Covid19Phase 3E-SPERANZANCT04695704
Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19:
A Phase 3 study testing Montelukast in people with Covid19 and SARS (Disease), run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 8 sites in Spain.
Trial summary
Recently, a new clinical presentation called "long covid" has been reported, for patients with symptoms lasting for more than 4 weeks from the onset of the disease. Typically, the symptoms comprise dyspnea, cough, headache, arthralgia, fever, abdominal pain, asthenia and skin manifestations This project aims to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19, SARS (Disease)
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 8 sitesSpain
- Study dates
- 11 Aug 2021to 28 Aug 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 to 80 years old with SARS-CoV-2 infection (positive CRP <10 days from the onset of symptoms) treated in Primary Health Care.
- Persistent respiratory symptoms (more than 1 and <12 months of evolution)
- Mild-moderate dyspnea: score at the beginning of the study according to the modified Medical Research Council (mMRC) scale from 0 to 3
- The patient must be competent to complement the follow-up evaluations.
- The patient agrees to participate in the study and take assigned medication during the 4 weeks.
- Sign the informed consent
Who cannot join
- Severity criteria: fever> 38ºC, or O2 saturation <93%.
- Patients with SARS-Cov-2 pneumonia in the acute / subacute phase.
- Patients who have required hospital admission for SARS-Cov-2.
- Chronic Obstructive Pulmonary Disease (COPD), asthma, bronchiectasis, pulmonary fibrosis, obstructive sleep apnea syndrome (OSAS), chronic respiratory failure from any cause, home oxygen therapy.
- Use of montelukast or zafirlukast ≤ 30 days prior to inclusion
- Use of any dose of systemic corticosteroids ≤ 30 days prior to inclusion
Show all 14Show fewer
- Use of gemfibrocil.
- Hypersensitivity to montelukast or to any of the excipients included (e.g. lactose.
- Any condition (including the inability to swallow pills) that, in the opinion of the researcher, would prevent the completion of taking the medication.
- Active malignancy, current or recent chemotherapy treatment (<6 months).
- Medical history of infection by the Human Immunodeficiency Virus (HIV) or any serious immunocompromised state.
- Pregnancy, planning to get pregnant or patients of childbearing age not undergoing birth control methods.
- Breastfeeding mother.
- Any other condition for which, in the opinion of the principal investigator, it is considered that the subject does not fit the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Primary Health Center Raval nord
Barcelona, 08001
Primaty health Center Corbera
Corbera de Llobregat, Barcelona, 08757
Primary Health Center Jaume Soler
Cornellà de Llobregat, Barcelona, 08940
Primary Health Center 17 Setember
el Prat de Llobregat, Barcelona, 08820
Primary Health Center Camps Blancs
Sant Boi de Llobregat, Barcelona, 08830
Primary Health Center Molí Nou
Sant Boi de Llobregat, Barcelona, 08830
Primary Health Center Vinyets
Sant Boi de Llobregat, Barcelona, 08830
Primary Health Center ElPla
Sant Feliu de Llobregat, Barcelona, 08980
About this study
Official title: Double-blind Randomized Clinical Trial, Placebo-controlled to Assess the Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19: E-SPERANZA COVID-19 PROJECT
Recently, a new clinical presentation called "long covid" has been reported, for patients with symptoms lasting for more than 4 weeks from the onset of the disease. Typically, the symptoms comprise dyspnea, cough, headache, arthralgia, fever, abdominal pain, asthenia and skin manifestations This project aims to evaluate the efficacy of Montelukast in improving the quality of life associated with respiratory symptoms in patients with persistent COVID-19 symptoms. The main objective is to compare the efficacy of low-dose Montelukast versus placebo to improve respiratory symptoms in patients with persistent COVID-19 symptoms.
Read the detailed description
In December 2019, the first case of a new coronavirus causing pneumonia was described in Wuhan (China), designated as SARS-CoV-2 by the World Health Organization.
From the start of the SARS-CoV-2 alert until May 21st, 2020, 250,287 cases of coronavirus disease (COVID-19) were reported in Spain. The importance of the COVID-19 pandemic with its high humanitarian and economic cost, urgently requires effective therapies to reduce the severity, complications and mortality associated with this infection.
As the number of cases of COVID-19 increases, so does information regarding the management and evolution of the disease. More recently, a new clinical presentation called "long COVID-19" has been reported, for patients with symptoms lasting for more than 4 weeks from the onset of the disease. Typically, the symptoms comprise dyspnea, cough, headache, arthralgia, fever, abdominal pain, asthenia and skin manifestations.
The inflammatory process produced at the pulmonary and extra pulmonary level, and the immune response triggered have been identified as important mechanisms in the pathophysiology of COVID-19.
Coronavirus infection activates the cytokine cascade at the immune level, in which leukotriene are possibly involved in the development of respiratory symptoms in patients with persistent symptoms after infection by SARS-CoV-2.
Leukotriene antagonists (LTRAs) have a bronchodilator action and inhibit inflammation of the airways, resulting in a significant improvement in asthma symptoms and allergic rhinitis. In asthma, they improve respiratory function, inhalation rate of inhaled β2 agonist, airway inflammation, airway hyper responsiveness, inhaled corticosteroid dosage, and reduce exacerbations.
Regarding the treatment of acute SARS-CoV-2 infection, to date, the available evidence is limited; there are few conclusive clinical trials that allow recommendations based on scientific evidence.
To date, no treatment has been evaluated in long COVID-19. The hypothesis of using Montelukast would be based on the pathophysiological response of the disease mediated by the immune system against the SARS-CoV-2 infection.
Montelukast blocks the action of substances such as leukotriene C4, D4 and E4 by binding to the CysLT1 receptor in the lungs and bronchi. This reduces the bronchoconstriction caused by leukotriene and results in less inflammation.
Montelukast effectively attenuated both lung inflammation induced by Lipopolysaccharides in a mouse model with Acute Respiratory Distress Syndrome, as in human neutrophils.
Individuals affected by long COVID-19 have self-organized to gain visibility. They have made a self-completed form to describe the characteristics of the disease. The "Persistent COVID19" network in Catalonia currently gathers more than 3000 people.
From the contact with the "Persistent COVID19 association" in Catalonia, and in search of a response to this symptomatology, which can be very disabling, a pilot study was carried out in patients with persistent COVID-19 symptoms with off-label use of Montelukast.
Empirical treatment with Montelukast at a dose of 10 mg / day for 14 days was started in 13 patients with long COVID-19, some with symptoms of more than a month of evolution since the beginning of the COVID-19 clinic. The patients were followed up to evaluate the improvement of the symptoms with a numerical scale from 0 to 100 and COPD Assessment Test Scale (CAT), 3 weeks after starting treatment.
An improvement in symptoms was observed a few days after treatment and a good evolution of the sensation of dyspnea, chest pain, symptoms of discomfort, dry cough, and nasal symptoms. Likewise, the incorporation of the patients to their work activity during that period was observed. To date, the improvement continues to exist, without evidence of clinical deterioration.
- Conditions
- Covid19, SARS (Disease)
- Being tested
- Montelukast, placebo
- Keywords
- SARS-CoV-2, Montelukast, Leukotriene Antagonists, Primary Health Care, Clinical Trial, Quality of Life, Long Term Covid
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called antileukotriene
10 mg oral montelukast once daily for 28 days
placeboOther
10 mg oral placebo once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Experimental | 10mg oral montelukast once daily for 28 days. Receives: Drug: Montelukast |
| Placebo | Placebo comparator | oral placebo once daily for 28 days. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
COP Assessment Test Scale (CAT)
Quality of life of respiratory symptoms according to COPD Assessment Test (CAT The COPD Assessment Test (CAT) is a questionnaire for people with COPD, designed to measure the impact of COPD on a person's life, and how this changes over time.Quality of life of respiratory symptoms according to COPD Assessment Test (CAT). This is a validated self-administered scale to quantify and monitor the impact of COPD on well-being and daily life. It consists of 8 items (from 0 to 5 points), and a total score of 0-40 (0-9 mild, 10-20 moderate, 21-30 severe and 31-40 very severe), being higher scores worse outcome. A difference of 2 or more points in health status is considered clinically significant.
Measured: 7, 14, 21 and 28 days
Secondary outcomes (10)
1min sit-to-stand test
Exercise capacity: number of repetitions performed in the 1min sit-to-stand test
Measured: 14 and 28 days
O2 desaturation
O2 desaturation ≥ 4% with effort (1min sit-to-stand test)
Measured: 14 and 28 days
Visual Analogical Scale (VAS)
Symptoms evaluated using numeric Visual Analogical Scale (VAS): asthenia, headache, ageusia, anosmia, and rhinitis . It is numbered from 0-10, where 0 is the absence and 10 the greatest intensity, meaning higher scores worse outcome. The patient selects the number that best evaluates the intensity of the symptom.
Measured: 7, 14, 21 and 28 days
All-cause mortality
Mortality from any cause during the study
Measured: 7, 14, 21 and 28 days
Number of visits to primary care
Number of visits of any kind to primary health care settings (phone visit or face to face visit) during the study period.
Measured: 28 days
Number of visits to the emergency room
Number of visits to emergency room form primary health o hospital settings during the study period.
Measured: 28 days
Number of hospital admissions.
Number of hospital admissions during the study period.
Measured: 28 days
Medication side effects
Number and type of adverse reactions during the study period related to medication.
Measured: 7, 14, 21 and 28 days
Days of sick leave
Number of days of incapacity for work (sick leave) during the study period.
Measured: 28 days
Factors of inflamatory and prothrombotic processes: D-Dimer, N-terminal prohormone of brain natriuretic peptide (NT Pro-BNP), C-reactive protenin and Antinuclear antibodies (ANA)
To analyze wether the factors of inflamatory and prothrombotic processes (D-Dimer, Pro-BNP, C-reactive protein, and ANA) at the begining of the study are response predictors to the treatment.
Measured: 0 and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start11 Aug 2021
- Primary completion24 Jul 2023
- Study completion28 Aug 2023
Why it stopped: The incidence of respiratory Long COVID has decreased in the new waves, thus made impossible to achieve the required study sample.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomized placebo-controlled clinical trial,.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut
- Responsible party
- Sponsor
- Investigators
- Jesus Almeda Ortega, PhD, Study chair, Institut Català de la SalutSara Bonet Monne, PhD, Study chair, Institut Català de la SalutBetlem Salvador Gonzalez, PhD, Study chair, Institut Català de la SalutFrancisco Mera Cordero, MD, Principal investigator, Institut Català de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695704
- Sponsor's protocol ID
- 4R21/006
- Acronym
- E-SPERANZA
- Status last verified
- Jul 2024
- First submitted
- 4 Jan 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mera-Cordero F, Bonet-Monne S, Almeda-Ortega J, Garcia-Sangenis A, Cunillera-Puertolas O, Contreras-Martos S, Alvarez-Munoz G, Monfa R, Balanzo-Joue M, Morros R, Salvador-Gonzalez B. Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol. Trials. 2022 Jan 6;23(1):19. doi: 10.1186/s13063-021-05951-w.
PubMed 34991703
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Clinical Trial, Placebo-controlled to Assess the Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19: E-SPERANZA COVID-19 PROJECT
- ClinicalTrials.gov ID
- NCT04695704
- Acronym / sponsor ID
- E-SPERANZA / 4R21/006
- Conditions
- Covid19, SARS (Disease)
- Keywords
- SARS-CoV-2, Montelukast, Leukotriene Antagonists, Primary Health Care, Clinical Trial, Quality of Life, Long Term Covid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The incidence of respiratory Long COVID has decreased in the new waves, thus made impossible to achieve the required study sample.
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Català de la Salut
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 5 Jan 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.
Recently, a new clinical presentation called "long covid" has been reported, for patients with symptoms lasting for more than 4 weeks from the onset of the disease. Typically, the symptoms comprise dyspnea, cough, headache, arthralgia, fever, abdominal pain, asthenia and skin manifestations This project aims to evaluate the efficacy of Montelukast in improving the quality of life associated with respiratory symptoms in patients with persistent COVID-19 symptoms. The main objective is to compare the efficacy of low-dose Montelukast versus placebo to improve respiratory symptoms in patients with persistent COVID-19 symptoms.
Detailed description
In December 2019, the first case of a new coronavirus causing pneumonia was described in Wuhan (China), designated as SARS-CoV-2 by the World Health Organization.
From the start of the SARS-CoV-2 alert until May 21st, 2020, 250,287 cases of coronavirus disease (COVID-19) were reported in Spain. The importance of the COVID-19 pandemic with its high humanitarian and economic cost, urgently requires effective therapies to reduce the severity, complications and mortality associated with this infection.
As the number of cases of COVID-19 increases, so does information regarding the management and evolution of the disease. More recently, a new clinical presentation called "long COVID-19" has been reported, for patients with symptoms lasting for more than 4 weeks from the onset of the disease. Typically, the symptoms comprise dyspnea, cough, headache, arthralgia, fever, abdominal pain, asthenia and skin manifestations.
The inflammatory process produced at the pulmonary and extra pulmonary level, and the immune response triggered have been identified as important mechanisms in the pathophysiology of COVID-19.
Coronavirus infection activates the cytokine cascade at the immune level, in which leukotriene are possibly involved in the development of respiratory symptoms in patients with persistent symptoms after infection by SARS-CoV-2.
Leukotriene antagonists (LTRAs) have a bronchodilator action and inhibit inflammation of the airways, resulting in a significant improvement in asthma symptoms and allergic rhinitis. In asthma, they improve respiratory function, inhalation rate of inhaled β2 agonist, airway inflammation, airway hyper responsiveness, inhaled corticosteroid dosage, and reduce exacerbations.
Regarding the treatment of acute SARS-CoV-2 infection, to date, the available evidence is limited; there are few conclusive clinical trials that allow recommendations based on scientific evidence.
To date, no treatment has been evaluated in long COVID-19. The hypothesis of using Montelukast would be based on the pathophysiological response of the disease mediated by the immune system against the SARS-CoV-2 infection.
Montelukast blocks the action of substances such as leukotriene C4, D4 and E4 by binding to the CysLT1 receptor in the lungs and bronchi. This reduces the bronchoconstriction caused by leukotriene and results in less inflammation.
Montelukast effectively attenuated both lung inflammation induced by Lipopolysaccharides in a mouse model with Acute Respiratory Distress Syndrome, as in human neutrophils.
Individuals affected by long COVID-19 have self-organized to gain visibility. They have made a self-completed form to describe the characteristics of the disease. The "Persistent COVID19" network in Catalonia currently gathers more than 3000 people.
From the contact with the "Persistent COVID19 association" in Catalonia, and in search of a response to this symptomatology, which can be very disabling, a pilot study was carried out in patients with persistent COVID-19 symptoms with off-label use of Montelukast.
Empirical treatment with Montelukast at a dose of 10 mg / day for 14 days was started in 13 patients with long COVID-19, some with symptoms of more than a month of evolution since the beginning of the COVID-19 clinic. The patients were followed up to evaluate the improvement of the symptoms with a numerical scale from 0 to 100 and COPD Assessment Test Scale (CAT), 3 weeks after starting treatment.
An improvement in symptoms was observed a few days after treatment and a good evolution of the sensation of dyspnea, chest pain, symptoms of discomfort, dry cough, and nasal symptoms. Likewise, the incorporation of the patients to their work activity during that period was observed. To date, the improvement continues to exist, without evidence of clinical deterioration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomized placebo-controlled clinical trial,.
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Experimental | Drug: Montelukast10mg oral montelukast once daily for 28 days. |
| Placebo | Placebo comparator | Other: placebooral placebo once daily for 28 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients 18 to 80 years old with SARS-CoV-2 infection (positive CRP <10 days from the onset of symptoms) treated in Primary Health Care.
- Persistent respiratory symptoms (more than 1 and <12 months of evolution)
- Mild-moderate dyspnea: score at the beginning of the study according to the modified Medical Research Council (mMRC) scale from 0 to 3
- The patient must be competent to complement the follow-up evaluations.
- The patient agrees to participate in the study and take assigned medication during the 4 weeks.
Key exclusion criteria (14 listed)
- Severity criteria: fever> 38ºC, or O2 saturation <93%.
- Patients with SARS-Cov-2 pneumonia in the acute / subacute phase.
- Patients who have required hospital admission for SARS-Cov-2.
- Chronic Obstructive Pulmonary Disease (COPD), asthma, bronchiectasis, pulmonary fibrosis, obstructive sleep apnea syndrome (OSAS), chronic respiratory failure from any cause, home oxygen therapy.
- Use of montelukast or zafirlukast ≤ 30 days prior to inclusion
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 |
|---|---|---|
| MontelukastAlso: antileukotriene10 mg oral montelukast once daily for 28 days | Drug | Montelukast |
| placebo10 mg oral placebo once daily for 28 days | Other | Placebo |
Primary outcome
COP Assessment Test Scale (CAT)
Time frame: 7, 14, 21 and 28 days
Quality of life of respiratory symptoms according to COPD Assessment Test (CAT The COPD Assessment Test (CAT) is a questionnaire for people with COPD, designed to measure the impact of COPD on a person's life, and how this changes over time.Quality of life of respiratory symptoms according to COPD Assessment Test (CAT). This is a validated self-administered scale to quantify and monitor the impact of COPD on well-being and daily life. It consists of 8 items (from 0 to 5 points), and a total score of 0-40 (0-9 mild, 10-20 moderate, 21-30 severe and 31-40 very severe), being higher scores worse outcome. A difference of 2 or more points in health status is considered clinically significant.
10 secondary outcomes
1min sit-to-stand test
Time frame: 14 and 28 days
O2 desaturation
Time frame: 14 and 28 days
Visual Analogical Scale (VAS)
Time frame: 7, 14, 21 and 28 days
All-cause mortality
Time frame: 7, 14, 21 and 28 days
Number of visits to primary care
Time frame: 28 days
Number of visits to the emergency room
Time frame: 28 days
Number of hospital admissions.
Time frame: 28 days
Medication side effects
Time frame: 7, 14, 21 and 28 days
Days of sick leave
Time frame: 28 days
Factors of inflamatory and prothrombotic processes: D-Dimer, N-terminal prohormone of brain natriuretic peptide (NT Pro-BNP), C-reactive protenin and Antinuclear antibodies (ANA)
Time frame: 0 and 28 days
Results and safety
The study was stopped early (reason given: The incidence of respiratory Long COVID has decreased in the new waves, thus made impossible to achieve the required study sample.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 34991703Mera-Cordero F, Bonet-Monne S, Almeda-Ortega J, Garcia-Sangenis A, Cunillera-Puertolas O, Contreras-Martos S, Alvarez-Munoz G, Monfa R, Balanzo-Joue M, Morros R, Salvador-Gonzalez B. Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol. Trials. 2022 Jan 6;23(1):19. doi: 10.1186/s13063-021-05951-w.
- 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.
Jesus Almeda Ortega, PhD study chair
Institut Català de la Salut
Sara Bonet Monne, PhD study chair
Institut Català de la Salut
Betlem Salvador Gonzalez, PhD study chair
Institut Català de la Salut
8 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 Montelukast in people with Covid19 and SARS (Disease), run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 8 sites in Spain.
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 6 inclusion and 14 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. 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: The incidence of respiratory Long COVID has decreased in the new waves, thus made impossible to achieve the required study sample.). 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?
COP Assessment Test Scale (CAT) (time frame: 7, 14, 21 and 28 days). 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 NCT04695704, which also lists 1 linked publication.
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 3 Jul 2024.