Ien72 schreef op 26 juli 2021 07:11:
Parallel aan de studie naar beperken van Covid klachten tijdens ziekte, loopt er een studie naar verbeteren conditie van personen met restverschijnselen post-covid. Dit is een fase 4 onderzoek met einddatum januari 2022. Er zijn 40 deelnemers.
Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection
ClinicalTrials.gov Identifier: NCT04705831
Sponsor:
IMMUNOe Research Centers
Information provided by (Responsible Party):
Isaac Melamed, MD, IMMUNOe Research Centers
Study Description
Brief Summary:
Randomized, Double Blind, Placebo Controlled, Proof-of-Concept Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post-SARS-CoV-2 Infection.
Condition or disease Intervention/treatment Phase Post-Viral Fatigue SyndromePost-Viral Disorder (Disorder)Covid19
Drug: Ruconest
Phase 4
Detailed Description:
This study will last approximately 19 weeks including 16 infusions total, each one week apart. This is to help patients that have developed "Post-Viral Fatigue Syndrome" which can include symptoms such as: extreme fatigue, lost of taste, brain fog, and/or seizures.
Study Design
Study Type :Interventional (Clinical Trial)
Estimated Enrollment :40 participantsAllocation:RandomizedIntervention Model:Crossover
AssignmentMasking:Double (Participant, Care Provider)Primary Purpose:TreatmentOfficial
Title:A Randomized, Double Blind, Placebo Controlled, Cross-Over, Proof-of-Concept Study to Evaluate the Benefit of RUCONEST (C1 Esterase Inhibitor [Recombinant]) in Improving Neurological Symptoms in Post-SARS-CoV-2 InfectionActual Study
Start Date :December 30, 2020Estimated Primary Completion Date :January 2022Estimated Study Completion Date :January 2022