Efficacy of Amantadine Treatment in COVID-19 Patients (TITAN)

Noblewell

Status and phase: Terminated; Phase 3

Conditions: Patients With Moderate or Severe COVID-19

Treatments: Drug: Amantadine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04952519

00980.045

2021-000981-13 (EudraCT Number)

Details and patient eligibility

About

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

Full 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).

Enrollment: 193 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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193 participants in 2 patient groups, including a placebo group

Amantadine

Experimental group

Treatment:

Drug: Amantadine

Placebo

Placebo Comparator group

Treatment:

Drug: Amantadine