Patients With Moderate or Severe COVID-19Phase 3TITANNCT04952519
Efficacy of Amantadine Treatment in COVID-19 Patients
A Phase 3 study testing Amantadine in people with Patients With Moderate or Severe COVID-19, run by Noblewell at 12 sites in Poland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Moderate or Severe COVID-19
- What is being tested?
- Amantadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 193 participants
- Where
- 12 sitesPoland
- Study dates
- 30 Mar 2021to 10 Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy or lactation
- Presence of medical contraindications for inclusion in the examination in the opinion of the attending physician, in particular:
- 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).
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Poland12 sites
I Klinika Chorób Płuc i Gruźlicy z Pododdziałem Chemioterapii - Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok
Szpital Tymczasowy Zespół Opieki Zdrowotnej
Bolesławiec
Oddział Chorób Płuc i Niewydolności Oddychania z Pododdziałem NWM i Pododdziałem Zaburzeń Oddychania w Czasie Snu, Kujawsko - Pomorskie Centrum Pulmonologii w Bydgoszczy
Bydgoszcz
Oddział Chorób Płuc i Chemioterapii - Szpital Powiatowy w Chrzanowie
Chrzanów
Oddział Pneumonologii Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice
Oddział Pulmonologii Szpital Powiatowy w Limanowej Imienia Miłosierdzia Bożego
Limanowa
Oddział Pulmonologiczny Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan
Szpital Tymczasowy w Pyrzowicach
Pyrzowice
Oddział Chorób Płuc; Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun
Oddział gruźlicy i chorób płuc; Lubuski Szpital Specjalistyczny Pulmonologiczno-Kardiologiczny w Torzymiu Spółka z o.o.
Torzym
Klinika Alergologii, Chorób Płuc i Chorób Wewnętrznych, Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw
Tymczasowy Szpital Narodowy, CSK MSWiA
Warsaw
About this study
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
Read the 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).
- Being tested
- Amantadine
- Keywords
- SARS-COV-2, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmantadineDrug
Patients are treated with high doses of amantadine.
| Study group | Role | What they receive |
|---|---|---|
| Amantadine | Experimental | Not described Receives: Drug: Amantadine |
| Placebo | Placebo comparator | Not described Receives: Drug: Amantadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start30 Mar 2021
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Why it stopped: The annual analysis did not show the efficacy of the investigational medicinal product in this application, therefore the study was not continued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Moderate or Severe COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noblewell
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical Research Agency, Poland, Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice, Poland
- Responsible party
- Sponsor
- Investigators
- Adam Barczyk, Prof., Study director, Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952519
- Sponsor's protocol ID
- 00980.045
- Other IDs
- 2021-000981-13
- Acronym
- TITAN
- Status last verified
- Jul 2021
- First submitted
- 28 Jun 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36931576
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Amantadine Treatment in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04952519
- Acronym / sponsor ID
- TITAN / 00980.045
- Keywords
- SARS-COV-2, COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The annual analysis did not show the efficacy of the investigational medicinal product in this application, therefore the study was not continued.
- Enrolment
- 193 participants (actual)
- Lead sponsor
- NoblewellIndustry (pharma, biotech, devices)
- Collaborators
- Medical Research Agency, Poland, Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice, Poland
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amantadine | Experimental | Drug: Amantadine |
| Placebo | Placebo comparator | Drug: Amantadine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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):
- 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.
Key exclusion criteria (4 listed)
- Pregnancy or lactation
- Presence of medical contraindications for inclusion in the examination in the opinion of the attending physician, in particular:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmantadinePatients are treated with high doses of amantadine. | Drug | Amantadine, Placebo |
Primary outcome
Time to recovery
Time frame: 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"
Results and safety
The study was stopped early (reason given: The annual analysis did not show the efficacy of the investigational medicinal product in this application, therefore the study was not continued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Derived from this study: PubMed 36931576Barczyk 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Barczyk, Prof. study director
Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amantadine in people with Patients With Moderate or Severe COVID-19, run by Noblewell at 12 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The annual analysis did not show the efficacy of the investigational medicinal product in this application, therefore the study was not continued.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recovery (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04952519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.