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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04952519
Recruitment Status : Recruiting
First Posted : July 7, 2021
Last Update Posted : July 7, 2021
Sponsor:
Collaborators:
Medical Research Agency, Poland
Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Patients With Moderate or Severe COVID-19 Drug: Amantadine Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Amantadine Treatment in COVID-19 Patients
Actual Study Start Date : March 30, 2021
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Amantadine Drug: Amantadine
Patients are treated with high doses of amantadine.

Placebo Comparator: Placebo Drug: Amantadine
Patients are treated with high doses of amantadine.




Primary Outcome Measures :
  1. 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"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 7 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04952519


Contacts
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Contact: Ewa Bachta +48323598918 ebachta@gcm.pl
Contact: Anna Gronostaj +48323598918 agronostaj@gcm.pl

Locations
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Poland
Oddział Chorób Płuc i Niewydolności Oddychania z Pododdziałem NWM i Pododdziałem Zaburzeń Oddychania w Czasie Snu, Kujawsko - Pomorskie Centrum Pulmonologii w Bydgoszczy Recruiting
Bydgoszcz, Poland
Contact: Małgorzata Czajkowska-Malinowska, MD         
Principal Investigator: Małgorzata Czajkowska-Malinowska, MD         
Oddział Pneumonologii Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach Recruiting
Katowice, Poland
Contact: Adam Barczyk, Prof.         
Principal Investigator: Adam Barczyk, Prof.         
Sponsors and Collaborators
Noblewell
Medical Research Agency, Poland
Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice
Investigators
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Study Director: Adam Barczyk, Prof. Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice
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Responsible Party: Noblewell
ClinicalTrials.gov Identifier: NCT04952519    
Other Study ID Numbers: 00980.045
2021-000981-13 ( EudraCT Number )
First Posted: July 7, 2021    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noblewell:
SARS-COV-2
COVID-19
Additional relevant MeSH terms:
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Amantadine
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents