SARS (Severe Acute Respiratory Syndrome)Phase 2/3COVID-19-HBONCT04327505
Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19
A Phase 2/3 study testing Hyperbaric oxygen in people with SARS (Severe Acute Respiratory Syndrome) and Cytokine Storm, run by Karolinska Institutet at 3 sites in 2 countries.
Trial summary
COVID-19 may cause severe pneumonitis that require ventilatory support in some patients, the ICU mortality is as high as 62%. Hospitals do not have enough ICU beds to handle the demand and to date there is no effective cure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- SARS (Severe Acute Respiratory Syndrome), Cytokine Storm, ARDS, Human
- What is being tested?
- Hyperbaric oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 3 Jun 2020to 1 Dec 2022
- Phase
- Phase 2/3
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-90 years
- PaO2/FiO2 (PFI) below 200 mmHg (26.7 kPa)
- Suspected or verified SARS-CoV-2 infection
- At least two risk factors for increased morbidity/mortality
- Age above 50 years
- Hypertension
Show all 14Show fewer
- Cardiovascular disease
- Diabetes or pre-diabetes
- Active or cured cancer
- Asthma/COPD
- Smoking
- D-Dimer > 1.0 mg/L
- Auto-immune disease
- Documented informed consent according to ICH-GCP and national regulations
Who cannot join
- ARDS/pneumonia caused by other viral infections (positive for other virus)
- ARDS/pneumonia caused by other non-viral infections or trauma
- Known pregnancy or positive pregnancy test in women of childbearing age
- Patients with previous lung fibrosis more than 10%
- CT- or Spirometry-verified severe COPD with Emphysema
- Contraindication for HBO according to local guidelines
Show all 9Show fewer
- Not likely to need ICU admission < 7 days of screening (Subjective criteria that may exclude any patients that fulfil the other inclusion criteria but where the treating physician suspect a spontaneous recovery)
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- Prisoner (Exclusion criteria according to IRB at UCSD)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Sweden2 sites
Blekingesjukhuset
Karlskrona, Blekinge County
Karolinska University Hospital
Stockholm, 171 76
About this study
Official title: A Randomized, Controlled, Open Label, Multicentre Clinical Trial to Explore Safety and Efficacy of Hyperbaric Oxygen for Preventing ICU Admission, Morbidity and Mortality in Adult Patients With COVID-19
COVID-19 may cause severe pneumonitis that require ventilatory support in some patients, the ICU mortality is as high as 62%. Hospitals do not have enough ICU beds to handle the demand and to date there is no effective cure.
We explore a treatment administered in a randomized clinical trial that could prevent ICU admission and reduce mortality.
The overall hypothesis to be evaluated is that HBO reduce mortality, increase hypoxia tolerance and prevent organ failure in patients with COVID19 pneumonitis by attenuating the inflammatory response.
Read the detailed description
Main objective: To evaluate if HBO reduce the number of ICU admissions compared to Best practice for COVID-19
Secondary objectives:
Main secondary objectives:
To evaluate if HBO:
- reduces mortality in severe cases of COVID-19.
- reduces morbidity associated with COVID-19.
- reduce the load on ICU resources in COVID-19.
- mitigate the inflammatory reaction in COVID-19.
Other secondary objectives (in selection):
To evaluate if HBO is safe for SARS-CoV-2 positive patients and staff.
Study design: Randomized, controlled, phase II, open label, multicentre
Study population: Adult patients with SARS-CoV-2 infection, with at least two risk factor for increased mortality, likely to develop ARDS criteria and need intubation within 7 days of admission to hospital.
Number of subjects: 200 (20+180)
Investigational product: Hyperbaric oxygen (HBO) compared with best practice treatment HBO: HBO 1.6-2.4 ATA for 30-60 min, maximum 5 treatments first 7 days Control: Best practice treatment for COVID-19
- Conditions
- SARS (Severe Acute Respiratory Syndrome), Cytokine Storm, ARDS, Human, COVID-19, Sars-CoV2, Acute Respiratory Failure
- Being tested
- Hyperbaric oxygen
- Keywords
- COVID-19, Hyperbaric oxygen, ARDS, SARS-CoV-2, ICU admission
- Medical subject headings
- Severe Acute Respiratory Syndrome, Cytokine Release Syndrome, Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygenDrug
Also called HBO
1.6- 2.4 ATA, 30-60 min (excluding compression/recompression)
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen | Experimental | Hyperbaric oxygen 1,6-2.4 Bar for 30-60 minutes (compression/decompression time, according to local routines) in addition to best practice Receives: Drug: Hyperbaric oxygen |
| Control | No intervention | Best practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU admission
The proportion of subjects admitted to ICU from day 1 to day 30, based on at least one of the following criteria:
- Rapid progression over hours ii) Lack of improvement on high flow oxygen >40L/min or non invasive ventilation with fraction of inspired oxygen (FiO2) > 0.6 iii) Evolving Hypercapnia or increased work of breathing not responding to increased oxygen despite maximum standard of care available outside ICU iv) Hemodynamic instability or multi organ failure with maximum standard of care available outside ICU
Measured: Through study completion 30 days
Secondary outcomes (5)
30-day mortality
Proportion of subjects with 30-day mortality, all cause Mortality, from day 1 to day 30.
Measured: Through study completion 30 days
Time-to-intubation
Time-to-Intubation, i.e. cumulative days free of invasive mechanical ventilation, from day 1 to day 30
Measured: Through study completion 30 days
Time-to-ICU
Time-to-ICU, i.e. cumulative ICU free days, derived as the number of days from day 1 to ICU, where all ICU free subjects are censored at day 30.
Measured: Through study completion 30 days
Inflammatory response
Mean change in inflammatory response from day 1 to day 30.
- White cell count + differentiation
- Procalcitonin
- C-Reactive protein
- Cytokines (IL-6) (if available at local laboratory)
- Ferritin
- D-Dimer
- LDH
Measured: Through study completion 30 days
Overall survival
Overall survival (Kaplan-Meier)
Measured: Through study completion 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start3 Jun 2020
- Primary completion30 Jun 2022
- Study completion1 Dec 2022
Why it stopped: Futility, change of disease due to virus mutations and/or vaccination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SARS (Severe Acute Respiratory Syndrome)Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Randomized controlled, open label, multi-centre clinical trial
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Trial Alliance, University of California, San Diego, Blekinge County Council Hospital, JK Biostatistics AB, The Swedish Research Council, University of Regensburg
- Responsible party
- Principal investigator, Anders Kjellberg, MD, Karolinska Institutet
- Investigators
- Anders Kjellberg, MD, Principal investigator, Karolinska InstitutetPeter Lindholm, MD, PhD, Study chair, Karolinska InstitutetKenny Rodriguez-Wallberg, MD, PhD, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327505
- Sponsor's protocol ID
- COVID-19-HBO
- Other IDs
- 2020-001349-37, K-1199/2020
- Acronym
- COVID-19-HBO
- Status last verified
- Jan 2023
- First submitted
- 25 Mar 2020
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full study protocol, statistical plan and consent form will be publicly available when results are published. Data will be available on patient level; data will be pseudonymized. The full dataset and statistical code will be available upon request.
Publications
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076Oscarsson N, Muller B, Rosen A, Lodding P, Molne J, Giglio D, Hjelle KM, Vaagbo G, Hyldegaard O, Vangedal M, Salling L, Kjellberg A, Lind F, Ettala O, Arola O, Seeman-Lodding H. Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2-3 trial. Lancet Oncol. 2019 Nov;20(11):1602-1614. doi: 10.1016/S1470-2045(19)30494-2. Epub 2019 Sep 16.
PubMed 31537473Thibodeaux K, Speyrer M, Raza A, Yaakov R, Serena TE. Hyperbaric oxygen therapy in preventing mechanical ventilation in COVID-19 patients: a retrospective case series. J Wound Care. 2020 May 1;29(Sup5a):S4-S8. doi: 10.12968/jowc.2020.29.Sup5a.S4.
PubMed 32412891Gorenstein SA, Castellano ML, Slone ES, Gillette B, Liu H, Alsamarraie C, Jacobson AM, Wall SP, Adhikari S, Swartz JL, McMullen JJS, Osorio M, Koziatek CA, Lee DC. Hyperbaric oxygen therapy for COVID-19 patients with respiratory distress: treated cases versus propensity-matched controls. Undersea Hyperb Med. 2020 Third Quarter;47(3):405-413. doi: 10.22462/01.03.2020.1.
PubMed 32931666Kjellberg A, De Maio A, Lindholm P. Can hyperbaric oxygen safely serve as an anti-inflammatory treatment for COVID-19? Med Hypotheses. 2020 Nov;144:110224. doi: 10.1016/j.mehy.2020.110224. Epub 2020 Aug 30.
PubMed 33254531Kjellberg A, Zhao A, Lussier A, Hassler A, Al-Ezerjawi S, Bostrom E, Catrina SB, Bergman P, Rodriguez-Wallberg KA, Lindholm P. Hyperbaric oxygen therapy as an immunomodulatory intervention in COVID-19-induced ARDS: Exploring clinical outcomes and transcriptomic signatures in a randomised controlled trial. Pulm Pharmacol Ther. 2024 Dec;87:102330. doi: 10.1016/j.pupt.2024.102330. Epub 2024 Oct 10.
PubMed 39393522Kjellberg A, Douglas J, Hassler A, Al-Ezerjawi S, Bostrom E, Abdel-Halim L, Liwenborg L, Hetting E, Jonasdottir Njastad AD, Kowalski J, Catrina SB, Rodriguez-Wallberg KA, Lindholm P. COVID-19-Induced Acute Respiratory Distress Syndrome Treated with Hyperbaric Oxygen: Interim Safety Report from a Randomized Clinical Trial (COVID-19-HBO). J Clin Med. 2023 Jul 24;12(14):4850. doi: 10.3390/jcm12144850.
PubMed 37510965Kjellberg A, Douglas J, Pawlik MT, Kraus M, Oscarsson N, Zheng X, Bergman P, Franberg O, Kowalski JH, Nyren SP, Silvanius M, Skold M, Catrina SB, Rodriguez-Wallberg KA, Lindholm P. Randomised, controlled, open label, multicentre clinical trial to explore safety and efficacy of hyperbaric oxygen for preventing ICU admission, morbidity and mortality in adult patients with COVID-19. BMJ Open. 2021 Jul 5;11(7):e046738. doi: 10.1136/bmjopen-2020-046738.
PubMed 34226219
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open Label, Multicentre Clinical Trial to Explore Safety and Efficacy of Hyperbaric Oxygen for Preventing ICU Admission, Morbidity and Mortality in Adult Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04327505
- Acronym / sponsor ID
- COVID-19-HBO / COVID-19-HBO
- Conditions
- SARS (Severe Acute Respiratory Syndrome), Cytokine Storm, ARDS, Human, COVID-19, Sars-CoV2, Acute Respiratory Failure
- Keywords
- COVID-19, Hyperbaric oxygen, ARDS, SARS-CoV-2, ICU admission
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility, change of disease due to virus mutations and/or vaccination
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska Trial Alliance, University of California, San Diego, Blekinge County Council Hospital, JK Biostatistics AB, The Swedish Research Council, University of Regensburg
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 31 Mar 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.
COVID-19 may cause severe pneumonitis that require ventilatory support in some patients, the ICU mortality is as high as 62%. Hospitals do not have enough ICU beds to handle the demand and to date there is no effective cure.
We explore a treatment administered in a randomized clinical trial that could prevent ICU admission and reduce mortality.
The overall hypothesis to be evaluated is that HBO reduce mortality, increase hypoxia tolerance and prevent organ failure in patients with COVID19 pneumonitis by attenuating the inflammatory response.
Detailed description
Main objective: To evaluate if HBO reduce the number of ICU admissions compared to Best practice for COVID-19
Secondary objectives:
Main secondary objectives:
To evaluate if HBO:
- reduces mortality in severe cases of COVID-19.
- reduces morbidity associated with COVID-19.
- reduce the load on ICU resources in COVID-19.
- mitigate the inflammatory reaction in COVID-19.
Other secondary objectives (in selection):
To evaluate if HBO is safe for SARS-CoV-2 positive patients and staff.
Study design: Randomized, controlled, phase II, open label, multicentre
Study population: Adult patients with SARS-CoV-2 infection, with at least two risk factor for increased mortality, likely to develop ARDS criteria and need intubation within 7 days of admission to hospital.
Number of subjects: 200 (20+180)
Investigational product: Hyperbaric oxygen (HBO) compared with best practice treatment HBO: HBO 1.6-2.4 ATA for 30-60 min, maximum 5 treatments first 7 days Control: Best practice treatment for COVID-19
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled, open label, multi-centre clinical trial
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen | Experimental | Drug: Hyperbaric oxygenHyperbaric oxygen 1,6-2.4 Bar for 30-60 minutes (compression/decompression time, according to local routines) in addition to best practice |
| Control | No intervention | –Best practice |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged 18-90 years
- PaO2/FiO2 (PFI) below 200 mmHg (26.7 kPa)
- Suspected or verified SARS-CoV-2 infection
- At least two risk factors for increased morbidity/mortality
- Documented informed consent according to ICH-GCP and national regulations
Key exclusion criteria (9 listed)
- ARDS/pneumonia caused by other viral infections (positive for other virus)
- ARDS/pneumonia caused by other non-viral infections or trauma
- Known pregnancy or positive pregnancy test in women of childbearing age
- Patients with previous lung fibrosis more than 10%
- CT- or Spirometry-verified severe COPD with Emphysema
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 |
|---|---|---|
| Hyperbaric oxygenAlso: HBO1.6- 2.4 ATA, 30-60 min (excluding compression/recompression) | Drug | Hyperbaric oxygen |
Primary outcome
ICU admission
Time frame: Through study completion 30 days
The proportion of subjects admitted to ICU from day 1 to day 30, based on at least one of the following criteria: i) Rapid progression over hours ii) Lack of improvement on high flow oxygen >40L/min or non invasive ventilation with fraction of inspired oxygen (FiO2) > 0.6 iii) Evolving Hypercapnia or increased work of breathing not responding to increased oxygen despite maximum standard of care available outside ICU iv) Hemodynamic instability or multi organ failure with maximum standard of care available outside ICU
5 secondary outcomes
30-day mortality
Time frame: Through study completion 30 days
Time-to-intubation
Time frame: Through study completion 30 days
Time-to-ICU
Time frame: Through study completion 30 days
Inflammatory response
Time frame: Through study completion 30 days
Overall survival
Time frame: Through study completion 30 days
Results and safety
The study was stopped early (reason given: Futility, change of disease due to virus mutations and/or vaccination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Background: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
- Background: PubMed 31537473Oscarsson N, Muller B, Rosen A, Lodding P, Molne J, Giglio D, Hjelle KM, Vaagbo G, Hyldegaard O, Vangedal M, Salling L, Kjellberg A, Lind F, Ettala O, Arola O, Seeman-Lodding H. Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2-3 trial. Lancet Oncol. 2019 Nov;20(11):1602-1614. doi: 10.1016/S1470-2045(19)30494-2. Epub 2019 Sep 16.
- Background: PubMed 32412891Thibodeaux K, Speyrer M, Raza A, Yaakov R, Serena TE. Hyperbaric oxygen therapy in preventing mechanical ventilation in COVID-19 patients: a retrospective case series. J Wound Care. 2020 May 1;29(Sup5a):S4-S8. doi: 10.12968/jowc.2020.29.Sup5a.S4.
- Background: PubMed 32931666Gorenstein SA, Castellano ML, Slone ES, Gillette B, Liu H, Alsamarraie C, Jacobson AM, Wall SP, Adhikari S, Swartz JL, McMullen JJS, Osorio M, Koziatek CA, Lee DC. Hyperbaric oxygen therapy for COVID-19 patients with respiratory distress: treated cases versus propensity-matched controls. Undersea Hyperb Med. 2020 Third Quarter;47(3):405-413. doi: 10.22462/01.03.2020.1.
- Background: PubMed 33254531Kjellberg A, De Maio A, Lindholm P. Can hyperbaric oxygen safely serve as an anti-inflammatory treatment for COVID-19? Med Hypotheses. 2020 Nov;144:110224. doi: 10.1016/j.mehy.2020.110224. Epub 2020 Aug 30.
- Derived from this study: PubMed 39393522Kjellberg A, Zhao A, Lussier A, Hassler A, Al-Ezerjawi S, Bostrom E, Catrina SB, Bergman P, Rodriguez-Wallberg KA, Lindholm P. Hyperbaric oxygen therapy as an immunomodulatory intervention in COVID-19-induced ARDS: Exploring clinical outcomes and transcriptomic signatures in a randomised controlled trial. Pulm Pharmacol Ther. 2024 Dec;87:102330. doi: 10.1016/j.pupt.2024.102330. Epub 2024 Oct 10.
- Derived from this study: PubMed 37510965Kjellberg A, Douglas J, Hassler A, Al-Ezerjawi S, Bostrom E, Abdel-Halim L, Liwenborg L, Hetting E, Jonasdottir Njastad AD, Kowalski J, Catrina SB, Rodriguez-Wallberg KA, Lindholm P. COVID-19-Induced Acute Respiratory Distress Syndrome Treated with Hyperbaric Oxygen: Interim Safety Report from a Randomized Clinical Trial (COVID-19-HBO). J Clin Med. 2023 Jul 24;12(14):4850. doi: 10.3390/jcm12144850.
- Derived from this study: PubMed 34226219Kjellberg A, Douglas J, Pawlik MT, Kraus M, Oscarsson N, Zheng X, Bergman P, Franberg O, Kowalski JH, Nyren SP, Silvanius M, Skold M, Catrina SB, Rodriguez-Wallberg KA, Lindholm P. Randomised, controlled, open label, multicentre clinical trial to explore safety and efficacy of hyperbaric oxygen for preventing ICU admission, morbidity and mortality in adult patients with COVID-19. BMJ Open. 2021 Jul 5;11(7):e046738. doi: 10.1136/bmjopen-2020-046738.
- Hyperbaric medicine research group, Karolinska InstitutetLink provided by the sponsor.
- COVID-19 EUBS-ECHM position statement on HBOTLink provided by the sponsor.
- KI News-description of trial in layman languageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The full study protocol, statistical plan and consent form will be publicly available when results are published. Data will be available on patient level; data will be pseudonymized. The full dataset and statistical code will be available upon request.
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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.
Anders Kjellberg, MD principal investigator
Karolinska Institutet
Peter Lindholm, MD, PhD study chair
Karolinska Institutet
Kenny Rodriguez-Wallberg, MD, PhD study chair
Karolinska Institutet
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hyperbaric oxygen in people with SARS (Severe Acute Respiratory Syndrome) and Cytokine Storm, run by Karolinska Institutet at 3 sites in 2 countries.
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 14 inclusion and 9 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 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden, Germany. 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. 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?
The study was stopped early (reason given: Futility, change of disease due to virus mutations and/or vaccination). Results are not available in the source record.
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?
ICU admission (time frame: Through study completion 30 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 NCT04327505, which also lists 8 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 9 Jan 2023.