COVID-19Phase 2/3INTENSE-COVNCT04466241
Combination Therapies to Reduce Carriage of SARS-Cov-2 and Improve Outcome of COVID-19 in Ivory Coast: a Phase Randomized IIb Trial
A Phase 2/3 study testing Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet, Telmisartan 40Mg Oral Tablet and Atorvastatin 20 Mg Oral Tablet in people with COVID-19 and COVID-19 Drug Treatment, run by ANRS, Emerging Infectious Diseases at 2 sites in Côte d’Ivoire.
Trial summary
In January 2020, the new SARS-CoV-2 coronavirus was identified in China. The disease caused by this coronavirus was named COVID-19 by the World Health Organization (WHO). Since March 11, 2020, the WHO has described the global situation of COVID-19 as a pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, COVID-19 Drug Treatment, Severe Acute Respiratory Syndrome Coronavirus 2
- What is being tested?
- Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet, Telmisartan 40Mg Oral Tablet and Atorvastatin 20 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 2 sitesCôte d’Ivoire
- Study dates
- 27 Nov 2020to 1 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 over 18 years of age.
- With SARS-CoV-2 infection confirmed by specific PCR.
- With clinical manifestations of the infection, such as fever or cough, or otolaryngologic (ORL) signs or respiratory difficulties, that started less than 7 days ago.
- COVID-19 specific treatment-naive.
- Women of childbearing age should accept the use of mechanical contraception during the study period.
- Informed consent signed by the patient.
Who cannot join
- Severe form of infection requiring oxygen therapy > 4l/min to achieve oxygen saturation > 94%.
- Patient whose weight is < 35kg.
- Pharmacological investigation contraindicating the introduction of a CYP450 inhibitor, in particular the CYP3A4 isoform.
- Known hypersensitivity to lopinavir, ritonavir, telmisartan, atorvastatin or their excipients.
- Renal impairment (eGFR <30 mL/min, CKD-EPI formulation).
- Known cirrhosis.
Show all 20Show fewer
- Transaminases > 3N.
- Bilirubin > 2.6N.
- Electrocardiogram showing QTc> 500 ms.
- HIV-infected patient without treatment or treated with protease inhibitors (lopinavir, darunavir, atazanavir).
- Ongoing exposure to statins.
- Contraindications to the use of statin:
- CPK > 5N, history of rhabdomyolysis or myopathies, increased risk when atorvastatin is administered with strong CYP3A4 inhibitors or transport proteins (cyclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole, letermovir, erythromycin, diltiazem, verapamil, fluconazole).
- Ongoing exposure to sartans.
- Contraindications to the use of telmisartan:
- patient on angiotensin-converting enzyme (ACE) inhibitors, aliskiren or other angiotensin receptor blockers (ARB).
- Curatorship or guardianship.
- Pregnancy or breastfeeding.
- Dementia or any other condition that prevents informed consent.
- Any reason that, at the discretion of the investigator, would compromise patient safety and cooperation in the trial.
Trial locations and contacts
2 sites in 1 country.
Côte d’Ivoire2 sites
Service des Maladies Infectieuses et Tropicales, Centre Hospitalier et Universitaire (CHU) Treichville
Abidjan, 01 BP V3
Centre de Traitement des Maladies Infectieuses (CTMI), CHU de Yopougon
Abidjan, 21 BP 632
About this study
Official title: Combination Therapies to Reduce the Nasopharyngeal Carriage of SARS-CoV-2 and Improve the Outcome of COVID-19 Infection in Ivory Coast (INTENSE-COV): a Phase IIb Randomized Clinical Trial
In January 2020, the new SARS-CoV-2 coronavirus was identified in China. The disease caused by this coronavirus was named COVID-19 by the World Health Organization (WHO). Since March 11, 2020, the WHO has described the global situation of COVID-19 as a pandemic. In Côte d'Ivoire, as in other African countries, the number of cases is increasing exponentially.
Coronaviruses are a family of viruses that cause illnesses ranging from the common cold to more severe pathologies. COVID-19 can result in fever or a feeling of fever (chills, hot-cold), cough, headache, aches and pains, unusual tiredness, sudden loss of smell, total disappearance of taste, or diarrhea. In severe forms, respiratory difficulties can lead to hospitalization in intensive care or even death.
Read more
Numerous studies are currently being conducted around the world to seek effective treatment, but few of them have started specifically in Africa. Moreover, most of these studies are using a single drug to control the infection, whether these are repositioned drugs, i.e. already being used for other diseases, or other newer drugs.
Currently in Côte d'Ivoire, the preferred treatment for COVID-19 is an antiviral: lopinavir/ritonavir (LPV/r), usually directed against the Human Immunodeficiency Virus (HIV).
Since the number of viruses (viral load) is high in the respiratory tract during COVID-19 infection, we propose in INTENSE-COV (ICOV) clinical trial to study whether the combination of two drugs is more effective than taking a single drug on reducing the viral load in the respiratory tract but also on reducing inflammation.
These drugs include the LPV/r already in use in Côte d'Ivoire as well as an antihypertensive drug - telmisartan, and a drug that lowers blood cholesterol - atorvastatin. All three have been known for a long time and have been shown to be effective against other viruses. In addition, they are generic, inexpensive and readily available in all countries.
The objectives of the ICOV study are therefore to improve viral eradication from the patient's body and respiratory tract, to reduce inflammation, to improve more rapidly the patient's state of health and to reduce the risk of transmission of the virus to others.
To participate in ICOV, patients must be over 18 years of age, have a COVID-19 infection confirmed by a specific test, have clinical manifestations of the infection, and have signed an informed consent. They will then be randomized into 3 treatment groups to ensure the robustness of the study results. The reference group will be treated with LPV/r, according to current recommendations in Côte d'Ivoire. The other 2 groups will be treated with LPV/r + telmisartan and LPV/r + atorvastatin respectively. The treatment will last 10 days and patients will be followed for a total of 28 days.
- Being tested
- Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet, Telmisartan 40Mg Oral Tablet, Atorvastatin 20 Mg Oral Tablet
- Keywords
- COVID-19, Combination therapy, Atorvastatin, Telmisartan, Lopinavir/ritonavir, SARS-COV-2, Viral load
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir/Ritonavir 200 MG-50 MG Oral TabletDrug
Also called LPV/r, Aluvia
2 tablets morning and evening from Day 1 to Day 10
Telmisartan 40Mg Oral TabletDrug
Also called TMS, Micardis, Pritor
1 tablet daily from Day 1 to Day 10
Atorvastatin 20 Mg Oral TabletDrug
Also called ATV, Tahor
1 tablet daily from Day 1 to Day 10
| Study group | Role | What they receive |
|---|---|---|
| Lopinavir/ritonavir | Active comparator | Lopinavir boosted by ritonavir 200mg/50mg: 2 tablets morning and evening from Day 1 to Day 10 Receives: Drug: Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet |
| Lopinavir/ritonavir + telmisartan | Experimental | * Lopinavir boosted by ritonavir 200mg/50mg: 2 tablets morning and evening from Day 1 to Day 10
* Telmisartan 40 mg : 1 tablet daily from Day 1 to Day 10 Receives: Drug: Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet; Drug: Telmisartan 40Mg Oral Tablet |
| Lopinavir/ritonavir + atorvastatin | Experimental | * Lopinavir boosted by ritonavir 200mg/50mg: 2 tablets morning and evening from Day 1 to Day 10
* Atorvastatin 20 mg : 1 tablet daily from Day 1 to Day 10 Receives: Drug: Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet; Drug: Atorvastatin 20 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with undetectable nasopharyngeal swab SARS-CoV-2 PCR and C-reactive protein (CRP) < 27 mg/L at Day 11
Measured: Day 11
Secondary outcomes (12)
Proportion of patients with clinical improvement on the 7-point ordinal scale at Day 11 and Day 28
Measured: Day 11 and Day 28
Kinetics of SARS-CoV-2 viral load
Measured: Up to Day 28
Death rate at Day 11 and Day 28
Measured: Day 11 and Day 28
All causes of death and Acute respiratory distress syndrome (ARDS) at Day 28
Measured: Day 28
Time to hospital discharge
Measured: Up to Day 28
Duration of oxygen supplementation
Measured: Up to Day 28
Prevalence of grade III or IV adverse events
Measured: Up to Day 28
Residual concentration of lopinavir, telmisartan and atorvastatin
Measured: Up to Day 28
Evolution of inflammatory and immunological markers (CRP, fibrinogen, ferritin, d-dimer, dosing of IgG, IgA, IgM; TCD4, CD8, B lymphocytes, NK lymphocytes; naïve/memory T lymphocytes)
Measured: Up to Day 28
Evolution of endothelial activation markers (VEGF and soluble VEGF receptor,VE-cadherin, PECAM/CD31, CD42 and angiopoietin-2)
Measured: Up to Day 28
Proportion of patients with good results according to HIV status
Measured: Up to Day 28
Number of contact cases infected by COVID-19 at Day 28
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start27 Nov 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
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 COVID-19Studies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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
- Phase IIb, comparative, multicenter, randomized, superiority, parallel-group, open-label clinical trial
- Masking
- None (open label)
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- University of Bordeaux, PACCI Program
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466241
- Sponsor's protocol ID
- ANRS COV01 INTENSE COV
- Acronym
- INTENSE-COV
- Status last verified
- Dec 2024
- First submitted
- 6 Jul 2020
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bonnet F, Doumbia A, Machault V, Ello FN, Bellecave P, Akpovo CB, Sidibe BT, Fernandez L, Kouame A, Adjogoua E, Dosso M, Niangoran S, Journot V, Eholie SP. Atorvastatin and telmisartan do not reduce nasopharyngeal carriage of SARS-CoV-2 in mild or moderate COVID-19 in a phase IIb randomized controlled trial. Sci Rep. 2024 Oct 23;14(1):25028. doi: 10.1038/s41598-024-72449-1.
PubMed 39443527
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapies to Reduce the Nasopharyngeal Carriage of SARS-CoV-2 and Improve the Outcome of COVID-19 Infection in Ivory Coast (INTENSE-COV): a Phase IIb Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04466241
- Acronym / sponsor ID
- INTENSE-COV / ANRS COV01 INTENSE COV
- Keywords
- COVID-19, Combination therapy, Atorvastatin, Telmisartan, Lopinavir/ritonavir, SARS-COV-2, Viral load
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- University of Bordeaux, PACCI Program
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 10 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.
In January 2020, the new SARS-CoV-2 coronavirus was identified in China. The disease caused by this coronavirus was named COVID-19 by the World Health Organization (WHO). Since March 11, 2020, the WHO has described the global situation of COVID-19 as a pandemic. In Côte d'Ivoire, as in other African countries, the number of cases is increasing exponentially.
Coronaviruses are a family of viruses that cause illnesses ranging from the common cold to more severe pathologies. COVID-19 can result in fever or a feeling of fever (chills, hot-cold), cough, headache, aches and pains, unusual tiredness, sudden loss of smell, total disappearance of taste, or diarrhea. In severe forms, respiratory difficulties can lead to hospitalization in intensive care or even death.
Numerous studies are currently being conducted around the world to seek effective treatment, but few of them have started specifically in Africa. Moreover, most of these studies are using a single drug to control the infection, whether these are repositioned drugs, i.e. already being used for other diseases, or other newer drugs.
Currently in Côte d'Ivoire, the preferred treatment for COVID-19 is an antiviral: lopinavir/ritonavir (LPV/r), usually directed against the Human Immunodeficiency Virus (HIV).
Since the number of viruses (viral load) is high in the respiratory tract during COVID-19 infection, we propose in INTENSE-COV (ICOV) clinical trial to study whether the combination of two drugs is more effective than taking a single drug on reducing the viral load in the respiratory tract but also on reducing inflammation.
These drugs include the LPV/r already in use in Côte d'Ivoire as well as an antihypertensive drug - telmisartan, and a drug that lowers blood cholesterol - atorvastatin. All three have been known for a long time and have been shown to be effective against other viruses. In addition, they are generic, inexpensive and readily available in all countries.
The objectives of the ICOV study are therefore to improve viral eradication from the patient's body and respiratory tract, to reduce inflammation, to improve more rapidly the patient's state of health and to reduce the risk of transmission of the virus to others.
To participate in ICOV, patients must be over 18 years of age, have a COVID-19 infection confirmed by a specific test, have clinical manifestations of the infection, and have signed an informed consent. They will then be randomized into 3 treatment groups to ensure the robustness of the study results. The reference group will be treated with LPV/r, according to current recommendations in Côte d'Ivoire. The other 2 groups will be treated with LPV/r + telmisartan and LPV/r + atorvastatin respectively. The treatment will last 10 days and patients will be followed for a total of 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase IIb, comparative, multicenter, randomized, superiority, parallel-group, open-label clinical trial
| Arm | Type | Receives |
|---|---|---|
| Lopinavir/ritonavir | Active comparator | Drug: Lopinavir/Ritonavir 200 MG-50 MG Oral TabletLopinavir boosted by ritonavir 200mg/50mg: 2 tablets morning and evening from Day 1 to Day 10 |
| Lopinavir/ritonavir + telmisartan | Experimental | Drug: Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet, Drug: Telmisartan 40Mg Oral Tablet* Lopinavir boosted by ritonavir 200mg/50mg: 2 tablets morning and evening from Day 1 to Day 10 * Telmisartan 40 mg : 1 tablet daily from Day 1 to Day 10 |
| Lopinavir/ritonavir + atorvastatin | Experimental | Drug: Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet, Drug: Atorvastatin 20 Mg Oral Tablet* Lopinavir boosted by ritonavir 200mg/50mg: 2 tablets morning and evening from Day 1 to Day 10 * Atorvastatin 20 mg : 1 tablet daily from Day 1 to Day 10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over 18 years of age.
- With SARS-CoV-2 infection confirmed by specific PCR.
- With clinical manifestations of the infection, such as fever or cough, or otolaryngologic (ORL) signs or respiratory difficulties, that started less than 7 days ago.
- COVID-19 specific treatment-naive.
- Women of childbearing age should accept the use of mechanical contraception during the study period.
Key exclusion criteria (20 listed)
- Severe form of infection requiring oxygen therapy > 4l/min to achieve oxygen saturation > 94%.
- Patient whose weight is < 35kg.
- Pharmacological investigation contraindicating the introduction of a CYP450 inhibitor, in particular the CYP3A4 isoform.
- Known hypersensitivity to lopinavir, ritonavir, telmisartan, atorvastatin or their excipients.
- Renal impairment (eGFR <30 mL/min, CKD-EPI formulation).
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 |
|---|---|---|
| Lopinavir/Ritonavir 200 MG-50 MG Oral TabletAlso: LPV/r, Aluvia2 tablets morning and evening from Day 1 to Day 10 | Drug | Lopinavir/ritonavir, Lopinavir/ritonavir + atorvastatin, Lopinavir/ritonavir + telmisartan |
| Telmisartan 40Mg Oral TabletAlso: TMS, Micardis, Pritor1 tablet daily from Day 1 to Day 10 | Drug | Lopinavir/ritonavir + telmisartan |
| Atorvastatin 20 Mg Oral TabletAlso: ATV, Tahor1 tablet daily from Day 1 to Day 10 | Drug | Lopinavir/ritonavir + atorvastatin |
Primary outcome
Proportion of patients with undetectable nasopharyngeal swab SARS-CoV-2 PCR and C-reactive protein (CRP) < 27 mg/L at Day 11
Time frame: Day 11
12 secondary outcomes
Proportion of patients with clinical improvement on the 7-point ordinal scale at Day 11 and Day 28
Time frame: Day 11 and Day 28
Kinetics of SARS-CoV-2 viral load
Time frame: Up to Day 28
Death rate at Day 11 and Day 28
Time frame: Day 11 and Day 28
All causes of death and Acute respiratory distress syndrome (ARDS) at Day 28
Time frame: Day 28
Time to hospital discharge
Time frame: Up to Day 28
Duration of oxygen supplementation
Time frame: Up to Day 28
Prevalence of grade III or IV adverse events
Time frame: Up to Day 28
Residual concentration of lopinavir, telmisartan and atorvastatin
Time frame: Up to Day 28
Evolution of inflammatory and immunological markers (CRP, fibrinogen, ferritin, d-dimer, dosing of IgG, IgA, IgM; TCD4, CD8, B lymphocytes, NK lymphocytes; naïve/memory T lymphocytes)
Time frame: Up to Day 28
Evolution of endothelial activation markers (VEGF and soluble VEGF receptor,VE-cadherin, PECAM/CD31, CD42 and angiopoietin-2)
Time frame: Up to Day 28
Proportion of patients with good results according to HIV status
Time frame: Up to Day 28
Number of contact cases infected by COVID-19 at Day 28
Time frame: Day 28
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 27 Dec 2024.
- Results publication: PubMed 39443527Bonnet F, Doumbia A, Machault V, Ello FN, Bellecave P, Akpovo CB, Sidibe BT, Fernandez L, Kouame A, Adjogoua E, Dosso M, Niangoran S, Journot V, Eholie SP. Atorvastatin and telmisartan do not reduce nasopharyngeal carriage of SARS-CoV-2 in mild or moderate COVID-19 in a phase IIb randomized controlled trial. Sci Rep. 2024 Oct 23;14(1):25028. doi: 10.1038/s41598-024-72449-1.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet, Telmisartan 40Mg Oral Tablet and Atorvastatin 20 Mg Oral Tablet in people with COVID-19 and COVID-19 Drug Treatment, run by ANRS, Emerging Infectious Diseases at 2 sites in Côte d’Ivoire.
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 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 27 Dec 2024. 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 Côte d’Ivoire. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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?
Proportion of patients with undetectable nasopharyngeal swab SARS-CoV-2 PCR and C-reactive protein (CRP) < 27 mg/L at Day 11 (time frame: Day 11). 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 NCT04466241, 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 27 Dec 2024.