the Lung Complication of COVID-19Phase 2NCT04568096
Combination of Chemopreventive Agents (All- Trans Retinoic Acid and Tamoxifen) as Potential Treatment for the Lung Complication of COVID-19
A Phase 2 study testing Aerosolized All-Trans Retinoic acid plus oral Tamoxifen and Standard treatment in people with the Lung Complication of COVID-19, run by Kafrelsheikh University.
Trial summary
Combination of Chemopreventive agents (All- Trans Retinoic Acid and Tamoxifen) as potential treatment for the Lung Complication of COVID-19 Abstract Angiotensin-converting enzyme (ACE2) protein found on the cell membranes is the target of SARS-CoV-2 for entering into the host cells. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- the Lung Complication of COVID-19
- What is being tested?
- Aerosolized All-Trans Retinoic acid plus oral Tamoxifen and Standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult SARI patients with 2019-ncov infection confirmed by PCR; Absolute value of lymphocytes < 0. 6x 109/L; Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 < 200 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP>=5cmH2O))
Who cannot join
- Age < 18 Pregnant Allergic to experimental drugs and patients have the following conditions:
- Hypercholesterolemia
- Hypertriglyceridemia
- Liver disease
- Renal disease
- Sjögren syndrome
Show all 23Show fewer
- Pregnancy
- Lactation
- Depressive disorder
- Body mass index less than 18 points or higher than 25 points
- Contraindications for hormonal contraception or intrauterine device.
- Autoimmune diseases A history of organ, bone marrow or hematopoietic stem cell transplantation
- Patients receiving anti-hcv treatment
- Permanent blindness in one eye
- History of iritis, endophthalmitis, scleral inflammation or retinitis 15-90 days of retinal detachment or eye surgery
- The competent physician considered it inappropriate to participate in the study Previous history of deep vein thrombosis or pulmonary embolism in the last 12 months.
- Patients with postmenopausal vaginal bleeding with no defined etiology.
- Patients with breast cancer who need to use tamoxifen for this neoplasm
- Another synchronous neoplasm that requires systemic treatment Patients with aggressive disease requiring cytotoxic therapy or locoregional therapies (eg hepatic embolization) A history of serious clinical or psychiatric illness that, by clinical judgment, may involve participation risk in this study
- Patients participating in other protocols with experimental drugs.
- Patients with oral food difficulties.
- Patients who underwent major recent surgery less than 4 weeks previously.
- Patients receiving chemotherapy or other oncologic therapy for less than 3 weeks
Trial locations and contacts
No sites are listed yet.
About this study
Combination of Chemopreventive agents (All- Trans Retinoic Acid and Tamoxifen) as potential treatment for the Lung Complication of COVID-19
Abstract
Read more
Angiotensin-converting enzyme (ACE2) protein found on the cell membranes is the target of SARS-CoV-2 for entering into the host cells. Viral spike protein-binding with ACE2 down-regulates it. As ACE2 is known to protect the lung from injuries, SARS-CoV-2-induced ACE2 deficiency may expose patients to lung damage. In this Review, we use established and emerging evidence based on the findings of previous studies and researches to propose a testable hypothesis that Combination of chemopreventive agents (All Trans Retinoic acid and Tamoxifen) can be tested to prevent inflammatory complication in severe acute respiratory syndrome coronavirus 2 infection via two mechanisms by inhibiting bradykinin B1,B2 receptors expression and upregulating the depleted ACE2 in COVID-19 . Bradykinin B1 receptors are not expressed under physiological conditions but are induced under inflammatory conditions. Here we hypothesize that permanent attack and invasion of COVID-19 to lung epithelial cells via binding to ACE2 leads to tissue injury and inflammation and that increases BK levels and BK-B2-receptor (B2R) stimulation A study reported that tissue injury and inflammation increases BK levels and BK-B2-receptor (B2R) stimulation. We suggest that Bradykinin mediates and induces lung injury, proinflammatory cytokines and inflammation likely precipitates life threatening respiratory complications in COVID-19. Further experiments showed that BK treatment stimulated IL-6 production On the other hand a study reported that cells treated with Retinoic acid and Tamoxifen for 48 h significantly decreased the BK-B2 receptor protein levels (70.3 ± 0.6% vs. 100% of control, P < 0.05). Retinoids inhibit bradykinin B1 receptor-sensitized responses and this action could participate in their anti-inflammatory and immunomodulatory effects. In addition retinoic acid, is known to possess in vivo anti-inflammatory, anti-platelet and fibrinolytic activities. A study investigated the in vitro thrombin and platelet aggregation inhibitory activities of retinoic acid and retinaldehyde.Retinoic acid, retinaldehyde and retinol exhibited potent inhibition of thrombin, with IC50 values of 67μg/ml, 74μg/ml and 152μg/ml, respectively for the inhibition of thrombin (Sigma); and 49μg/ml, 74μg/ml and 178μg/ml, respectively for the inhibition of thrombin (plasma). Amongst vitamin A and its derivatives, retinoic acid showed the highest inhibition of both the forms of thrombin. Beside the effectiveness of TAM on cancer cells, it also has other effects on numerous microbes including parasite, fungi, bacteria, and some viruses such as Ebola virus and human immunodeficiency virus (HIV).Furthermore Tamoxifen can block the action of interleukin 6 and inhibit neutrophils. A study demonstrated that tamoxifen has side effects associated with neutropenia. Since tamoxifen can cause neutropenia and subsequently influence the neutrophil-to-lymphocyte ratio (NLR) value In addition it has anti malarial effect similar to chloroquine In conclusion
Keywords: COVID 2019 , Retinoic acid, Endosomal toll-like receptor 3,T Cells, IFN type1, AT1, ACE2,TMPRSS2
Read the detailed description
This is a Phase 2, , randomized (1:1), placebo-controlled, 2-weeks, proof-of-concept study to evaluate the safety and tolerability as well as the mechanistic effect of Aerosol administration of Inhaled All trans retinoic acid and oral Tamoxifen in subjects infected with COVID -19
After randomization and standard treatment The infected patients will receive Aerosolized All-Trans Retinoic Acid in gradual in 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled All-Trans Retinoic Acid therapy plus tamoxifen 20mg orally once daily. for 14 days
Inclusion Criteria:
Adult SARI patients with 2019-ncov infection confirmed by PCR; Absolute value of lymphocytes < 0. 6x 109/L; Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 < 200 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP>=5cmH2O))
Exclusion Criteria:
Age < 18 Pregnant Allergic to experimental drugs and patients have the following conditions:
Hypercholesterolemia Hypertriglyceridemia Liver disease Renal disease Sjögren syndrome Pregnancy Lactation Depressive disorder Body mass index less than 18 points or higher than 25 points Contraindications for hormonal contraception or intrauterine device. Autoimmune diseases A history of organ, bone marrow or hematopoietic stem cell transplantation Patients receiving anti-hcv treatment Permanent blindness in one eye History of iritis, endophthalmitis, scleral inflammation or retinitis 15-90 days of retinal detachment or eye surgery The competent physician considered it inappropriate to participate in the study Previous history of deep vein thrombosis or pulmonary embolism in the last 12 months.
Patients with postmenopausal vaginal bleeding with no defined etiology. Patients with breast cancer who need to use tamoxifen for this neoplasm Another synchronous neoplasm that requires systemic treatment Patients with aggressive disease requiring cytotoxic therapy or locoregional therapies (eg hepatic embolization) A history of serious clinical or psychiatric illness that, by clinical judgment, may involve participation risk in this study Patients participating in other protocols with experimental drugs. Patients with oral food difficulties. Patients who underwent major recent surgery less than 4 weeks previously. Patients receiving chemotherapy or other oncologic therapy for less than 3 weeks
Study Type: Interventional Primary Purpose: Treatment Study Phase: Phase 2 Interventional Study Model: Parallel Assignment Number of Arms: 2 Masking: None (Open Label) Allocation: Randomized Enrollment: 160 [Anticipated]
- Conditions
- the Lung Complication of COVID-19
- Being tested
- Aerosolized All-Trans Retinoic acid plus oral Tamoxifen, Standard treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerosolized All-Trans Retinoic acid plus oral TamoxifenCombination product
After randomization and standard treatment The infected patients will receive Aerosolized All-Trans Retinoic Acid in gradual in 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled All-Trans Retinoic Acid therapy plus tamoxifen 20mg orally once daily. for 14 days
Standard treatmentOther
Standard treatment is according to the protocol of treatment of 2019-nCoV infection
| Study group | Role | What they receive |
|---|---|---|
| Aerosolized All-Trans Retinoic acid plus oral Tamoxifen | Active comparator | The infected patients will receive Aerosolized All-Trans Retinoic Acid in gradual in 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled All-Trans Retinoic Acid therapy plus tamoxifen 20mg orally once daily. for 14 days Receives: Combination Product: Aerosolized All-Trans Retinoic acid plus oral Tamoxifen |
| The standard therapy | Placebo comparator | The infected patients will receive the standard therapy for COVID-19 for 14 days Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung injury score
Proportion of lung injury score decreased or increased after treatment
Measured: at 7and 14 days
Secondary outcomes (12)
Angiotensin 1-7 (Ang 1-7) changes over time
Measured: at day 7 and 14
Angiotensin 1-5 (Ang 1-5) changes over time
Measured: at day 7 and 14
Renin changes over time
Measured: at day 7 and 14]
Aldosterone changes over time
Measured: at day 7 and 14
Angiotensin-converting enzyme (ACE) changes over time
Measured: at day 7 and 14
Frequency of adverse events and severe adverse events
Measured: 14 days
Angiotensin II (Ang II) changes over time
Measured: at day 7 and 14
Sequential organ failure assessment score(SOFA score) over time
Measured: at day 7 and 14
Transe membrane protease ,serine II (TMPRSS2) changes over time
Measured: at day 7 and 14
Testosterone levels changes over time
Measured: day 7 and 14
Dihydrotestosterone(DHT) levels changes over time
Measured: day 7 and 14
Thrombin time (TT)
Measured: day 7 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study startNov 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Lung Complication of COVID-19Studies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ramadan mohamed Elkazzaz, Kafrelsheikh University
- Investigators
- Mahmoud Elkazzaz, B.Sc in Biochemistry, Principal investigator, Facculty of Science, Damietta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568096
- Sponsor's protocol ID
- COVID-2019
- Status last verified
- Oct 2020
- First submitted
- 26 Sep 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Chemopreventive Agents (All- Trans Retinoic Acid and Tamoxifen) as Potential Treatment for the Lung Complication of COVID-19
- ClinicalTrials.gov ID
- NCT04568096
- Acronym / sponsor ID
- COVID-2019
- Conditions
- the Lung Complication of COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 29 Sep 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.
Combination of Chemopreventive agents (All- Trans Retinoic Acid and Tamoxifen) as potential treatment for the Lung Complication of COVID-19
Abstract
Angiotensin-converting enzyme (ACE2) protein found on the cell membranes is the target of SARS-CoV-2 for entering into the host cells. Viral spike protein-binding with ACE2 down-regulates it. As ACE2 is known to protect the lung from injuries, SARS-CoV-2-induced ACE2 deficiency may expose patients to lung damage. In this Review, we use established and emerging evidence based on the findings of previous studies and researches to propose a testable hypothesis that Combination of chemopreventive agents (All Trans Retinoic acid and Tamoxifen) can be tested to prevent inflammatory complication in severe acute respiratory syndrome coronavirus 2 infection via two mechanisms by inhibiting bradykinin B1,B2 receptors expression and upregulating the depleted ACE2 in COVID-19 . Bradykinin B1 receptors are not expressed under physiological conditions but are induced under inflammatory conditions. Here we hypothesize that permanent attack and invasion of COVID-19 to lung epithelial cells via binding to ACE2 leads to tissue injury and inflammation and that increases BK levels and BK-B2-receptor (B2R) stimulation A study reported that tissue injury and inflammation increases BK levels and BK-B2-receptor (B2R) stimulation. We suggest that Bradykinin mediates and induces lung injury, proinflammatory cytokines and inflammation likely precipitates life threatening respiratory complications in COVID-19. Further experiments showed that BK treatment stimulated IL-6 production On the other hand a study reported that cells treated with Retinoic acid and Tamoxifen for 48 h significantly decreased the BK-B2 receptor protein levels (70.3 ± 0.6% vs. 100% of control, P < 0.05). Retinoids inhibit bradykinin B1 receptor-sensitized responses and this action could participate in their anti-inflammatory and immunomodulatory effects. In addition retinoic acid, is known to possess in vivo anti-inflammatory, anti-platelet and fibrinolytic activities. A study investigated the in vitro thrombin and platelet aggregation inhibitory activities of retinoic acid and retinaldehyde.Retinoic acid, retinaldehyde and retinol exhibited potent inhibition of thrombin, with IC50 values of 67μg/ml, 74μg/ml and 152μg/ml, respectively for the inhibition of thrombin (Sigma); and 49μg/ml, 74μg/ml and 178μg/ml, respectively for the inhibition of thrombin (plasma). Amongst vitamin A and its derivatives, retinoic acid showed the highest inhibition of both the forms of thrombin. Beside the effectiveness of TAM on cancer cells, it also has other effects on numerous microbes including parasite, fungi, bacteria, and some viruses such as Ebola virus and human immunodeficiency virus (HIV).Furthermore Tamoxifen can block the action of interleukin 6 and inhibit neutrophils. A study demonstrated that tamoxifen has side effects associated with neutropenia. Since tamoxifen can cause neutropenia and subsequently influence the neutrophil-to-lymphocyte ratio (NLR) value In addition it has anti malarial effect similar to chloroquine In conclusion
Keywords: COVID 2019 , Retinoic acid, Endosomal toll-like receptor 3,T Cells, IFN type1, AT1, ACE2,TMPRSS2
Detailed description
This is a Phase 2, , randomized (1:1), placebo-controlled, 2-weeks, proof-of-concept study to evaluate the safety and tolerability as well as the mechanistic effect of Aerosol administration of Inhaled All trans retinoic acid and oral Tamoxifen in subjects infected with COVID -19
After randomization and standard treatment The infected patients will receive Aerosolized All-Trans Retinoic Acid in gradual in 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled All-Trans Retinoic Acid therapy plus tamoxifen 20mg orally once daily. for 14 days
Inclusion Criteria:
Adult SARI patients with 2019-ncov infection confirmed by PCR; Absolute value of lymphocytes < 0. 6x 109/L; Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 < 200 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP>=5cmH2O))
Exclusion Criteria:
Age < 18 Pregnant Allergic to experimental drugs and patients have the following conditions:
Hypercholesterolemia Hypertriglyceridemia Liver disease Renal disease Sjögren syndrome Pregnancy Lactation Depressive disorder Body mass index less than 18 points or higher than 25 points Contraindications for hormonal contraception or intrauterine device. Autoimmune diseases A history of organ, bone marrow or hematopoietic stem cell transplantation Patients receiving anti-hcv treatment Permanent blindness in one eye History of iritis, endophthalmitis, scleral inflammation or retinitis 15-90 days of retinal detachment or eye surgery The competent physician considered it inappropriate to participate in the study Previous history of deep vein thrombosis or pulmonary embolism in the last 12 months.
Patients with postmenopausal vaginal bleeding with no defined etiology. Patients with breast cancer who need to use tamoxifen for this neoplasm Another synchronous neoplasm that requires systemic treatment Patients with aggressive disease requiring cytotoxic therapy or locoregional therapies (eg hepatic embolization) A history of serious clinical or psychiatric illness that, by clinical judgment, may involve participation risk in this study Patients participating in other protocols with experimental drugs. Patients with oral food difficulties. Patients who underwent major recent surgery less than 4 weeks previously. Patients receiving chemotherapy or other oncologic therapy for less than 3 weeks
Study Type: Interventional Primary Purpose: Treatment Study Phase: Phase 2 Interventional Study Model: Parallel Assignment Number of Arms: 2 Masking: None (Open Label) Allocation: Randomized Enrollment: 160 [Anticipated]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerosolized All-Trans Retinoic acid plus oral Tamoxifen | Active comparator | Combination Product: Aerosolized All-Trans Retinoic acid plus oral TamoxifenThe infected patients will receive Aerosolized All-Trans Retinoic Acid in gradual in 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled All-Trans Retinoic Acid therapy plus tamoxifen 20mg orally once daily. for 14 days |
| The standard therapy | Placebo comparator | Other: Standard treatmentThe infected patients will receive the standard therapy for COVID-19 for 14 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult SARI patients with 2019-ncov infection confirmed by PCR; Absolute value of lymphocytes < 0. 6x 109/L; Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 < 200 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP>=5cmH2O))
Key exclusion criteria (23 listed)
- Age < 18 Pregnant Allergic to experimental drugs and patients have the following conditions:
- Hypercholesterolemia
- Hypertriglyceridemia
- Liver disease
- Renal disease
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 |
|---|---|---|
| Aerosolized All-Trans Retinoic acid plus oral TamoxifenAfter randomization and standard treatment The infected patients will receive Aerosolized All-Trans Retinoic Acid in gradual in 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled All-Trans Retinoic Acid therapy plus tamoxifen 20mg orally once daily. for 14 days | Combination product | Aerosolized All-Trans Retinoic acid plus oral Tamoxifen |
| Standard treatmentStandard treatment is according to the protocol of treatment of 2019-nCoV infection | Other | The standard therapy |
Primary outcome
lung injury score
Time frame: at 7and 14 days
Proportion of lung injury score decreased or increased after treatment
12 secondary outcomes
Angiotensin 1-7 (Ang 1-7) changes over time
Time frame: at day 7 and 14
Angiotensin 1-5 (Ang 1-5) changes over time
Time frame: at day 7 and 14
Renin changes over time
Time frame: at day 7 and 14]
Aldosterone changes over time
Time frame: at day 7 and 14
Angiotensin-converting enzyme (ACE) changes over time
Time frame: at day 7 and 14
Frequency of adverse events and severe adverse events
Time frame: 14 days
Angiotensin II (Ang II) changes over time
Time frame: at day 7 and 14
Sequential organ failure assessment score(SOFA score) over time
Time frame: at day 7 and 14
Transe membrane protease ,serine II (TMPRSS2) changes over time
Time frame: at day 7 and 14
Testosterone levels changes over time
Time frame: day 7 and 14
Dihydrotestosterone(DHT) levels changes over time
Time frame: day 7 and 14
Thrombin time (TT)
Time frame: day 7 and 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
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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.
Mahmoud Elkazzaz, B.Sc in Biochemistry principal investigator
Facculty of Science, Damietta University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerosolized All-Trans Retinoic acid plus oral Tamoxifen and Standard treatment in people with the Lung Complication of COVID-19, run by Kafrelsheikh University.
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 1 inclusion and 23 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 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Mahmoud Elkazzaz, B.Sc in Biochemistry (00201090302015, mahmoudramadan2051@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung injury score (time frame: at 7and 14 days). 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 26 Oct 2020.