Patients With Moderate or Severe COVID-19
Conditions
Keywords
SARS-COV-2, COVID-19
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).
Interventions
DRUGAmantadine
Patients are treated with high doses of amantadine.
Sponsors
Medical Research Agency, Poland
Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice, Poland
Noblewell
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recovery | 28 days | 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 |
Countries
Poland
Outcome results
None listed