Covid19Phase 2NCT04725110
Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress Syndrome
A Phase 2 study testing Instilled T3 in people with Covid19 and SARS-CoV Infection, run by University of Minnesota at 1 site in United States.
Trial summary
Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19, SARS-CoV Infection, ARDS
- What is being tested?
- Instilled T3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to 15 Oct 2031
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of SARS-CoV-2 with first positive test within 14 days, and,
- Diagnosis of ARDS by the Berlin Criteria (2012):
- Onset: < 7 days
- Chest x-ray: Bilateral Patchy Opacities, Infiltrates
- Mechanical Vent Support: PEEP or CPAP Support >= 5 cm H2O
- Pulmonary Edema: Not fully explained by cardiogenic etiology
- Hypoxia: PaO2/FIO2 Ratio < 300, or O2Sat/FIO2 Ratio < 315
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55117
About this study
Official title: Phase II Trial of Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 ARDS - A Multi-Site, Randomized, Double-blinded, Placebo-Controlled Clinical Trial
Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation.
Read the detailed description
Post-hospitalization follow-up for 6 and 12-months of survival and end-organ dysfunction (lung, heart, kidney, neuropsychological), plus quality of life and return to work of those previously working
- Conditions
- Covid19, SARS-CoV Infection, ARDS, ARDS, Human
- Being tested
- Instilled T3, Placebo Therapy
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instilled T3Drug
The first dose of T3 (50 micrograms in 10 mls volume BID) will be instilled by an investigator or under their direct supervision within 48 hours of obtaining consent after verifying that the patient is not too unstable to treat at that time. T3 doses will be given in 50 mcg doses twice daily for 4 days.
Placebo TherapyOther
A placebo therapy will be instilled into the lungs by the investigator or under their direct supervision within 48 hours of obtaining consent after verifying that the patient is not too unstable to treat at that time. Doses will be given twice daily for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| T3 Intervention | Experimental | Participants in this arm will receive the experimental intervention. Receives: Drug: Instilled T3 |
| Placebo Therapy | Placebo comparator | Participants in this arm will receive placebo therapy. Receives: Other: Placebo Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Extravascular Lung Water Index
EVLWI is calculated as ml of extravascular lung water fluid reported by VolumeView system (Edwards Lifesciences) divided by patient's body weight in kg. EVLWI will be measured at baseline and 1 hour post T3 installation to calculate change in EVLWI. Lower EVLWI values indicate greater treatment efficacy.
Measured: 1 hour
Secondary outcomes (6)
Length of ICU Stay
Outcome is reported as the mean length of stay (in days) in the Intensive Care Unit (ICU) for participants in each arm.
Measured: Baseline to ICU discharge up to 30 days
Number of Ventilator-Free Days
Outcome is reported as the mean number of days participants in each arm did not require mechanical ventilation during an in-patient hospital admission.
Measured: 30 days
30-day Survival
Outcome is reported as the number of participants in each arm who are alive 30-days post enrollment.
Measured: 30 days
Creatinine Concentration
Outcome is reported as the number of participants in each arm with abnormally high plasma creatinine concentration (greater 1.21 milligrams per deciliter).
Measured: 4 days
Glomerular Filtration Rate
Outcome is reported as the number of participants in each arm with impaired kidney function, defined as a glomerular filtration rate (GFR) less than 60 mL/min/1.73 m^2.
Measured: 4 days
New York Heart Association (NYHA) Functional Classification
Outcome is reported as the number of participants in each arm who fall into each of 4 categories: 1 (no limitation in normal physical activity), 2 (mild symptoms only in normal activity), 3 (marked symptoms during daily activities, asymptomatic only at rest), and 4 (severe limitations, symptoms even at rest).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start15 Jan 2026 (estimated)
- Primary completion15 Oct 2030 (estimated)
- Study completion15 Oct 2031 (estimated)
Why it stopped: Duplicate record to NCT04115514
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy P Rich, MD, Principal investigator, University of MinnesotaDavid Ingbar, MD, Study chair, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725110
- Sponsor's protocol ID
- PACCS-2020-23242
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2021
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 ARDS - A Multi-Site, Randomized, Double-blinded, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04725110
- Acronym / sponsor ID
- PACCS-2020-23242
- Conditions
- Covid19, SARS-CoV Infection, ARDS, ARDS, Human
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Duplicate record to NCT04115514
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Oct 2030 (estimated)
- Study completion
- 15 Oct 2031 (estimated)
- First posted
- 26 Jan 2021 (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.
Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation.
Detailed description
Post-hospitalization follow-up for 6 and 12-months of survival and end-organ dysfunction (lung, heart, kidney, neuropsychological), plus quality of life and return to work of those previously working
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T3 Intervention | Experimental | Drug: Instilled T3Participants in this arm will receive the experimental intervention. |
| Placebo Therapy | Placebo comparator | Other: Placebo TherapyParticipants in this arm will receive placebo therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of SARS-CoV-2 with first positive test within 14 days, and,
- Diagnosis of ARDS by the Berlin Criteria (2012):
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| Instilled T3The first dose of T3 (50 micrograms in 10 mls volume BID) will be instilled by an investigator or under their direct supervision within 48 hours of obtaining consent after verifying that the patient is not too unstable to treat at that time. T3 doses will be given in 50 mcg doses twice daily for 4 days. | Drug | T3 Intervention |
| Placebo TherapyA placebo therapy will be instilled into the lungs by the investigator or under their direct supervision within 48 hours of obtaining consent after verifying that the patient is not too unstable to treat at that time. Doses will be given twice daily for 4 days. | Other | Placebo Therapy |
Primary outcome
Change Extravascular Lung Water Index
Time frame: 1 hour
EVLWI is calculated as ml of extravascular lung water fluid reported by VolumeView system (Edwards Lifesciences) divided by patient's body weight in kg. EVLWI will be measured at baseline and 1 hour post T3 installation to calculate change in EVLWI. Lower EVLWI values indicate greater treatment efficacy.
6 secondary outcomes
Length of ICU Stay
Time frame: Baseline to ICU discharge up to 30 days
Number of Ventilator-Free Days
Time frame: 30 days
30-day Survival
Time frame: 30 days
Creatinine Concentration
Time frame: 4 days
Glomerular Filtration Rate
Time frame: 4 days
New York Heart Association (NYHA) Functional Classification
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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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. This study is not recruiting at the moment.
Timothy P Rich, MD principal investigator
University of Minnesota
David Ingbar, MD study chair
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Instilled T3 in people with Covid19 and SARS-CoV Infection, run by University of Minnesota at 1 site in United States.
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 7 inclusion and 1 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: withdrawn, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Extravascular Lung Water Index (time frame: 1 hour). 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 10 Feb 2026.