Efficacy of Amantadine Treatment in COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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).

Official Title
-----------------
Efficacy of Amantadine Treatment in COVID-19 Patients

Conditions
-----------------
Patients With Moderate or Severe COVID-19

Intervention / Treatment
-----------------
* Drug: Amantadine


Participation Criteria
=================
Eligibility Criteria
-----------------
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 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: Pregnancy or lactation 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amantadine<br> | Drug: Amantadine<br>* Patients are treated with high doses of amantadine.<br>|
| Placebo Comparator: Placebo<br> | Drug: Amantadine<br>* Patients are treated with high doses of amantadine.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery | Time to recovery, defined as the first day during the 28-day clinical follow-up during which the patient's clinical condition is graded 1, 2, or 3 on an eight-point Normal Symptom Score | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-COV-2, COVID-19