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===''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.
**Holosystolic (pansystolic) murmurs:
*Parallel Assignment,Phase 2/3, randomized, double blind, placebo-controlled study.
***chronic MR.
*Masking: Triple (Participant, Care Provider, Investigator)
***chronic TR.
*Intervention:
***VSD
**ABX464 50mg QD for 28 days + Standard of Care
***PDA with pulmonary hypertension
**Placebo 50mg QD for 28 days + Standard of Care
**Midsystolic (systolic ejection) murmurs
***Innocent murmur (still's murmur)
***AS
***PS
***HOCM
***Functional:
****ASD
****VSD
****Straight back syndrome
****Aortic root dilation
****Pulmonary artery dilation
****pulmonary hypertension
****Hyper-kinetic status:
*****pregnancy
*****Anemia
*****hyperthyroidism
*****exercise
*****A-V fistula
**Early systolic murmurs
***Acute MR
***Acute TR
***Small VSD
**Mid to late systolic murmurs


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Revision as of 18:00, 9 August 2020



    • Holosystolic (pansystolic) murmurs:
      • chronic MR.
      • chronic TR.
      • VSD
      • PDA with pulmonary hypertension
    • Midsystolic (systolic ejection) murmurs
      • Innocent murmur (still's murmur)
      • AS
      • PS
      • HOCM
      • Functional:
        • ASD
        • VSD
        • Straight back syndrome
        • Aortic root dilation
        • Pulmonary artery dilation
        • pulmonary hypertension
        • Hyper-kinetic status:
          • pregnancy
          • Anemia
          • hyperthyroidism
          • exercise
          • A-V fistula
    • Early systolic murmurs
      • Acute MR
      • Acute TR
      • Small VSD
    • Mid to late systolic murmurs


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