SARS-CoV InfectionPhase 3ConCorD-19NCT04552379
The Containing Coronavirus Disease 19 (COVID-19) Trial
A Phase 3 study testing Peginterferon beta-1a in people with SARS-CoV Infection and Interferon, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
In recent months severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has emerged as a novel human pathogen and, susceptibility amongst humans is presumed to be universal. Prevention measures of COVID-19 have included distancing, quarantines, use of facemasks in public places, and hand hygiene measures. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection, Interferon, Covid19
- What is being tested?
- Peginterferon beta-1a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,173 participants
- Where
- 1 siteChile
- Study dates
- 1 Dec 2020to 30 Jun 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 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Index Cases:
- Provided a signed and dated informed consent form
- Aged 18 to <80 years of age
- Confirmed SARS-CoV-2 diagnosis by PCR within 72 hours of first treatment dose
- The first known diagnosis in the household
- Not currently enrolled in a clinical trial and agree to not take any other investigational treatments over the next 28 days
Show all 20Show fewer
- Must plan to remain resident in the household during the study
- Lives in household with at least one other 'treatment-eligible household contact'
- Treatment-eligible Household Contacts:
- Provided a signed and dated informed consent form
- Aged 18 to <80 years of age,
- Not currently enrolled in a clinical trial and agree to not take any other investigational treatments over the next 28 days
- Must plan to remain resident in the household during the study
- No history of previously confirmed SARS-CoV-2 diagnosis
- Treatment-ineligible Household Contacts:
- Provided a signed and dated informed consent form, parental informed consent, and assent if applicable
- Under 18 years OR ≥ 80 years of age OR aged 18 to <80 years with any contraindication for IFN treatment listed in 'exclusion criteria'
- Not currently enrolled in a clinical trial and agree to not take any other investigational treatments over the next 28 days
- Must plan to remain resident in the household during the study
- No history of previously confirmed SARS-CoV-2 diagnosis
Who cannot join
- Index Cases and Treatment-eligible Household contacts:
- Inability to take medications orally or injected
- Known sensitivity/allergy to interferons or use of interferons for another indication
- Known adverse drug-drug interactions with any study drugs
- Malignancy
- Known clinical immune deficiency
Show all 18Show fewer
- Pregnancy or unwillingness, of female participants of childbearing potential to use recognised methods of birth control/contraception during the trial period,
- Retinopathy,
- Known grade 4 or 5 chronic kidney or liver disease,
- Known arrhythmias,
- Known autoimmune diseases or chronic inflammatory disease,
- Chronic liver disease,
- Hospitalisation for depression in the last 3 months,
- Current suicidal ideation,
- Previous therapeutic use of IFN
- All subjects:
- Declined participation,
- The index case has been in complete self-quarantine from other household members during the 48 hours prior to diagnosis of SARS-CoV-2 infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomised Trial of Interferon Versus Standard of Care in the Reduction of Transmission of SARS-Cov-2. The Containing Coronavirus Disease 19 Trial (ConCorD-19)
In recent months severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has emerged as a novel human pathogen and, susceptibility amongst humans is presumed to be universal. Prevention measures of COVID-19 have included distancing, quarantines, use of facemasks in public places, and hand hygiene measures. Mandatory quarantines have also been applied on index cases and their contacts, as well as an active search for asymptomatic patients.
Current strategies to reduce the spread of SARS-CoV-2 do not include measures that could prevent transmission prior to the onset of symptoms. Subjects infected with SARS-CoV-2 have been known to shed virus and be contagious for up to 5 days prior to developing symptoms ('pre-symptomatic transmission'). In fact, nearly 60% of all infected subjects can shed virus pre-symptomatically. Pre- or even asymptomatic shedding occurs across all age groups, contributing to the rapidly expanding pandemic.
Read more
Post-exposure prophylaxis (PEP) using type 1 interferon (IFN) can potentially eliminate the spread of SARS-CoV-2. IFN could reduce the period of viral shedding by ~1 week. Since pre-symptomatic shedding of virus can start up to 5 days prior to symptom onset, our approach of a PEP intervention to all contacts recently exposed to a case could possibly entirely interrupt the spread of the virus, and with that, the pandemic. The current study focuses on prevention of the disease in addition to its treatment. Thus, the key distinction between these other trials and this study is that this study focuses on containing coronavirus (i.e. cause) in the community, rather than simply its treatment (i.e. consequence) in the individual.
Viral spread could be eliminated through interventions effective at abolishing viral transmission. However, such post-exposure prophylaxis interventions, that is initiation of antiviral therapy in pre-infectious contacts to reduce or even eliminate such spread, must be safe since they are given to asymptomatic and possibly uninfected subjects. In none of the previous clinical trials of IFN therapy for SARS-CoV-2 have serious adverse events been recorded. Furthermore, the IFN chosen for this study (pegylated IFN 1b) has been extensively studied in clinical trials, and has been in clinical use for years for multiple sclerosis. Pegylated IFN formulations allow for weekly injections while maintaining serum levels and limiting dose-dependent side effects. Together these data support a sound safety profile for the planned intervention.
The aim of this study is to ascertain whether IFN administered to index cases and household contacts of an index case, starting immediately following confirmed exposure (index case confirmed positive for SARS-CoV-2), will reduce duration of SARS-CoV-2 detectable by PCR in the index cases, and incidence of SARS-CoV-2 detectable by PCR in household contacts.
Read the detailed description
Participants with COVID-19 will be identified from lists of patients with positive SARS-CoV-2 PCR that is obtained daily from clinical laboratories, at COVID-19 outpatient and hospital clinics, or the Emergency Rooms in Chile. After telephonically pre-screening eligibility of the index case and his/her household, and participants providing informed consent, households will be randomized 1:1 to three doses of IFN beta 1a or standard of care. Only the index case and treatment-eligible household members will receive IFN if their household is assigned to treatment arm. Other non-eligible household participants (e.g. children) will be monitored by serial SARS-CoV-2 saliva PCR and diary cards, and at day 29 all participants will be evaluated for SARS-CoV-2 antibodies in blood.
- Conditions
- SARS-CoV Infection, Interferon, Covid19
- Being tested
- Peginterferon beta-1a
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon beta-1aBiological
Also called Plegridy
Administration of trial drug: PLEGRIDY is given by an injection under the skin (subcutaneous injection). It will be administered to participants in accordance with product insert instructions by appropriately trained trial staff for whom administration of subcutaneous injections is within their normal scope of practice (e.g. RN or MD). They will wait for 20 mins after the last individual receives the interferon before leaving a residence. Administering staff will be supplied with appropriate PPE, trained in the use of this equipment and protocols for infection control, and will always attend in pairs.
PLEGRIDY will be administered in the home of the participants. Due to the heat-labile nature of the trial product (storage required at ~4oC) a verified English Spanish version of the product label will be printed by a GMP certified company and applied to the product and patient band just at the time of use.
| Study group | Role | What they receive |
|---|---|---|
| Interferon | Active comparator | Peginterferon beta-1alfa will be made available from Biogen Inc. Switzerland. 125 micrograms of pegylated IFNß1alfa (PLEGRIDY, Biogen) administered on Study Days 1, 6 and 11 (i.e. for a total of 3 doses) via subcutaneous injection. Receives: Biological: Peginterferon beta-1a |
| Standard of Care | No intervention | Standard of Care; following national guidelines regarding self-isolation and infection prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of index cases shedding SARS-CoV-2, at Day 11, in the active arm compared to the standard of care arm.
Measured: Day 11
The proportion of household contacts shedding SARS-CoV-2, at Day 11, in the active arm compared to the standard of care arm.
Measured: Day 11
Secondary outcomes (4)
Duration (in days) of SARS-CoV-2 by PCR of samples taken on study days 1, 6, 11, 16, 21, and 29.
Measured: Days 1,6,11, 21 and 29
Number of household contacts of participants in the IFN arm with positive upper airway PCR compared to that in the standard of care arm at day 1 & 11, and seroconversion (Ig) over the study period, up to day 29.
Measured: Days 1,11 and 29
The proportion of infected cases in the active arm that are hospitalised or die due to COVID-19, as compared to the proportion in the standard of care arm.
Measured: Days 1 to 29
Incidence and severity of reported adverse events in the interferon arm compared to the standard of care arm.
Measured: Days 1 to 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Dec 2020
- Primary completion31 May 2021
- Study completion30 Jun 2021
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 SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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
- Model description
- A prospective, cluster randomised trial of interferon versus standard of care. Index cases will be identified from databases of positive COVID-19 PCR patients from the virology lab,('Fever') clinics, outpatient clinics and hospital emergency room visits for possible COVID-19. Household contacts will be identified via the index cases and will be approached with the consent of the index case. Randomisation: Households will be randomised to receive IFN or standard of care (as recommended by the Public Health Department). Trial population: Index cases positively infected with SARS-CoV-2 and their exposed household contacts. Index cases will be recruited from databases of individuals with confirmed COVID-19 identified from COVID-19 ('Fever') clinics and emergency room visits in Santiago, Chile. Eligibility criteria: Households will be randomised only if cases and at least one treatment-eligible household contact meets all the inclusion criteria and none of the exclusion criteria.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Telethon Kids Institute
- Responsible party
- Sponsor
- Investigators
- Jose A Castro-Rodriguez, MD,PhD, Principal investigator, Pontificia Universidad Catolica de Chile, Santiago, ChileStephen Stick, MD,PhD, Principal investigator, Telethon Kids Institute, University of Western Australia, Perth, AustraliaArturo Borzutzky, MD, Study director, Pontificia Universidad Catolica de Chile, Santiago, ChileCarolina Iturriaga, NP, Study chair, Pontificia Universidad Catolica de Chile, Santiago, ChileTobias Kollmann, MD,PhD, Study chair, Telethon Kids Institute, University of Western Australia, Perth, AustraliaEleanor N Fish, PhD, Study chair, Department of Immunology, University of Toronto, CanadaCecilia Perret, MD, Study chair, Pontificia Universidad Catolica de Chile, Santiago, ChileDiego Garcia-Huidobro, MD,PhD, Study chair, Pontificia Universidad Catolica de Chile, Santiago, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552379
- Sponsor's protocol ID
- 200703013
- Acronym
- ConCorD-19
- Status last verified
- Dec 2020
- First submitted
- 21 Aug 2020
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are evaluating the best way to share the information.
Publications
Castro-Rodriguez JA, Fish EN, Montgomery ST, Kollmann TR, Iturriaga C, Shannon C, Karpievitch Y, Ho J, Chen V, Balshaw R, Ben-Othman R, Aniba R, Gidi-Yunge F, Hartnell L, Hancock DG, Perez-Mateluna G, Urzua M, Tebbutt SJ, Garcia-Huidobro D, Perret C, Borzutzky A, Stick SM. Interferon beta-1a ring prophylaxis to reduce household transmission of SARS-CoV-2: a cluster randomised clinical trial. EClinicalMedicine. 2023 Jul 20;62:102082. doi: 10.1016/j.eclinm.2023.102082. eCollection 2023 Aug.
PubMed 37538539Iturriaga C, Eiffler N, Aniba R, Ben-Othman R, Perez-Mateluna G, Meyer JKV, Fish EN, Kollmann TR, Severino N, Stick S, Borzutzky A, Perret C, Castro-Rodriguez JA, Garcia-Huidobro D. A cluster randomized trial of interferon ss-1a for the reduction of transmission of SARS-Cov-2: protocol for the Containing Coronavirus Disease 19 trial (ConCorD-19). BMC Infect Dis. 2021 Aug 13;21(1):814. doi: 10.1186/s12879-021-06519-4.
PubMed 34388972
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomised Trial of Interferon Versus Standard of Care in the Reduction of Transmission of SARS-Cov-2. The Containing Coronavirus Disease 19 Trial (ConCorD-19)
- ClinicalTrials.gov ID
- NCT04552379
- Acronym / sponsor ID
- ConCorD-19 / 200703013
- Conditions
- SARS-CoV Infection, Interferon, Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,173 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Telethon Kids Institute
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 17 Sep 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.
In recent months severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has emerged as a novel human pathogen and, susceptibility amongst humans is presumed to be universal. Prevention measures of COVID-19 have included distancing, quarantines, use of facemasks in public places, and hand hygiene measures. Mandatory quarantines have also been applied on index cases and their contacts, as well as an active search for asymptomatic patients.
Current strategies to reduce the spread of SARS-CoV-2 do not include measures that could prevent transmission prior to the onset of symptoms. Subjects infected with SARS-CoV-2 have been known to shed virus and be contagious for up to 5 days prior to developing symptoms ('pre-symptomatic transmission'). In fact, nearly 60% of all infected subjects can shed virus pre-symptomatically. Pre- or even asymptomatic shedding occurs across all age groups, contributing to the rapidly expanding pandemic.
Post-exposure prophylaxis (PEP) using type 1 interferon (IFN) can potentially eliminate the spread of SARS-CoV-2. IFN could reduce the period of viral shedding by ~1 week. Since pre-symptomatic shedding of virus can start up to 5 days prior to symptom onset, our approach of a PEP intervention to all contacts recently exposed to a case could possibly entirely interrupt the spread of the virus, and with that, the pandemic. The current study focuses on prevention of the disease in addition to its treatment. Thus, the key distinction between these other trials and this study is that this study focuses on containing coronavirus (i.e. cause) in the community, rather than simply its treatment (i.e. consequence) in the individual.
Viral spread could be eliminated through interventions effective at abolishing viral transmission. However, such post-exposure prophylaxis interventions, that is initiation of antiviral therapy in pre-infectious contacts to reduce or even eliminate such spread, must be safe since they are given to asymptomatic and possibly uninfected subjects. In none of the previous clinical trials of IFN therapy for SARS-CoV-2 have serious adverse events been recorded. Furthermore, the IFN chosen for this study (pegylated IFN 1b) has been extensively studied in clinical trials, and has been in clinical use for years for multiple sclerosis. Pegylated IFN formulations allow for weekly injections while maintaining serum levels and limiting dose-dependent side effects. Together these data support a sound safety profile for the planned intervention.
The aim of this study is to ascertain whether IFN administered to index cases and household contacts of an index case, starting immediately following confirmed exposure (index case confirmed positive for SARS-CoV-2), will reduce duration of SARS-CoV-2 detectable by PCR in the index cases, and incidence of SARS-CoV-2 detectable by PCR in household contacts.
Detailed description
Participants with COVID-19 will be identified from lists of patients with positive SARS-CoV-2 PCR that is obtained daily from clinical laboratories, at COVID-19 outpatient and hospital clinics, or the Emergency Rooms in Chile. After telephonically pre-screening eligibility of the index case and his/her household, and participants providing informed consent, households will be randomized 1:1 to three doses of IFN beta 1a or standard of care. Only the index case and treatment-eligible household members will receive IFN if their household is assigned to treatment arm. Other non-eligible household participants (e.g. children) will be monitored by serial SARS-CoV-2 saliva PCR and diary cards, and at day 29 all participants will be evaluated for SARS-CoV-2 antibodies in blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, cluster randomised trial of interferon versus standard of care. Index cases will be identified from databases of positive COVID-19 PCR patients from the virology lab,('Fever') clinics, outpatient clinics and hospital emergency room visits for possible COVID-19. Household contacts will be identified via the index cases and will be approached with the consent of the index case. Randomisation: Households will be randomised to receive IFN or standard of care (as recommended by the Public Health Department). Trial population: Index cases positively infected with SARS-CoV-2 and their exposed household contacts. Index cases will be recruited from databases of individuals with confirmed COVID-19 identified from COVID-19 ('Fever') clinics and emergency room visits in Santiago, Chile. Eligibility criteria: Households will be randomised only if cases and at least one treatment-eligible household contact meets all the inclusion criteria and none of the exclusion criteria.
| Arm | Type | Receives |
|---|---|---|
| Interferon | Active comparator | Biological: Peginterferon beta-1aPeginterferon beta-1alfa will be made available from Biogen Inc. Switzerland. 125 micrograms of pegylated IFNß1alfa (PLEGRIDY, Biogen) administered on Study Days 1, 6 and 11 (i.e. for a total of 3 doses) via subcutaneous injection. |
| Standard of Care | No intervention | –Standard of Care; following national guidelines regarding self-isolation and infection prevention |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Index Cases:
- Treatment-eligible Household Contacts:
- Treatment-ineligible Household Contacts:
Key exclusion criteria (18 listed)
- Index Cases and Treatment-eligible Household contacts:
- All subjects:
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 beta-1aAlso: PlegridyAdministration of trial drug: PLEGRIDY is given by an injection under the skin (subcutaneous injection). It will be administered to participants in accordance with product insert instructions by appropriately trained trial staff for whom administration of subcutaneous injections is within their normal scope of practice (e.g. RN or MD). They will wait for 20 mins after the last individual receives the interferon before leaving a residence. Administering staff will be supplied with appropriate PPE, trained in the use of this equipment and protocols for infection control, and will always attend in pairs. PLEGRIDY will be administered in the home of the participants. Due to the heat-labile nature of the trial product (storage required at ~4oC) a verified English Spanish version of the product label will be printed by a GMP certified company and applied to the product and patient band just at the time of use. | Biological | Interferon |
Primary outcome
The proportion of index cases shedding SARS-CoV-2, at Day 11, in the active arm compared to the standard of care arm.
Time frame: Day 11
The proportion of household contacts shedding SARS-CoV-2, at Day 11, in the active arm compared to the standard of care arm.
Time frame: Day 11
4 secondary outcomes
Duration (in days) of SARS-CoV-2 by PCR of samples taken on study days 1, 6, 11, 16, 21, and 29.
Time frame: Days 1,6,11, 21 and 29
Number of household contacts of participants in the IFN arm with positive upper airway PCR compared to that in the standard of care arm at day 1 & 11, and seroconversion (Ig) over the study period, up to day 29.
Time frame: Days 1,11 and 29
The proportion of infected cases in the active arm that are hospitalised or die due to COVID-19, as compared to the proportion in the standard of care arm.
Time frame: Days 1 to 29
Incidence and severity of reported adverse events in the interferon arm compared to the standard of care arm.
Time frame: Days 1 to 29
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 10 Sep 2021.
- Derived from this study: PubMed 37538539Castro-Rodriguez JA, Fish EN, Montgomery ST, Kollmann TR, Iturriaga C, Shannon C, Karpievitch Y, Ho J, Chen V, Balshaw R, Ben-Othman R, Aniba R, Gidi-Yunge F, Hartnell L, Hancock DG, Perez-Mateluna G, Urzua M, Tebbutt SJ, Garcia-Huidobro D, Perret C, Borzutzky A, Stick SM. Interferon beta-1a ring prophylaxis to reduce household transmission of SARS-CoV-2: a cluster randomised clinical trial. EClinicalMedicine. 2023 Jul 20;62:102082. doi: 10.1016/j.eclinm.2023.102082. eCollection 2023 Aug.
- Derived from this study: PubMed 34388972Iturriaga C, Eiffler N, Aniba R, Ben-Othman R, Perez-Mateluna G, Meyer JKV, Fish EN, Kollmann TR, Severino N, Stick S, Borzutzky A, Perret C, Castro-Rodriguez JA, Garcia-Huidobro D. A cluster randomized trial of interferon ss-1a for the reduction of transmission of SARS-Cov-2: protocol for the Containing Coronavirus Disease 19 trial (ConCorD-19). BMC Infect Dis. 2021 Aug 13;21(1):814. doi: 10.1186/s12879-021-06519-4.
- Individual participant dataSharing planned: Yes. We are evaluating the best way to share the information.
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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.
Jose A Castro-Rodriguez, MD,PhD principal investigator
Pontificia Universidad Catolica de Chile, Santiago, Chile
Stephen Stick, MD,PhD principal investigator
Telethon Kids Institute, University of Western Australia, Perth, Australia
Arturo Borzutzky, MD study director
Pontificia Universidad Catolica de Chile, Santiago, Chile
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 beta-1a in people with SARS-CoV Infection and Interferon, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 20 inclusion and 18 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 10 Sep 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 Chile. 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?
The proportion of index cases shedding SARS-CoV-2, at Day 11, in the active arm compared to the standard of care arm. (time frame: Day 11). 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 NCT04552379, 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 10 Sep 2021.