COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-001177-22/DK

Copenhagen University Hospital, Hvidovre - Department of Infectious diseases

Nina.Weis@regionh.dk

2021-03-29

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

● 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.

● 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

2

Copenhagen University Hospital, Hvidovre , Capital Region

18

100

Denmark

Mild disease at enrollment

1: Mild disease at enrollment

242

The primary outcome is clinical status on day 14 assessed by the ordinal scale suggested by WHO. 1)Ambulatory with no limitations to activities. 2) Ambulatory with limitations to activities. 3) Hospitalized without oxygen therapy. 4) Hopitalized and oxygen therapy by mask or nasal prongs. 5) Hospitalized and non-invasive ventilation or high flow oxygen. 6) Intubation and mechanical ventilation. 7) Ventilation + additional organ support -pressors, ECMO. 8) Death

Declared number of arm (3.0) differs from found arms (2.0)

Phase 3

[{"arm_notes": "", "treatment_id": 74, "treatment_name": "Amantadine", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]