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AV-001 for COVID-19

Phase 2

Recruiting

Research Sponsored by Vasomune Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female patients of reproductive potential must be on an effective contraceptive method

Presence of at least 1 of the following signs: respiratory rate > 30 breaths/min, fever (> 38.0ºC or > 100.4o F), leukopenia (≤ 4,000 WBC/mm3) or leukocytosis (≥ 12,000 WBC/mm3), adults ≥ 70 years of age with altered mental status with no other recognized cause

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 60

Awards & highlights

Study Summary

This trial is testing a possible treatment for severe Covid-19. 120 patients will be given either the treatment or a placebo, and the effects will be monitored.

Who is the study for?

This trial is for hospitalized patients with presumed pneumonia needing extra oxygen but not on mechanical ventilation or ECMO. They should have symptoms like new cough, fever, or breathlessness and signs of lung infection on imaging. Adults over 70 must be mentally stable and women able to bear children need effective contraception.Check my eligibility

What is being tested?

The study tests AV-001 Injection versus a placebo in addition to standard care for pneumonia. It's randomized and double-blind, meaning neither the doctors nor patients know who gets the real treatment. Patients receive daily doses until day 28 or hospital discharge.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones from similar treatments may include injection site reactions, allergic responses, gastrointestinal issues like nausea or diarrhea, headaches, dizziness, and potential interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am using effective birth control.

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I have a high fever, fast breathing, unusual white blood cell count, or confusion if over 70.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and tolerability of multiple doses of IV administrations of AV-001 Injection compared with AV-001 placebo Injection in hospitalized patients with pneumonia due to COVID-19 and/or other respiratory infections.

Secondary outcome measures

Efficacy of multiple IV administrations of AV-001 Injection compared with AV-001 placebo Injection in patients hospitalized with pneumonia due to COVID-19 and/or other respiratory infections.

Other outcome measures

Effect of multiple IV administrations of AV-001 Injection compared with AV-001 placebo Injection on disease biomarker ICAM-1, in in patients with pneumonia due to COVID-19 and/or other respiratory infections.

Effect of multiple IV administrations of AV-001 Injection compared with AV-001 placebo Injection on disease biomarker IL-8 in patients with pneumonia due to COVID-19 and/or other respiratory infections.

Effect of multiple IV administrations of AV-001 Injection compared with AV-001 placebo Injection on disease biomarker IP-10 in patients with pneumonia due to COVID-19 and/or other respiratory infections.

+9 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: AV-001 Injection with standard of care (SOC).Active Control1 Intervention

A total of 120 eligible patients (20 patients in each of cohort 1, 2 and 3 and 60 patients in cohort 4) will be randomized in a 1:1 ratio to receive either AV-001 Injection or AV-001 placebo Injection, together with standard of care (SOC). Doses of AV-001 Injection will start with 12.5 μg/kg/day in cohort 1 and are anticipated to increase to 25 μg/kg/day in cohort 2, 56 μg/kg/day in cohort 3 and to be determined (TBD) in cohort 4. The dose for cohort 4 will be determined by the Data Safety Monitoring Board (DSMB) based on emerging data from cohorts 1, 2 and 3.

Group II: AV-001 Placebo Injection with standard of care (SOC).Placebo Group1 Intervention

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Vasomune Therapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

48 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over fifty years of age being considered as participants in this clinical trial?

"To be considered for enrollment in this trial, individuals must between 18 and 75 years of age."

Answered by AI

What safety concerns have been raised about using AV-001 Injection in addition to the standard of care?

"Based on the research, our team at Power assigned AV-001 Injection with standard of care (SOC) a score of 2. As it is a Phase 2 trial and there exists data affirmng safety but none indicating efficacy."

Answered by AI

How many participants have enrolled in this clinical research study?

"Affirmative. According to the clinicaltrials.gov database, this research project was initially released on December 20th 2021 and recently updated on June 1st 2022. The trial is now recruiting for 120 patients from a single site."

Answered by AI

Is there an opportunity for me to participate in this scientific investigation?

"This clinical trial is searching for 120 participants, aged 18 to 75 years old, who are currently afflicted with neonatal respiratory distress syndrome. The prospective patients must have an oxygen saturation below 94%, pulmonary infiltrates that affect more than 50% of their lung tissue, consent to the study's terms and conditions, be hospitalized less than 48 hours due to pneumonia related to COVID-19 infection, a PaO2/FiO2 ratio lower than 300 mmHg , a respiration rate above 30 breaths per minute according to WHO standards (CPS), and female individuals of childbearing age must utilize effective contraceptive measures."

Answered by AI

Is enrollment available for this investigation?

"According to clinicaltrial.gov, this medical trial is still seeking participants; it was initially posted on December 20th 2021 and modified as recently as June 1st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.

2021. "Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05123755.

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