SARS-CoV2Phase 2/3CANDIDATENCT04467918
CANnabiDiol for CoviD-19 pATiEnts With Mild to Moderate Symptoms
A Phase 2/3 study testing Cannabidiol in people with SARS-CoV2, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
The aim of this work is to conduct a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of cannabidiol (CBD - 300 mg a day) in patients infected with SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV2
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesBrazil
- Study dates
- 6 Jul 2020to 16 Nov 2021
- Phase
- Phase 2/3
- 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
- Patients of both sexes, older than 18 years of age, with SARS-CoV-2 infection confirmed in upper or lower respiratory tract secretion, through reverse transcription followed by polymerase chain reaction (RT- PCR), with mild or moderate manifestations of Covid-19, who wish to participate, and consent by signing the informed consent form and not involved in another clinical trial during the study period
- Pneumonia assessed clinically and / or radiologically will not be mandatory for inclusion
- Have a telephone (cellular or landline) that may be available to receive daily calls throughout the study period.
- Willingness to voluntarily participate in the study to accept randomization for either treatment arm.
- Signing of the approved Free and Informed Consent Form (ICF) by the Research Ethics Committee (CEP) and CONEP
Who cannot join
- Age below 18 years
- Patients who do not want or can fulfill the necessary home isolation for at least 14 days
- Chronic clinical conditions, severe or not compensated, such as: insulin-dependent diabetes (types 1 or 2); uncontrolled hypertension, lung disease such as asthma or COPD; hematological and liver diseases, chronic kidney disease in advanced stage (grades 3, 4 and 5), metabolic disorders and immunosuppression
- Use of any medication with potential interaction with CBD (such as chloroquine, clobazan, warfarin, or valproic acid) or history of undesirable reactions prior to the use of this cannabinoid
- Inability to use oral medication
- Pregnancy or lactation
Show all 11Show fewer
- History of alcohol or drug addiction
- Smoking in the last three years
- Marijuana use in the last three months
- Inability to cooperate with researchers due to cognitive impairment or mental state
- Patients with severe forms of SARS-CoV-2, (on screening, inclusion or initial visit)
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Serviço de Assistência Médica e Social do Pessoal do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14049-900
Unidade de Pronto Atendimento/UPA - 13 de Maio/Dr. Luis Atílio Losi Viana (UPA Covid)
Ribeirão Preto, São Paulo, 14090-270
About this study
Official title: Cannabidiol (CBD) in Patients With Mild to Moderate Symptoms of Coronavirus 2019: A Randomized, Double-blind, Placebo-controlled Clinical Trial
The aim of this work is to conduct a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of cannabidiol (CBD - 300 mg a day) in patients infected with SARS-CoV-2.
The specific objectives are to assess whether, in patients with mild and moderate forms of SARS-CoV-2, daily use of CBD 300 mg for fourteen days is capable of:
- decrease viral load; ii) modify inflammatory parameters, such as cytokines, measured from serum; iii) reduce clinical and emotional symptoms through daily clinical evaluation; iv) improve sleep; v) reduce hospitalization and worsen the severity of the disease; v) Monitor the possible adverse effects of CBD use in these patients.
Read the detailed description
The present study will be a single-center, randomized, parallel, double-blind, placebo-controlled clinical trial of CBD in patients with mild to moderate SARS-CoV-2 infection. The investigators will use random stratification by minimizing the sample to stratify all eligible patients according to gender, age, disease severity (mild or moderate) and presence of comorbidity (controlled diabetes and/or hypertension), followed by random designation (in a ratio 1: 1) in each stratum to ensure a balanced distribution of disease severity among treatment groups (CBD plus symptomatic clinical and pharmacological measures) and control (symptomatic clinical and pharmacological measures and placebo). All patients will receive the clinical and pharmacological measures standardized by the Brazilian Ministry of Health's practical guidelines for diagnosis and treatment for mild and moderate cases for SARS-CoV-2 (https://portalarquivos.saude.gov.br/images/pdf /2020/April/18/Dirursos-Covid19.pdf). In other words, the following pharmacological measures: "prescription of drugs for symptom control, if there is no contraindication, with the possibility of intercalating antipyretic drugs in cases of difficult control of fever. • Oral antipyretic: 1st option: Paracetamol 500-1000 mg/dose (maximum 3mg / day) • 2nd option: Dipyrone 500-1000 mg VO (maximum dose in adults 4 grams)", and clinical measures:" Home isolation by 14 days from the date of onset of symptoms; review every 48 hours, preferably by phone, providing face-to-face assistance, if necessary; maintain rest, a balanced diet and a good supply of fluids; isolation from home contacts for 14 days".
Thus, all patients will receive clinical and pharmacological measures of symptoms. Patients in the investigational treatment group will also receive CBD within 24 hours after randomization, with a daily dose of 300mg / day (two 150mg doses; 1mL of the formulation) for 14 days. Patients in the placebo group will also receive, within 24 hours after randomization, 1mL of the same investigational medication vehicle (medium/coconut chain triglyceride oil - MCT) for 14 days, using a dosing device/syringe indistinguishable from the CBD medication. Patients, nursing staff, laboratory technicians, doctors who will carry out the assessments, researchers, and statisticians will be blind to the treatment group and will not know about the treatment information.
Secretions from the upper respiratory tract, lower respiratory tract, or both, by swab, will be obtained from each patient in the screening (day -3 to day 1) during treatment and post-treatment follow-up at the patient's home on days 1, 2, 3, 4, 5, 7, 10, 14, 21, and 28, to test the viral load and SARS-CoV-2 genotyping. On all these dates, nurses will visit home to collect swab (only from the oropharynx, to minimize discomfort), blood and will be evaluated at each visit for vital signs, pulse oximetry, odor test, and treatment guidelines. Each patient will also receive a digital thermometer to measure the axillary temperature in case of suspected fever and daily measurement immediately before lunch and dinner.
- Conditions
- SARS-CoV2
- Being tested
- Cannabidiol, PLACEBO
- Keywords
- SARS-CoV2; Cannabidiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called CBD
Already described
PLACEBOOther
Also called PLB
Already described
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol (CBD) | Experimental | 50 cases in the CBD group plus pharmacological and clinical measures. Patients in the investigational treatment group will receive CBD within 24 hours after randomization, with a daily dose of 300mg / day (two 150mg doses; 1mL of the formulation) for 14 days. Receives: Drug: Cannabidiol |
| Placebo (PLB) | Placebo comparator | 50 in the placebo group plus pharmacological and clinical measures. Patients in the placebo group will also receive, within 24 hours after randomization, 1mL of the same investigational medication vehicle (medium / coconut chain triglyceride oil - MCT) for 14 days Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of severe/critical stage of Covid19
Deterioration in clinical status from mild/moderate to severe/critical over time during the study period
Measured: Up to 28 days
Time to CoVid19 symptoms relief and number of participants with negative Clinical CoVid19 symptoms as assessed by CTCAE v5.0
Clinical CoVid19 symptoms Clinical improvement
Measured: Up to 28 days
Secondary outcomes (10)
Change in proinflammatory cytokine concentration
Immune reaction
Measured: Up to 28 days
Describe the parenchymal lung damage induced by COVID-19 through a qualitative analysis with chest CT
A qualitative CT analysis of parenchymal lung damage induced by COVID-19
Measured: 14 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured: Up to 28 days
Time to clinical improvement with CTCAE v5.0 CoVid19 symptoms to 0
Time to clinical improvement
Measured: Up to 28 days
Number of participants that need hospitalisation
CoVid severity worsening
Measured: Up to 28 days
28-day mortality
Mortality
Measured: Up to 28 days
Time to positive-to-negative saliva 2019-n-CoV RT-PCR conversion
Time to negative saliva
Measured: Up to 28 days
Reduction in viral load
Mean reduction in viral load (reduction of ≥1 log10) over time during the study period
Measured: Up to 28 days
Brief measure for assessing generalized anxiety disorder and depression
Brief measure for assessing generalized anxiety disorder (The GAD-7) and depression (PHQ-9)
Measured: Through study completion, over time during the study period (day 0-28)]
Increment of odor detection sensitivity
Scores of the brief peanut butter olfactory test (Univ Florida)
Measured: Through study completion, over time during the study period (day 0-28)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start6 Jul 2020
- Primary completion16 Nov 2021 (estimated)
- Study completion16 Nov 2021 (estimated)
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 SARS-CoV2Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 104 patients with SARS-CoV-2 infection will be included in the study (i.e., 52 cases in the CBD group plus pharmacological and clinical measures and 52 in the placebo group plus pharmacological and clinical measures). All patients will receive the clinical and pharmacological measures standardized by the Brazilian Ministry of Health's practical guidelines for diagnosis and treatment for mild and moderate cases for SARS-CoV-2
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Jose Alexandre de Souza Crippa, University of Sao Paulo
- Investigators
- Jose ALEXANDRE DE S CRIPPA, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467918
- Sponsor's protocol ID
- CANDIDATE study
- Acronym
- CANDIDATE
- Status last verified
- Sep 2021
- First submitted
- 3 Jul 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Crippa JAS, Pacheco JC, Zuardi AW, Guimaraes FS, Campos AC, Osorio FL, Loureiro SR, Dos Santos RG, Souza JDS, Ushirohira JM, Ferreira RR, Mancini Costa KC, Scomparin DS, Scarante FF, Pires-Dos-Santos I, Mechoulam R, Kapczinski F, Fonseca BAL, Esposito DLA, Passos ADC, Dal Fabbro AL, Bellissimo-Rodrigues F, Arruda E, Scarpelini S, Andraus MH, Nather Junior JC, Wada DT, Koenigkam-Santos M, Santos AC, Busatto Filho G, Hallak JEC. Cannabidiol for COVID-19 Patients with Mild to Moderate Symptoms (CANDIDATE Study): A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Cannabis Cannabinoid Res. 2022 Oct;7(5):658-669. doi: 10.1089/can.2021.0093. Epub 2021 Oct 7.
PubMed 34619044
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol (CBD) in Patients With Mild to Moderate Symptoms of Coronavirus 2019: A Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04467918
- Acronym / sponsor ID
- CANDIDATE / CANDIDATE study
- Conditions
- SARS-CoV2
- Keywords
- SARS-CoV2; Cannabidiol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 16 Nov 2021 (estimated)
- Study completion
- 16 Nov 2021 (estimated)
- First posted
- 13 Jul 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.
The aim of this work is to conduct a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of cannabidiol (CBD - 300 mg a day) in patients infected with SARS-CoV-2.
The specific objectives are to assess whether, in patients with mild and moderate forms of SARS-CoV-2, daily use of CBD 300 mg for fourteen days is capable of:
- decrease viral load; ii) modify inflammatory parameters, such as cytokines, measured from serum; iii) reduce clinical and emotional symptoms through daily clinical evaluation; iv) improve sleep; v) reduce hospitalization and worsen the severity of the disease; v) Monitor the possible adverse effects of CBD use in these patients.
Detailed description
The present study will be a single-center, randomized, parallel, double-blind, placebo-controlled clinical trial of CBD in patients with mild to moderate SARS-CoV-2 infection. The investigators will use random stratification by minimizing the sample to stratify all eligible patients according to gender, age, disease severity (mild or moderate) and presence of comorbidity (controlled diabetes and/or hypertension), followed by random designation (in a ratio 1: 1) in each stratum to ensure a balanced distribution of disease severity among treatment groups (CBD plus symptomatic clinical and pharmacological measures) and control (symptomatic clinical and pharmacological measures and placebo). All patients will receive the clinical and pharmacological measures standardized by the Brazilian Ministry of Health's practical guidelines for diagnosis and treatment for mild and moderate cases for SARS-CoV-2 (https://portalarquivos.saude.gov.br/images/pdf /2020/April/18/Dirursos-Covid19.pdf). In other words, the following pharmacological measures: "prescription of drugs for symptom control, if there is no contraindication, with the possibility of intercalating antipyretic drugs in cases of difficult control of fever. • Oral antipyretic: 1st option: Paracetamol 500-1000 mg/dose (maximum 3mg / day) • 2nd option: Dipyrone 500-1000 mg VO (maximum dose in adults 4 grams)", and clinical measures:" Home isolation by 14 days from the date of onset of symptoms; review every 48 hours, preferably by phone, providing face-to-face assistance, if necessary; maintain rest, a balanced diet and a good supply of fluids; isolation from home contacts for 14 days".
Thus, all patients will receive clinical and pharmacological measures of symptoms. Patients in the investigational treatment group will also receive CBD within 24 hours after randomization, with a daily dose of 300mg / day (two 150mg doses; 1mL of the formulation) for 14 days. Patients in the placebo group will also receive, within 24 hours after randomization, 1mL of the same investigational medication vehicle (medium/coconut chain triglyceride oil - MCT) for 14 days, using a dosing device/syringe indistinguishable from the CBD medication. Patients, nursing staff, laboratory technicians, doctors who will carry out the assessments, researchers, and statisticians will be blind to the treatment group and will not know about the treatment information.
Secretions from the upper respiratory tract, lower respiratory tract, or both, by swab, will be obtained from each patient in the screening (day -3 to day 1) during treatment and post-treatment follow-up at the patient's home on days 1, 2, 3, 4, 5, 7, 10, 14, 21, and 28, to test the viral load and SARS-CoV-2 genotyping. On all these dates, nurses will visit home to collect swab (only from the oropharynx, to minimize discomfort), blood and will be evaluated at each visit for vital signs, pulse oximetry, odor test, and treatment guidelines. Each patient will also receive a digital thermometer to measure the axillary temperature in case of suspected fever and daily measurement immediately before lunch and dinner.
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
- A total of 104 patients with SARS-CoV-2 infection will be included in the study (i.e., 52 cases in the CBD group plus pharmacological and clinical measures and 52 in the placebo group plus pharmacological and clinical measures). All patients will receive the clinical and pharmacological measures standardized by the Brazilian Ministry of Health's practical guidelines for diagnosis and treatment for mild and moderate cases for SARS-CoV-2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol (CBD) | Experimental | Drug: Cannabidiol50 cases in the CBD group plus pharmacological and clinical measures. Patients in the investigational treatment group will receive CBD within 24 hours after randomization, with a daily dose of 300mg / day (two 150mg doses; 1mL of the formulation) for 14 days. |
| Placebo (PLB) | Placebo comparator | Other: PLACEBO50 in the placebo group plus pharmacological and clinical measures. Patients in the placebo group will also receive, within 24 hours after randomization, 1mL of the same investigational medication vehicle (medium / coconut chain triglyceride oil - MCT) for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of both sexes, older than 18 years of age, with SARS-CoV-2 infection confirmed in upper or lower respiratory tract secretion, through reverse transcription followed by polymerase chain reaction (RT- PCR), with mild or moderate manifestations of Covid-19, who wish to participate, and consent by signing the informed consent form and not involved in another clinical trial during the study period
- Pneumonia assessed clinically and / or radiologically will not be mandatory for inclusion
- Have a telephone (cellular or landline) that may be available to receive daily calls throughout the study period.
- Willingness to voluntarily participate in the study to accept randomization for either treatment arm.
- Signing of the approved Free and Informed Consent Form (ICF) by the Research Ethics Committee (CEP) and CONEP
Key exclusion criteria (11 listed)
- Age below 18 years
- Patients who do not want or can fulfill the necessary home isolation for at least 14 days
- Chronic clinical conditions, severe or not compensated, such as: insulin-dependent diabetes (types 1 or 2); uncontrolled hypertension, lung disease such as asthma or COPD; hematological and liver diseases, chronic kidney disease in advanced stage (grades 3, 4 and 5), metabolic disorders and immunosuppression
- Use of any medication with potential interaction with CBD (such as chloroquine, clobazan, warfarin, or valproic acid) or history of undesirable reactions prior to the use of this cannabinoid
- Inability to use oral medication
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 |
|---|---|---|
| CannabidiolAlso: CBDAlready described | Drug | Cannabidiol (CBD) |
| PLACEBOAlso: PLBAlready described | Other | Placebo (PLB) |
Primary outcome
Prevention of severe/critical stage of Covid19
Time frame: Up to 28 days
Deterioration in clinical status from mild/moderate to severe/critical over time during the study period
Time to CoVid19 symptoms relief and number of participants with negative Clinical CoVid19 symptoms as assessed by CTCAE v5.0
Time frame: Up to 28 days
Clinical CoVid19 symptoms Clinical improvement
10 secondary outcomes
Change in proinflammatory cytokine concentration
Time frame: Up to 28 days
Describe the parenchymal lung damage induced by COVID-19 through a qualitative analysis with chest CT
Time frame: 14 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 28 days
Time to clinical improvement with CTCAE v5.0 CoVid19 symptoms to 0
Time frame: Up to 28 days
Number of participants that need hospitalisation
Time frame: Up to 28 days
28-day mortality
Time frame: Up to 28 days
Time to positive-to-negative saliva 2019-n-CoV RT-PCR conversion
Time frame: Up to 28 days
Reduction in viral load
Time frame: Up to 28 days
Brief measure for assessing generalized anxiety disorder and depression
Time frame: Through study completion, over time during the study period (day 0-28)]
Increment of odor detection sensitivity
Time frame: Through study completion, over time during the study period (day 0-28)]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 34619044Crippa JAS, Pacheco JC, Zuardi AW, Guimaraes FS, Campos AC, Osorio FL, Loureiro SR, Dos Santos RG, Souza JDS, Ushirohira JM, Ferreira RR, Mancini Costa KC, Scomparin DS, Scarante FF, Pires-Dos-Santos I, Mechoulam R, Kapczinski F, Fonseca BAL, Esposito DLA, Passos ADC, Dal Fabbro AL, Bellissimo-Rodrigues F, Arruda E, Scarpelini S, Andraus MH, Nather Junior JC, Wada DT, Koenigkam-Santos M, Santos AC, Busatto Filho G, Hallak JEC. Cannabidiol for COVID-19 Patients with Mild to Moderate Symptoms (CANDIDATE Study): A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Cannabis Cannabinoid Res. 2022 Oct;7(5):658-669. doi: 10.1089/can.2021.0093. Epub 2021 Oct 7.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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 ALEXANDRE DE S CRIPPA, MD, PhD principal investigator
University of Sao Paulo
2 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 Cannabidiol in people with SARS-CoV2, run by University of Sao Paulo at 2 sites in Brazil.
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 5 inclusion and 11 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 28 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 2 sites in Brazil. 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?
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?
Prevention of severe/critical stage of Covid19 (time frame: Up to 28 days). 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 NCT04467918, 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 28 Sep 2021.