Efficacy of Amantadine Treatment in COVID-19 Patients

Phase 3

Terminated

• Conditions: Patients With Moderate or Severe COVID-19
• Interventions: Drug: Amantadine

• Registration Number: NCT04952519
• Lead Sponsor: Noblewell

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).

Study Timeline

• Study Start: 2021-03-30
• Study First Submitted: 2021-06-28
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-02
• Study First Posted: 2021-07-07
• Primary Completion: 2022-03-10
• Study Completion: 2022-03-10
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 193

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amantadine	Amantadine	-
Placebo	Amantadine	-

Primary Outcome Measures

Name	Time	Method
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"

Trial Locations

Locations (12)

Tymczasowy Szpital Narodowy, CSK MSWiA; 🇵🇱 Warsaw, Poland

Szpital Tymczasowy Zespół Opieki Zdrowotnej; 🇵🇱 Bolesławiec, Poland

Oddział gruźlicy i chorób płuc; Lubuski Szpital Specjalistyczny Pulmonologiczno-Kardiologiczny w Torzymiu Spółka z o.o.; 🇵🇱 Torzym, Poland

Klinika Alergologii, Chorób Płuc i Chorób Wewnętrznych, Centralny Szpital Kliniczny MSWiA w Warszawie; 🇵🇱 Warszawa, Poland

Oddział Chorób Płuc i Niewydolności Oddychania z Pododdziałem NWM i Pododdziałem Zaburzeń Oddychania w Czasie Snu, Kujawsko - Pomorskie Centrum Pulmonologii w Bydgoszczy; 🇵🇱 Bydgoszcz, Poland

Oddział Chorób Płuc; Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu; 🇵🇱 Toruń, Poland

Oddział Pneumonologii Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach; 🇵🇱 Katowice, Poland

Oddział Pulmonologiczny Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu; 🇵🇱 Poznań, Poland

I Klinika Chorób Płuc i Gruźlicy z Pododdziałem Chemioterapii - Uniwersytecki Szpital Kliniczny w Białymstoku; 🇵🇱 Białystok, Poland

Oddział Chorób Płuc i Chemioterapii - Szpital Powiatowy w Chrzanowie; 🇵🇱 Chrzanów, Poland

Oddział Pulmonologii Szpital Powiatowy w Limanowej Imienia Miłosierdzia Bożego; 🇵🇱 Limanowa, Poland

Szpital Tymczasowy w Pyrzowicach; 🇵🇱 Pyrzowice, Poland