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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental |
| |
| Control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amantadine Hydrochloride | Drug | 100 mg, capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Development of clinical deterioration | Defined as dyspnoea - physical examination - doctor's assessment | 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%) | 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) | Up to day 15 from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 15, 30 complementary visit-optional, 90, 150, 210 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Konrad Rejdak, Professor, PhD, MD | Contact | 81 72 44 720 | 0048 | konradrejdak@umlub.pl |
| Paweł Pinkosz | Contact | 81 72 44 484 | 0048 | pawel.pinkosz@spsk4.lublin.pl |
| Name | Affiliation | Role |
|---|---|---|
| Konrad Rejdak, Professor, PhD, MD | Independent Public Clinical Hospital No. 4 in Lublin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego Oddział Neurologii i Neuroimmunologii Klinicznej | Recruiting | Grudziądz | 86-300 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35390511 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000547 | Amantadine |
| ID | Term |
|---|---|
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Drug |
100 mg, capsule |
|
| The neurological assessment | will include the assessment of neurological functions based on:
| Day 15, 30 complementary visit-optional, 90, 150, 210 |
| Time to clinical deterioration | Day 15, 30 complementary visit-optional, 90, 150, 210 |
| Survival time | Day 15, 30 complementary visit-optional, 90, 150, 210 |
| Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kalwarii Zebrzydowskiej | Recruiting | Kalwaria Zebrzydowska | 34-130 | Poland |
|
| Oddział Obserwacyjno-Zakaźny SPSz Woj. Im. Jana Bożego Lublin | Recruiting | Lublin | 20-089 | Poland |
|
| Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie | Recruiting | Lublin | 20-954 | Poland |
|
| Klinika Chorób Wewnętrznych Nefrologii i Endokrynologii Klinicznego Szpitala Wojewódzkiego nr 2 im. Św. Jadwigi Królowej | Recruiting | Rzeszów | 35-301 | Poland |
|
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus | Recruiting | Warsaw | 02-005 | Poland |
|
| Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie | Recruiting | Warsaw | 02-507 | Poland |
|
| Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Wyszkowie | Recruiting | Wyszków | 07-200 | Poland |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009930 |
| Organic Chemicals |