Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- 126
Summary
- Conditions
- ARDS
- COVID-19
- Influenza, Human
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a two-armed randomized, double-blinded, placebo control controlled study. Each arm (one arm of COVID-19 mediated ARDS and one arm of influenza (A or B) mediated ARDS will be randomized to 3:1 (active to placebo)Masking: Triple (Participant, Care Provider, Investigator)Masking Description: The pharmacist will prepare the infusion solution and medication for delivery to the patient's bedside for administration. The active and placebo medications look identical, preventing care-givers and the participant from breaking the blind.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The primary objective of the study is to evaluate the safety and tolerability of a single dose of AVM0703 in patients with moderate, severe or immediately life-threatening ARDS due to COVID-19 or Influenza (A or B) infection. The secondary objectives of the study are to 1) evaluate the pharmacokinet...
The primary objective of the study is to evaluate the safety and tolerability of a single dose of AVM0703 in patients with moderate, severe or immediately life-threatening ARDS due to COVID-19 or Influenza (A or B) infection. The secondary objectives of the study are to 1) evaluate the pharmacokinetics (PK) and 2) evaluate potential clinical findings following a single dose of AVM0703. The exploratory objective of the study is to assess potential biomarkers indicative of natural killer T (NKT) cell activity and biomarkers predictive of response to AVM0703 in peripheral blood and bronchoalveolar lavage. The results of the Phase 1 study will guide the design of the Phase 2 study.
Tracking Information
- NCT #
- NCT04366115
- Collaborators
- Medpace, Inc.
- Investigators
- Not Provided
Get Well Soon