Study Stopped
The annual analysis did not show the efficacy of the investigational medicinal product in this application, therefore the study was not continued.
Efficacy of Amantadine Treatment in COVID-19 Patients
TITAN
2 other identifiers
interventional
193
1 country
12
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2021
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2021
CompletedFirst Submitted
Initial submission to the registry
June 28, 2021
CompletedFirst Posted
Study publicly available on registry
July 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2022
CompletedSeptember 30, 2022
July 1, 2021
12 months
June 28, 2021
September 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to recovery
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"
28 days
Study Arms (2)
Amantadine
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age of respondents - 18 years and older.
- Confirmation of SARS-CoV-2 infection by PCR
- Hospitalized patient with COVID-19, defined according to the following criteria (all of the following criteria must be present):
- radiological (X-ray of klp or TK klp) features of pneumonia,
- blood saturation (SaO2) measured at rest in the absence of oxygen \<95%,
- it is not necessary to apply on the day of patient enrollment: high-flow oxygen therapy or mechanical ventilation (non-invasive or invasive).
- 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.
You may not qualify if:
- Pregnancy or lactation
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
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
Related Publications (1)
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.
PMID: 36931576DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Adam Barczyk, Prof.
Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2021
First Posted
July 7, 2021
Study Start
March 30, 2021
Primary Completion
March 10, 2022
Study Completion
March 10, 2022
Last Updated
September 30, 2022
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share