Efficacy of Amantadine Treatment in COVID-19 Patients
Launched by NOBLEWELL · Jul 2, 2021
Trial Information
Current as of July 24, 2025
Terminated
Keywords
ClinConnect Summary
Use of high-doses of amantadine in hospitalized patients in the early phase of moderate or severe COVID-19, compared to placebo, will shorten the duration of the disease and reduce the risk of death and treatment with invasive mechanical ventilation in Intensive Care Units (ICU).
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age of respondents - 18 years and older.
- • 2. Confirmation of SARS-CoV-2 infection by PCR
- 3. Hospitalized patient with COVID-19, defined according to the following criteria (all of the following criteria must be present):
- • 1. radiological (X-ray of klp or TK klp) features of pneumonia,
- • 2. blood saturation (SaO2) measured at rest in the absence of oxygen \<95%,
- • 3. it is not necessary to apply on the day of patient enrollment: high-flow oxygen therapy or mechanical ventilation (non-invasive or invasive).
- • 4. Time up to 10 days from the onset of COVID-19 symptoms. The onset of COVID-19 symptoms is the first day on which the first symptom typical for SARS-CoV-2 or COVID-19 infection (in the opinion of the attending physician at the center) occurred, such as: fever, cough, shortness of breath, changes in taste or smell , muscle pain, chest pain, diarrhea, nausea, vomiting, sore throat, nasal congestion.
- Exclusion Criteria:
- • 1. Pregnancy or lactation
- 2. Presence of medical contraindications for inclusion in the examination in the opinion of the attending physician, in particular:
- • a) comorbidities: i) clinically significant hepatic or renal insufficiency; ii) epilepsy or seizures (current or history of); iii) psychiatric or somatic diseases (present or in a history of agitation or confusion, delirium syndromes or exogenous psychoses); iv) cardiovascular diseases such as: severe congestive heart failure, cardiomyopathy, myocarditis, grade II-IV AV block, bradycardia, QT prolongation, perceived U waves or family history of congenital long QT syndrome, severe ventricular arrhythmias a history of heart (including torsade de pointes); v) diseases or conditions that significantly reduce the immunity of a patient (e.g. solid organ transplant, bone marrow transplantation (BMT), AIDS, immune biologics and / or high-dose steroids (\> 20 mg prednisone daily).
- • b) hypersensitivity to any component of the preparation, c) parallel use of drugs that prolong the QT interval, d) hypokalemia or hypomagnesaemia, e) untreated angle-closure glaucoma, f) use of amantadine currently or in the last 3 months prior to study inclusion; g) participation in another clinical program
About Noblewell
Noblewell is a leading clinical trial sponsor dedicated to advancing healthcare through innovative research and development. Committed to improving patient outcomes, Noblewell collaborates with healthcare professionals, regulatory bodies, and research institutions to design and implement robust clinical studies across various therapeutic areas. With a focus on transparency, patient safety, and scientific integrity, Noblewell strives to deliver high-quality data that supports the development of effective treatments and therapies, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bydgoszcz, , Poland
Katowice, , Poland
Białystok, , Poland
Bolesławiec, , Poland
Chrzanów, , Poland
Limanowa, , Poland
Poznań, , Poland
Pyrzowice, , Poland
Toruń, , Poland
Torzym, , Poland
Warsaw, , Poland
Warszawa, , Poland
Patients applied
Trial Officials
Adam Barczyk, Prof.
Study Director
Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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