Covid19Phase 3NCT04530422
Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment
A Phase 3 study testing Sofosbuvir plus Ledipasvir in people with Covid19, run by Almaza Military Fever Hospital at 1 site in Egypt.
Trial summary
Currently there is no known effective therapy or vaccine for treatment of SARS-CoV-2, highlighting urgency around identifying effective therapies. This study aiming to evaluate the anti-HCV medications efficacy "Sofosbuvir-Ledipasvir" in treatment of moderate cases with SARS-COV-2 infection, in comparison to the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19
- What is being tested?
- Sofosbuvir plus Ledipasvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2020to 23 Jul 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pneumonic patients with SARS-COV-2 infection confirmed to be positive by RT-PCR; and demonstrated moderate cases criteria (fever "measured temperature of at least 38 °C", lower respiratory symptoms "cough, shortness of breath" and imaging-confirmed pneumonia").
- Female patients enrolled in the study should have no planned pregnancy for 6 months, after participating in the study, with administration of proper contraceptive measures within 30 days from the first therapeutic dose of the investigational drugs.
- Patients agreed to sign an informed consent to participate in the current study and that they would not participate in other clinical trials within 30 days from the last administration of the study drugs.
Who cannot join
- Severe COVID-19 patients who met one of the following conditions: (1) Respiratory rate (RR) ≥ 30 times / min; (2) SaO2 / SpO2 ≤ 93% in resting state; (3) arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) ≤ 300 mmHg
- Critical COVID-19 patients with one of the following conditions: (1) respiratory failure and need mechanical ventilation; (2) shock; (3) other organ failure combined with ICU treatment; severe liver disease (such as child Pugh score ≥ C, AST > 5 times upper limit);
- Patients with contraindications specified for sofosbuvir- ledipasvir; the pregnancy test of female subjects during the screening period was positive, the researchers judged that the patient was not suitable to participate in this clinical study due to devastating co-morbid diseases (e.g. de-compensated liver disease, congested heart failure, chronic kidney disease, malignant or hematological disease under therapy or 3 months ago) and patients received antiviral eradication therapy for hepatitis C or B viruses within the previous 6 months.
- Patients with chloroquine contra-indications: QTc > 500 m/sec, myasthenia gravis, porphyria, retinal pathology, epilepsy, G6PD deficiency, allergy to 4-aminoquinolone, chronic heart, kidney or liver disease, and arrhythmias.
- Any patient demonstrates worsening of symptoms, radiological progression with virologically persistence within at least 5 days of the therapeutic evaluation period of the study after exclusion of cytokine storm was considered as a clinical failure and was shifted to the other management protocol.
- Treatment was terminated at any time by a multidisciplinary team if a serious side effect occurred, which was attributed to the medications used ,e.g. cardiac arrhythmia, deteriorated liver or kidney function or unfortunately patient died .
Trial locations and contacts
1 site in 1 country.
About this study
Currently there is no known effective therapy or vaccine for treatment of SARS-CoV-2, highlighting urgency around identifying effective therapies.
This study aiming to evaluate the anti-HCV medications efficacy "Sofosbuvir-Ledipasvir" in treatment of moderate cases with SARS-COV-2 infection, in comparison to the standard treatment (hydroxychloroquine, oseltamivir and azithromycin).
Read the detailed description
This randomized controlled clinical trial is a prospective, comparative, single blind, randomized study that was conducted on 250 patients, divided into two equal groups. The group I received Sofosbuvir plus Ledipasvir and Group II received Oseltamivir, hydroxychloroquine "HCQ" plus Azithromycin (the local medical committee of Almaza Fever Hospital guided standard treatment protocol for COVID-19).
Randomization (in RCT only)
Once enrolled in the study, patients randomly assigned to one of the following groups:
- Group I (SL group, n=125): patients received Sofosbuvir plus Ledipasvir.
- Group II (OCH group, n=125): patients received Oseltamivir plus HCQ \& Azithromycin.
Randomization applied through computer-generated number and concealed using sequentially numbered, sealed opaque envelope.
Group I Patients assigned to this group (125 patients) were received Sofosbuvir plus Ledipasvir (FDA approved Anti-HCV drug since 2014, with Reference ID: 4081324), once daily for 15 to 21days as minimum and maximum duration of therapy, respectively.
Additional conservative medications were given including, third generation cephalosporines (Ceftriaxone 2 gm /24 hours) for 7 days, methylprednisolone 1 mg/kg/day for 7 days; and prophylactic low molecular weight heparin (enoxaparine) 40 mg/24 hours was given throughout hospitalization period.
Patients were evaluated as scheduled on day 0,5,10 \& 15 (also, day 21 if extended duration) clinically, laboratory investigations including RT-PCR \& C.T chest. RT-PCR with negative result was repeated after 24-48 hrs.
Medications stopped any time if there was any clinical, radiological or laboratory deterioration.
Group II
Patients in this group (125 patients) were received the local medical committee of Almaza Fever Hospital guided standard treatment protocol for COVID-19:
- Oseltamivir 150 mg q 12 hours for 10 days ;
- HCQ 400 q 12 hours for one day followed by 200mg q 12 hours for 9 days ; and
- Azithromycin 500mg once daily for 1 day , followed by 250mg once daily for 6 days.
- Additional conservative medications were also given. Patients were evaluated as scheduled on day 0, 5 \& 11 clinically, laboratory Investigations including RT-PCR \& C.T chest. RT-PCR with negative result was repeated after 24-48 hrs. Medication were stopped any time, if there was any clinical, radiological or laboratory deterioration.
2.3 Assessment tools
Basic investigations were applied for all patients on day 0 , repeated on days 5 ,10 \& 15 or earlier regarding physician order , including :
- CBC, NLR "neutrophil lymphocyte ratio ".
- ESR.
- AST, ALT, creatinine; fasting blood glucose.
- ECG.
- C.T chest , pneumonia was assessed on admission using CT Severity Scoring System (CT-SSS) and CO-RADS ( Percentage per lobe with max of 5 points for each lobe and 25 points for both lungs ; Right Lung" RUL , RML \& RLL " ; Left lung " LUL \& LLL " ) (11)
Follow up CT chest was repeated on day 5, 10 and day15 or earlier according to physician's request. It was reported as progressive, regressive, stationary or resolved (progressive: crazy paving +↑CTSS ± consolidation; regressive: i.e. absorption (resolved crazy paving pattern +↓CTSS (12); Cured: complete resolution of pneumonic patches).
Other investigations were asked and repeated when needed including:
- LDH.
- TG.
- D. dimmer.
- S.Ferritin.
- Interleukin 6 level.
- Abdominal U.S.
COVID-19 RT-PCR test was done by extraction of the DNA of the virus by using either device (QIA cube or QIA symphony), it takes 70 minutes for every 12 sample on QIA cube or 5 hours for every 96 samples on the QIA symphony. Then the process was applied for the preparation and implementation of the RT-PCR step by using chemicals for detection of the COVID-19, which takes from one and half hour to two hours for 72 samples.
Discharge criteria
- Resolution of symptoms (Normal body temperature for at least 3 days and significantly improved respiratory symptoms).
- Radiological improvement of pneumonic pattern in CT chest.
- Documented virological clearance in 2 samples at least 24 hours apart.
- There was no co-morbidities or complications, which require hospitalization.
- SpO2 > 93 % without assisted oxygen inhalation.
- Discharge approved by multi-disciplinary medical team.
- Conditions
- Covid19
- Being tested
- Sofosbuvir plus Ledipasvir
- Keywords
- SARS-COV-2, Covid-19, Sofosbuvir- Ledipasvir, Hydroxychloroquine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir plus LedipasvirDrug
Also called Oseltamivir plus Hydroxychloroquine & Azithromycin
Sofosbuvir plus Ledipasvir, once daily for 15 to 21days
- Oseltamivir 150 mg q 12 hours for 10 days ;
- HCQ 400 q 12 hours for one day followed by 200mg q 12 hours for 9 days ; and
- Azithromycin 500mg once daily for 1 day , followed by 250mg once daily for 6 days.
| Study group | Role | What they receive |
|---|---|---|
| • Group I (Sofosbuvir plus Ledipasvir) | Experimental | Patients assigned to this group (125 patients) were received Sofosbuvir plus Ledipasvir, once daily for 15 to 21 days as minimum and maximum duration of therapy, respectively. Receives: Drug: Sofosbuvir plus Ledipasvir |
| Group II (Oseltamivir plus HCQ & Azithromycin) | Active comparator | Patients in this group (125 patients) were received the local medical committee of Almaza Fever Hospital guided standard treatment protocol for COVID-19:
* Oseltamivir 150 mg q 12 hours for 10 days ;
* HCQ 400 q 12 hours for one day followed by 200mg q 12 hours for 9 days ; and
* Azithromycin 500mg once daily for 1 day , followed by 250mg once daily for 6 days.
* Additional conservative medications were also given. Patients were evaluated as scheduled on day 0, 5 \& 11 clinically Receives: Drug: Sofosbuvir plus Ledipasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic success (cured)
Cured: Documented virological clearance in 2 samples at least 24 hours apart.
Measured: 21 days
28 days in hospital mortality
any incidence of deaths for any participant within 28 days from starting the treatments
Measured: 28 days
Secondary outcomes (3)
Percentage of clinical failure of treatments
participants who failed to achieve documented virological clearance in 2 samples at least 24 hours apart.
Measured: 21 Days
Length of hospital stay
days of length of hospital staying in isolation till documented virological clearance in 2 samples at least 24 hours apart.
Measured: Through study completion, an average of 14 weeks
Incidence of side effects
Incidence of any side effects known to be related to the medication administrated either in group 1 or 2
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start15 Apr 2020
- Primary completion8 Jul 2020
- Study completion23 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- This randomized controlled clinical trial is a prospective, comparative, single blind, randomized study that was conducted on 250 patients, divided into two equal groups. The group I received Sofosbuvir plus Ledipasvir and Group II received Oseltamivir, hydroxychloroquine "HCQ" plus Azithromycin (the local medical committee of Almaza Fever Hospital guided standard treatment protocol for COVID-19)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almaza Military Fever Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelsalam El-Gohary, Almaza Military Fever Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530422
- Sponsor's protocol ID
- 14
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment
- ClinicalTrials.gov ID
- NCT04530422
- Acronym / sponsor ID
- 14
- Conditions
- Covid19
- Keywords
- SARS-COV-2, Covid-19, Sofosbuvir- Ledipasvir, Hydroxychloroquine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Almaza Military Fever HospitalUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 28 Aug 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.
Currently there is no known effective therapy or vaccine for treatment of SARS-CoV-2, highlighting urgency around identifying effective therapies.
This study aiming to evaluate the anti-HCV medications efficacy "Sofosbuvir-Ledipasvir" in treatment of moderate cases with SARS-COV-2 infection, in comparison to the standard treatment (hydroxychloroquine, oseltamivir and azithromycin).
Detailed description
This randomized controlled clinical trial is a prospective, comparative, single blind, randomized study that was conducted on 250 patients, divided into two equal groups. The group I received Sofosbuvir plus Ledipasvir and Group II received Oseltamivir, hydroxychloroquine "HCQ" plus Azithromycin (the local medical committee of Almaza Fever Hospital guided standard treatment protocol for COVID-19).
Randomization (in RCT only)
Once enrolled in the study, patients randomly assigned to one of the following groups:
- Group I (SL group, n=125): patients received Sofosbuvir plus Ledipasvir.
- Group II (OCH group, n=125): patients received Oseltamivir plus HCQ \& Azithromycin.
Randomization applied through computer-generated number and concealed using sequentially numbered, sealed opaque envelope.
Group I Patients assigned to this group (125 patients) were received Sofosbuvir plus Ledipasvir (FDA approved Anti-HCV drug since 2014, with Reference ID: 4081324), once daily for 15 to 21days as minimum and maximum duration of therapy, respectively.
Additional conservative medications were given including, third generation cephalosporines (Ceftriaxone 2 gm /24 hours) for 7 days, methylprednisolone 1 mg/kg/day for 7 days; and prophylactic low molecular weight heparin (enoxaparine) 40 mg/24 hours was given throughout hospitalization period.
Patients were evaluated as scheduled on day 0,5,10 \& 15 (also, day 21 if extended duration) clinically, laboratory investigations including RT-PCR \& C.T chest. RT-PCR with negative result was repeated after 24-48 hrs.
Medications stopped any time if there was any clinical, radiological or laboratory deterioration.
Group II
Patients in this group (125 patients) were received the local medical committee of Almaza Fever Hospital guided standard treatment protocol for COVID-19:
- Oseltamivir 150 mg q 12 hours for 10 days ;
- HCQ 400 q 12 hours for one day followed by 200mg q 12 hours for 9 days ; and
- Azithromycin 500mg once daily for 1 day , followed by 250mg once daily for 6 days.
- Additional conservative medications were also given. Patients were evaluated as scheduled on day 0, 5 \& 11 clinically, laboratory Investigations including RT-PCR \& C.T chest. RT-PCR with negative result was repeated after 24-48 hrs. Medication were stopped any time, if there was any clinical, radiological or laboratory deterioration.
2.3 Assessment tools
Basic investigations were applied for all patients on day 0 , repeated on days 5 ,10 \& 15 or earlier regarding physician order , including :
- CBC, NLR "neutrophil lymphocyte ratio ".
- ESR.
- AST, ALT, creatinine; fasting blood glucose.
- ECG.
- C.T chest , pneumonia was assessed on admission using CT Severity Scoring System (CT-SSS) and CO-RADS ( Percentage per lobe with max of 5 points for each lobe and 25 points for both lungs ; Right Lung" RUL , RML \& RLL " ; Left lung " LUL \& LLL " ) (11)
Follow up CT chest was repeated on day 5, 10 and day15 or earlier according to physician's request. It was reported as progressive, regressive, stationary or resolved (progressive: crazy paving +↑CTSS ± consolidation; regressive: i.e. absorption (resolved crazy paving pattern +↓CTSS (12); Cured: complete resolution of pneumonic patches).
Other investigations were asked and repeated when needed including:
- LDH.
- TG.
- D. dimmer.
- S.Ferritin.
- Interleukin 6 level.
- Abdominal U.S.
COVID-19 RT-PCR test was done by extraction of the DNA of the virus by using either device (QIA cube or QIA symphony), it takes 70 minutes for every 12 sample on QIA cube or 5 hours for every 96 samples on the QIA symphony. Then the process was applied for the preparation and implementation of the RT-PCR step by using chemicals for detection of the COVID-19, which takes from one and half hour to two hours for 72 samples.
Discharge criteria
- Resolution of symptoms (Normal body temperature for at least 3 days and significantly improved respiratory symptoms).
- Radiological improvement of pneumonic pattern in CT chest.
- Documented virological clearance in 2 samples at least 24 hours apart.
- There was no co-morbidities or complications, which require hospitalization.
- SpO2 > 93 % without assisted oxygen inhalation.
- Discharge approved by multi-disciplinary medical team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This randomized controlled clinical trial is a prospective, comparative, single blind, randomized study that was conducted on 250 patients, divided into two equal groups. The group I received Sofosbuvir plus Ledipasvir and Group II received Oseltamivir, hydroxychloroquine "HCQ" plus Azithromycin (the local medical committee of Almaza Fever Hospital guided standard treatment protocol for COVID-19)
| Arm | Type | Receives |
|---|---|---|
| • Group I (Sofosbuvir plus Ledipasvir) | Experimental | Drug: Sofosbuvir plus LedipasvirPatients assigned to this group (125 patients) were received Sofosbuvir plus Ledipasvir, once daily for 15 to 21 days as minimum and maximum duration of therapy, respectively. |
| Group II (Oseltamivir plus HCQ & Azithromycin) | Active comparator | Drug: Sofosbuvir plus LedipasvirPatients in this group (125 patients) were received the local medical committee of Almaza Fever Hospital guided standard treatment protocol for COVID-19: * Oseltamivir 150 mg q 12 hours for 10 days ; * HCQ 400 q 12 hours for one day followed by 200mg q 12 hours for 9 days ; and * Azithromycin 500mg once daily for 1 day , followed by 250mg once daily for 6 days. * Additional conservative medications were also given. Patients were evaluated as scheduled on day 0, 5 \& 11 clinically |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pneumonic patients with SARS-COV-2 infection confirmed to be positive by RT-PCR; and demonstrated moderate cases criteria (fever "measured temperature of at least 38 °C", lower respiratory symptoms "cough, shortness of breath" and imaging-confirmed pneumonia").
- Female patients enrolled in the study should have no planned pregnancy for 6 months, after participating in the study, with administration of proper contraceptive measures within 30 days from the first therapeutic dose of the investigational drugs.
- Patients agreed to sign an informed consent to participate in the current study and that they would not participate in other clinical trials within 30 days from the last administration of the study drugs.
Key exclusion criteria (6 listed)
- Severe COVID-19 patients who met one of the following conditions: (1) Respiratory rate (RR) ≥ 30 times / min; (2) SaO2 / SpO2 ≤ 93% in resting state; (3) arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) ≤ 300 mmHg
- Critical COVID-19 patients with one of the following conditions: (1) respiratory failure and need mechanical ventilation; (2) shock; (3) other organ failure combined with ICU treatment; severe liver disease (such as child Pugh score ≥ C, AST > 5 times upper limit);
- Patients with contraindications specified for sofosbuvir- ledipasvir; the pregnancy test of female subjects during the screening period was positive, the researchers judged that the patient was not suitable to participate in this clinical study due to devastating co-morbid diseases (e.g. de-compensated liver disease, congested heart failure, chronic kidney disease, malignant or hematological disease under therapy or 3 months ago) and patients received antiviral eradication therapy for hepatitis C or B viruses within the previous 6 months.
- Patients with chloroquine contra-indications: QTc > 500 m/sec, myasthenia gravis, porphyria, retinal pathology, epilepsy, G6PD deficiency, allergy to 4-aminoquinolone, chronic heart, kidney or liver disease, and arrhythmias.
- Any patient demonstrates worsening of symptoms, radiological progression with virologically persistence within at least 5 days of the therapeutic evaluation period of the study after exclusion of cytokine storm was considered as a clinical failure and was shifted to the other management protocol.
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 |
|---|---|---|
| Sofosbuvir plus LedipasvirAlso: Oseltamivir plus Hydroxychloroquine & AzithromycinSofosbuvir plus Ledipasvir, once daily for 15 to 21days * Oseltamivir 150 mg q 12 hours for 10 days ; * HCQ 400 q 12 hours for one day followed by 200mg q 12 hours for 9 days ; and * Azithromycin 500mg once daily for 1 day , followed by 250mg once daily for 6 days. | Drug | Group II (Oseltamivir plus HCQ & Azithromycin), • Group I (Sofosbuvir plus Ledipasvir) |
Primary outcome
Therapeutic success (cured)
Time frame: 21 days
Cured: Documented virological clearance in 2 samples at least 24 hours apart.
28 days in hospital mortality
Time frame: 28 days
any incidence of deaths for any participant within 28 days from starting the treatments
3 secondary outcomes
Percentage of clinical failure of treatments
Time frame: 21 Days
Length of hospital stay
Time frame: Through study completion, an average of 14 weeks
Incidence of side effects
Time frame: 21 days
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 28 Aug 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sofosbuvir plus Ledipasvir in people with Covid19, run by Almaza Military Fever Hospital at 1 site in Egypt.
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 3 inclusion and 6 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 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 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 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?
Therapeutic success (cured) (time frame: 21 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?
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 Aug 2020.