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

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04854759
• Other study ID #: LUB-COV-2021-01
• Status: Recruiting
• Phase: Phase 3
• Start date: March 15, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: August 2021
• Source: Independent Public Clinical Hospital No. 4 in Lublin
• Contact: Konrad Rejdak, Professor, PhD, MD
• Phone: 81 72 44 720
• Email: konradrejdak[@]umlub.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Disease Progression
• SARS-CoV-2

Intervention

Drug:
• Amantadine Hydrochloride
100 mg, capsule
• Placebo
100 mg, capsule

Locations

Country	Name	City	State
Poland	Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego Oddzial Neurologii i Neuroimmunologii Klinicznej	Grudziadz
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kalwarii Zebrzydowskiej	Kalwaria Zebrzydowska
Poland	Oddzial Obserwacyjno-Zakazny SPSz Woj. Im. Jana Bozego Lublin	Lublin
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie	Lublin
Poland	Klinika Chorób Wewnetrznych Nefrologii i Endokrynologii Klinicznego Szpitala Wojewódzkiego nr 2 im. Sw. Jadwigi Królowej	Rzeszów
Poland	Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie	Warszawa
Poland	Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciatka Jezus	Warszawa
Poland	Oddzial Kardiologiczny Samodzielny Publiczny Zespól Zakladów Opieki Zdrowotnej w Wyszkowie	Wyszków

Sponsors (1)

Lead Sponsor	Collaborator
Independent Public Clinical Hospital No. 4 in Lublin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of clinical deterioration	Defined as dyspnoea - physical examination - doctor's assessment	Up to day 15 from randomization
Primary	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
Primary	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	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
Secondary	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
Secondary	Time to clinical deterioration		Day 15, 30 complementary visit-optional, 90, 150, 210
Secondary	Survival time		Day 15, 30 complementary visit-optional, 90, 150, 210