Sars-CoV2Phase 3NCT04967430
TOGETHER - Toronto: Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19
A Phase 3 study testing Peginterferon Lambda-1A in people with Sars-CoV2 and Covid19, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Interferon (IFN) lambda is one of the fundamental responses of the innate immune system. Peginterferon lambda is a long-acting form that has been studied extensively in human trials in viral hepatitis, confirming it safety and tolerability. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Peginterferon Lambda-1A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 763 participants
- Where
- 1 siteCanada
- Study dates
- 27 Aug 2021to 30 Jun 2022
- 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
- Adult 18 years of age or older.
- Symptomatic and within 7 days of symptom onset.
- High risk for severe disease (as defined by one or more of the following):
- Age >50
- Diabetes mellitus requiring therapy
- Hypertension on medication
Show all 17Show fewer
- BMI >30 kg/m2
- Cardiovascular disease
- Asthma requiring chronic controller medication
- Symptomatic respiratory disease
- Immunosuppressed patients (to maximum of 10mg prednisone daily +/- other immunosuppressive agents)
- Documented fever (>38C)
- One or more of the following symptoms: cough, shortness of breath (SOB), pleuritic chest pain and/or myalgias (to a maximum of 25% of enrollment)
- Discharged to home isolation.
- Willing and able to provide informed consent (including by substitute decision maker).
- Willing and able to follow-up by phone or videoconference.
- Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication. Female patients of childbearing potential are all those except patients who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal.
Who cannot join
- Pregnancy (or positive urine pregnancy test) or lactating.
- More than 14 days following completion of SARS-CoV-2 vaccition series
- The following pre-existing medical conditions:
- Known cirrhosis with any history of decompensation (ascites, variceal bleeding or hepatic encephalopathy)
- Known chronic kidney disease with estimated creatinine clearance < 30 mL/minute or need for dialysis
- Uncontrolled severe psychiatric disorder - schizophrenia, bipolar disorder, depression with prior suicidality
Show all 12Show fewer
- Uncontrolled seizures or seizure in the prior 1 month
- Any other underlying medical (cardiac, liver, renal, neurological, respiratory) or psychiatric condition that in the view of the investigator would preclude use of peginterferon lambda
- Known alcohol or drug dependence that in the opinion of the investigator would impair study participation.
- Known prior intolerance to interferon treatment.
- Enrolment in another clinical trial testing an antiviral agent or receipt of an antiviral agent for COVID-19 in the past 7 days.
- Use of investigational, off-label therapy for COVID-19, or unproven therapy for COVID-19.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TOGETHER-Toronto: A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter, Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19
Interferon (IFN) lambda is one of the fundamental responses of the innate immune system. Peginterferon lambda is a long-acting form that has been studied extensively in human trials in viral hepatitis, confirming it safety and tolerability. It is particularly attractive for consideration in the use of acute respiratory illness due to the high expression of the lambda receptor in lung epithelia. We propose to evaluate peginterferon-lambda in ambulatory patients with mild to moderate COVID-19.
Read the detailed description
In this study, individuals who attend an Assessment Centre/Emergency Department to be swabbed for COVID-19 and deemed well enough for home isolation will be informed about the study. There will be two major routes of recruitment. Where feasible, a rapid point-of-care (POC) laminar flow based COVID-19 test (the Abbott PanBio) will be performed and those who do not have a POC test at the assessment centre will be tested by PCR.
Interested participants who contact study staff will be confirmed to have a positive COVID-19 test. Once confirmed will be further screened for eligibility criteria by research study staff. After review, a consent form will be emailed to the participant and informed consent will be obtained through witnessed telephone consent from the participant or a substitute decision maker (SDM). Participants who consent will be randomized to receive a single subcutaneous injection of Peginterferon lambda 180µg or saline placebo.
Patients will be followed remotely with visits. In addition, participants will also attend outpatient clinic for swabs and blood work for routine laboratory and inflammatory markers on Days 7 and 14 with the primary endpoint being the time to SARS-CoV-2 RNA negativity and the proportion with COVID-19 related emergency room assessment >6 hours, hospitalization or death by Day 28. Numerous secondary endpoints will be evaluated as well.
Safety data will be reviewed by the Data Safety and Monitoring Committee after the first 50% of randomized participants complete 14 days of follow-up after treatment.
- Being tested
- Peginterferon Lambda-1A, Placebo
- Keywords
- Peginterferon lambda
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon Lambda-1ADrug
Peginterferon lambda is a covalent conjugate of human recombinant non-pegylated IFN lambda (IFN L) and a 20-kDa linear PEG chain.
Peginterferon lambda Injection is a sterile, nonpyrogenic, ready-to-use solution (0.4 mg/mL) that is clear to opalescent, colorless to pale yellow, and essentially free of particles. Lambda Injection is provided in a 1-mL long Type I glass syringe (0.18 mg/syringe) with a staked 29-gauge, 1/2- inch, thin-walled needle. The syringe has a rigid needle shield and is stoppered with a plunger stopper. Syringes are prefilled with a solution of Peginterferon lambda Injection, mannitol, L-histidine, polysorbate 80, hydrochloric acid, and water for injection; they are intended for a single use at adjustable doses. The syringe is marked with dose indicator lines, which are used as a reference point for administering the correct dose.
PlaceboOther
The placebo will be 0.9% sodium chloride (normal saline) solution. A plastic 1 mL syringe will be prefilled by the study pharmacy. Each syringe will contain 0.5 mL (0.45 mL to match the volume of the Interferon plus 0.05 mL overfill) to allow for needle priming by the unblinded study nurse.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | To receive a dose of peginterferon lambda 180mcg SC at baseline (Day 0). Receives: Drug: Peginterferon Lambda-1A |
| Placebo | Placebo comparator | Patients in this arm will receive a single SC dose of 0.9% sodium chloride (normal saline) solution at baseline (Day 0).
A plastic 1 mL syringe will be prefilled by the study pharmacy. Each syringe will contain 0.5 mL (0.45 mL to match the volume of the Interferon plus 0.05 mL overfill) to allow for needle priming by the unblinded study nurse. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 related urgent care visit, emergency room assessment, hospitalization or death by Day 28 (Primary efficacy endpoint)
Proportion with COVID-19-related emergency room assessment, hospitalization, or death by Day 28
Measured: At day 28
SARS-CoV-2 RNA negativity (Primary virological endpoint)
The time to SARS-CoV-2 RNA negativity.
Measured: Day 0 to Day 28
Treatment-emergent and treatment-related serious adverse events (Primary safety endpoint)
The rate of treatment-emergent and treatment-related serious adverse events (SAEs) by Day 28.
Measured: Day 0 to Day 28
Secondary outcomes (27)
Respiratory symptom resolution (Clinical Outcome #1)
Time to resolution of respiratory symptoms.
Measured: Day 0 to Day 28
Hospitalization (Clinical outcome #2)
Hospitalization for any cause
Measured: Day 0 to Day 28
Death (Clinical outcome #3)
Death due to respiratory or cardiovascular causes
Measured: Day 0 to Day 28
All symptom resolution (Clinical outcome #4)
Time to resolution of all symptoms (return to usual state of heath).
Measured: Day 0 to Day 28
Oxygen saturation on room air (Clinical outcome #5)
Proportion of days with oxygen saturation below 93% on room air by Day 14
Measured: Day 0 to Day 14
Seeking care from healthcare professional for COVID-19 (Clinical outcome #6)
Proportion seeking care from primary care provider/walk-in clinic or study healthcare provider for COVID-19.
Measured: Day 0 - Day 14
Hospital Admission (Clinical outcome #7)
Duration of hospital admission up to Day 28
Measured: Day 0 to Day 28
Time to viral negativity (Virologic/immunological outcome #1)
Time to SARS-CoV-2 RNA negativity.
Measured: Day 0 to Day 14
Mean log of SARS-CoV-2 RNA (Virologic/immunological outcome #2)
Difference in mean SARS-CoV-2 RNA in log copies/mL
Measured: Day 3, 5, 7, 10 and 14
Mean log decline in SARS-CoV-2 RNA (Virologic/immunological outcome #3)
Difference in mean log decline in SARS-CoV-2 RNA.
Measured: Day 3, 5, 7, 10 and 14
Negative for SARS-CoV-2 RNA (Virologic/immunological outcome #4)
Proportion negative for SARS-CoV-2 RNA.
Measured: Day 3
Negative for SARS-CoV-2 RNA (Virologic/immunological outcome #5)
Proportion negative for SARS-CoV-2 RNA.
Measured: Day 7
Negative for SARS-CoV-2 RNA (Virologic/immunological outcome #6)
Proportion negative for SARS-CoV-2 RNA.
Measured: Day 14
Proportion with antibodies (Virologic/immunological outcome #7)
Proportion with SARS-CoV-2 antibodies in blood.
Measured: Day 0, 7, 14 and 90
Correlation with interferon lambda 4 genotype (Virologic/immunological outcome #8)
Correlation of response with interferon lambda 4 (IFNL4) genotype.
Measured: Day 0 to Day 28
Laboratory markers (Virologic/immunological outcome #9)
Change in hemoglobin over time
Measured: Day 0 to Day 7 and Day 7 to Day 14.
Laboratory markers (Virologic/immunological outcome #10)
Change in white blood cell count over time
Measured: Day 0 to Day 7 and Day 7 to Day 14.
Laboratory markers (Virologic/immunological outcome #11)
Change in lymphocyte count over time.
Measured: Day 0 to Day 7 and Day 7 to Day 14.
Laboratory markers (Virologic/immunological outcome #12)
Change in ALT over time.
Measured: Day 0 to Day 7 and Day 7 to Day 14.
Laboratory markers (Virologic/immunological outcome #13)
Change in AST over time.
Measured: Day 0 to Day 7 and Day 7 to Day 14.
Laboratory markers (Virologic/immunological outcome #14)
Change in ALP over time.
Measured: Day 0 to Day 7 and Day 7 to Day 14.
Laboratory markers (Virologic/immunological outcome #15)
Change in total bilirubin over time.
Measured: Day 0 to Day 7 and Day 7 to Day 14.
Inflammatory markers (Virologic/immunological outcome #16)
Change in lactate dehydrogenase over time.
Measured: Day 0 to Day 7 and Day 7 to Day 14.
Inflammatory markers (Virologic/immunological outcome #17)
Change in c-reactive protein over time.
Measured: Day 0 to Day 7 and Day 7 to Day 14.
Inflammatory markers (Virologic/immunological outcome #18)
Change in D-dimers over time.
Measured: Day 0 to Day 7 and Day 7 to Day 14.
Inflammatory markers (Virologic/immunological outcome #19)
Change in creatine kinase over time.
Measured: Day 0 to Day 7 and Day 7 to Day 14.
COVID-19 in household contacts (Transmission outcome #1)
Confirmed diagnosis of COVID-19 in household contacts.
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start27 Aug 2021
- Primary completion21 Mar 2022
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 763 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordan Feld, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967430
- Sponsor's protocol ID
- JF-12-2020
- Other IDs
- 21-5018
- Status last verified
- Mar 2022
- First submitted
- 13 Jul 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOGETHER-Toronto: A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter, Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT04967430
- Acronym / sponsor ID
- JF-12-2020
- Keywords
- Peginterferon lambda
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 763 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interferon (IFN) lambda is one of the fundamental responses of the innate immune system. Peginterferon lambda is a long-acting form that has been studied extensively in human trials in viral hepatitis, confirming it safety and tolerability. It is particularly attractive for consideration in the use of acute respiratory illness due to the high expression of the lambda receptor in lung epithelia. We propose to evaluate peginterferon-lambda in ambulatory patients with mild to moderate COVID-19.
Detailed description
In this study, individuals who attend an Assessment Centre/Emergency Department to be swabbed for COVID-19 and deemed well enough for home isolation will be informed about the study. There will be two major routes of recruitment. Where feasible, a rapid point-of-care (POC) laminar flow based COVID-19 test (the Abbott PanBio) will be performed and those who do not have a POC test at the assessment centre will be tested by PCR.
Interested participants who contact study staff will be confirmed to have a positive COVID-19 test. Once confirmed will be further screened for eligibility criteria by research study staff. After review, a consent form will be emailed to the participant and informed consent will be obtained through witnessed telephone consent from the participant or a substitute decision maker (SDM). Participants who consent will be randomized to receive a single subcutaneous injection of Peginterferon lambda 180µg or saline placebo.
Patients will be followed remotely with visits. In addition, participants will also attend outpatient clinic for swabs and blood work for routine laboratory and inflammatory markers on Days 7 and 14 with the primary endpoint being the time to SARS-CoV-2 RNA negativity and the proportion with COVID-19 related emergency room assessment >6 hours, hospitalization or death by Day 28. Numerous secondary endpoints will be evaluated as well.
Safety data will be reviewed by the Data Safety and Monitoring Committee after the first 50% of randomized participants complete 14 days of follow-up after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Peginterferon Lambda-1ATo receive a dose of peginterferon lambda 180mcg SC at baseline (Day 0). |
| Placebo | Placebo comparator | Other: PlaceboPatients in this arm will receive a single SC dose of 0.9% sodium chloride (normal saline) solution at baseline (Day 0). A plastic 1 mL syringe will be prefilled by the study pharmacy. Each syringe will contain 0.5 mL (0.45 mL to match the volume of the Interferon plus 0.05 mL overfill) to allow for needle priming by the unblinded study nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Adult 18 years of age or older.
- Symptomatic and within 7 days of symptom onset.
- High risk for severe disease (as defined by one or more of the following):
- Discharged to home isolation.
- Willing and able to provide informed consent (including by substitute decision maker).
Key exclusion criteria (12 listed)
- Pregnancy (or positive urine pregnancy test) or lactating.
- More than 14 days following completion of SARS-CoV-2 vaccition series
- The following pre-existing medical conditions:
- Known alcohol or drug dependence that in the opinion of the investigator would impair study participation.
- Known prior intolerance to interferon treatment.
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 |
|---|---|---|
| Peginterferon Lambda-1APeginterferon lambda is a covalent conjugate of human recombinant non-pegylated IFN lambda (IFN L) and a 20-kDa linear PEG chain. Peginterferon lambda Injection is a sterile, nonpyrogenic, ready-to-use solution (0.4 mg/mL) that is clear to opalescent, colorless to pale yellow, and essentially free of particles. Lambda Injection is provided in a 1-mL long Type I glass syringe (0.18 mg/syringe) with a staked 29-gauge, 1/2- inch, thin-walled needle. The syringe has a rigid needle shield and is stoppered with a plunger stopper. Syringes are prefilled with a solution of Peginterferon lambda Injection, mannitol, L-histidine, polysorbate 80, hydrochloric acid, and water for injection; they are intended for a single use at adjustable doses. The syringe is marked with dose indicator lines, which are used as a reference point for administering the correct dose. | Drug | Treatment |
| PlaceboThe placebo will be 0.9% sodium chloride (normal saline) solution. A plastic 1 mL syringe will be prefilled by the study pharmacy. Each syringe will contain 0.5 mL (0.45 mL to match the volume of the Interferon plus 0.05 mL overfill) to allow for needle priming by the unblinded study nurse. | Other | Placebo |
Primary outcome
COVID-19 related urgent care visit, emergency room assessment, hospitalization or death by Day 28 (Primary efficacy endpoint)
Time frame: At day 28
Proportion with COVID-19-related emergency room assessment, hospitalization, or death by Day 28
SARS-CoV-2 RNA negativity (Primary virological endpoint)
Time frame: Day 0 to Day 28
The time to SARS-CoV-2 RNA negativity.
Treatment-emergent and treatment-related serious adverse events (Primary safety endpoint)
Time frame: Day 0 to Day 28
The rate of treatment-emergent and treatment-related serious adverse events (SAEs) by Day 28.
27 secondary outcomes
Respiratory symptom resolution (Clinical Outcome #1)
Time frame: Day 0 to Day 28
Hospitalization (Clinical outcome #2)
Time frame: Day 0 to Day 28
Death (Clinical outcome #3)
Time frame: Day 0 to Day 28
All symptom resolution (Clinical outcome #4)
Time frame: Day 0 to Day 28
Oxygen saturation on room air (Clinical outcome #5)
Time frame: Day 0 to Day 14
Seeking care from healthcare professional for COVID-19 (Clinical outcome #6)
Time frame: Day 0 - Day 14
Hospital Admission (Clinical outcome #7)
Time frame: Day 0 to Day 28
Time to viral negativity (Virologic/immunological outcome #1)
Time frame: Day 0 to Day 14
Mean log of SARS-CoV-2 RNA (Virologic/immunological outcome #2)
Time frame: Day 3, 5, 7, 10 and 14
Mean log decline in SARS-CoV-2 RNA (Virologic/immunological outcome #3)
Time frame: Day 3, 5, 7, 10 and 14
Negative for SARS-CoV-2 RNA (Virologic/immunological outcome #4)
Time frame: Day 3
Negative for SARS-CoV-2 RNA (Virologic/immunological outcome #5)
Time frame: Day 7
Negative for SARS-CoV-2 RNA (Virologic/immunological outcome #6)
Time frame: Day 14
Proportion with antibodies (Virologic/immunological outcome #7)
Time frame: Day 0, 7, 14 and 90
Correlation with interferon lambda 4 genotype (Virologic/immunological outcome #8)
Time frame: Day 0 to Day 28
Laboratory markers (Virologic/immunological outcome #9)
Time frame: Day 0 to Day 7 and Day 7 to Day 14.
Laboratory markers (Virologic/immunological outcome #10)
Time frame: Day 0 to Day 7 and Day 7 to Day 14.
Laboratory markers (Virologic/immunological outcome #11)
Time frame: Day 0 to Day 7 and Day 7 to Day 14.
Laboratory markers (Virologic/immunological outcome #12)
Time frame: Day 0 to Day 7 and Day 7 to Day 14.
Laboratory markers (Virologic/immunological outcome #13)
Time frame: Day 0 to Day 7 and Day 7 to Day 14.
Laboratory markers (Virologic/immunological outcome #14)
Time frame: Day 0 to Day 7 and Day 7 to Day 14.
Laboratory markers (Virologic/immunological outcome #15)
Time frame: Day 0 to Day 7 and Day 7 to Day 14.
Inflammatory markers (Virologic/immunological outcome #16)
Time frame: Day 0 to Day 7 and Day 7 to Day 14.
Inflammatory markers (Virologic/immunological outcome #17)
Time frame: Day 0 to Day 7 and Day 7 to Day 14.
Inflammatory markers (Virologic/immunological outcome #18)
Time frame: Day 0 to Day 7 and Day 7 to Day 14.
Inflammatory markers (Virologic/immunological outcome #19)
Time frame: Day 0 to Day 7 and Day 7 to Day 14.
COVID-19 in household contacts (Transmission outcome #1)
Time frame: Day 0 to Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- 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.
Jordan Feld, MD principal investigator
University Health Network, Toronto
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 Peginterferon Lambda-1A in people with Sars-CoV2 and Covid19, run by University Health Network, Toronto at 1 site 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 17 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 5 Apr 2022. 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 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?
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?
COVID-19 related urgent care visit, emergency room assessment, hospitalization or death by Day 28 (Primary efficacy endpoint) (time frame: At day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.