LaRed Home

LaRed

Treatment of outpatients with anti-Coronavirus immunoglobulin (INSIGHT-012_OTAC)

by

An International Multicenter, Randomized, Double-Blind, Placebo-Controlled Trials of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19 (INSIGHT-012_OTAC)

This study will evaluate a treatment strategy for COVID-19 patients with passive immunotherapy plus current standard of care treatment. The goal is to find out if the study drug is safe, and if it will help people stay out of the hospital and have fewer problems caused by COVID-19.

International study on COVID-19 Vaccine to assess Immunogenicity, Reactogenicity and Efficacy (InVITE)

by

It is a multicenter study on the immunogenicity and durability of vaccines against COVID-19 and severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infections in people receiving a COVID-19 vaccine through the national program of vaccination.

Previous SARS-CoV-2 infection/immunity will be measured. Immune response to vaccine and SARS-CoV-2 infection is measured at visits 2 and 10 months after
completion of an initial or booster regimen. The durability of the immune response is captured through 2 optional extended follow-up visits. Symptomatic SARS-CoV-2 infections during the study are evaluated by virus detection and viral genomic sequencing. The analyzes will estimate the vaccine immunogenicity for the different vaccines in the study countries and in subgroups, including, but not limited to, HIV, pregnancy, tuberculosis and diabetes.

International SARS-CoV-2 Infection Observational Study (ICOS)

by

An International Observational of Outpatients with SARSCoV2 Infection

This is an observational cohort study of outpatients with COVID-19. Enrolment will begin in June 2020 and is expected to continue for at least 12 months. Followup will be 28 days from enrolment in those who are positive. Those with a negative test will not be followed, after enrolment or disclosure of a negative result.

Study Objectives

The two primary objectives of this observational study are:

1. Estimate the rate of hospitalization or death during the 28 day follow-up period.

2. Identify risk factors for hospitalization or death.

Endpoints

The primary endpoint is hospitalization or death during the 28 day follow-up period. Special facilities are being built for the care of COVID-19 patients requiring medical care. Hospitalization is defined as a stay for at least 18 hours, irrespective of reason, at a hospital or one of these special facilities after study enrolment.

Key secondary outcomes include:

• Participant-reported evaluation of health status

• Change in severity of dyspnoea.

A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults

by

Adaptive COVID-19 Treatment Trial (ACTT)

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19.

The study is a multicenter trial that will be conducted in up to approximately 100 sites globally.

The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s).

ACTT-1 (Remdesivir vs Placebo)

Protocol closed with 10 participants enrolled (6 at INCMNSZ & 4 at INER) (https://www.nejm.org/doi/10.1056/NEJMoa2007764)

ACTT-2 (Baricitinib tablets + Remdesivir IV vs Placebo tablets + Remdesivir IV)

Protocol closed with 68 participants enrolled (45 at INCMNSZ & 23 at INER) (https://www.nejm.org/doi/full/10.1056/NEJMoa2031994)

ACTT-3 (Interferon beta-1a SQ injection + Remdesivir IV vs Placebo SQ injection + Remdesivir IV)

Protocol closed with 57 participants enrolled (31 at INCMNSZ & 26 at INER). Database is being completed and cleaned to permit the “Study Data Analysis”.

ACTT-4 (Baricitinib/Remdesivir vs Dexamethasone/Remdesivir)

Protocol amendment Ver 9.0.

Implementation in progress

An Observational Study to Characterize Children and Adults with Influenza-like Illness (ILI) in Mexico (ILI002)

by

The purpose of this observational study was to characterize children and adults in Mexico who sought medical care for influenza-like illness (ILI), describe clinical course over a period of 28 days after enrollment and determine risk factors for severe disease and death among those with H1N1. The study started on April 2010 and was completed on May 2014 with an enrollment of 5,819 participants.

Development of an instrument to measure symptoms of Influenza (FLU) and Influenza-like Illness: a patient-reported outcome measure (PRO).

by

The goal of the FLUPRO study was to develop a patient reported outcome (PRO) measure to assess symptoms of influenza (FLU) and influenza-like illness for use in clinical studies and to define disease severity including a valid measurement scale of patients’ symptoms.

The study included three stages:

Stage I. Elicitation interviews including item phrasing, length, response options, recall. The outcome of Stage 1 was a draft instrument and item pool suitable for evaluation at Stage II.

Stage II. Evaluative interviews to assess comprehension and interpretability of the written questionnaire from the respondent´s perspective, adjusting the items as needed. The outcome of Stage II was a final instrument and item pool ready for quantitative empirical evaluation

Stage III. Item reduction and instrument validation to evaluate item properties, reduce the number of items, and validate the performance of the final measure quantitatively.