Treatment of mild COVID-19: a randomized, double blinded, placebo controlled study

Phase 1

• Conditions: COVID-19; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10070255Term: Coronavirus test positiveSystem Organ Class: 10022891 - Investigations; MedDRA version: 23.0Level: LLTClassification code 10084382Term: Coronavirus disease 2019System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-001177-22-DK
• Lead Sponsor: Copenhagen University Hospital, Hvidovre , Capital Region

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-29
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

?Population at risk of developing severe COVID-19, defined as either:
Age = 40 years of age
Age = 18 years of age and at least one known comorbidity
Age = 18 years of age and a BMI = 30
?COVID-19 disease confirmed by the presence of SARS-CoV-2 nucleic acid by polymerase chain reaction (PCR) within 5 days prior to inclusion.
?For women of childbearing age (defined as non-sterile premenopausal women): Negative pregnancy test and willingness to use contraceptive during the study period (90 days)
?Provision of informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 121
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 121

Exclusion Criteria

?Current hospitalization
?Allergy to amantadine hydrochloride, rimantadine or inactive ingredients.
?Known history of:
Untreated narrow-angle glaucoma
Kidney disease with eGFR < 35 ml/min
Heart failure, proarrhythmic conditions, ventricular arrhythmias.
Seizures
Parkinson’s disease
Gastric ulcer
Liver Disease
Hereditary galactose intolerance, lactose intolerance or glucose/galactose malabsorption
?Current use of:
Neuroleptics/antipsychotics/ levodopa
Anticholinergics
Thiazides
?Concurrent malignancy requiring chemotherapy
?Pregnancy and breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified