COVID-19Phase 3NCT04329611
ALBERTA HOPE COVID-19 for the Prevention of Severe COVID19 Disease
A Phase 3 study testing Hydroxychloroquine in people with COVID-19, run by Dr. Michael Hill at 2 sites in Canada.
Trial summary
Albertans with COVID-19 are at risk of deteriorating and developing severe illness. Those over age 40 or with co-morbid illness, and likely those who are immune suppressed, are at highest risk. This study will include a focus on people with immune-suppressed states. 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?
- Hydroxychloroquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 2 sitesCanada
- Study dates
- 13 Apr 2020to 20 Jul 2020
- 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
- Confirmed SARS-CoV-2 infection, defined as RT-PCR provincial laboratory confirmation.
- Self-reported symptoms of SARS-CoV-2 infection including any of the following: fever ≥37.5°C, cough, dyspnea, chest tightness, malaise, sore throat, myalgias, or coryza
- Time from a positive test result to day 1 of treatment within 4 days
- Time from patient reported first symptoms to day 1 of treatment within 12 days
- Adults, age 18 and over, with any risk factor for severe disease
- Resident of Alberta or if not a resident of Alberta able to provide complete follow-up data
- Agrees to use adequate contraception for the duration of the study
- Informed consent
Who cannot join
- Currently or imminently planned admission to hospital
- Any contraindication to hydroxychloroquine :
- Known hypersensitivity to hydroxychloroquine, chloroquine, or other 4-aminoquinoline derivatives, or any component of the formulation
- Known diagnosis of G6PD deficiency or porphyria
- Known retinal eye disease with vision impairment, in which hydroxychloroquine is a known contraindication
- Known history of QTc prolongation or QTc of > 470 msec (males) or > 480 msec (females) on any ECG within the previous year, if available
Show all 17Show fewer
- Unexplained syncope or family history of long QT syndrome or family history of premature sudden cardiac death at < 50 years of age
- Severe diarrhea and/or vomiting or any eating disorders or any persistent vomiting condition
- Known significant liver disease including cirrhosis associated with any history of ascites, encephalopathy, or variceal bleeding as per history or medical chart (or Child Pugh B\&C) or alcoholic hepatitis
- Uncontrolled epilepsy (more than 2 seizures within the previous year or any hospitalizations for status epilepticus within the previous 2 years)
- Current use of hydroxychloroquine (Plaquenil), chloroquine, lumefantrine, mefloquine, quinine, artemether, cyclosporine, dapsone, digoxin, and drugs that are known to prolong the QTc as per section 7.5.2.
- Score of 7 or more on the Tisdale scale modified such that instead of (1) admission potassium, any known serum potassium within the previous 30 days will be used; if no serum potassium is available the sub-score will be 0, and (2) admission ECG, any known ECG within the previous year will be used; if no ECG is available, the sub-score will be 0; (3) Use of HCQ will be included as one risk factor and anyone concurrently using a medication from the list of drugs known to prolong the QTc will already be excluded. (The other major risk factors for prolonged QTc are sepsis, heart failure, acute myocardial infarction, none of which are likely to be encountered in the outpatient setting).
- Participation in an ongoing interventional clinical trial within the previous 30 days
- Use of hydroxychloroquine (Plaquenil) or chloroquine, lumefantrine, mefloquine, or quinine within the previous 30 days.
- Inability to swallow pills or any other reason that compliance with the medical regimen is not likely
- Pregnant or breastfeeding
- Severe underlying disease where treatment is not likely to be beneficial to the patient.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary/Foothills Medical Centre
Calgary, Alberta, T2N 2T9
University of Alberta
Edmonton, Alberta
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Oral Hydroxychloroquine for the Treatment of SARS-CoV-2 Positive Patients for the Prevention of Severe COVID-19 Disease.
Albertans with COVID-19 are at risk of deteriorating and developing severe illness. Those over age 40 or with co-morbid illness, and likely those who are immune suppressed, are at highest risk. This study will include a focus on people with immune-suppressed states. Individuals confirmed to have SARS-CoV-2 infection will be identified using administrative data (positive lab result, age 18 or over, not hospitalized, and not living in SL4 level of care). They will then be contacted by AHS staff, independent of the researchers, to obtain their consent for the researchers to contact them about this trial. The AHS staff member who contacts the individual will enroll consenting individuals into a study database. If they provided an email address an email will automatically be sent to the individual with study information. Those who decline to be contacted will also be informed of the study website so they can choose to review the study information and self-enrol, although they will need to do so quickly to meet study timelines. Enrolled participants will be contacted by a study coordinator. Those without access to the internet will be informed about the study details when they are contacted by a study coordinator. When the study coordinator contacts potential participants the study will be reviewed, and the potential participant will have an opportunity to ask questions. Consent for participation will be obtained by telephone. Telephone consent will be recorded. Participants will then be screened for inclusion and exclusion criteria by telephone interview and review of Alberta Netcare. Alberta Netcare is the province of Alberta's public Electronic Health Record used to store patient information so that it is easily accessible to healthcare professionals for the purpose of care. Information like immunizations, ECG results, diagnostic images and reports, written medical reports (e.g. surgery reports, consultations, hospital admissions), diagnostic lab testing results (e.g. blood tests, urine tests, blood bank info), allergies and intolerances (drug and food allergies, food intolerances), prescription history, and general patient information (e.g. name, birthdate, personal health number, address, phone number). Those who are not eligible for the study will be informed of the reason(s) for ineligibility (generally it will be a safety exclusion and they should be aware of this). Those who are eligible will be randomized to receive HCQ or placebo for a total duration of 5 days. Study drug will be delivered to their residence by courier. Telephone follow-up will occur at day 7 (range 7-10 days) and at day 30 (range 25-35 days).
Read the detailed description
This double-blind placebo-controlled, randomized clinical trial will determine if hydroxychloroquine for 5 days, initiated within 96 hours of confirmation of a positive COVID-19 result, and within 12 days of symptom onset, reduces the occurrence of severe COVID-19 disease. Severe disease is defined as the composite of hospitalization, invasive mechanical ventilation and 30-day mortality. This trial will enrol consenting adults who are not hospitalized, are age 18 or over, have a risk factor for severe disease, have no contraindication to treatment with hydroxychloroquine, can swallow pills, and who do not have a severe underlying comorbidity where treatment is not likely to be beneficial to the patient.
Secondary outcomes will be the proportion of participants requiring hospitalization, invasive mechanical ventilation, 30-day mortality, and disposition at 30 days, defined as recovered, ongoing symptoms but not hospitalized, hospitalized, or deceased.
Randomization will be stratified by age, risk of severe disease, and Alberta Health zone of primary residence. A pre-specified risk classification that includes immunosuppressed status will define those at high risk of severe disease. Health care delivery across Alberta Health zones will likely differ, in part due to the remote location of most patients in some zones.
Alberta has a single publicly funded health care system with processes and administrative data that will allow complete capture of health system encounters and resource utilization. The population is ethnically diverse. In 2016, 23.5% of Albertans belonged to a visible minority group compared with 22.3% for Canada overall (1). Also, in 2018, 94.1% of Albertans age 15 and older used the internet for personal use compared with 91.3% for Canada overall; this excluded full-time residents of institutions (2). This will support a high degree of electronic recruitment and data capture.
The current COVID-19 epidemic has also paused most ongoing research, thus providing access to many experienced researchers and highly trained research staff.
Lack of any proven treatments for this severe condition makes it imperative that we use the resources we have to try to improve the lives of Albertans and determine if there is evidence for the use of hydroxychloroquine for confirmed COVID-19 disease, overall, and in high risk participants.
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine
- Keywords
- SARS-Cov2, viral pneumonia
- Medical subject headings
- COVID-19, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called plaquenil
COVID19
| Study group | Role | What they receive |
|---|---|---|
| hydroxychloroquine | Active comparator | hydroxychloroquine 400 mg po bid loading dose for 1 day followed by 200 mg po twice daily for 4 days Receives: Drug: Hydroxychloroquine |
| Placebo | Placebo comparator | Matching Placebo Receives: Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of hospitalization, invasive mechanical ventilation or death within 30 days
The aim of this intervention is to prevent severe COVID-19 disease.
This trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine.The aim of this intervention is to prevent severe COVID-19 disease.
This trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine.The aim of this intervention is to prevent severe COVID-19 disease.
This trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine.
Measured: Within 30 days of randomization
Secondary outcomes (3)
mortality
Mortality within 30 days of randomization
Measured: Within 30 days of randomization
Symptom duration
defined as the number of days from randomization to complete symptom resolution, based on public health follow-up and day 7 and day 30 telephone interview (continuous)
Measured: Within 30 days of randomization
Disposition at 30 days defined as recovered, ongoing symptoms but not hospitalized, hospitalized, or deceased (categorical)
Disposition of the patient at the Day 30 telephone followup
Measured: Within 30 days of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start13 Apr 2020
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
Why it stopped: Enrolment was suspended on 22may2020, after Mehra et al (Lancet 2020) then stopped due to lack of Covid19 cases.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Single group
- Model description
- Randomization will be conducted using an online tool. The use of an online tool will allow for dynamic randomization which ensures concealment of allocation. We will use a minimal sufficient balance randomization tool to ensure balance on age, sex, risk status (binary variable based on immune competence and other identified risks), days from symptom onset to randomization and provincial health zone (5 categories). These variables will be identified at telephone screening by a study coordinator, clarified with a physician when necessary, and entered into the online randomization tool. It is predicted that many patients will want treatment. Further, immunosuppressed patients may be at the highest risk of fatal outcomes. Therefore, we will use 2:1 randomization (HCQ: placebo).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Michael Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services, University of Alberta, University of Calgary, Calgary Health Trust, Alberta Innovates Health Solutions, Government of Alberta
- Responsible party
- Sponsor-investigator, Dr. Michael Hill, University of Calgary
- Investigators
- Luanne Metz, MD, Principal investigator, University of CalgaryMichael D Hill, MD, Study director, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329611
- Sponsor's protocol ID
- ABCOV-01 version 1.5
- Status last verified
- Jul 2020
- First submitted
- 29 Mar 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ganesh A, Rosentreter RE, Chen Y, Mehta R, McLeod GA, Wan MW, Krett JD, Mahjoub Y, Lee AS, Schwartz IS, Richer LP, Metz LM, Smith EE, Hill MD; Alberta HOPE COVID-19 Collaborators. Patient-reported outcomes of neurologic and neuropsychiatric symptoms in mild COVID-19: a prospective cohort study. CMAJ Open. 2023 Aug 8;11(4):E696-E705. doi: 10.9778/cmajo.20220248. Print 2023 Jul-Aug.
PubMed 37553227Schwartz I, Boesen ME, Cerchiaro G, Doram C, Edwards BD, Ganesh A, Greenfield J, Jamieson S, Karnik V, Kenney C, Lim R, Menon BK, Mponponsuo K, Rathwell S, Ryckborst KJ, Stewart B, Yaskina M, Metz L, Richer L, Hill MD; ALBERTA HOPE COVID-19 Collaborators. Assessing the efficacy and safety of hydroxychloroquine as outpatient treatment of COVID-19: a randomized controlled trial. CMAJ Open. 2021 Jun 18;9(2):E693-E702. doi: 10.9778/cmajo.20210069. Print 2021 Apr-Jun.
PubMed 34145052
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Oral Hydroxychloroquine for the Treatment of SARS-CoV-2 Positive Patients for the Prevention of Severe COVID-19 Disease.
- ClinicalTrials.gov ID
- NCT04329611
- Acronym / sponsor ID
- ABCOV-01 version 1.5
- Conditions
- COVID-19
- Keywords
- SARS-Cov2, viral pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolment was suspended on 22may2020, after Mehra et al (Lancet 2020) then stopped due to lack of Covid19 cases.
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Dr. Michael HillUniversity, hospital or other
- Collaborators
- Alberta Health services, University of Alberta, University of Calgary, Calgary Health Trust, Alberta Innovates Health Solutions, Government of Alberta
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Albertans with COVID-19 are at risk of deteriorating and developing severe illness. Those over age 40 or with co-morbid illness, and likely those who are immune suppressed, are at highest risk. This study will include a focus on people with immune-suppressed states. Individuals confirmed to have SARS-CoV-2 infection will be identified using administrative data (positive lab result, age 18 or over, not hospitalized, and not living in SL4 level of care). They will then be contacted by AHS staff, independent of the researchers, to obtain their consent for the researchers to contact them about this trial. The AHS staff member who contacts the individual will enroll consenting individuals into a study database. If they provided an email address an email will automatically be sent to the individual with study information. Those who decline to be contacted will also be informed of the study website so they can choose to review the study information and self-enrol, although they will need to do so quickly to meet study timelines. Enrolled participants will be contacted by a study coordinator. Those without access to the internet will be informed about the study details when they are contacted by a study coordinator. When the study coordinator contacts potential participants the study will be reviewed, and the potential participant will have an opportunity to ask questions. Consent for participation will be obtained by telephone. Telephone consent will be recorded. Participants will then be screened for inclusion and exclusion criteria by telephone interview and review of Alberta Netcare. Alberta Netcare is the province of Alberta's public Electronic Health Record used to store patient information so that it is easily accessible to healthcare professionals for the purpose of care. Information like immunizations, ECG results, diagnostic images and reports, written medical reports (e.g. surgery reports, consultations, hospital admissions), diagnostic lab testing results (e.g. blood tests, urine tests, blood bank info), allergies and intolerances (drug and food allergies, food intolerances), prescription history, and general patient information (e.g. name, birthdate, personal health number, address, phone number). Those who are not eligible for the study will be informed of the reason(s) for ineligibility (generally it will be a safety exclusion and they should be aware of this). Those who are eligible will be randomized to receive HCQ or placebo for a total duration of 5 days. Study drug will be delivered to their residence by courier. Telephone follow-up will occur at day 7 (range 7-10 days) and at day 30 (range 25-35 days).
Detailed description
This double-blind placebo-controlled, randomized clinical trial will determine if hydroxychloroquine for 5 days, initiated within 96 hours of confirmation of a positive COVID-19 result, and within 12 days of symptom onset, reduces the occurrence of severe COVID-19 disease. Severe disease is defined as the composite of hospitalization, invasive mechanical ventilation and 30-day mortality. This trial will enrol consenting adults who are not hospitalized, are age 18 or over, have a risk factor for severe disease, have no contraindication to treatment with hydroxychloroquine, can swallow pills, and who do not have a severe underlying comorbidity where treatment is not likely to be beneficial to the patient.
Secondary outcomes will be the proportion of participants requiring hospitalization, invasive mechanical ventilation, 30-day mortality, and disposition at 30 days, defined as recovered, ongoing symptoms but not hospitalized, hospitalized, or deceased.
Randomization will be stratified by age, risk of severe disease, and Alberta Health zone of primary residence. A pre-specified risk classification that includes immunosuppressed status will define those at high risk of severe disease. Health care delivery across Alberta Health zones will likely differ, in part due to the remote location of most patients in some zones.
Alberta has a single publicly funded health care system with processes and administrative data that will allow complete capture of health system encounters and resource utilization. The population is ethnically diverse. In 2016, 23.5% of Albertans belonged to a visible minority group compared with 22.3% for Canada overall (1). Also, in 2018, 94.1% of Albertans age 15 and older used the internet for personal use compared with 91.3% for Canada overall; this excluded full-time residents of institutions (2). This will support a high degree of electronic recruitment and data capture.
The current COVID-19 epidemic has also paused most ongoing research, thus providing access to many experienced researchers and highly trained research staff.
Lack of any proven treatments for this severe condition makes it imperative that we use the resources we have to try to improve the lives of Albertans and determine if there is evidence for the use of hydroxychloroquine for confirmed COVID-19 disease, overall, and in high risk participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomization will be conducted using an online tool. The use of an online tool will allow for dynamic randomization which ensures concealment of allocation. We will use a minimal sufficient balance randomization tool to ensure balance on age, sex, risk status (binary variable based on immune competence and other identified risks), days from symptom onset to randomization and provincial health zone (5 categories). These variables will be identified at telephone screening by a study coordinator, clarified with a physician when necessary, and entered into the online randomization tool. It is predicted that many patients will want treatment. Further, immunosuppressed patients may be at the highest risk of fatal outcomes. Therefore, we will use 2:1 randomization (HCQ: placebo).
| Arm | Type | Receives |
|---|---|---|
| hydroxychloroquine | Active comparator | Drug: Hydroxychloroquinehydroxychloroquine 400 mg po bid loading dose for 1 day followed by 200 mg po twice daily for 4 days |
| Placebo | Placebo comparator | Drug: HydroxychloroquineMatching Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed SARS-CoV-2 infection, defined as RT-PCR provincial laboratory confirmation.
- Self-reported symptoms of SARS-CoV-2 infection including any of the following: fever ≥37.5°C, cough, dyspnea, chest tightness, malaise, sore throat, myalgias, or coryza
- Time from a positive test result to day 1 of treatment within 4 days
- Time from patient reported first symptoms to day 1 of treatment within 12 days
- Adults, age 18 and over, with any risk factor for severe disease
Key exclusion criteria (17 listed)
- Currently or imminently planned admission to hospital
- Any contraindication to hydroxychloroquine :
- Participation in an ongoing interventional clinical trial within the previous 30 days
- Use of hydroxychloroquine (Plaquenil) or chloroquine, lumefantrine, mefloquine, or quinine within the previous 30 days.
- Inability to swallow pills or any other reason that compliance with the medical regimen is not likely
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 |
|---|---|---|
| HydroxychloroquineAlso: plaquenilCOVID19 | Drug | Placebo, hydroxychloroquine |
Primary outcome
Composite of hospitalization, invasive mechanical ventilation or death within 30 days
Time frame: Within 30 days of randomization
The aim of this intervention is to prevent severe COVID-19 disease. This trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine.The aim of this intervention is to prevent severe COVID-19 disease. This trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine.The aim of this intervention is to prevent severe COVID-19 disease. This trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine.
3 secondary outcomes
mortality
Time frame: Within 30 days of randomization
Symptom duration
Time frame: Within 30 days of randomization
Disposition at 30 days defined as recovered, ongoing symptoms but not hospitalized, hospitalized, or deceased (categorical)
Time frame: Within 30 days of randomization
Results and safety
The study was stopped early (reason given: Enrolment was suspended on 22may2020, after Mehra et al (Lancet 2020) then stopped due to lack of Covid19 cases.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Derived from this study: PubMed 37553227Ganesh A, Rosentreter RE, Chen Y, Mehta R, McLeod GA, Wan MW, Krett JD, Mahjoub Y, Lee AS, Schwartz IS, Richer LP, Metz LM, Smith EE, Hill MD; Alberta HOPE COVID-19 Collaborators. Patient-reported outcomes of neurologic and neuropsychiatric symptoms in mild COVID-19: a prospective cohort study. CMAJ Open. 2023 Aug 8;11(4):E696-E705. doi: 10.9778/cmajo.20220248. Print 2023 Jul-Aug.
- Derived from this study: PubMed 34145052Schwartz I, Boesen ME, Cerchiaro G, Doram C, Edwards BD, Ganesh A, Greenfield J, Jamieson S, Karnik V, Kenney C, Lim R, Menon BK, Mponponsuo K, Rathwell S, Ryckborst KJ, Stewart B, Yaskina M, Metz L, Richer L, Hill MD; ALBERTA HOPE COVID-19 Collaborators. Assessing the efficacy and safety of hydroxychloroquine as outpatient treatment of COVID-19: a randomized controlled trial. CMAJ Open. 2021 Jun 18;9(2):E693-E702. doi: 10.9778/cmajo.20210069. Print 2021 Apr-Jun.
- Individual participant dataSharing planned: Yes
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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.
Luanne Metz, MD principal investigator
University of Calgary
Michael D Hill, MD study director
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine in people with COVID-19, run by Dr. Michael Hill at 2 sites in Canada.
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 17 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 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 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: Enrolment was suspended on 22may2020, after Mehra et al (Lancet 2020) then stopped due to lack of Covid19 cases.). 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?
Composite of hospitalization, invasive mechanical ventilation or death within 30 days (time frame: Within 30 days of randomization). 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 NCT04329611, 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 31 Jul 2020.