Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS

NCT04366115 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AVM0703-101
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, double-blinded, placebo-controlled study of AVM0703 administered as a single intravenous (IV) infusion to patients with moderate or severe immediately life-threatening Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 or influenza (A or B). The study is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose of AVM0703 in these ARDS patients.

Conditions

ARDS; Covid19; Influenza, Human

Keywords

ARDS; COVID19; Influenza

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicities

  The primary endpoint of the Phase 1 portion of the study is to evaluate the safety of AVM0703 in subjects with severe or life-threatening COVID-19 infection, and to identify the RP2D.

  0-12 months

• 28 day all-cause mortality will be a primary end point for Phase 1 and 2

  The primary endpoint of the Phase 1/2 portion of the study is to evaluate the efficacy of AVM0703 in subjects with severe or life-threatening COVID-19 infection.

  0-12 months

Study Arms (4)

AVM0703 COVID-19 ARDS - active

ACTIVE COMPARATOR

Supra-pharmacologic dexamethasone sodium phosphate

Drug: AVM0703

Placebo COVID-19 ARDS - placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

AVM0703 Influenza ARDS - active

ACTIVE COMPARATOR

Supra-pharmacologic dexamethasone sodium phosphate

Drug: AVM0703

AVM0703 Influenza ARDS - placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

AVM0703 DRUG

Single IV infusion at 10 mg/mL in normal saline over 1 hour to patients.

Also known as: Suprapharmacologic dexamethasone sodium phosphate

AVM0703 COVID-19 ARDS - active; AVM0703 Influenza ARDS - active

Placebo DRUG

Single IV infusion in normal saline over 1 hour to patients.

AVM0703 Influenza ARDS - placebo; Placebo COVID-19 ARDS - placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet all of the following criteria will be eligible to participate in the study:
• Age ≥18 years;
• Must have laboratory confirmed COVID-19;
• Must have moderate or severe, immediately life-threatening COVID-19 or Influenza (A or B), as follows:
• a. COVID-19 patients with ARDS (Berlin Criteria) as demonstrated by:
• i. Chest radiograph or CT scan showing bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules;
• ii. Respiratory failure not fully explained by cardiac failure or fluid overload; and
• iii. Impaired oxygenation defined as Moderate (partial pressure of oxygen \[PaO2\]:fraction of inspired oxygen \[FiO2\] ratio 100 mm Hg to \<200 mm Hg with positive end-expiratory airway pressure \[PEEP\] \>5 cm H2O) or Severe (PaO2:FiO2 ratio \<100 mm Hg with PEEP\>5 cm H2O) on more than 2 arterial blood gases at least 6 hours apart within a 24 hour period;
• b. Influenza (A or B) patients with ARDS (Berlin Criteria) as demonstrated by:
• i. Chest radiograph or CT scan showing bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules;
• ii. Respiratory failure not fully explained by cardiac failure or fluid overload; and
• iii. Impaired oxygenation defined as Severe (PaO2:FiO2 ratio\<100 mm Hg with PEEP \>5 cm H2O) on more than 2 arterial blood gases at least 6 hours apart within a 24 hour period;
• Requires invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) despite standard of care rescue measures (eg, prone positioning, and/or PEEP ladder, and/or inhaled pulmonary vasodilators, and/or recruitment maneuvers and/or neuromuscular blockade);
• Females of childbearing potential must have a negative serum pregnancy test at screening;
• Females of childbearing potential and nonsterile males must agree to use medically effective methods of contraception from the time of informed consent through 1 month after study drug infusion; and

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from participation in the study:
• Moribund patient who, in the opinion of the Investigator, is not expected to survive at least 24 hours;
• Known hypersensitivity or allergy to the study drug or any of its excipients;
• D-dimer level \>3 times above normal range;
• Known gastric or duodenal ulcer;
• Uncontrolled type 1 or type 2 diabetes, per judgment of the Investigator;
• Active and untreated bacterial, fungal, parasitic, or viral infection other than COVID-19 or Influenza (A or B). Patients with a history of a positive hepatitis B surface antigen and/or hepatitis B core antibody must have a negative hepatitis B polymerase chain reaction (PCR) assay result. Patients with history of a positive hepatitis C virus antibody test must have a negative hepatitis C PCR assay result;
• Positive testing for tuberculosis during screening;
• Known to have received a live vaccine within the previous 1 month;
• Immunocompromised patients, defined as those who have received a bone marrow or solid organ transplant on immunosuppressive therapy; or history of human immunodeficiency virus (HIV) infection who have not been taking anti retroviral therapy for at least 6 months before enrollment and/or with most recent CD4 count \<200 cells/mL and/or most recent detectable viral load within the previous 6 months;
• Moderate to End-stage liver disease (Childs-Pugh Score \>10);
• Dialysis-dependent due to underlying chronic renal disease. Note: patients who require dialysis for treatment of renal failure due to complications of COVID-19 or Influenza (A or B) infection are not excluded from enrollment;
• Significant cardiovascular disease (eg, myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to the start of AVM0703 administration, including: angina requiring therapy, symptomatic peripheral vascular disease, New York Heart Association Class III or IV congestive heart failure, left ventricular ejection fraction \<30%, left ventricular fractional shortening \<20%, or uncontrolled Grade 3 hypertension (diastolic blood pressure \[DBP\] \>100 mm Hg or systolic blood pressure \[SBP\] \>150 mm Hg) despite antihypertensive therapy.
• Note: patients with heart failure requiring medical support due solely to complications of COVID-19 infection are not excluded from enrollment;
• Significant screening 12-lead ECG abnormalities, including unstable cardiac arrhythmia requiring medication, atrial fibrillation/flutter, left bundle-branch block, second degree atrioventricular (AV) block type 2, third-degree AV block, Grade 2 bradycardia, or heart rate corrected QT interval using Fridericia's formula average of triplicate ECGs \>450 ms;

Sponsors & Collaborators

• AVM Biotechnology Inc: lead
• Medpace, Inc.: collaborator

MeSH Terms

Conditions

COVID-19; Influenza, Human

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Central Study Contacts

Theresa A Deisher, MSPH

CONTACT

2068513942; tdeisher@avmbiotech.com

Mia Lor

CONTACT

2069069922; mlor@avmbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: April 28, 2020
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): March 1, 2032
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share