COVID-19Phase 2/3NCT04380519
Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19)
A Phase 2/3 study testing RPH-104 80 mg and Olokizumab 64 mg in people with COVID-19, run by R-Pharm International, LLC at 16 sites in Russia.
Trial summary
The primary objective of the study was to evaluate the efficacy and safety of a single dose of RPH-104 (80 mg) or OKZ (64 mg) compared to placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 15 of the study. 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?
- RPH-104 80 mg and Olokizumab 64 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 372 participants
- Where
- 16 sitesRussia
- Study dates
- 23 Apr 2020to 24 Jul 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The presence of a voluntarily signed and dated Patient Informed Consent Form for participation in this study, or a record of an Medical Consilium decision justifying patient's participation in case of patient is unable to state his/her will.
- Having either of the following COVID-associated respiratory syndromes:
- pneumonia with oxygenation saturation SpO2 ≤93% (on room air) or respiratory rate greater than 30/min;
- Acute respiratory distress syndrome (ARDS) ( PaO2/FiO2 ≤ 300 mmHg or SpO2/FiO2 ≤ 315 if PaO2 is not available).
- COVID-19 diagnosis based on:
- laboratory-confirmed SARS-CoV-2 infection as determined by Polymerase Chain Reaction method (PCR).
- OR
- Bilateral changes in the lungs typical for COVID-19, based on chest computed tomography results.
Who cannot join
- A history of hypersensitivity to the study drugs (RPH-104 and/or OKZ), and/or their components.
- The presence of any of the following laboratory abnormalities:
- absolute neutrophil counts < 0.5 x 10^9 L
- white blood cell count < 2 x 10^9 L
- platelet count <50 x 10^9 L
- Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) ≥ 3.0 x Upper Limit of Normal (ULN)
Show all 20Show fewer
- Severe renal failure: creatinine clearance < 30 mL/min
- Septic shock (vasopressors are required to maintain mean arterial pressure ≥ 65 mm Hg and lactate ≥ 2 mmol/L in the absence of hypovolemia)
- The disease progresses to death over the next 24 hours, regardless of treatment, according to Investigator.
- Perforation of the gastrointestinal tract, a history of diverticulitis.
- Administration of plasma from COVID-19 convalescent donors within 4 weeks before study enrollment and/or planned administration during the study.
- Recent (less then 5 half-lives) administration of tocilizumab or sarilumab;
- Recent (less then 5 half-lives) or planned during the current study period use of the following drugs:
- biologics (except RPH-104 or OKZ) with immunosuppressive effect, including, but not limited to: Interleukin-1 (IL-1) inhibitors (anakinra, rilonacept, canakinumab), IL- 6 inhibitors (except tocilizumab and sarilumab), IL-17A inhibitors (secukinumab), tumor necrosis factor α (TNFα) inhibitors (infliximab, adalimumab, etanercept, etc.), antiB-cell drugs, etc.
- other immunosuppressive drugs (with the exception of methotrexate in a dose of up to 25 mg/week), including, but not limited to:
- high doses of glucocorticoids (equivalent to prednisolone > 1 mg/kg) orally or parenterally;
- Janus kinase (JAK) kinase inhibitors; cyclophosphamide, etc.
- Concurrent participation in another clinical trial.
- Pregnancy, breastfeeding.
- A history of active tuberculosis, or active tuberculosis suspected by the Investigator.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Russia16 sites
Private healthcare institution "Clinical Hospital" Russian Railways-Medicine named after N. A. Semashko"
Moscow, 109386
State Budget Healthcare Institution "City Clinical Hospital № 15 named after O.M. Filatov" of Moscow City Healthcare Department
Moscow, 111539
Federal State Budgetary Institution "Federal Center for Cerebrovascular Pathology and Stroke" of the Ministry of Health of the Russian Federation
Moscow, 117997
Federal State Autonomous Education Insitution of High Education the First Moscow State Medical University named after I.M. Sechenov of Ministry of Healthcare of Russian Federation (Sechenov University)
Moscow, 119991
Federal State Autonomous Education Institution of High Education the First Moscow State Medical University named after I.M. Sechenov of Ministry of Healthcare of the Russian Federation (Sechenov University)
Moscow, 119991
Federal State Budgetary Institution "Central Clinical Hospital with Polyclinic" of Administrative Directorate of the President of the Russian Federation
Moscow, 121359
Federal State Budget Institution "National Medicine Research Center on Cardiology" By Ministry of Healthcare of Russian Federation
Moscow, 121552
State Budget Institution of Healthcare "City Clinical Hospital #52", Moscow City Healthcare Department
Moscow, 123182
State budgetary healthcare institution City Clinical Hospital named after S.I. Spasokukotsky Department of Health of the city of Moscow City Clinical Hospital No. 50
Moscow, 127206
Moscow State Budget Institution of Healthcare "Scientific Research Institute of Emergency Medicine named after N.V. Sklifosovsky of Moscow Department of Healthcare"
Moscow, 129090
АО "State Company "Medsi" based on Clinical Hospital №1"
Moscow, 143442
Federal State Budgetary Educational Institution of Higher Education "Volga Research Medical University" of the Ministry of Health of the Russian Federation
Nizhny Novgorod, 603950
Federal Budgetary State Healthcare Institution "National Medical Research Center named after B.A. Almazov"
Saint Petersburg, 197341
Saint-Petersburg State Budget Institution of Healthcare "City Hospital №40"
Saint Petersburg, 197706
Budgetary Health Institution Voronezh Regional Clinical Hospital №1
Voronezh, 394066
State Budget Healthcare Institution of Yaroslavl Region "Yaroslavl Region Clinical Hospital of War Veterans"
Yaroslavl, 150047
About this study
Official title: An International, Multicenter, Randomized, Double-blind, Adaptive Placebo-controlled Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe SARS-CoV-2 Infection (COVID-19)
The primary objective of the study was to evaluate the efficacy and safety of a single dose of RPH-104 (80 mg) or OKZ (64 mg) compared to placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 15 of the study.
Read the detailed description
The study consisted of two phases:
- Pilot phase: the first 189 patients were randomized in three groups to receive OKZ, RPH-104 (63 patients per group), followed by an interim analysis of efficacy and safety data.
- The main phase was the conduct of all procedures prespecified in the protocol. Based on results of interim analysis no changes were made regarding the sample size or primary efficacy endpoint.
For each patient the study included the following periods:
- Screening period for no more than 48 hours before the start of the day of randomization (Day 1). During the screening period, an assessment was performed to determine whether the patient met the eligibility criteria;
- Treatment period lasting from the end of the screening (considered as the beginning of the Day 1) to 23:59 of the Day 1, including randomization of the patients in the treatment groups and then a single administration of the study drug;
- Follow-up period lasting from 00:00 of the Day 2 to 23:59 of the Day 29, including an assessment of the efficacy and safety after administration of the study drug.
Eligible patients were randomized to one of three treatment groups to receive a single subcutaneous injection: RPH-104 80 mg, OKZ 64 mg or placebo in addition to standard care for patients with COVID-19 as per the routine practice in participating facilities. Further, during the term of hospitalization, the clinical observation was performed (Day 1 - Day 15 of the Last Hospitalization Day (LHD), whichever comes first). This was followed by a follow-up period from the from Day 15 or LHD (whichever comes first) to Day 29.
Standard COVID-19 therapy, as per the institution routine practice, was permitted during the study, except the prohibited protocol medication (during the whole period of the study) and tocilizumab and sarilumab (during the first 24 hours after the study treatment administration).
In the absence of positive dynamics in the patient's condition (as per Investigator's judgement), it was possible to administrate a single dose of tocilizumab or sarilumab (in accordance with the actual recommendations), after the 24 hours from one of the study drug's administration.
On Day 15 primary endpoint of patient's clinical status (response to the study therapy) was assessed. The response to the therapy was considered as improvement of the patient's clinical status by at least 1 point on a 6-point COVID-19 scale in the absence of tocilizumab or sarilumab administration.
The last patient's visit in the study was the visit on Day 29. If the patient was discharged from the hospital earlier than Day 15 or Day 29, patient's clinical status at these visits were assessed by phone call.
The total expected duration of the study for each patient was not more than 31 days, including 48 hours of screening, 1 day of the study drug administration and 28 days of observation.
- Conditions
- COVID-19
- Being tested
- RPH-104 80 mg, Olokizumab 64 mg, Placebo
- Keywords
- SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2, 2019-nCoV, 2019 novel coronavirus, Respiratory disease, lung disease, COVID-19, coronavirus
- Medical subject headings
- COVID-19, Respiration Disorders, Lung Diseases, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPH-104 80 mgDrug
solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial
Olokizumab 64 mgDrug
solution for subcutaneous administration 160 mg/mL, in the 2-mL glass vial (target volume 0,4 ml)
PlaceboDrug
Normal Saline (0.9% Sodium Chloride solution for Injection), in the market package
| Study group | Role | What they receive |
|---|---|---|
| RPH -104 80 mg | Experimental | Subject randomized to receive subcutaneous single injection of 2 ml solution of RPH-104 on Day 1, in addition to standard therapy Receives: Drug: RPH-104 80 mg |
| Olokizumab 64 mg | Experimental | Subject randomized to receive subcutaneous single injection of 0,4 ml solution of Olokizumab on Day 1, in addition to standard therapy Receives: Drug: Olokizumab 64 mg |
| Placebo | Placebo comparator | Subject randomized to receive subcutaneous single injection of 2 ml solution of Placebo on Day 1, in addition to standard therapy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Responders in Each Treatment Group
Proportion of patients, responded to the study therapy, in each of the treatment groups.
A responder is a patient who has not received tocilizumab or sarilumab and who has a clinical status improvement of ≥1 point on the 6-point COVID-19 scale (where 1 is the most favorable outcome and 6 is the most undesirable outcome) 15 days after the administration of the study drug:
- Not hospitalized, no activity limitations.
- Not hospitalized, limited activity.
- Hospitalized, not requiring supplemental oxygen.
- Hospitalized, supplemental oxygen with independent breathing.
- Hospitalized; mechanical ventilation (invasive/non-invasive) or Extracorporeal membrane oxygenation (ECMO).
- Death.
Measured: Day 15
Secondary outcomes (4)
Change Over Time in the Clinical Status of Patients Using a 6-point Ordinal Scale
Changes of patients' clinical status on a 6 points ordinal scale (where 1 was the most favorable outcome and 6 was the most undesirable outcome) over time.
The 6-point ordinal scale included the following categories:
- Not hospitalized, no activity limitations.
- Not hospitalized, limited activity.
- Hospitalized, not requiring supplemental oxygen.
- Hospitalized, supplemental oxygen, with independent breathing.
- Hospitalized, mechanical ventilation (invasive/non-invasive) or ECMO.
- Death.
Measured: from Day 2 until Day 15, Day 29
The Proportion of Patients With an Improvement in Clinical Status by 2 or More Points on the 6-point Ordinal Scale During the Study With no Use of Tocilizumab or Sarilumab
The proportion of patients with an improvement in clinical status by 2 or more points on the 6-point ordinal scale (where 1 was the most favorable outcome and 6 was the most undesirable outcome) during the study with no use of tocilizumab or sarilumab.
The 6-point ordinal scale included the following categories:
- Not hospitalized, no activity limitations.
- Not hospitalized, limited activity.
- Hospitalized, not requiring supplemental oxygen.
- Hospitalized, supplemental oxygen, with independent breathing.
- Hospitalized, mechanical ventilation (invasive/non-invasive) or ECMO.
- Death.
Measured: Day 29
The Proportion of Patients Who Received Tocilizumab or Sarilumab for COVID-19 During the Study
The proportion of patients who received tocilizumab or sarilumab for COVID-19 during the study
Measured: from Day 2 until the Day 29
Mortality Rate During the Study
Mortality rate over the follow-up period of the study
Measured: from Day 1 until Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start23 Apr 2020
- Primary completion10 Jul 2020
- Study completion24 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm International, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Data Management 365, K-Research, LLC
- Responsible party
- Sponsor
- Investigators
- Mikhail Samsonov, Study director, Chief Medical Officer, R-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380519
- Sponsor's protocol ID
- CL04041078
- Status last verified
- Jan 2022
- First submitted
- 6 May 2020
- Last updated
- 24 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicenter, Randomized, Double-blind, Adaptive Placebo-controlled Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe SARS-CoV-2 Infection (COVID-19)
- ClinicalTrials.gov ID
- NCT04380519
- Acronym / sponsor ID
- CL04041078
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2, 2019-nCoV, 2019 novel coronavirus, Respiratory disease, lung disease, COVID-19, coronavirus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- R-Pharm International, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Data Management 365, K-Research, LLC
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Posted 24 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study was to evaluate the efficacy and safety of a single dose of RPH-104 (80 mg) or OKZ (64 mg) compared to placebo in addition to standard therapy in patients with severe SARS-CoV-2 infection (COVID-19) at Day 15 of the study.
Detailed description
The study consisted of two phases:
- Pilot phase: the first 189 patients were randomized in three groups to receive OKZ, RPH-104 (63 patients per group), followed by an interim analysis of efficacy and safety data.
- The main phase was the conduct of all procedures prespecified in the protocol. Based on results of interim analysis no changes were made regarding the sample size or primary efficacy endpoint.
For each patient the study included the following periods:
- Screening period for no more than 48 hours before the start of the day of randomization (Day 1). During the screening period, an assessment was performed to determine whether the patient met the eligibility criteria;
- Treatment period lasting from the end of the screening (considered as the beginning of the Day 1) to 23:59 of the Day 1, including randomization of the patients in the treatment groups and then a single administration of the study drug;
- Follow-up period lasting from 00:00 of the Day 2 to 23:59 of the Day 29, including an assessment of the efficacy and safety after administration of the study drug.
Eligible patients were randomized to one of three treatment groups to receive a single subcutaneous injection: RPH-104 80 mg, OKZ 64 mg or placebo in addition to standard care for patients with COVID-19 as per the routine practice in participating facilities. Further, during the term of hospitalization, the clinical observation was performed (Day 1 - Day 15 of the Last Hospitalization Day (LHD), whichever comes first). This was followed by a follow-up period from the from Day 15 or LHD (whichever comes first) to Day 29.
Standard COVID-19 therapy, as per the institution routine practice, was permitted during the study, except the prohibited protocol medication (during the whole period of the study) and tocilizumab and sarilumab (during the first 24 hours after the study treatment administration).
In the absence of positive dynamics in the patient's condition (as per Investigator's judgement), it was possible to administrate a single dose of tocilizumab or sarilumab (in accordance with the actual recommendations), after the 24 hours from one of the study drug's administration.
On Day 15 primary endpoint of patient's clinical status (response to the study therapy) was assessed. The response to the therapy was considered as improvement of the patient's clinical status by at least 1 point on a 6-point COVID-19 scale in the absence of tocilizumab or sarilumab administration.
The last patient's visit in the study was the visit on Day 29. If the patient was discharged from the hospital earlier than Day 15 or Day 29, patient's clinical status at these visits were assessed by phone call.
The total expected duration of the study for each patient was not more than 31 days, including 48 hours of screening, 1 day of the study drug administration and 28 days of observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RPH -104 80 mg | Experimental | Drug: RPH-104 80 mgSubject randomized to receive subcutaneous single injection of 2 ml solution of RPH-104 on Day 1, in addition to standard therapy |
| Olokizumab 64 mg | Experimental | Drug: Olokizumab 64 mgSubject randomized to receive subcutaneous single injection of 0,4 ml solution of Olokizumab on Day 1, in addition to standard therapy |
| Placebo | Placebo comparator | Drug: PlaceboSubject randomized to receive subcutaneous single injection of 2 ml solution of Placebo on Day 1, in addition to standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The presence of a voluntarily signed and dated Patient Informed Consent Form for participation in this study, or a record of an Medical Consilium decision justifying patient's participation in case of patient is unable to state his/her will.
- Having either of the following COVID-associated respiratory syndromes:
- COVID-19 diagnosis based on:
- OR
- Bilateral changes in the lungs typical for COVID-19, based on chest computed tomography results.
Key exclusion criteria (20 listed)
- A history of hypersensitivity to the study drugs (RPH-104 and/or OKZ), and/or their components.
- The presence of any of the following laboratory abnormalities:
- Severe renal failure: creatinine clearance < 30 mL/min
- Septic shock (vasopressors are required to maintain mean arterial pressure ≥ 65 mm Hg and lactate ≥ 2 mmol/L in the absence of hypovolemia)
- The disease progresses to death over the next 24 hours, regardless of treatment, according to Investigator.
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 |
|---|---|---|
| RPH-104 80 mgsolution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial | Drug | RPH -104 80 mg |
| Olokizumab 64 mgsolution for subcutaneous administration 160 mg/mL, in the 2-mL glass vial (target volume 0,4 ml) | Drug | Olokizumab 64 mg |
| PlaceboNormal Saline (0.9% Sodium Chloride solution for Injection), in the market package | Drug | Placebo |
Primary outcome
Proportion of Responders in Each Treatment Group
Time frame: Day 15
Proportion of patients, responded to the study therapy, in each of the treatment groups. A responder is a patient who has not received tocilizumab or sarilumab and who has a clinical status improvement of ≥1 point on the 6-point COVID-19 scale (where 1 is the most favorable outcome and 6 is the most undesirable outcome) 15 days after the administration of the study drug: 1. Not hospitalized, no activity limitations. 2. Not hospitalized, limited activity. 3. Hospitalized, not requiring supplemental oxygen. 4. Hospitalized, supplemental oxygen with independent breathing. 5. Hospitalized; mechanical ventilation (invasive/non-invasive) or Extracorporeal membrane oxygenation (ECMO). 6. Death.
4 secondary outcomes
Change Over Time in the Clinical Status of Patients Using a 6-point Ordinal Scale
Time frame: from Day 2 until Day 15, Day 29
The Proportion of Patients With an Improvement in Clinical Status by 2 or More Points on the 6-point Ordinal Scale During the Study With no Use of Tocilizumab or Sarilumab
Time frame: Day 29
The Proportion of Patients Who Received Tocilizumab or Sarilumab for COVID-19 During the Study
Time frame: from Day 2 until the Day 29
Mortality Rate During the Study
Time frame: from Day 1 until Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Mikhail Samsonov study director
Chief Medical Officer, R-Pharm
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RPH-104 80 mg and Olokizumab 64 mg in people with COVID-19, run by R-Pharm International, LLC at 16 sites in Russia.
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 20 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 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Russia. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Responders in Each Treatment Group (time frame: Day 15). 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 24 Jan 2022.