Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zotatifin · 1 trial · 1 indication
Incidence of Treatment Emergent Adverse Events and Serious Adverse Events
Adverse Events of Special Interest to be assessed: * Incidence of hospitalizations * incidence of cytokine release syndrome * hemophagocytic lymphohistiocytosis * acute respiratory distress syndrome * need for oxygen supplementation
Changes as assessed by respiration rate
Changes as assessed by physical exam
Changes as assessed by serum chemistry
| Arm | Type | Description |
|---|---|---|
| Active Arm, Zota Cohort 1 | ACTIVE_COMPARATOR | 0.01 mg/kg zotatifin |
| Active Arm, Zota Cohort 2 | ACTIVE_COMPARATOR | 0.02 mg/kg zotatifin |
| Active Arm, Zota Cohort 3 | ACTIVE_COMPARATOR | 0.035 mg/kg zotatifin |
| Placebo | PLACEBO_COMPARATOR | 5% dextrose injection, USP |
| Name | Type | Description |
|---|---|---|
| Zotatifin | DRUG | Zotatifin is a potent and sequence-selective inhibitor of eukaryotic translation initiation factor (eIF) 4A1-mediated translation that imparts its regulation through a reversible enhancement of eIF4A1 binding to RNAs (ribonucleic acids) with specific polypurine motifs within the 5'-untranslated region (UTR). |
| Placebo | DRUG | 5% dextrose injection, USP |
Inclusion Criteria: 1. Has provided informed consent and any authorizations required by local law; 2. Is a male or female patient ≥18 and \<65 years of age; 3. Has a laboratory-documented positive test for SARS CoV 2 infection as determined by local laboratory using a standard, Food and Drug Admini...