An adaptive randomised placebo controlled phase II trial of antivirals for COVID-19 infection (VIRCO): A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesPrimary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisationSecondary objectives:• To determine the safety of the antiviral• To determine the clinical benefit of the antiviral over placebo according to the WHO 7-point ordinal scale• To determine the clinical benefit of the antiviral over placebo on time to resolution of clinical symptoms• To determine the effect of the antiviral over placebo on biomarkers of inflammation and immune activationTrial designThis is a multi-centre, triple-blind, randomised...
Source: Trials - October 13, 2020 Category: Research Source Type: clinical trials
A Randomized Open label Phase-II Clinical Trial with or without Infusion of Plasma from Subjects after Convalescence of SARS-CoV-2 Infection in High-Risk Patients with Confirmed Severe SARS-CoV-2 Disease (RECOVER): A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesPrimary objectives• To assess the time from randomisation until an improvement within 84 days defined as two points on a seven point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of SARS-CoV-2 infection or standard of care.Secondary objectives• To assess overall survival, and the overall survival rate at 28 56 and 84 days.• To assess SARS-CoV-2 viral clearance and load as well as antibody titres.• To assess the percentage of patients that req...
Source: Trials - October 5, 2020 Category: Research Source Type: clinical trials
Results and lessons learnt from a randomized controlled trial: prophylactic treatment of vestibular migraine with metoprolol (PROVEMIG)
ConclusionsAfter randomizing 130 patients PROVEMIG had to be discontinued because of poor participant accrual not related to the tolerability of the study medication or safety concerns; no treatment benefit of metoprolol over placebo could be established. Additional preparatory work is much needed in the development, psychometric evaluation and interpretation of clinically meaningful end points in trials on episodic syndromes like VM taking into consideration the complexity of this disease entity comprising two domains (vertigo- and headache-related disability).Trial registrationEudraCT,2009-013701-34. Prospectively regist...
Source: Trials - December 29, 2019 Category: Research Source Type: clinical trials
Feasibility of Balloon Dilation of the Eustachian Tubes Under Local Anesthesia
Condition: Chronic Eustachian Salpingitis Intervention: Device: Balloon dilation of the Eustachian tubes Sponsors: Piedmont Ear, Nose, Throat and Related Allergy, PC; Acclarent Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - August 14, 2019 Category: Research Source Type: clinical trials
