Efficacy of Amantadine Treatment in COVID-19 Patients

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Noblewell
• Collaborators: Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice; Medical Research Agency (ABM)
• Treatments: Amantadine

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 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:

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