COVID-19Phase 3COV-PREVENTNCT04854759
The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms
A Phase 3 study testing Amantadine Hydrochloride in people with COVID-19 and SARS-CoV-2, run by Independent Public Clinical Hospital No. 4 in Lublin at 8 sites in Poland.
Trial summary
The use of amantadine in the prevention of progression and treatment of COVID-19 symptoms in patients infected with the SARS-CoV-2 virus. Multicenter randomized, double-blind, placebo-controlled, non-commercial clinical trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- Amantadine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 8 sitesPoland
- Study dates
- 15 Mar 2021to 31 May 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
- Men and women aged 18 and over
- Can give informed consent
- Confirmed positive result for SARS-CoV-2 within 72 hours from the date the result was issued (according to the laboratory report)
- Patient presently symptomatic with one or more of the following symptoms: fever, cough, myalgia, mild dyspnoea, chest pain, diarrhea, nausea, vomiting, anosmia, lack of taste, sore throat, nasal congestion
- At initial screening, the subject will report at least one and no more than 3 of the following risk factors for clinical worsening: age ≥40, obesity, hypertension, diabetes, pulmonary disease (e.g., asthma, COPD), and immune disorders (e.g. rheumatoid arthritis, lupus), neurological diseases: e.g. after a distant stroke or trauma to the brain, multiple sclerosis, dementia and other neurodegenerative diseases)
- Patients hospitalized due to meeting the above criteria and requiring observation in a hospital or outpatient setting.
Who cannot join
- Disease severe enough to meet the study's primary endpoint of clinical worsening (eg, current O2 saturation <92% with patient exposure to room air, current use of supplemental oxygen to maintain O2 saturation ≥ 92%).
- WHO score ≥4 (requires oxygen therapy during hospitalization)
- Concomitant diseases which, in the opinion of the attending physician, prevent the patient from participating in the study, such as: decompensated cirrhosis, active ulcer disease, epilepsy and symptomatic convulsions, untreated angle-closure glaucoma determined on the basis of the patient's interview and / or medical documentation . In addition, immunocompromised patients (solid organ transplant, BMT, AIDS, renal failure (patients with renal impairment may develop drug poisoning) or other diseases not mentioned and other diseases treated with biological, immunological and / or steroids in high doses will not be eligible for the study. doses (> 20 mg prednisone daily).
- Hypersensitivity to any component of the preparation, severe congestive heart failure, cardiomyopathy, myocarditis, II-III degree AV block, bradycardia, clinically significant prolongation of the QT interval, or a family history of congenital long QT syndrome, severe ventricular arrhythmias (including torsade de pointes), concomitant use of drugs that prolong the QT interval, hypokalaemia, hypomagnesaemia,
- Pregnancy, the period of breastfeeding.
- Parallel intake of memantine or other drugs acting on the CNS (neuroleptics, anxiolytics, antiepileptic drugs, antidepressants).
- Other neurological conditions with agitation or confusion, delirium syndromes or psychoses.
- Receipt of a partial or full vaccination schedule against SARS-CoV-2 is also an exclusion criterion from the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Poland8 sites, 8 recruiting
- Recruiting
Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego Oddział Neurologii i Neuroimmunologii Klinicznej
Grudziądz, 86-300
Robert Bonek, PhD, MD
- Recruiting
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kalwarii Zebrzydowskiej
Kalwaria Zebrzydowska, 34-130
Mateusz Dec, MD
- Recruiting
Oddział Obserwacyjno-Zakaźny SPSz Woj. Im. Jana Bożego Lublin
Lublin, 20-089
Slawomir Kiciak, PhD, MD
- Recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954
Konrad Rejdak, Professor, PhD, MD
- Recruiting
Klinika Chorób Wewnętrznych Nefrologii i Endokrynologii Klinicznego Szpitala Wojewódzkiego nr 2 im. Św. Jadwigi Królowej
Rzeszów, 35-301
Agnieszka Gala- Błądzińska, PhD, MD
- Recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus
Warsaw, 02-005
Piotr Fiedor, Professor, PhD, MD
- Recruiting
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie
Warsaw, 02-507
Zbigniew J. Król, PhD, MD
- Recruiting
Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Wyszkowie
Wyszków, 07-200
Waldemar Chełstowski, MD
About this study
Official title: The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms in Patients Infected With the SARS-CoV-2 Virus
The use of amantadine in the prevention of progression and treatment of COVID-19 symptoms in patients infected with the SARS-CoV-2 virus. Multicenter randomized, double-blind, placebo-controlled, non-commercial clinical trial
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- Amantadine Hydrochloride, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amantadine HydrochlorideDrug
100 mg, capsule
PlaceboDrug
100 mg, capsule
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Drug: Amantadine Hydrochloride |
| Control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of clinical deterioration
Defined as dyspnoea - physical examination - doctor's assessment
Measured: Up to day 15 from randomization
Clinical deterioration occurs
Defined as drop in O2 saturation (<92% with patient exposure to room air) and / or additional oxygen demand to maintain O2 saturation ≥92%)
Measured: Up to day 15 from randomization
Clinical deterioration occurs
Defined as achievement of ≥4 points on the WHO [OSCI-WHO] scale (7-point clinical status assessment scale)
Measured: Up to day 15 from randomization
Secondary outcomes (4)
General Health Scale (PROMIS® Global Health Scale)
Mean Global Health scores for each arm at day 15, 30 complementary visit-optional, 90, 150, 210. PROMIS® instruments are scored using item-level calibrations. This method of scoring uses "response pattern scoring," which uses responses to each item for each participant.
Measured: Day 15, 30 complementary visit-optional, 90, 150, 210
The neurological assessment
will include the assessment of neurological functions based on:
- scales for fatigue,
- depression,
- disorders of smell and taste,
- sleep disorders,
- quality of life.
Measured: Day 15, 30 complementary visit-optional, 90, 150, 210
Time to clinical deterioration
Measured: Day 15, 30 complementary visit-optional, 90, 150, 210
Survival time
Measured: Day 15, 30 complementary visit-optional, 90, 150, 210
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start15 Mar 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 May 2022 (estimated)
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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Independent Public Clinical Hospital No. 4 in Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Konrad Rejdak, Professor, PhD, MD, Principal investigator, Independent Public Clinical Hospital No. 4 in Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854759
- Sponsor's protocol ID
- LUB-COV-2021-01
- Acronym
- COV-PREVENT
- Status last verified
- Aug 2021
- First submitted
- 17 Apr 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rejdak K, Fiedor P, Bonek R, Goch A, Gala-Bladzinska A, Chelstowski W, Lukasiak J, Kiciak S, Dabrowski P, Dec M, Krol ZJ, Papuc E, Zasybska A, Segiet A, Grieb P. The use of amantadine in the prevention of progression and treatment of COVID-19 symptoms in patients infected with the SARS-CoV-2 virus (COV-PREVENT): Study rationale and design. Contemp Clin Trials. 2022 May;116:106755. doi: 10.1016/j.cct.2022.106755. Epub 2022 Apr 4.
PubMed 35390511
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms in Patients Infected With the SARS-CoV-2 Virus
- ClinicalTrials.gov ID
- NCT04854759
- Acronym / sponsor ID
- COV-PREVENT / LUB-COV-2021-01
- Conditions
- COVID-19, SARS-CoV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Independent Public Clinical Hospital No. 4 in LublinUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 22 Apr 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.
The use of amantadine in the prevention of progression and treatment of COVID-19 symptoms in patients infected with the SARS-CoV-2 virus. Multicenter randomized, double-blind, placebo-controlled, non-commercial clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Amantadine Hydrochloride |
| Control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 18 and over
- Can give informed consent
- Confirmed positive result for SARS-CoV-2 within 72 hours from the date the result was issued (according to the laboratory report)
- Patient presently symptomatic with one or more of the following symptoms: fever, cough, myalgia, mild dyspnoea, chest pain, diarrhea, nausea, vomiting, anosmia, lack of taste, sore throat, nasal congestion
- At initial screening, the subject will report at least one and no more than 3 of the following risk factors for clinical worsening: age ≥40, obesity, hypertension, diabetes, pulmonary disease (e.g., asthma, COPD), and immune disorders (e.g. rheumatoid arthritis, lupus), neurological diseases: e.g. after a distant stroke or trauma to the brain, multiple sclerosis, dementia and other neurodegenerative diseases)
Key exclusion criteria (8 listed)
- Disease severe enough to meet the study's primary endpoint of clinical worsening (eg, current O2 saturation <92% with patient exposure to room air, current use of supplemental oxygen to maintain O2 saturation ≥ 92%).
- WHO score ≥4 (requires oxygen therapy during hospitalization)
- Concomitant diseases which, in the opinion of the attending physician, prevent the patient from participating in the study, such as: decompensated cirrhosis, active ulcer disease, epilepsy and symptomatic convulsions, untreated angle-closure glaucoma determined on the basis of the patient's interview and / or medical documentation . In addition, immunocompromised patients (solid organ transplant, BMT, AIDS, renal failure (patients with renal impairment may develop drug poisoning) or other diseases not mentioned and other diseases treated with biological, immunological and / or steroids in high doses will not be eligible for the study. doses (> 20 mg prednisone daily).
- Hypersensitivity to any component of the preparation, severe congestive heart failure, cardiomyopathy, myocarditis, II-III degree AV block, bradycardia, clinically significant prolongation of the QT interval, or a family history of congenital long QT syndrome, severe ventricular arrhythmias (including torsade de pointes), concomitant use of drugs that prolong the QT interval, hypokalaemia, hypomagnesaemia,
- Pregnancy, the period of breastfeeding.
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 |
|---|---|---|
| Amantadine Hydrochloride100 mg, capsule | Drug | Study group |
| Placebo100 mg, capsule | Drug | Control group |
Primary outcome
Development of clinical deterioration
Time frame: Up to day 15 from randomization
Defined as dyspnoea - physical examination - doctor's assessment
Clinical deterioration occurs
Time frame: Up to day 15 from randomization
Defined as drop in O2 saturation (<92% with patient exposure to room air) and / or additional oxygen demand to maintain O2 saturation ≥92%)
Clinical deterioration occurs
Time frame: Up to day 15 from randomization
Defined as achievement of ≥4 points on the WHO [OSCI-WHO] scale (7-point clinical status assessment scale)
4 secondary outcomes
General Health Scale (PROMIS® Global Health Scale)
Time frame: Day 15, 30 complementary visit-optional, 90, 150, 210
The neurological assessment
Time frame: Day 15, 30 complementary visit-optional, 90, 150, 210
Time to clinical deterioration
Time frame: Day 15, 30 complementary visit-optional, 90, 150, 210
Survival time
Time frame: Day 15, 30 complementary visit-optional, 90, 150, 210
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Derived from this study: PubMed 35390511Rejdak K, Fiedor P, Bonek R, Goch A, Gala-Bladzinska A, Chelstowski W, Lukasiak J, Kiciak S, Dabrowski P, Dec M, Krol ZJ, Papuc E, Zasybska A, Segiet A, Grieb P. The use of amantadine in the prevention of progression and treatment of COVID-19 symptoms in patients infected with the SARS-CoV-2 virus (COV-PREVENT): Study rationale and design. Contemp Clin Trials. 2022 May;116:106755. doi: 10.1016/j.cct.2022.106755. Epub 2022 Apr 4.
- Individual participant dataSharing planned: Undecided
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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.
Konrad Rejdak, Professor, PhD, MD principal investigator
Independent Public Clinical Hospital No. 4 in Lublin
8 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 Hydrochloride in people with COVID-19 and SARS-CoV-2, run by Independent Public Clinical Hospital No. 4 in Lublin at 8 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konrad Rejdak, Professor, PhD, MD (81 72 44 720 ext. 0048, konradrejdak@umlub.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of clinical deterioration (time frame: Up to day 15 from randomization). The study lists 3 primary outcomes in all. 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 NCT04854759, 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 13 Aug 2021.