COVID-19Phase 3COLCOVIDNCT04328480
The ECLA PHRI COLCOVID Trial. Effects of Colchicine on Moderate/High-risk Hospitalized COVID-19 Patients.
A Phase 3 study testing Colchicine in people with COVID-19, run by Estudios Clínicos Latino América at 1 site in Argentina.
Trial summary
The ECLA PHRI COLCOVID Trial is a simple, pragmatic randomized open controlled trial to test the effects of colchicine on moderate/high-risk hospitalized COVID-19 patients with the aim of reducing mortality and/or new requirement for mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,279 participants
- Where
- 1 siteArgentina
- Study dates
- 17 Apr 2020to 26 Apr 2021
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consented adults (age ≥18 years) and
- COVID-19 suspicious and
- Admitted to hospital or already in hospital and
- COVID-19 suggestive symptoms (fever or febrile equivalent, loss of smell and taste, fatigue, etc.) that may be present or absent at randomization time and
- SARS (severe acute respiratory syndrome)
- shortness of breath (dyspnea) or
- image of typical or atypical pneumonia or
- oxygen desaturation (SpO2 ≤ 93)
Who cannot join
- Clear indication or contraindication for the use of colchicine
- Pregnant or breastfeeding female.
- Chronic renal disease with creatinine clearance <15 ml/min/m2
- Negative PCR test for SARS-COV2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The ECLA PHRI COLCOVID Trial
The ECLA PHRI COLCOVID Trial is a simple, pragmatic randomized open controlled trial to test the effects of colchicine on moderate/high-risk hospitalized COVID-19 patients with the aim of reducing mortality and/or new requirement for mechanical ventilation.
Read the detailed description
Various anti-viral treatments are being tested in clinical trials worldwide. The World Health Organization (WHO) launched a simple,pragmatic worldwide open-label trial to test Remdesivir, Lopinavir/Ritonavir, Interferon and Hydroxychloroquine or Chloroquine.The most important complication of COVID-19 severe cases is respiratory failure from severe acute respiratory syndrome (SARS), the leading cause of mortality. Accumulating evidence suggests that patients with severe COVID-19 might have a cytokine storm syndrome, a hyperinflammatory syndrome characterized by a fulminant and fatal hypercytokinemia and multiorgan failure.
The proposed pathophysiological mechanism of cytokine storm and inflammatory cascade activation is based on evidence collected primarily during the SARS-CoV and MERS-CoV epidemics (with a significant increase in IL1B, IL6, IL12, IFNγ, IP10, TNFα, IL15, and IL17 among others). The data collected during the pandemic with COVID-19 also shows a significant increase in inflammatory cytokines (GCSF, IP10, MCP1, MIP1A, and TNFα, among others) in sicker patients admitted to intensive care. In the absence of effective treatments for the management of patients with COVID-19 and respiratory failure, the immunomodulatory and anti-inflammatory effect of colchicine on cytokines involved in the hyper-inflammatory state is postulated. Several lines of research worldwide are testing powerful anti-inflammatory drugs for the pandemic, with different options including steroids, cytokine blockers, and other potent anti-inflammatory agents. Steroids are partially contraindicated in viral infections.
Colchicine is a powerful anti-inflammatory drug approved for the treatment or prevention of gout and Familial Mediterranean Fever at doses ranging between 0.3 mg and 2.4 mg/day. Its mechanism of action is through the inhibition of tubulin polymerization, as well as through potential effects on cellular adhesion molecules and inflammatory chemokines. It might also have direct anti-inflammatory effects by inhibiting key inflammatory signalling networks known as inflammasome and pro-inflammatory cytokines. Additionally, evidence suggests that colchicine exerts a direct anti-inflammatory effect by inhibiting the synthesis of tumor necrosis factor alpha and IL-6, monocyte migration, and the secretion of matrix metalloproteinase-9. Through the disruption of the cytoskeleton, colchicine is believed to suppress secretion of cytokines and chemokines as well as in vitro platelet aggregation. All these are potentially beneficial effects that might diminish or ameliorate the COVID-19 inflammatory storm associated with severe forms of the disease. Importantly, in one contemporary trial low-dose colchicine administered to patients who survived from acute coronary syndrome shows a statistically significantly reduction of cardiovascular complications.
We have therefore designed in a simple, pragmatic randomized controlled trial to test the effects of colchicine on severe hospitalized COVID-19 cases with the aim of reducing mortality.
Sample size calculation:
A minimum sample size of 1200 patients will provide 80% power to detect a relative risk reduction of approximately 30% in the treated group if the assumed composite rate (new requirement of intubation and / or death) in the control group is about 24%.
The ECLA PHRI COLCOVID Trial allows randomization to another trial, specifically patients included in the trial might be (or not) randomized to an antithrombotic strategy.
- Conditions
- COVID-19
- Being tested
- Colchicine, Local standard of care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called Colchicina
The colchicine dosage schedule will vary according to the following scenarios:
- In patients not receiving Lopinavir/Ritonavir
- Loading dose of 1.5 mg followed by 0.5 mg after two hours (day 1)
- The next day 0.5 mg bid for 14 days or until discharge.
- In patients receiving Lopinavir/Ritonavir
- Loading dose of 0.5 mg (day 1)
- After 72 hours from the loading dose, 0.5 mg every 72 hours for 14 days or until discharge.
- Patients under treatment with Colchicine that are starting with Lopinavir/Ritonavir
- Dose of 0.5 mg 72 hours after starting Lopinavir/Ritonavir.
- Continue with 0.5 mg every 72 hours for 14 days or until discharge.
Only the oral route will be used except in the case of patients associated with mechanical ventilation or with contraindications to the oral route, in whom it will be administered by nasogastric tube.
Local standard of careOther
Local standard of care for COVID-19 SARS moderate /high-risk patients
| Study group | Role | What they receive |
|---|---|---|
| Local standard of care plus colchicine | Active comparator | Local standard of care plus colchicine (specific dosage schedule) Receives: Drug: Colchicine; Other: Local standard of care |
| Local standard of care | Other | Local standard of care for COVID-19 SARS moderate / high-risk patients Receives: Other: Local standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome: New requirement for mechanical ventilation or death
Number of participants who require new intubation for mechanical ventilation or die
Measured: 28 days post randomization
Mortality
Number of participants who die
Measured: 28 days post randomization
Secondary outcomes (10)
New requirement for mechanical ventilation or death from respiratory failure
Number of participants who require new intubation for mechanical ventilation or die from respiratory failure
Measured: 28 days post randomization
New requirement for mechanical ventilation or death from non-respiratory failure
Number of participants who require new intubation for mechanical ventilation or die from non-respiratory failure
Measured: 28 days post randomization
Mortality due to respiratory failure
Number of participants who die from respiratory failure
Measured: 28 days post randomization
Mortality due to non-respiratory failure
Number of participants who die from non-respiratory failure
Measured: 28 days post randomization
In hospital - Composite outcome
Number of participants who require intubation for mechanical ventilation or die
Measured: During hospitalization or until death, whichever comes first, assessed up to 28 days
In hospital - Mortality
Number of participants who die
Measured: During hospitalization or until death, whichever comes first, assessed up to 28 days
Composite outcome (New requirement for mechanical ventilation or death) evaluated in Non-intubated population
Number of participants who were not intubated at randomization and require new intubation for mechanical ventilation or die
Measured: 28 days post randomization
Mortality evaluated in Non-intubated population
Number of participants who were not intubated at randomization and die
Measured: 28 days post randomization
Mean WHO descriptive score of COVID-19 during hospitalization
Mean WHO descriptive score of COVID-19 in the active treatment group compared to the placebo group
Measured: During hospitalization or until death, whichever comes first, assessed up to 28 days
Highest WHO descriptive score of COVID-19 during hospitalization
Mean highest WHO descriptive score of COVID-19 in the active treatment group compared to the placebo group
Measured: During hospitalization or until death, whichever comes first, assessed up to 28 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 start17 Apr 2020
- Primary completion25 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Simple pragmatic randomized open controlled trial
- Masking
- None (open label)
- Enrolment
- 1,279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Estudios Clínicos Latino América
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Rafael Diaz, MD, Principal investigator, ECLA- ICR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328480
- Sponsor's protocol ID
- COLCOVID version 2.0
- Acronym
- COLCOVID
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slobodnick A, Shah B, Krasnokutsky S, Pillinger MH. Update on colchicine, 2017. Rheumatology (Oxford). 2018 Jan 1;57(suppl_1):i4-i11. doi: 10.1093/rheumatology/kex453.
PubMed 29272515Tardif JC, Kouz S, Waters DD, Bertrand OF, Diaz R, Maggioni AP, Pinto FJ, Ibrahim R, Gamra H, Kiwan GS, Berry C, Lopez-Sendon J, Ostadal P, Koenig W, Angoulvant D, Gregoire JC, Lavoie MA, Dube MP, Rhainds D, Provencher M, Blondeau L, Orfanos A, L'Allier PL, Guertin MC, Roubille F. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019 Dec 26;381(26):2497-2505. doi: 10.1056/NEJMoa1912388. Epub 2019 Nov 16.
PubMed 31733140Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials? Stat Med. 1984 Oct-Dec;3(4):409-22. doi: 10.1002/sim.4780030421. No abstract available.
PubMed 6528136McDermott MM, Newman AB. Preserving Clinical Trial Integrity During the Coronavirus Pandemic. JAMA. 2020 Jun 2;323(21):2135-2136. doi: 10.1001/jama.2020.4689. No abstract available.
PubMed 32211830Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
PubMed 32192578Diaz R, Orlandini A, Castellana N, Caccavo A, Corral P, Corral G, Chacon C, Lamelas P, Botto F, Diaz ML, Dominguez JM, Pascual A, Rovito C, Galatte A, Scarafia F, Sued O, Gutierrez O, Jolly SS, Miro JM, Eikelboom J, Loeb M, Maggioni AP, Bhatt DL, Yusuf S; ECLA PHRI COLCOVID Trial Investigators. Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized With COVID-19: A Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2141328. doi: 10.1001/jamanetworkopen.2021.41328.
PubMed 34964849
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ECLA PHRI COLCOVID Trial
- ClinicalTrials.gov ID
- NCT04328480
- Acronym / sponsor ID
- COLCOVID / COLCOVID version 2.0
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,279 participants (actual)
- Lead sponsor
- Estudios Clínicos Latino AméricaUniversity, hospital or other
- Collaborators
- Population Health Research Institute
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 25 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (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.
The ECLA PHRI COLCOVID Trial is a simple, pragmatic randomized open controlled trial to test the effects of colchicine on moderate/high-risk hospitalized COVID-19 patients with the aim of reducing mortality and/or new requirement for mechanical ventilation.
Detailed description
Various anti-viral treatments are being tested in clinical trials worldwide. The World Health Organization (WHO) launched a simple,pragmatic worldwide open-label trial to test Remdesivir, Lopinavir/Ritonavir, Interferon and Hydroxychloroquine or Chloroquine.The most important complication of COVID-19 severe cases is respiratory failure from severe acute respiratory syndrome (SARS), the leading cause of mortality. Accumulating evidence suggests that patients with severe COVID-19 might have a cytokine storm syndrome, a hyperinflammatory syndrome characterized by a fulminant and fatal hypercytokinemia and multiorgan failure.
The proposed pathophysiological mechanism of cytokine storm and inflammatory cascade activation is based on evidence collected primarily during the SARS-CoV and MERS-CoV epidemics (with a significant increase in IL1B, IL6, IL12, IFNγ, IP10, TNFα, IL15, and IL17 among others). The data collected during the pandemic with COVID-19 also shows a significant increase in inflammatory cytokines (GCSF, IP10, MCP1, MIP1A, and TNFα, among others) in sicker patients admitted to intensive care. In the absence of effective treatments for the management of patients with COVID-19 and respiratory failure, the immunomodulatory and anti-inflammatory effect of colchicine on cytokines involved in the hyper-inflammatory state is postulated. Several lines of research worldwide are testing powerful anti-inflammatory drugs for the pandemic, with different options including steroids, cytokine blockers, and other potent anti-inflammatory agents. Steroids are partially contraindicated in viral infections.
Colchicine is a powerful anti-inflammatory drug approved for the treatment or prevention of gout and Familial Mediterranean Fever at doses ranging between 0.3 mg and 2.4 mg/day. Its mechanism of action is through the inhibition of tubulin polymerization, as well as through potential effects on cellular adhesion molecules and inflammatory chemokines. It might also have direct anti-inflammatory effects by inhibiting key inflammatory signalling networks known as inflammasome and pro-inflammatory cytokines. Additionally, evidence suggests that colchicine exerts a direct anti-inflammatory effect by inhibiting the synthesis of tumor necrosis factor alpha and IL-6, monocyte migration, and the secretion of matrix metalloproteinase-9. Through the disruption of the cytoskeleton, colchicine is believed to suppress secretion of cytokines and chemokines as well as in vitro platelet aggregation. All these are potentially beneficial effects that might diminish or ameliorate the COVID-19 inflammatory storm associated with severe forms of the disease. Importantly, in one contemporary trial low-dose colchicine administered to patients who survived from acute coronary syndrome shows a statistically significantly reduction of cardiovascular complications.
We have therefore designed in a simple, pragmatic randomized controlled trial to test the effects of colchicine on severe hospitalized COVID-19 cases with the aim of reducing mortality.
Sample size calculation:
A minimum sample size of 1200 patients will provide 80% power to detect a relative risk reduction of approximately 30% in the treated group if the assumed composite rate (new requirement of intubation and / or death) in the control group is about 24%.
The ECLA PHRI COLCOVID Trial allows randomization to another trial, specifically patients included in the trial might be (or not) randomized to an antithrombotic strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Simple pragmatic randomized open controlled trial
| Arm | Type | Receives |
|---|---|---|
| Local standard of care plus colchicine | Active comparator | Drug: Colchicine, Other: Local standard of careLocal standard of care plus colchicine (specific dosage schedule) |
| Local standard of care | Other | Other: Local standard of careLocal standard of care for COVID-19 SARS moderate / high-risk patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Consented adults (age ≥18 years) and
- COVID-19 suspicious and
- Admitted to hospital or already in hospital and
- COVID-19 suggestive symptoms (fever or febrile equivalent, loss of smell and taste, fatigue, etc.) that may be present or absent at randomization time and
- SARS (severe acute respiratory syndrome)
Key exclusion criteria (4 listed)
- Clear indication or contraindication for the use of colchicine
- Pregnant or breastfeeding female.
- Chronic renal disease with creatinine clearance <15 ml/min/m2
- Negative PCR test for SARS-COV2
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 |
|---|---|---|
| ColchicineAlso: ColchicinaThe colchicine dosage schedule will vary according to the following scenarios: 1. In patients not receiving Lopinavir/Ritonavir * Loading dose of 1.5 mg followed by 0.5 mg after two hours (day 1) * The next day 0.5 mg bid for 14 days or until discharge. 2. In patients receiving Lopinavir/Ritonavir * Loading dose of 0.5 mg (day 1) * After 72 hours from the loading dose, 0.5 mg every 72 hours for 14 days or until discharge. 3. Patients under treatment with Colchicine that are starting with Lopinavir/Ritonavir * Dose of 0.5 mg 72 hours after starting Lopinavir/Ritonavir. * Continue with 0.5 mg every 72 hours for 14 days or until discharge. Only the oral route will be used except in the case of patients associated with mechanical ventilation or with contraindications to the oral route, in whom it will be administered by nasogastric tube. | Drug | Local standard of care plus colchicine |
| Local standard of careLocal standard of care for COVID-19 SARS moderate /high-risk patients | Other | Local standard of care, Local standard of care plus colchicine |
Primary outcome
Composite outcome: New requirement for mechanical ventilation or death
Time frame: 28 days post randomization
Number of participants who require new intubation for mechanical ventilation or die
Mortality
Time frame: 28 days post randomization
Number of participants who die
10 secondary outcomes
New requirement for mechanical ventilation or death from respiratory failure
Time frame: 28 days post randomization
New requirement for mechanical ventilation or death from non-respiratory failure
Time frame: 28 days post randomization
Mortality due to respiratory failure
Time frame: 28 days post randomization
Mortality due to non-respiratory failure
Time frame: 28 days post randomization
In hospital - Composite outcome
Time frame: During hospitalization or until death, whichever comes first, assessed up to 28 days
In hospital - Mortality
Time frame: During hospitalization or until death, whichever comes first, assessed up to 28 days
Composite outcome (New requirement for mechanical ventilation or death) evaluated in Non-intubated population
Time frame: 28 days post randomization
Mortality evaluated in Non-intubated population
Time frame: 28 days post randomization
Mean WHO descriptive score of COVID-19 during hospitalization
Time frame: During hospitalization or until death, whichever comes first, assessed up to 28 days
Highest WHO descriptive score of COVID-19 during hospitalization
Time frame: During hospitalization or until death, whichever comes first, assessed up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 29272515Slobodnick A, Shah B, Krasnokutsky S, Pillinger MH. Update on colchicine, 2017. Rheumatology (Oxford). 2018 Jan 1;57(suppl_1):i4-i11. doi: 10.1093/rheumatology/kex453.
- Background: PubMed 31733140Tardif JC, Kouz S, Waters DD, Bertrand OF, Diaz R, Maggioni AP, Pinto FJ, Ibrahim R, Gamra H, Kiwan GS, Berry C, Lopez-Sendon J, Ostadal P, Koenig W, Angoulvant D, Gregoire JC, Lavoie MA, Dube MP, Rhainds D, Provencher M, Blondeau L, Orfanos A, L'Allier PL, Guertin MC, Roubille F. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019 Dec 26;381(26):2497-2505. doi: 10.1056/NEJMoa1912388. Epub 2019 Nov 16.
- Background: PubMed 6528136Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials? Stat Med. 1984 Oct-Dec;3(4):409-22. doi: 10.1002/sim.4780030421. No abstract available.
- Background: PubMed 32211830McDermott MM, Newman AB. Preserving Clinical Trial Integrity During the Coronavirus Pandemic. JAMA. 2020 Jun 2;323(21):2135-2136. doi: 10.1001/jama.2020.4689. No abstract available.
- Results publication: PubMed 32192578Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
- Derived from this study: PubMed 34964849Diaz R, Orlandini A, Castellana N, Caccavo A, Corral P, Corral G, Chacon C, Lamelas P, Botto F, Diaz ML, Dominguez JM, Pascual A, Rovito C, Galatte A, Scarafia F, Sued O, Gutierrez O, Jolly SS, Miro JM, Eikelboom J, Loeb M, Maggioni AP, Bhatt DL, Yusuf S; ECLA PHRI COLCOVID Trial Investigators. Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized With COVID-19: A Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2141328. doi: 10.1001/jamanetworkopen.2021.41328.
- 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.
Rafael Diaz, MD principal investigator
ECLA- ICR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine in people with COVID-19, run by Estudios Clínicos Latino América at 1 site in Argentina.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 27 Apr 2021. 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 Argentina. 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 phase mean?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite outcome: New requirement for mechanical ventilation or death (time frame: 28 days post randomization). 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?
On the ClinicalTrials.gov record for NCT04328480, which also lists 6 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 27 Apr 2021.