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Active Arm, Zota Cohort 2 for Coronavirus (PROPEL Trial)
Phase 1
Waitlist Available
Research Sponsored by Effector Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 days
Awards & highlights
PROPEL Trial Summary
This trial is testing a new drug to see if it is safe and effective against mild or moderate cases of COVID-19.
Eligible Conditions
- Coronavirus
PROPEL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety as assessed by the incidence of Treatment Emergent Adverse Events and Serious Adverse Events
Safety as assessed by the incidence of adverse events of special interest
Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1)
+2 moreSecondary outcome measures
Mean change in SARS-CoV-2 viral load;
Proportion of patients with SARS-CoV-2 viral load below the level of detectability;
The time to clinical resolution;
+2 moreOther outcome measures
Assessment and quantification of infectious virus
Change in the WHO 9-point ordinal scale for clinical improvement
Mean change in viral load in plasma
+4 morePROPEL Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Active Arm, Zota Cohort 2Active Control1 Intervention
0.02 mg/kg zotatifin
Group II: Active Arm, Zota Cohort 3Active Control1 Intervention
0.035 mg/kg zotatifin
Group III: Active Arm, Zota Cohort 1Active Control1 Intervention
0.01 mg/kg zotatifin
Group IV: PlaceboPlacebo Group1 Intervention
5% dextrose injection, USP
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Who is running the clinical trial?
Effector TherapeuticsLead Sponsor
9 Previous Clinical Trials
437 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
94 Previous Clinical Trials
29,579 Total Patients Enrolled
Douglas Warner, MDStudy DirectorEFFECTOR Therapeutics, Inc.
2 Previous Clinical Trials
210 Total Patients Enrolled
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