ARDSPhase 1AVM0703NCT04366115
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
A Phase 1 study testing AVM0703 in people with ARDS and Covid19, run by AVM Biotechnology Inc.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Covid19, Influenza, Human
- What is being tested?
- AVM0703
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Mar 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- COVID-19 patients with ARDS (Berlin Criteria) as demonstrated by:
- Chest radiograph or CT scan showing bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules;
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- Respiratory failure not fully explained by cardiac failure or fluid overload; and
- 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;
- Influenza (A or B) patients with ARDS (Berlin Criteria) as demonstrated by:
- Chest radiograph or CT scan showing bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules;
- Respiratory failure not fully explained by cardiac failure or fluid overload; and
- 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
- Capable of providing informed consent, or if not capable, a legally authorized representative is capable of providing informed consent
Who cannot join
- 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;
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- 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;
- Manic-depressive disorder, schizophrenia, or a history of severe depression or substance abuse;
- Pregnant or breastfeeding;
- Concurrent enrollment in any other clinical study involving administration of a novel (ie, unapproved or not considered standard of care) investigational pharmacological agent(s). Concurrent enrollment in observational and device studies and studies involving administration of pharmacological agent(s) approved for other indications or considered emerging standard of care for treatment of COVID-19 (eg, hydroxychloroquine, remdesivir, low-dose dexamethasone), will be allowed if approved by the Sponsor;
- Treatment with standard of care or off-label treatments for COVID-19 (eg, remdesivir), not administered as part of a formal clinical study, where the first dose was initiated within 72 hours of study drug start; and
- Inability to obtain informed consent from the patient or legally authorized representative.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study Evaluating AVM0703 in Patients With Acute Respiratory Distress Syndrome
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.
Read the detailed 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 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.
- Conditions
- ARDS, Covid19, Influenza, Human
- Being tested
- AVM0703, Placebo
- Keywords
- ARDS, COVID19, Influenza
- Medical subject headings
- COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVM0703Drug
Also called Suprapharmacologic dexamethasone sodium phosphate
Single IV infusion at 10 mg/mL in normal saline over 1 hour to patients.
PlaceboDrug
Single IV infusion in normal saline over 1 hour to patients.
| Study group | Role | What they receive |
|---|---|---|
| AVM0703 COVID-19 ARDS - active | Active comparator | Supra-pharmacologic dexamethasone sodium phosphate Receives: Drug: AVM0703 |
| Placebo COVID-19 ARDS - placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
| AVM0703 Influenza ARDS - active | Active comparator | Supra-pharmacologic dexamethasone sodium phosphate Receives: Drug: AVM0703 |
| AVM0703 Influenza ARDS - placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2031 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AVM Biotechnology Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366115
- Sponsor's protocol ID
- AVM0703-101
- Acronym
- AVM0703
- Status last verified
- Oct 2026
- First submitted
- 26 Apr 2020
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study Evaluating AVM0703 in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04366115
- Acronym / sponsor ID
- AVM0703 / AVM0703-101
- Conditions
- ARDS, Covid19, Influenza, Human
- Keywords
- ARDS, COVID19, Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- AVM Biotechnology IncIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2031 (estimated)
- Study completion
- 1 Mar 2032 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- 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)
| Arm | Type | Receives |
|---|---|---|
| AVM0703 COVID-19 ARDS - active | Active comparator | Drug: AVM0703Supra-pharmacologic dexamethasone sodium phosphate |
| Placebo COVID-19 ARDS - placebo | Placebo comparator | Drug: PlaceboMatching placebo |
| AVM0703 Influenza ARDS - active | Active comparator | Drug: AVM0703Supra-pharmacologic dexamethasone sodium phosphate |
| AVM0703 Influenza ARDS - placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- 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);
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVM0703Also: Suprapharmacologic dexamethasone sodium phosphateSingle IV infusion at 10 mg/mL in normal saline over 1 hour to patients. | Drug | AVM0703 COVID-19 ARDS - active, AVM0703 Influenza ARDS - active |
| PlaceboSingle IV infusion in normal saline over 1 hour to patients. | Drug | AVM0703 Influenza ARDS - placebo, Placebo COVID-19 ARDS - placebo |
Primary outcome
Dose-Limiting Toxicities
Time frame: 0-12 months
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.
28 day all-cause mortality will be a primary end point for Phase 1 and 2
Time frame: 0-12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVM0703 in people with ARDS and Covid19, run by AVM Biotechnology Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Theresa A Deisher, PhD (2068513942, tdeisher@avmbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicities (time frame: 0-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.