Efficacy of Amantadine Treatment in COVID-19 Patients

NCT ID: NCT04952519

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2022-03-10

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).

Conditions

Patients With Moderate or Severe COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Amantadine

Group Type: EXPERIMENTAL

Amantadine

Intervention Type: DRUG

Patients are treated with high doses of amantadine.

Placebo

Group Type: PLACEBO_COMPARATOR

Amantadine

Intervention Type: DRUG

Patients are treated with high doses of amantadine.

Interventions

Amantadine

Patients are treated with high doses of amantadine.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Agency, Poland

OTHER_GOV

Sponsor Role: collaborator

Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice, Poland

UNKNOWN

Sponsor Role: collaborator

Noblewell

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Barczyk, Prof.

Role: STUDY_DIRECTOR

Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice

Locations

I Klinika Chorób Płuc i Gruźlicy z Pododdziałem Chemioterapii - Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, , Poland

Szpital Tymczasowy Zespół Opieki Zdrowotnej

Bolesławiec, , 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 i Chemioterapii - Szpital Powiatowy w Chrzanowie

Chrzanów, , Poland

Oddział Pneumonologii Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach

Katowice, , Poland

Oddział Pulmonologii Szpital Powiatowy w Limanowej Imienia Miłosierdzia Bożego

Limanowa, , Poland

Oddział Pulmonologiczny Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

Poznan, , Poland

Szpital Tymczasowy w Pyrzowicach

Pyrzowice, , Poland

Oddział Chorób Płuc; Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu

Torun, , 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

Warsaw, , Poland

Tymczasowy Szpital Narodowy, CSK MSWiA

Warsaw, , Poland

Countries

Poland

References

Barczyk A, Czajkowska-Malinowska M, Farnik M, Barczyk M, Boda L, Cofta S, Dulawa J, Dyrbus M, Harat R, Huk M, Kotecka S, Nahorecki A, Nasilowski J, Naumnik W, Przybylski G, Slabon-Willand M, Skoczynski S, Wita K, Ziolo G, Kuna P. Efficacy of oral amantadine among patients hospitalised with COVID-19: A randomised, double-blind, placebo-controlled, multicentre study. Respir Med. 2023 Jun;212:107198. doi: 10.1016/j.rmed.2023.107198. Epub 2023 Mar 15.

Reference Type: DERIVED

PMID: 36931576 (View on PubMed)

Other Identifiers

2021-000981-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

00980.045

Identifier Type: -

Identifier Source: org_study_id