AV001-004: Phase 2a multiple-dose escalating study in hospitalized patients with COVID-19 disease

About this Study

The purpose of this study is to assess the safety and tolerability of multiple IV administrations of AV-001 shots compared with placebo in COVID-19 patients.  

Sponsor Protocol ID:AV001-004
IRB Number:2021V0784
Actively Enrolling
Interventional
Phase 2
May 03, 2022
Eligibility Criteria
18 years old
75 years old
Both Male and Female
No
No
No

Inclusion Criteria
  • Aged 18 -75 years
  • Able and willing to give signed informed consent
  • Has been in hospital for less than 48 hours with pneumonia and confirmed COVID-19 disease
  • Female patients that are able to get pregnant must be on effective contraceptive (birth control)

Exclusion Criteria
  • Pregnant and/or lactating women
  • Currently on other interventional study
  • Body Mass Index (BMI) greater than 35
  • Use of endotracheal intubation and mechanical ventilation
  • Known history of HIV and/or hepatitis
  • Severe renal insufficiency or end stage renal disease
  • Symptomatic congestive heart failure or symptomatic or poorly controlled abnormal heart beats
  • History of autonomic disorder or uncontrolled hypotension

Categories Click category to view its trials.
COVID-19 (Coronavirus)
Infectious Diseases
Lungs/Breathing
Participating Locations
University Hospital - UMMC
Contact Information
Contact Name: Jamie Brown
Phone Number: 601-496-7810
Email: jlbrown@umc.edu
Principal Investigator:Marshall, Gailen D, M.D.Ph.D., M.D., Ph.D.
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