Sandbox:Nuha

ABX464 [ClinicalTrials.gov Identifier: NCT04393038]

• ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19
• Assess Safety and Immunogenicity of Two Doses of Intramuscular AG0301-COVID19 (1mg/2mg) in Healthy Adults.
• Parallel Assignment,Phase 2/3, randomized, double blind, placebo-controlled study.
• Masking: Triple (Participant, Care Provider, Investigator)
• Intervention:
  • ABX464 50mg QD for 28 days + Standard of Care
  • Placebo 50mg QD for 28 days + Standard of Care

Table 1. Risk Score For Drug-Associated QTc Prolongation

Risk Factors	Points
Age ≥68 y	1
Female sex	1
Loop diuretic	1
Serum K+ ≤3.5 mEq/L	2
Admission QTc ≥450 ms	2
Acute MI	2
≥2 QTc-prolonging drugs	3
sepsis	3
Heart failure	3
One QTc-prolonging drug	3
Maximum Risk Score	21
K+ indicates potassium; and MI, myocardial infarction.

A Tisdale score of ≤ 6 predicts low risk, 7-10 medium risk, and ≥ 11 high risk of drug-associated QT prolongation (Table 2).

Table 2. Risk Levels For Drug-Associated QT Prolongation
Low risk = ≤6 points
Moderate risk = 7-10 points
High-risk = ≥11 points