20-954
5 Klinika Chorób Wewnętrznych Nefrologii i Endokrynologii Klinicznego Szpitala Wojewódzkiego nr 2 im. Św. Jadwigi Królowej Rzeszów Poland 35-301
6 Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus Warszawa Poland 02-005
7 Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie Warszawa Poland 02-507
8 Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Wyszkowie Wyszków Poland 07-200

Sponsors and Collaborators

  • Independent Public Clinical Hospital No. 4 in Lublin


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

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Independent Public Clinical Hospital No. 4 in Lublin Identifier:
Other Study ID Numbers:
  • LUB-COV-2021-01
First Posted:
Apr 22, 2021
Last Update Posted:
Aug 13, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 13, 2021