COVID-19Phase 2/3CoTeTNCT05459532
A Randomised, Multi-centre, Double-blind, Phase 3 Study to Observe the Effectiveness, Safety and Tolerability of Molnupiravir Compared to Placebo Administered Orally to High-risk Adult Outpatients With Mild COVID-19 Receiving Local Standard of Care in South Africa
A Phase 2/3 study testing Molnupiravir 200 mg in people with COVID-19, run by University of Witwatersrand, South Africa at 4 sites in South Africa.
Trial summary
This is a multi-centre, double-blind, phase 3 study to observe the effectiveness, safety, and tolerability of molnupiravir 800 mg administered 12-hourly for five days in adult patients with mild COVID-19 at the time of enrolment, who are at risk of progression to severe disease, compared to a placebo. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Molnupiravir 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 4 sitesSouth Africa
- Study dates
- 12 Aug 2022to 30 Sep 2023
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able and willing to provide written or electronic informed consent prior to any study-specific procedure.
- Age ≥50 at the time of signing the informed consent form.
- Women of reproductive potential must have a negative pregnancy test at screening and be using a highly effective method of contraception. Highly effective methods of contraception
- A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another while taking the investigational product. Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak.
- Self-reported symptoms of COVID-19 with onset no more than five days prior to screening informed consent including at least one of, fever or chills, cough, sore throat, rhinorrhoea or rhinitis or sinusitis, shortness of breath, headache, myalgia, new onset anosmia or ageusia, nausea, diarrhoea, or extreme fatigue, or other symptoms recognized in local and international guidelines as typical of mild COVID-19.
- SARS-CoV-2 infection confirmed through a positive LumiraDx rapid antigen test on the day of screening or a positive RT-PCR within two days prior to screening.
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- Participant is at high risk for progression to severe COVID-19, this defined as either:
- Age ≥50 with at least one of the following background or medical conditions: diabetes mellitus, obesity (BMI 30 kg/m2), hypertension, HIV, active or previous TB.
- Age ≥65
- Participant agrees to comply with study procedures, including the completion of a daily diary for 10 days from the time of enrolment, and to be available for study contacts and visits.
- -
Who cannot join
- Pregnant or breastfeeding women, or women planning/desiring to become pregnant during the 28 days following enrolment into the study.
- Duration of self-reported symptoms of COVID-19 for more than five days prior to screening.
- Signs of respiratory distress or severe disease prior to enrolment, including:
- Inability/unlikely to be in the study area for the duration of the 28-day follow-up period.
- Inability to tolerate oral medications.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the patient or the objectives of the study. The Investigator should make this determination in consideration of the volunteer's medical history.
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- The volunteer is assessed to be clinically unstable in the Investigator's opinion.
- Participation in another investigational study involving an investigational product within 30 days, or 5 half-lives, whichever is longer, prior to screening.
- Personnel (e.g., investigator, sub-investigator, research assistant, pharmacist, study coordinator or anyone mentioned in the delegation log) directly involved in the conduct of the study.
- Any physical, mental, or social condition, drug/alcohol use, history of illness or laboratory abnormality that, in the Investigator's judgment, might jeopardise the safety of the patient in the context of this study, or might interfere with study procedures or the ability of the subject to adhere to and complete the study. The Investigator should make this determination in consideration of the volunteer's medical history.
Trial locations and contacts
4 sites in 1 country.
South Africa4 sites
Nelson R. Mandela School of Medicine 3rd Floor, K-RITH Tower Building
Durban, KwaZulu-Natal, 3935
Sunnyside Office Park
Johannesburg, Gauteng, 2193
The Aurum Institute: Gavin J Churchyard Legacy Centre Klerksdorp Clinical Research Centre
Klerksdorp, North West, 2571
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
Umtata, Eastern Cape, 5099
About this study
Official title: This is a Multi-centre, Double-blind, Phase 3 Study to Observe the Effectiveness, Safety, and Tolerability of Molnupiravir 800 mg Administered 12-hourly for Five Days to Adult Patients With Mild COVID-19 at the Time of Enrolment Who Are at Risk of Progression to Severe Disease, Compared to a Placebo. Patients With Recent Onset of COVID-19 Symptoms Will be Screened to Assess Eligibility for Enrolment. Confirmation of SARS-CoV-2 Infection Will be Performed Through Rapid Antigen Detection Using the LumiraDx Point of Care Diagnostic Platform.
This is a multi-centre, double-blind, phase 3 study to observe the effectiveness, safety, and tolerability of molnupiravir 800 mg administered 12-hourly for five days in adult patients with mild COVID-19 at the time of enrolment, who are at risk of progression to severe disease, compared to a placebo.
Read the detailed description
This is a multi-centre, double-blind, phase 3 study to observe the effectiveness, safety, and tolerability of molnupiravir 800 mg administered 12-hourly for five days in adult patients with mild COVID-19 at the time of enrolment, who are at risk of progression to severe disease, compared to a placebo.
Patients with recent onset of COVID-19 symptoms will be screened to assess eligibility for enrolment. Confirmation of SARS-CoV-2 infection will be performed through rapid antigen detection using the LumiraDx point of care diagnostic platform. Approximately 4000 eligible patients will be enrolled and will be randomised in a 1:1 manner to start treatment with either molnupiravir or a placebo on the same day. Patients will record their symptoms (through a self-administered questionnaire) and self-observed vital signs daily for 10 days from the time of enrolment and will be contacted by study team personnel on Days 3, 6 and 10 to monitor their well-being. Adverse event and concomitant medication data will be collected. A final end-of-study follow-up visit will be conducted on Day 29.
An independent Data and Safety Monitoring Board (DSMB) will be convened for this study with expertise in COVID-19 or respiratory viruses, and emerging epidemics. The purpose of the DSMB is to monitor the study for safety and operational futility.
In addition to the usual, regular, required reporting to SAHPRA, the investigator anticipates that additional reporting will be required by the Clinical Trials Committee, noting the severity of the 3rd and 4th waves, the level of ''breakthrough'' infections in the context of high background comorbidities, and the urgent interest in this class of drugs.
- Conditions
- COVID-19
- Being tested
- Molnupiravir 200 mg
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molnupiravir 200 mgDrug
The drug is orally bioavailable (and is indicated for treatment of mild to moderate COVID-19 in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness. The recommended dose is 800 mg (four 200 mg capsules) taken orally 12-hourly for five days, and should be administered as soon as possible after diagnosis of COVID-19 has been made and within five days of symptom onset.
| Study group | Role | What they receive |
|---|---|---|
| Monulpiravir | Experimental | Eligible participants will be randomised in a 1:1 manner to receive either molnupiravir 800 mg orally approximately 12-hourly for five days or a placebo for the equivalent amount of time. Receives: Drug: Molnupiravir 200 mg |
| Placebo | Placebo comparator | Eligible participants will be randomised in a 1:1 manner to receive either molnupiravir 800 mg orally approximately 12-hourly for five days or a placebo for the equivalent amount of time. Receives: Drug: Molnupiravir 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effectiveness of molnupiravir compared to placebo in preventing severe disease progression in adults with mild COVID-19
Combination of incidence of COVID-19-related hospitalisation (24 hours of care in a hospital or similar acute care facility) and COVID-19-related mortality to Day 29
Measured: 29 Days
To evaluate the safety of molnupiravir in adults with mild COVID-19
Adverse events (including serious adverse events and adverse drug reactions)
Measured: 29 Days
To evaluate the safety of molnupiravir in adults with mild COVID-19
Self-assessed vital signs to Day 10
Measured: 29 Days
Secondary outcomes (16)
To facilitate same-day COVID-19 diagnosis and treatment initiation in adults with mild COVID-19 and comorbid conditions
Proportion of enrolled patients for whom diagnosis and same day treatment initiation was facilitated through use of a LumiraDx™ rapid antigen test
Measured: 29 Days
To assess the tolerability of molnupiravir in adults with mild COVID-19
Severity of adverse events
Measured: 29 Days
To assess the tolerability of molnupiravir in adults with mild COVID-19
Adverse event-related study drug discontinuations
Measured: 29 Days
To describe time to symptom resolution in adults with mild COVID-19 treated with molnupiravir compared to placebo
Time to sustained resolution of symptoms as reported in the Flu-PRO© Plus
Measured: 29 Days
To evaluate maximum COVID-19 disease severity in adults treated with molnupiravir compared to placebo
Maximum score on the WHO Clinical Progression Scale from Day 1 to Day 29
Measured: 29 Days
To evaluate the relationship between effectiveness of molnupiravir and time between onset of symptoms and initiation of treatment
Number of days from symptom onset to initiation of treatment
Measured: 29 Days
To evaluate the relationship between effectiveness of molnupiravir and time between onset of symptoms and initiation of treatment
Incidence of hospitalisation (24 hours of care in a hospital or similar acute care facility) and/or death to Day 29 in patients with co-morbid conditions
Measured: 29 Days
To evaluate the relationship between effectiveness of molnupiravir and time between onset of symptoms and initiation of treatment
Time to sustained resolution of symptoms as reported in the Flu-PRO Plus
Measured: Day 1 to Day 10 and Day 29
To evaluate the relationship between effectiveness of molnupiravir and time between onset of symptoms and initiation of treatment
Maximum score on the WHO Clinical Progression Scale from Day 1 to Day 29. On a scale of 0 to 10 (0 being uninfected and 10 being worse/death)
Measured: Day 0, 3, 6, 10, 29
To describe adherence to a 5-day course of molnupiravir in adults with mild COVID-19
Proportion of patients completing the course of molnupiravir as prescribed
Measured: 29 Days
To describe the utilisation of health care services by adults with mild COVID-19 treated with molnupiravir compared to placebo
Rate of hospital, emergency facility, clinic, health care practitioner or home visits to Day 29
Measured: 29 Days
To report the incidence and outcome of pregnancies in female participants who received molnupiravir
Incidence of pregnancy in female participants to Day 29
Measured: 29 Days
To report the incidence and outcome of pregnancies in female participants who received molnupiravir
20-week gestational age ultrasound findings
Measured: Once
To report the incidence and outcome of pregnancies in female participants who received molnupiravir
Pregnancy complications
Measured: Throughout the pregnancy
To report the incidence and outcome of pregnancies in female participants who received molnupiravir
Pregnancy outcome
Measured: Once
To report the incidence and outcome of pregnancies in female participants who received molnupiravir
Infant wellbeing to three months of age
Measured: Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start12 Aug 2022
- Primary completion7 Jul 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Molnupiravir is a broad-spectrum antiviral that is an orally bioavailable prodrug of the nucleoside analogue NHC. NHC distributes into cells where it is phosphorylated to form the pharmacologically active NHC-TP. NHC-TP acts by a mechanism known as viral error catastrophe. NHC-TP incorporation into viral RNA by the viral RNA polymerase, results in an accumulation of errors in the viral genome leading to inhibition of replication.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Professor Francois Venter, University of Witwatersrand, South Africa
- Investigators
- Francois WD Venter, Study director, Ezintsha, Faculty of Health Sciences University of the Witwatersrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459532
- Sponsor's protocol ID
- EZ-SS-029
- Acronym
- CoTeT
- Status last verified
- Jun 2025
- First submitted
- 13 Jul 2022
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that will be shared is all of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This is a Multi-centre, Double-blind, Phase 3 Study to Observe the Effectiveness, Safety, and Tolerability of Molnupiravir 800 mg Administered 12-hourly for Five Days to Adult Patients With Mild COVID-19 at the Time of Enrolment Who Are at Risk of Progression to Severe Disease, Compared to a Placebo. Patients With Recent Onset of COVID-19 Symptoms Will be Screened to Assess Eligibility for Enrolment. Confirmation of SARS-CoV-2 Infection Will be Performed Through Rapid Antigen Detection Using the LumiraDx Point of Care Diagnostic Platform.
- ClinicalTrials.gov ID
- NCT05459532
- Acronym / sponsor ID
- CoTeT / EZ-SS-029
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 15 Jul 2022 (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.
This is a multi-centre, double-blind, phase 3 study to observe the effectiveness, safety, and tolerability of molnupiravir 800 mg administered 12-hourly for five days in adult patients with mild COVID-19 at the time of enrolment, who are at risk of progression to severe disease, compared to a placebo.
Detailed description
This is a multi-centre, double-blind, phase 3 study to observe the effectiveness, safety, and tolerability of molnupiravir 800 mg administered 12-hourly for five days in adult patients with mild COVID-19 at the time of enrolment, who are at risk of progression to severe disease, compared to a placebo.
Patients with recent onset of COVID-19 symptoms will be screened to assess eligibility for enrolment. Confirmation of SARS-CoV-2 infection will be performed through rapid antigen detection using the LumiraDx point of care diagnostic platform. Approximately 4000 eligible patients will be enrolled and will be randomised in a 1:1 manner to start treatment with either molnupiravir or a placebo on the same day. Patients will record their symptoms (through a self-administered questionnaire) and self-observed vital signs daily for 10 days from the time of enrolment and will be contacted by study team personnel on Days 3, 6 and 10 to monitor their well-being. Adverse event and concomitant medication data will be collected. A final end-of-study follow-up visit will be conducted on Day 29.
An independent Data and Safety Monitoring Board (DSMB) will be convened for this study with expertise in COVID-19 or respiratory viruses, and emerging epidemics. The purpose of the DSMB is to monitor the study for safety and operational futility.
In addition to the usual, regular, required reporting to SAHPRA, the investigator anticipates that additional reporting will be required by the Clinical Trials Committee, noting the severity of the 3rd and 4th waves, the level of ''breakthrough'' infections in the context of high background comorbidities, and the urgent interest in this class of drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Molnupiravir is a broad-spectrum antiviral that is an orally bioavailable prodrug of the nucleoside analogue NHC. NHC distributes into cells where it is phosphorylated to form the pharmacologically active NHC-TP. NHC-TP acts by a mechanism known as viral error catastrophe. NHC-TP incorporation into viral RNA by the viral RNA polymerase, results in an accumulation of errors in the viral genome leading to inhibition of replication.
| Arm | Type | Receives |
|---|---|---|
| Monulpiravir | Experimental | Drug: Molnupiravir 200 mgEligible participants will be randomised in a 1:1 manner to receive either molnupiravir 800 mg orally approximately 12-hourly for five days or a placebo for the equivalent amount of time. |
| Placebo | Placebo comparator | Drug: Molnupiravir 200 mgEligible participants will be randomised in a 1:1 manner to receive either molnupiravir 800 mg orally approximately 12-hourly for five days or a placebo for the equivalent amount of time. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able and willing to provide written or electronic informed consent prior to any study-specific procedure.
- Age ≥50 at the time of signing the informed consent form.
- Women of reproductive potential must have a negative pregnancy test at screening and be using a highly effective method of contraception. Highly effective methods of contraception
- A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another while taking the investigational product. Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak.
- Self-reported symptoms of COVID-19 with onset no more than five days prior to screening informed consent including at least one of, fever or chills, cough, sore throat, rhinorrhoea or rhinitis or sinusitis, shortness of breath, headache, myalgia, new onset anosmia or ageusia, nausea, diarrhoea, or extreme fatigue, or other symptoms recognized in local and international guidelines as typical of mild COVID-19.
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding women, or women planning/desiring to become pregnant during the 28 days following enrolment into the study.
- Duration of self-reported symptoms of COVID-19 for more than five days prior to screening.
- Signs of respiratory distress or severe disease prior to enrolment, including:
- Inability/unlikely to be in the study area for the duration of the 28-day follow-up period.
- Inability to tolerate oral medications.
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 |
|---|---|---|
| Molnupiravir 200 mgThe drug is orally bioavailable (and is indicated for treatment of mild to moderate COVID-19 in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness. The recommended dose is 800 mg (four 200 mg capsules) taken orally 12-hourly for five days, and should be administered as soon as possible after diagnosis of COVID-19 has been made and within five days of symptom onset. | Drug | Monulpiravir, Placebo |
Primary outcome
To evaluate the effectiveness of molnupiravir compared to placebo in preventing severe disease progression in adults with mild COVID-19
Time frame: 29 Days
Combination of incidence of COVID-19-related hospitalisation (24 hours of care in a hospital or similar acute care facility) and COVID-19-related mortality to Day 29
To evaluate the safety of molnupiravir in adults with mild COVID-19
Time frame: 29 Days
Adverse events (including serious adverse events and adverse drug reactions)
To evaluate the safety of molnupiravir in adults with mild COVID-19
Time frame: 29 Days
Self-assessed vital signs to Day 10
16 secondary outcomes
To facilitate same-day COVID-19 diagnosis and treatment initiation in adults with mild COVID-19 and comorbid conditions
Time frame: 29 Days
To assess the tolerability of molnupiravir in adults with mild COVID-19
Time frame: 29 Days
To assess the tolerability of molnupiravir in adults with mild COVID-19
Time frame: 29 Days
To describe time to symptom resolution in adults with mild COVID-19 treated with molnupiravir compared to placebo
Time frame: 29 Days
To evaluate maximum COVID-19 disease severity in adults treated with molnupiravir compared to placebo
Time frame: 29 Days
To evaluate the relationship between effectiveness of molnupiravir and time between onset of symptoms and initiation of treatment
Time frame: 29 Days
To evaluate the relationship between effectiveness of molnupiravir and time between onset of symptoms and initiation of treatment
Time frame: 29 Days
To evaluate the relationship between effectiveness of molnupiravir and time between onset of symptoms and initiation of treatment
Time frame: Day 1 to Day 10 and Day 29
To evaluate the relationship between effectiveness of molnupiravir and time between onset of symptoms and initiation of treatment
Time frame: Day 0, 3, 6, 10, 29
To describe adherence to a 5-day course of molnupiravir in adults with mild COVID-19
Time frame: 29 Days
To describe the utilisation of health care services by adults with mild COVID-19 treated with molnupiravir compared to placebo
Time frame: 29 Days
To report the incidence and outcome of pregnancies in female participants who received molnupiravir
Time frame: 29 Days
To report the incidence and outcome of pregnancies in female participants who received molnupiravir
Time frame: Once
To report the incidence and outcome of pregnancies in female participants who received molnupiravir
Time frame: Throughout the pregnancy
To report the incidence and outcome of pregnancies in female participants who received molnupiravir
Time frame: Once
To report the incidence and outcome of pregnancies in female participants who received molnupiravir
Time frame: Once
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 1 Jul 2025.
- Individual participant dataSharing planned: Yes. The data that will be shared is 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.
Francois WD Venter study director
Ezintsha, Faculty of Health Sciences University of the Witwatersrand
4 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 Molnupiravir 200 mg in people with COVID-19, run by University of Witwatersrand, South Africa at 4 sites in South Africa.
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 11 inclusion and 10 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 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Africa. 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?
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?
To evaluate the effectiveness of molnupiravir compared to placebo in preventing severe disease progression in adults with mild COVID-19 (time frame: 29 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.