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

Primary Purpose

Patients With Moderate or Severe COVID-19

Status

Terminated

Phase

Phase 3

Locations

Poland

Study Type

Interventional

Intervention

Amantadine

About this trial

This is an interventional treatment trial for Patients With Moderate or Severe COVID-19 focused on measuring SARS-COV-2, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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):
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).
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:

Pregnancy or lactation
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

Sites / Locations

I Klinika Chorób Płuc i Gruźlicy z Pododdziałem Chemioterapii - Uniwersytecki Szpital Kliniczny w Białymstoku
Szpital Tymczasowy Zespół Opieki Zdrowotnej
Oddział Chorób Płuc i Niewydolności Oddychania z Pododdziałem NWM i Pododdziałem Zaburzeń Oddychania w Czasie Snu, Kujawsko - Pomorskie Centrum Pulmonologii w Bydgoszczy
Oddział Chorób Płuc i Chemioterapii - Szpital Powiatowy w Chrzanowie
Oddział Pneumonologii Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
Oddział Pulmonologii Szpital Powiatowy w Limanowej Imienia Miłosierdzia Bożego
Oddział Pulmonologiczny Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Szpital Tymczasowy w Pyrzowicach
Oddział Chorób Płuc; Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
Oddział gruźlicy i chorób płuc; Lubuski Szpital Specjalistyczny Pulmonologiczno-Kardiologiczny w Torzymiu Spółka z o.o.
Tymczasowy Szpital Narodowy, CSK MSWiA
Klinika Alergologii, Chorób Płuc i Chorób Wewnętrznych, Centralny Szpital Kliniczny MSWiA w Warszawie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Amantadine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

Full Information

NCT ID

NCT04952519

First Posted

June 28, 2021

Last Updated

September 28, 2022

Sponsor

Noblewell

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04952519

Brief Title

Efficacy of Amantadine Treatment in COVID-19 Patients

Acronym

TITAN

Official Title

Efficacy of Amantadine Treatment in COVID-19 Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Why Stopped

The annual analysis did not show the efficacy of the investigational medicinal product in this application, therefore the study was not continued.

Study Start Date

March 30, 2021 (Actual)

Primary Completion Date

March 10, 2022 (Actual)

Study Completion Date

March 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Noblewell

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With Moderate or Severe COVID-19

Keywords

SARS-COV-2, COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

193 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amantadine

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Amantadine

Intervention Description

Patients are treated with high doses of amantadine.

Primary Outcome Measure Information:

Title

Time to recovery

Description

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"

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Pregnancy or lactation 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adam Barczyk, Prof.

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Białystok

Country

Poland

Facility Name

Szpital Tymczasowy Zespół Opieki Zdrowotnej

City

Bolesławiec

Country

Poland

Facility Name

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

City

Bydgoszcz

Country

Poland

Facility Name

Oddział Chorób Płuc i Chemioterapii - Szpital Powiatowy w Chrzanowie

City

Chrzanów

Country

Poland

Facility Name

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

City

Katowice

Country

Poland

Facility Name

Oddział Pulmonologii Szpital Powiatowy w Limanowej Imienia Miłosierdzia Bożego

City

Limanowa

Country

Poland

Facility Name

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

City

Poznań

Country

Poland

Facility Name

Szpital Tymczasowy w Pyrzowicach

City

Pyrzowice

Country

Poland

Facility Name

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

City

Toruń

Country

Poland

Facility Name

Oddział gruźlicy i chorób płuc; Lubuski Szpital Specjalistyczny Pulmonologiczno-Kardiologiczny w Torzymiu Spółka z o.o.

City

Torzym

Country

Poland

Facility Name

Tymczasowy Szpital Narodowy, CSK MSWiA

City

Warsaw

Country

Poland

Facility Name

Klinika Alergologii, Chorób Płuc i Chorób Wewnętrznych, Centralny Szpital Kliniczny MSWiA w Warszawie

City

Warszawa

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Efficacy of Amantadine Treatment in COVID-19 Patients

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