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Search / Trial NCT04952519

Efficacy of Amantadine Treatment in COVID-19 Patients

Launched by NOBLEWELL · Jul 2, 2021

Trial Information

Current as of July 24, 2025

Terminated

Keywords

Sars Cov 2 Covid 19

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.

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

0 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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