Last updated: August 12, 2021
Sponsor: Independent Public Clinical Hospital No. 4 in Lublin
Overall Status: Active - Recruiting
Phase
3
Condition
Sars-cov-2
Covid-19
Treatment
N/AClinical Study ID
NCT04854759
LUB-COV-2021-01
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 wasissued (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, lackof taste, sore throat, nasal congestion
- At initial screening, the subject will report at least one and no more than 3 of thefollowing 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 ortrauma to the brain, multiple sclerosis, dementia and other neurodegenerativediseases)
- Patients hospitalized due to meeting the above criteria and requiring observation in ahospital or outpatient setting.
Exclusion
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 ofsupplemental 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 thepatient from participating in the study, such as: decompensated cirrhosis, activeulcer disease, epilepsy and symptomatic convulsions, untreated angle-closure glaucomadetermined on the basis of the patient's interview and / or medical documentation . Inaddition, immunocompromised patients (solid organ transplant, BMT, AIDS, renal failure (patients with renal impairment may develop drug poisoning) or other diseases notmentioned and other diseases treated with biological, immunological and / or steroidsin 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, clinicallysignificant prolongation of the QT interval, or a family history of congenital long QTsyndrome, severe ventricular arrhythmias (including torsade de pointes), concomitantuse 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 orpsychoses.
- Receipt of a partial or full vaccination schedule against SARS-CoV-2 is also anexclusion criterion from the study.
Study Design
Total Participants: 200
Study Start date:
March 15, 2021
Estimated Completion Date:
May 31, 2022
Connect with a study center
Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego Oddział Neurologii i Neuroimmunologii Klinicznej
Grudziądz, 86-300
PolandActive - Recruiting
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kalwarii Zebrzydowskiej
Kalwaria Zebrzydowska, 34-130
PolandActive - Recruiting
Oddział Obserwacyjno-Zakaźny SPSz Woj. Im. Jana Bożego Lublin
Lublin, 20-089
PolandActive - Recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954
PolandActive - Recruiting
Oddział Hematologii MSWiA w Poznaniu
Poznań, 60-631
PolandSite Not Available
Klinika Chorób Wewnętrznych Nefrologii i Endokrynologii Klinicznego Szpitala Wojewódzkiego nr 2 im. Św. Jadwigi Królowej
Rzeszów, 35-301
PolandActive - Recruiting
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie
Warszawa, 02-507
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus
Warszawa, 02-005
PolandActive - Recruiting
Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Wyszkowie
Wyszków, 07-200
PolandActive - Recruiting
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