Coronavirus Disease 2019 (COVID-19)Phase 2/3NCT04389840

Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure

A Phase 2/3 study testing Dociparstat sodium in people with Coronavirus Disease 2019 (COVID-19) and Acute Lung Injury, run by Jazz Pharmaceuticals at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Coronavirus Disease 2019 (COVID-19), Acute Lung Injury, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
What is being tested?: Dociparstat sodium
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 12 sitesUnited States
Study dates: 8 Jul 2020to 20 May 2021
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A potential participant must have met all the following criteria to be included in the study:
Was hospitalized for laboratory-documented Coronavirus Disease 2019 (COVID-19) (e.g., positive for severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] via nasopharyngeal swab real time polymerase chain reaction [RT-PCR; or other commercial or public health assay]).
Was aged ≥18 years and ≤85 years.
Had a resting oxygen saturation (SaO2) of <94% while breathing ambient air.
Had a score of 3 or 4 on the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale (required supplemental oxygen or non-invasive ventilation).
Had provided informed consent to participate in the study (by participant or legally-acceptable representative).

Who cannot join

A potential participant who met any of the following criteria was not eligible to participate in the study:
Was currently receiving invasive mechanical ventilation (e.g., via an endotracheal tube) (score of 2 on NIAID ordinal scale).
Had severe chronic respiratory disease, defined by any oxygen requirement prior to incident COVID-19.
Had active or uncontrolled bleeding at the time of randomization; a bleeding disorder, either inherited or caused by disease; history of known arterial-venous malformation, intracranial hemorrhage, or suspected or known cerebral aneurysm; or clinically significant (in the judgment of the Investigator) gastrointestinal bleeding within the 3 weeks prior to randomization.
Was receiving any other investigational (non-approved) therapy for the treatment of COVID-19 or participating in the treatment period of any other therapeutic intervention clinical study. Participating in the follow-up period of an interventional study may be permitted with prior medical monitor approval; participation in an observational study is permitted.
Was receiving systemic corticosteroids for a chronic condition.

Show all 24Show fewer

Was receiving chronic anticoagulation with warfarin or direct oral anticoagulants (e.g., rivaroxaban, dabigatran, apixaban, edoxaban).
Was receiving or anticipated to require other systemic anticoagulation dosing at a therapeutic intensity. Prophylaxis of venous thromboembolism (VTE) using subcutaneous (SC) unfractionated heparin or enoxaparin was permitted with appropriate monitoring of coagulation status and within the guidelines described in the protocol.
Was receiving antiplatelet therapy, alone or in combination, including aspirin and other antiplatelet agents (e.g., clopidogrel, ticagrelor, and prasugrel), unless able to discontinue these agents at the time of randomization and was able to remain off these agents throughout the duration of the study intervention infusion period.
Had treatment with systemic (non-steroid) immunomodulators or immunosuppressant medications, including but not limited to tumor necrosis factor (TNF) inhibitors, anti-interleukin-1 agents and Janus kinase (JAK) inhibitors within 5 half-lives or 30 days (whichever was longer) prior to randomization.
Had a history of congestive heart failure requiring hospitalization.
Had active pericarditis (based on clinical assessment).
Had malignancy or other irreversible disease or condition for which 6-month mortality was estimated ≥50%.
Had a corrected QT interval (QTc) >500 msec (or >530-550 msec in participants with QRS greater than >120 msec).
Had a Tisdale risk score ≥11 without the ability to monitor with serial electrocardiograms (ECGs) or telemetry.
Had severe renal impairment, as determined by calculated creatinine clearance <30 mL/min or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2.
Had alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values >5x upper limit of normal (ULN).
Had activated partial thromboplastin time (aPTT) >42 seconds.
Had thrombocytopenia with a platelet count <80,000/mm3.
Had severe chronic liver disease (Child-Pugh Score of 10 to 15).
Had received dociparstat in a different clinical study.
Woman of childbearing potential who was pregnant, breastfeeding, and/or not using a highly-effective method of contraception (consistent with local regulations regarding the methods of contraception for those participating in clinical studies).
Had evidence of clinical improvement in COVID-19 status including, but not limited to, a sustained reduction in oxygen requirements over the previous 48 hours, or extubated and/or no longer requiring mechanical ventilation following intubation for COVID-19.
Had any other condition, including abnormal laboratory values, that, in the judgment of the Investigator, could have put the participant at increased risk, or would have interfered with the conduct or planned analysis of the study.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Augusta University
Augusta, Georgia, 30912
Our Lady of the Lake
Baton Rouge, Louisiana, 70808
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Texas Health Harris Methodist Hospital Fort Worth
Dallas, Texas, 76104
Advanced Pulmonary Research Institute/Wellington Regional Medical Center
Loxahatchee Groves, Florida, 33470
Ascension St. Francis Hospital
Milwaukee, Wisconsin, 53215
Tulane University
New Orleans, Louisiana, 70112
University Medical Center
New Orleans, Louisiana, 70112
Ascension All Saints Hospital
Racine, Wisconsin, 53405
William Beaumont Hospital
Royal Oak, Michigan, 48073
Ascension Macomb-Oakland Cardiovascular Research
Warren, Michigan, 48072
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase 2/3 Study to Evaluate the Safety and Efficacy of Dociparstat Sodium for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure

This was a randomized, double-blind, placebo-controlled Phase 2/3 study to evaluate the safety and efficacy of dociparstat sodium in adult patients with acute lung injury (ALI) due to Coronavirus Disease 2019 (COVID-19). This study was designed to determine if dociparstat sodium could accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19.

Read the detailed description

This was a randomized, double-blind, placebo-controlled, Phase 2/3 trial to evaluate the safety and efficacy of dociparsat sodium in adults patients with severe COVID-19 who were at high risk of respiratory failure. Eligible subjects were with confirmed COVID-19 and required hospitalization and supplemental oxygen therapy. This study was designed to determine if dociparstat sodium could accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19.

Conditions: Coronavirus Disease 2019 (COVID-19), Acute Lung Injury, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Being tested: Dociparstat sodium, Placebo
Keywords: COVID-19, ALI, SARS-CoV-2
Medical subject headings: COVID-19, Acute Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dociparstat sodiumDrug
Also called DSTAT, CX-01, 2-0,3-0 desulfated heparin, ODSH
Dociparstat is a glycosaminoglycan derived from porcine heparin.
PlaceboDrug
Also called Normal saline, Sodium chloride 0.9%, 0.9% Normal Saline
0.9% Normal Saline

Study groups in NCT04389840
Study group	Role	What they receive
Cohort 1 dociparstat	Experimental	Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.25 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Receives: Drug: Dociparstat sodium
Cohort 1 placebo	Placebo comparator	Placebo IV bolus on Day 1, followed by Placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]) Receives: Drug: Placebo
Cohort 2 dociparstat	Experimental	Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Receives: Drug: Dociparstat sodium
Cohort 2 placebo	Placebo comparator	Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Receives: Drug: Placebo
Cohort 3 dociparstat	Experimental	Subjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Receives: Drug: Dociparstat sodium
Cohort 3 placebo	Placebo comparator	Subjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Are Alive and Free of Invasive Mechanical Ventilation or ECMO Through Day 28
The primary efficacy endpoint was to be the proportion of participants who were alive and free of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) through Day 28. Data also shows proportion of participants with invasive mechanical ventilation or ECMO, all-cause mortality, or early study discontinuation (<Day 25), whichever occurred first, by Day 28.
Measured: Day 1 to Day 28 (28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 202020 May 2021

First posted15 May 2020
Study start8 Jul 2020
Primary completion20 May 2021
Study completion20 May 2021

Why it stopped: Due to improvement in the Coronavirus Disease 2019 (COVID-19) pandemic and low subject accrual.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Coronavirus Disease 2019 (COVID-19)Studies of the same condition, open and under way.
More trials run by Jazz PharmaceuticalsThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The first 12 subjects were to be randomized 1:1 (dociparstat:placebo) All other subjects were to be randomized 2:1 (dociparstat:placebo)
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04389840
Sponsor's protocol ID: CMX-DS-004
Status last verified: Aug 2022
First submitted: 13 May 2020
Last updated: 30 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Lasky JA, Fuloria J, Morrison ME, Lanier R, Naderer O, Brundage T, Melemed A. Design and Rationale of a Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study Evaluating Dociparstat in Acute Lung Injury Associated with Severe COVID-19. Adv Ther. 2021 Jan;38(1):782-791. doi: 10.1007/s12325-020-01539-z. Epub 2020 Oct 27.
PubMed 33108622
Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
PubMed 35244208

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2/3 Study to Evaluate the Safety and Efficacy of Dociparstat Sodium for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure
ClinicalTrials.gov ID: NCT04389840
Acronym / sponsor ID: CMX-DS-004
Conditions: Coronavirus Disease 2019 (COVID-19), Acute Lung Injury, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Keywords: COVID-19, ALI, SARS-CoV-2
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to improvement in the Coronavirus Disease 2019 (COVID-19) pandemic and low subject accrual.
Enrolment: 27 participants (actual)
Lead sponsor: Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 8 Jul 2020 (actual)
Primary completion: 20 May 2021 (actual)
Study completion: 20 May 2021 (actual)
First posted: 15 May 2020 (actual)
Results: Posted 30 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6
Model description: The first 12 subjects were to be randomized 1:1 (dociparstat:placebo) All other subjects were to be randomized 2:1 (dociparstat:placebo)

Arm	Type	Receives
Cohort 1 dociparstat	Experimental	Drug: Dociparstat sodiumSubjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.25 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]).
Cohort 1 placebo	Placebo comparator	Drug: PlaceboPlacebo IV bolus on Day 1, followed by Placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours])
Cohort 2 dociparstat	Experimental	Drug: Dociparstat sodiumSubjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]).
Cohort 2 placebo	Placebo comparator	Drug: PlaceboSubjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]).
Cohort 3 dociparstat	Experimental	Drug: Dociparstat sodiumSubjects received 4 mg/kg of dociparstat administered as an intravenous (IV) bolus on Day 1, followed by 0.325 mg/kg/hr dociparstat by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]).
Cohort 3 placebo	Placebo comparator	Drug: PlaceboSubjects received placebo IV bolus on Day 1, followed by placebo by continuous IV infusion for 24 hours daily for up to 7 days (starting on Day 1 and ending on Day 8 [168 hours]).

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

A potential participant must have met all the following criteria to be included in the study:
Was hospitalized for laboratory-documented Coronavirus Disease 2019 (COVID-19) (e.g., positive for severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] via nasopharyngeal swab real time polymerase chain reaction [RT-PCR; or other commercial or public health assay]).
Was aged ≥18 years and ≤85 years.
Had a resting oxygen saturation (SaO2) of <94% while breathing ambient air.
Had a score of 3 or 4 on the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale (required supplemental oxygen or non-invasive ventilation).

Key exclusion criteria (24 listed)

A potential participant who met any of the following criteria was not eligible to participate in the study:
Was currently receiving invasive mechanical ventilation (e.g., via an endotracheal tube) (score of 2 on NIAID ordinal scale).
Had severe chronic respiratory disease, defined by any oxygen requirement prior to incident COVID-19.
Had active or uncontrolled bleeding at the time of randomization; a bleeding disorder, either inherited or caused by disease; history of known arterial-venous malformation, intracranial hemorrhage, or suspected or known cerebral aneurysm; or clinically significant (in the judgment of the Investigator) gastrointestinal bleeding within the 3 weeks prior to randomization.
Was receiving any other investigational (non-approved) therapy for the treatment of COVID-19 or participating in the treatment period of any other therapeutic intervention clinical study. Participating in the follow-up period of an interventional study may be permitted with prior medical monitor approval; participation in an observational study is permitted.

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
Dociparstat sodiumAlso: DSTAT, CX-01, 2-0,3-0 desulfated heparin, ODSHDociparstat is a glycosaminoglycan derived from porcine heparin.	Drug	Cohort 1 dociparstat, Cohort 2 dociparstat, Cohort 3 dociparstat
PlaceboAlso: Normal saline, Sodium chloride 0.9%, 0.9% Normal Saline0.9% Normal Saline	Drug	Cohort 1 placebo, Cohort 2 placebo, Cohort 3 placebo

Primary outcome

Number of Participants Who Are Alive and Free of Invasive Mechanical Ventilation or ECMO Through Day 28
Time frame: Day 1 to Day 28 (28 days)
The primary efficacy endpoint was to be the proportion of participants who were alive and free of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) through Day 28. Data also shows proportion of participants with invasive mechanical ventilation or ECMO, all-cause mortality, or early study discontinuation (<Day 25), whichever occurred first, by Day 28.

Results and safety

Results posted to the registry on 30 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 Dociparstat	6	4
Cohort 1 Placebo	6	5
Cohort 2 Dociparstat	8	8
Cohort 2 Placebo	4	3
Cohort 3 Dociparstat	2	1
Cohort 3 Placebo	1	1

Primary outcome: Number of Participants Who Are Alive and Free of Invasive Mechanical Ventilation or ECMO Through Day 28

Time frame: Day 1 to Day 28 (28 days). Count of participants. Unit: Participants

Measure	Cohort 1 Dociparstat n = 6	Cohort 1 Placebo n = 6	Cohort 2 Dociparstat n = 8	Cohort 2 Placebo n = 4	Cohort 3 Dociparstat n = 2	Cohort 3 Placebo n = 1
Value	3	4	7	3	2	1

Population analysed: Note: This outcome measure was analyzed using the Intent-to-Treat (ITT) Analysis Set. In the ITT Analysis Set included 4 placebo-treated subjects for Cohort 2; however, only 3 placebo-treated subjects from Cohort 2 were included in the Safety Analysis Set. This subject was randomized to receive placebo but never received treatment due to consent withdrawal.

Adverse events

Time frame: From randomization through Day 28. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 Dociparstat	2 of 6 (33.3%)	5 of 6 (83.3%)	0 of 6
Cohort 1 Placebo	3 of 6 (50%)	6 of 6 (100%)	1 of 6
Cohort 2 Dociparstat	1 of 8 (12.5%)	5 of 8 (62.5%)	0 of 8
Cohort 2 Placebo	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Cohort 3 Dociparstat	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Cohort 3 Placebo	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Limitations and caveats (from the sponsor): Due to improvement in the Coronavirus Disease 2019 (COVID-19) pandemic and low subject accrual, study enrollment was prematurely terminated on 20 May 2021. Therefore, formal statistical analyses were not performed, and no conclusions can be drawn about docipartstat with regards to efficacy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33108622Lasky JA, Fuloria J, Morrison ME, Lanier R, Naderer O, Brundage T, Melemed A. Design and Rationale of a Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study Evaluating Dociparstat in Acute Lung Injury Associated with Severe COVID-19. Adv Ther. 2021 Jan;38(1):782-791. doi: 10.1007/s12325-020-01539-z. Epub 2020 Oct 27.
Derived from this study: PubMed 35244208Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Dociparstat sodium in people with Coronavirus Disease 2019 (COVID-19) and Acute Lung Injury, run by Jazz Pharmaceuticals at 12 sites 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 6 inclusion and 24 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: stopped early, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Are Alive and Free of Invasive Mechanical Ventilation or ECMO Through Day 28 (time frame: Day 1 to Day 28 (28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04389840, which also lists 2 linked publications.

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 30 Aug 2022.