Clinical trial NCT04952519: Efficacy of Amantadine Treatment in COVID-19 Patients
Official title: Efficacy of Amantadine Treatment in COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Patients With Moderate or Severe COVID-19
Keywords: SARS-COV-2
COVID-19
Lead sponsor: Noblewell
Sponsor class: INDUSTRY
Collaborators: name: Medical Research Agency, Poland
name: Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice, Poland
First posted: 2021-07-07
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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 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

Primary outcomes:
measure: Time to recovery
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: I Klinika Chorób Płuc i Gruźlicy z Pododdziałem Chemioterapii - Uniwersytecki Szpital Kliniczny w Białymstoku
city: Bolesławiec
country: Poland
facility: Szpital Tymczasowy Zespół Opieki Zdrowotnej
city: Bydgoszcz
country: Poland
facility: Oddział Chorób Płuc i Niewydolności Oddychania z Pododdziałem NWM i Pododdziałem Zaburzeń Oddychania w Czasie Snu, Kujawsko - Pomorskie Centrum Pulmonologii w Bydgoszczy
city: Chrzanów
country: Poland
facility: Oddział Chorób Płuc i Chemioterapii - Szpital Powiatowy w Chrzanowie
city: Katowice
country: Poland
facility: Oddział Pneumonologii Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
city: Limanowa
country: Poland
facility: Oddział Pulmonologii Szpital Powiatowy w Limanowej Imienia Miłosierdzia Bożego
city: Poznań
country: Poland
facility: Oddział Pulmonologiczny Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
city: Pyrzowice
country: Poland
facility: Szpital Tymczasowy w Pyrzowicach
city: Toruń
country: Poland
facility: Oddział Chorób Płuc; Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
city: Torzym
country: Poland
facility: Oddział gruźlicy i chorób płuc; Lubuski Szpital Specjalistyczny Pulmonologiczno-Kardiologiczny w Torzymiu Spółka z o.o.
city: Warsaw
country: Poland
facility: Tymczasowy Szpital Narodowy, CSK MSWiA
city: Warszawa
country: Poland
facility: Klinika Alergologii, Chorób Płuc i Chorób Wewnętrznych, Centralny Szpital Kliniczny MSWiA w Warszawie
Study officials:
affiliation: Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice
name: Adam Barczyk, Prof.
role: STUDY_DIRECTOR
References: