---
title: The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms
nct_id: NCT04854759
overall_status: UNKNOWN
phase: PHASE3
sponsor: Independent Public Clinical Hospital No. 4 in Lublin
study_type: INTERVENTIONAL
primary_condition: COVID-19
countries: Poland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04854759.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04854759"
ct_last_update_post_date: 2021-08-13
last_seen_at: "2026-05-12T06:58:21.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Use of Amantadine in the Prevention of Progression and Treatment of COVID-19 Symptoms

**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

**NCT ID:** [NCT04854759](https://clinicaltrials.gov/study/NCT04854759)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** Independent Public Clinical Hospital No. 4 in Lublin
- **Conditions:** COVID-19, SARS-CoV-2
- **Start Date:** 2021-03-15
- **Completion Date:** 2022-05-31
- **CT.gov Last Update:** 2021-08-13

## Brief 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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
```

## Arms

- **Study group** (EXPERIMENTAL)
- **Control group** (PLACEBO_COMPARATOR)

## Interventions

- **Amantadine Hydrochloride** (DRUG) — 100 mg, capsule
- **Placebo** (DRUG) — 100 mg, capsule

## Primary Outcomes

- **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)

## 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)_

## Locations (8)

- Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego Oddział Neurologii i Neuroimmunologii Klinicznej, Grudziądz, Poland — _RECRUITING_
- Samodzielny Publiczny Zakład Opieki Zdrowotnej w Kalwarii Zebrzydowskiej, Kalwaria Zebrzydowska, Poland — _RECRUITING_
- Oddział Obserwacyjno-Zakaźny SPSz Woj. Im. Jana Bożego Lublin, Lublin, Poland — _RECRUITING_
- Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Lublin, Poland — _RECRUITING_
- Klinika Chorób Wewnętrznych Nefrologii i Endokrynologii Klinicznego Szpitala Wojewódzkiego nr 2 im. Św. Jadwigi Królowej, Rzeszów, Poland — _RECRUITING_
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus, Warsaw, Poland — _RECRUITING_
- Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji w Warszawie, Warsaw, Poland — _RECRUITING_
- Oddział Kardiologiczny Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Wyszkowie, Wyszków, Poland — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.regionalny szpital specjalistyczny im. dr władysława biegańskiego oddział neurologii i neuroimmunologii klinicznej|grudziądz||poland` — added _(2026-05-12)_
- `locations.samodzielny publiczny zakład opieki zdrowotnej w kalwarii zebrzydowskiej|kalwaria zebrzydowska||poland` — added _(2026-05-12)_
- `locations.oddział obserwacyjno-zakaźny spsz woj. im. jana bożego lublin|lublin||poland` — added _(2026-05-12)_
- `locations.samodzielny publiczny szpital kliniczny nr 4 w lublinie|lublin||poland` — added _(2026-05-12)_
- `locations.klinika chorób wewnętrznych nefrologii i endokrynologii klinicznego szpitala wojewódzkiego nr 2 im. św. jadwigi królowej|rzeszów||poland` — added _(2026-05-12)_
- `locations.uniwersyteckie centrum kliniczne warszawskiego uniwersytetu medycznego szpital kliniczny dzieciątka jezus|warsaw||poland` — added _(2026-05-12)_
- `locations.centralny szpital kliniczny ministerstwa spraw wewnętrznych i administracji w warszawie|warsaw||poland` — added _(2026-05-12)_
- `locations.oddział kardiologiczny samodzielny publiczny zespół zakładów opieki zdrowotnej w wyszkowie|wyszków||poland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04854759.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04854759*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*