COV-PREVENT: The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms
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 |
|---|---|---|
|
Phase 3 |
Study Design
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
- Development of clinical deterioration [Up to day 15 from randomization]
Defined as dyspnoea - physical examination - doctor's assessment
- 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%)
- 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
- 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.
- 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.
- Time to clinical deterioration [Day 15, 30 complementary visit-optional, 90, 150, 210]
- Survival time [Day 15, 30 complementary visit-optional, 90, 150, 210]
Eligibility Criteria
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
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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)
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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,
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Pregnancy, the period of breastfeeding.
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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
| 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
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.- LUB-COV-2021-01