CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

ABX464Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D007249 Inflammation NIH 0.20

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase 2/3, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and the Safety of ABX464 in Treating Inflammation and Preventing COVID-19 Associated Acute Respiratory Failure in Patients Aged ≥ 65 and Patients Aged ≥18 With at Least One Additional Risk Factor Who Are Infected With SARS-CoV-2.

A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing acute respiratory failure in patients aged ≥65 and patients aged ≥18 with at least one additional risk factor who are infected with SARS-CoV-2 (the MiR-AGE study).

NCT04393038 COVID-19 Drug: ABX464 Drug: Placebo
MeSH:Respiratory Insufficiency Inflammation

Primary Outcomes

Measure: Rate of patients with no invasive or non-invasive mechanical ventilation (IMV and NIV, respectively), but excluding simple nasal/mask oxygen supplementation, and who are alive

Time: at the end of the 28-day treatment period

Secondary Outcomes

Measure: Rate of patients hospitalized

Time: 28-day treatment period

Description: 7-point ordinal scale is defined as Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death

Measure: Percentage of patients reporting each severity rating on a 7-point ordinal scale

Time: 28-day treatment period

Measure: Change from enrolment in inflammatory markers in plasma and in immune phenotype and assessment of cell-activation markers in PBMCs

Time: at each study visit during the 28-day treatment period

Measure: Rate of patients requiring oxygen supplementation

Time: 28-day treatment period

Measure: Time to hospitalization

Time: 28-day treatment period

Measure: Time to assisted ventilation and oxygen supplementation

Time: 28-day treatment period

Measure: Change from baseline in microRNA-124 levels

Time: at each study visit during the 28-day treatment period

Measure: Change from baseline in CRP, Troponin I & T and D-dimer

Time: at each study visit during the 28-day treatment period

Description: Nasopharyngeal sample and/or in blood

Measure: SARS-CoV-2 viral load

Time: at each study visit during the 28-day treatment period

Measure: Number and rates of participants with Treatment Emergent Adverse Event

Time: 28-day treatment period

No related HPO nodes (Using clinical trials)