Efficacy of Amantadine Treatment in COVID-19 Patients

  • End date
    Apr 30, 2022
  • participants needed
  • sponsor
Updated on 16 July 2021


Demonstration of the efficacy of amantadine over placebo in the population of patients with moderate or severe COVID-19 in the initial stage of the disease treated in the hospital


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).

Condition Patients With Moderate or Severe COVID-19, Patients With Moderate or Severe COVID-19
Treatment Amantadine
Clinical Study IdentifierNCT04952519
Last Modified on16 July 2021


Yes No Not Sure

Inclusion Criteria

Age of respondents - 18 years and older
Confirmation of SARS-CoV-2 infection by PCR
Hospitalized patient with COVID-19, defined according to the following criteria (all of the following criteria must be present)
radiological (X-ray of klp or TK klp) features of pneumonia
blood saturation (SaO2) measured at rest in the absence of oxygen <95%
it is not necessary to apply on the day of patient enrollment: high-flow oxygen therapy or mechanical ventilation (non-invasive or invasive)
Time up to 7 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

Pregnancy or lactation
Presence of medical contraindications for inclusion in the examination in the opinion of the attending physician, in particular
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)
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
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