Covid19NCT04873349
Standardized Olive Leaf Capsules; as a Co-therapy in the Treatment of COVID-19 Patients
A study testing Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein) in people with Covid19 and COVID-19 Respiratory Infection, run by Shimaa M. Abdelgawad at 1 site in Egypt.
Trial summary
Starting from December 2019, novel coronavirus disease 2019 (COVID-19) pandemic has caused a tremendous economic loss and unprecedented health crisis across the globe. Discovering an effective and safe drug candidates for the treatment of COVID-19 and its associated symptoms became a global urgent demand especially… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, COVID-19 Respiratory Infection, Symptoms and Signs
- What is being tested?
- Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2021to 1 Aug 2022
- Phase
- Interventional
- 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
- Adults.
- Confirmed SARS-CoV-2 diagnosis (positive polymerase chain reaction by nasopharyngeal swab).
- Mild to Moderate COVID-19 patients.
- No history of the current use of olive leaf capsules supplement.
Who cannot join
- Severe and critical COVID-19 patients who need hospitalization.
- Patients need ventilatory support or showing chronic obstructive pulmonary disease (COPD).
- Patients showing any chronic disease (except hypertension and diabetes mellitus).
- Patients who have multiorgan failure.
- 3. Use of alcohol, other investigational medicines, and illegal drugs (during the last 30 days).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Clinical Effectiveness of Standardized Olive Leaf Capsules; as a Co-therapy in the Treatment of Non-hospitalized COVID-19 Patients; a Randomized Clinical Trial
Starting from December 2019, novel coronavirus disease 2019 (COVID-19) pandemic has caused a tremendous economic loss and unprecedented health crisis across the globe. Discovering an effective and safe drug candidates for the treatment of COVID-19 and its associated symptoms became a global urgent demand especially due to limited data that have been released regarding the vaccine efficacy and safety in humans. Reviewing the recent research, Olive leaf was selected as a potential co-therapy supplement for the treatment and the improvement of clinical manifestations in COVID-19 patients. Olive leaves reported to be rich in phenolic compounds such as oleuropein, hydroxy tyrosol, verbascoside, apigenin-7-glucoside and luteolin-7-glucoside which has been reported as anti-SARS-CoV-2 metabolites in recent In silico, computational and in vitro studies. In addition, olive leaf extract was previously reported in several in vivo studies for its anti-inflammatory, analgesic, antipyretic, immunomodulatory and anti-thrombotic activities which is of a great benefit in the control of associated inflammatory cytokine storm and disseminated intravascular coagulation in COVID-19 patients.
A placebo-controlled, randomized clinical trial at Fayoum University Hospital in Egypt will be conducted. RT-PCR confirmed COVID-19 adults showing mild to moderate disease will be enrolled in the study. Patients presenting with multi-organ failure, ventilator support, and chronic diseases (except diabetes mellitus and hypertension) were excluded. Patients were randomly assigned in 1:1 ratio to receive standardized olive leaves capsules (containing 20-50% oleuropein) or placebo up-to 10 days along with standard care. The expected outcomes included symptom alleviation, viral clearance, improvement of analysis (CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT and AST) and a 10-day mortality in intention-to-treat population.
Read the detailed description
Objectives:
We will evaluate the efficacy of standardized olive leaf capsules as additive therapy to the standard therapeutic regimen (for a period 10 days) on clinical symptoms, viral clearance, improvement of analysis:
- Complete blood count (CBC).
- C-Reactive Protein (CRP)
- Lactate dehydrogenase (LDH).
- Erythrocyte Sedimentation rate (ESR).
- Serum Ferritin
- D-dimer
- Serum creatinine.
- Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST).
- Also, a 30-day mortality in patients with confirmed COVID-19, who are mild to moderately ill.
Trial design:
This is a single-center, randomized, double-blind, placebo-controlled clinical trial with a parallel-group design conducted at Fayoum university Hospital, Fayoum, Egypt.
Research Plan and Methodology 1-Complete patient history will be recorded (other diseases, current medications, age, sex, etc.) 2-Clinical investigation of patients by the physicians at Chest Department, Fayoum University Hospital including measurements such as Temperature and Oxygen saturation.
3-Patients will be tested for infection by PCR and all patients to be enrolled at the study should show positive PCR result.
4-The following analysis will be carried out for all the patients included in the study; CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT and AST before treatment and for follow up after 10 days.
Participants:
All outpatients admitted to Chest Diseases Departments of Fayoum university Hospital, will be screened for the following criteria.
Inclusion criteria:
- Adults.
- Confirmed SARS-CoV-2 diagnosis (positive polymerase chain reaction by nasopharyngeal swab).
- Mild to Moderate COVID-19 patients.
- No history of the current use of olive leaf capsules supplement.
Exclusion criteria:
- Severe and critical COVID-19 patients who need hospitalization.
- Patients need ventilatory support or showing chronic obstructive pulmonary disease (COPD).
- Patients showing any chronic disease (except hypertension and diabetes mellitus).
- Patients who have multiorgan failure.
- Use of alcohol, other investigational medicines, and illegal drugs (during the last 30 days).
Intervention and comparator:
A total of 60 patients randomized into two groups (30 in each group). The patients will be divided into 2 groups Intervention group: All patients receive the standard treatment regimen for COVID-19, according to the Egyptian Ministry of Health protocol, along with 2-3 capsules/day of standardized olive leaf containing 20-50% oleuropein (500-750 mg oleuropein daily) for a period of ten days.
Control group: The standard therapeutic regimen for COVID-19 along with placebo capsules daily for a period of ten days.
Main outcomes:
The main outcomes are the improvement of clinical symptoms, as well as oxygen saturation, viral clearance, improvement of analysis (CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT and AST) within 10 days of randomization in patients with confirmed COVID-19, who are mild to moderately ill.
Randomization:
Included patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). This randomization method ensures a balanced allocation between the arms during the study. A web-based system will generate random numbers for the allocation sequence and concealment of participants. Each number relates to one of the study arms.
Ethical considerations All participants should Sign informed consent and show willingness to accept randomization to any assigned treatment arm.
- Conditions
- Covid19, COVID-19 Respiratory Infection, Symptoms and Signs, COVID-19 Acute Bronchitis, Disseminated Intravascular Coagulation
- Being tested
- Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein)
- Keywords
- COVID-19, Infection, Bronchitis, Coagulation, Symptoms
- Medical subject headings
- COVID-19, Signs and Symptoms, Disseminated Intravascular Coagulation, Infections, Bronchitis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein)Dietary supplement
two study groups; test group will receive Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein) while placebo group will receive starch group
| Study group | Role | What they receive |
|---|---|---|
| Olive leaf capsules | Active comparator | Non-hospitalized COVID-19 patients who have positive PCR results and show mild to moderate clinical manifestations and symptoms (20-30 patients) will receive a 50% standardized olive leaf capsule 750 mg (700 mg oleuropein/day; the active principle in olive leaf) two times daily for a period of ten days alongside with the Egyptian protocol medications. All the active comparator participants should be adults, with no chronic diseases (except hypertension and diabetes), non addict or alcoholics. Receives: Dietary Supplement: Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein) |
| Starch capsules | Placebo comparator | Non-hospitalized COVID-19 patients who have positive PCR results and show mild to moderate clinical manifestations and symptoms (20-30 patients) will receive a placebo starch capsules (750 mg) two times daily for a period of ten days alongside with the Egyptian protocol medications. All the placebo comparator participants should be adults, with no chronic diseases (except hypertension and diabetes), non addict or alcoholics. Receives: Dietary Supplement: Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving the clinical symptoms in mild to moderate COVID -19 patients
It is expected that the examined drug will alleviate symptoms such as fever, cough, sore throat and muscles ache
Measured: 10 days after treatment
Viral clearance in mild to moderate COVID -19 patients
It is expected that the examined drug will make the Polymerase chain reaction (PCR ) results for the test group negative within 10 days of treatment
Measured: 10 days after treatment
Improvement of analysis (CBC)
It is expected that the treatment will improve the lab analysis for treatment group such as increase lymphocyte count in complete blood count (CBC).
Measured: 10 days after treatment
Improvement of analysis (CRP)
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of C-reactive protein (CRP).
Measured: 10 days after treatment
Improvement of analysis (LDH)
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of Lactate dehydrogenase (LDH).
Measured: 10 days after treatment
Improvement of analysis (ESR)
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of Erythrocyte sedimentation rate (ESR).
Measured: 10 days after treatment
Improvement of analysis (Ferritin)
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of Ferritin.
Measured: 10 days after treatment
Improvement of analysis (D-dimer)
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of D-dimer.
Measured: 10 days after treatment
Secondary outcomes (4)
Evaluate mortality rate in patients with confirmed COVID-19 moderately ill
It is expected that the drug will reduce the conversion in cases from moderate to sever cases and so decrease the mortality rate
Measured: 10 days after treatment
Improvement of analysis (creatinine)
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of creatinine.
Measured: 10 days after treatment
Improvement of analysis (ALT)
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of Alanine Amino Transferase (ALT).
Measured: 10 days after treatment
improvement of analysis (AST)
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of Aspartate Amino Transferase (AST).
Measured: 10 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start10 May 2021
- Primary completion1 Mar 2022
- Study completion1 Aug 2022
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shimaa M. Abdelgawad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shimaa M. Abdelgawad, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873349
- Sponsor's protocol ID
- EC 2121
- Status last verified
- Feb 2023
- First submitted
- 4 May 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Clinical Effectiveness of Standardized Olive Leaf Capsules; as a Co-therapy in the Treatment of Non-hospitalized COVID-19 Patients; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04873349
- Acronym / sponsor ID
- EC 2121
- Conditions
- Covid19, COVID-19 Respiratory Infection, Symptoms and Signs, COVID-19 Acute Bronchitis, Disseminated Intravascular Coagulation
- Keywords
- COVID-19, Infection, Bronchitis, Coagulation, Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shimaa M. AbdelgawadUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 5 May 2021 (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.
Starting from December 2019, novel coronavirus disease 2019 (COVID-19) pandemic has caused a tremendous economic loss and unprecedented health crisis across the globe. Discovering an effective and safe drug candidates for the treatment of COVID-19 and its associated symptoms became a global urgent demand especially due to limited data that have been released regarding the vaccine efficacy and safety in humans. Reviewing the recent research, Olive leaf was selected as a potential co-therapy supplement for the treatment and the improvement of clinical manifestations in COVID-19 patients. Olive leaves reported to be rich in phenolic compounds such as oleuropein, hydroxy tyrosol, verbascoside, apigenin-7-glucoside and luteolin-7-glucoside which has been reported as anti-SARS-CoV-2 metabolites in recent In silico, computational and in vitro studies. In addition, olive leaf extract was previously reported in several in vivo studies for its anti-inflammatory, analgesic, antipyretic, immunomodulatory and anti-thrombotic activities which is of a great benefit in the control of associated inflammatory cytokine storm and disseminated intravascular coagulation in COVID-19 patients.
A placebo-controlled, randomized clinical trial at Fayoum University Hospital in Egypt will be conducted. RT-PCR confirmed COVID-19 adults showing mild to moderate disease will be enrolled in the study. Patients presenting with multi-organ failure, ventilator support, and chronic diseases (except diabetes mellitus and hypertension) were excluded. Patients were randomly assigned in 1:1 ratio to receive standardized olive leaves capsules (containing 20-50% oleuropein) or placebo up-to 10 days along with standard care. The expected outcomes included symptom alleviation, viral clearance, improvement of analysis (CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT and AST) and a 10-day mortality in intention-to-treat population.
Detailed description
Objectives:
We will evaluate the efficacy of standardized olive leaf capsules as additive therapy to the standard therapeutic regimen (for a period 10 days) on clinical symptoms, viral clearance, improvement of analysis:
- Complete blood count (CBC).
- C-Reactive Protein (CRP)
- Lactate dehydrogenase (LDH).
- Erythrocyte Sedimentation rate (ESR).
- Serum Ferritin
- D-dimer
- Serum creatinine.
- Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST).
- Also, a 30-day mortality in patients with confirmed COVID-19, who are mild to moderately ill.
Trial design:
This is a single-center, randomized, double-blind, placebo-controlled clinical trial with a parallel-group design conducted at Fayoum university Hospital, Fayoum, Egypt.
Research Plan and Methodology 1-Complete patient history will be recorded (other diseases, current medications, age, sex, etc.) 2-Clinical investigation of patients by the physicians at Chest Department, Fayoum University Hospital including measurements such as Temperature and Oxygen saturation.
3-Patients will be tested for infection by PCR and all patients to be enrolled at the study should show positive PCR result.
4-The following analysis will be carried out for all the patients included in the study; CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT and AST before treatment and for follow up after 10 days.
Participants:
All outpatients admitted to Chest Diseases Departments of Fayoum university Hospital, will be screened for the following criteria.
Inclusion criteria:
- Adults.
- Confirmed SARS-CoV-2 diagnosis (positive polymerase chain reaction by nasopharyngeal swab).
- Mild to Moderate COVID-19 patients.
- No history of the current use of olive leaf capsules supplement.
Exclusion criteria:
- Severe and critical COVID-19 patients who need hospitalization.
- Patients need ventilatory support or showing chronic obstructive pulmonary disease (COPD).
- Patients showing any chronic disease (except hypertension and diabetes mellitus).
- Patients who have multiorgan failure.
- Use of alcohol, other investigational medicines, and illegal drugs (during the last 30 days).
Intervention and comparator:
A total of 60 patients randomized into two groups (30 in each group). The patients will be divided into 2 groups Intervention group: All patients receive the standard treatment regimen for COVID-19, according to the Egyptian Ministry of Health protocol, along with 2-3 capsules/day of standardized olive leaf containing 20-50% oleuropein (500-750 mg oleuropein daily) for a period of ten days.
Control group: The standard therapeutic regimen for COVID-19 along with placebo capsules daily for a period of ten days.
Main outcomes:
The main outcomes are the improvement of clinical symptoms, as well as oxygen saturation, viral clearance, improvement of analysis (CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT and AST) within 10 days of randomization in patients with confirmed COVID-19, who are mild to moderately ill.
Randomization:
Included patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). This randomization method ensures a balanced allocation between the arms during the study. A web-based system will generate random numbers for the allocation sequence and concealment of participants. Each number relates to one of the study arms.
Ethical considerations All participants should Sign informed consent and show willingness to accept randomization to any assigned treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olive leaf capsules | Active comparator | Dietary Supplement: Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein)Non-hospitalized COVID-19 patients who have positive PCR results and show mild to moderate clinical manifestations and symptoms (20-30 patients) will receive a 50% standardized olive leaf capsule 750 mg (700 mg oleuropein/day; the active principle in olive leaf) two times daily for a period of ten days alongside with the Egyptian protocol medications. All the active comparator participants should be adults, with no chronic diseases (except hypertension and diabetes), non addict or alcoholics. |
| Starch capsules | Placebo comparator | Dietary Supplement: Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein)Non-hospitalized COVID-19 patients who have positive PCR results and show mild to moderate clinical manifestations and symptoms (20-30 patients) will receive a placebo starch capsules (750 mg) two times daily for a period of ten days alongside with the Egyptian protocol medications. All the placebo comparator participants should be adults, with no chronic diseases (except hypertension and diabetes), non addict or alcoholics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults.
- Confirmed SARS-CoV-2 diagnosis (positive polymerase chain reaction by nasopharyngeal swab).
- Mild to Moderate COVID-19 patients.
- No history of the current use of olive leaf capsules supplement.
Key exclusion criteria (5 listed)
- Severe and critical COVID-19 patients who need hospitalization.
- Patients need ventilatory support or showing chronic obstructive pulmonary disease (COPD).
- Patients showing any chronic disease (except hypertension and diabetes mellitus).
- Patients who have multiorgan failure.
- 3. Use of alcohol, other investigational medicines, and illegal drugs (during the last 30 days).
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 |
|---|---|---|
| Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein)two study groups; test group will receive Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein) while placebo group will receive starch group | Dietary supplement | Olive leaf capsules, Starch capsules |
Primary outcome
Improving the clinical symptoms in mild to moderate COVID -19 patients
Time frame: 10 days after treatment
It is expected that the examined drug will alleviate symptoms such as fever, cough, sore throat and muscles ache
Viral clearance in mild to moderate COVID -19 patients
Time frame: 10 days after treatment
It is expected that the examined drug will make the Polymerase chain reaction (PCR ) results for the test group negative within 10 days of treatment
Improvement of analysis (CBC)
Time frame: 10 days after treatment
It is expected that the treatment will improve the lab analysis for treatment group such as increase lymphocyte count in complete blood count (CBC).
Improvement of analysis (CRP)
Time frame: 10 days after treatment
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of C-reactive protein (CRP).
Improvement of analysis (LDH)
Time frame: 10 days after treatment
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of Lactate dehydrogenase (LDH).
Improvement of analysis (ESR)
Time frame: 10 days after treatment
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of Erythrocyte sedimentation rate (ESR).
Improvement of analysis (Ferritin)
Time frame: 10 days after treatment
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of Ferritin.
Improvement of analysis (D-dimer)
Time frame: 10 days after treatment
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of D-dimer.
4 secondary outcomes
Evaluate mortality rate in patients with confirmed COVID-19 moderately ill
Time frame: 10 days after treatment
Improvement of analysis (creatinine)
Time frame: 10 days after treatment
Improvement of analysis (ALT)
Time frame: 10 days after treatment
improvement of analysis (AST)
Time frame: 10 days after treatment
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 8 Feb 2023.
- 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 study testing Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein) in people with Covid19 and COVID-19 Respiratory Infection, run by Shimaa M. Abdelgawad 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 4 inclusion and 5 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 8 Feb 2023. 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. 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.
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?
Improving the clinical symptoms in mild to moderate COVID -19 patients (time frame: 10 days after treatment). The study lists 8 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 8 Feb 2023.