Sars-cov-2Phase 3NCT05222425
Treatment of Non-severe Covid-19 Outpatients With Xagrotin, Phase 3
A Phase 3 study testing Xagrotin and Green tea in people with Sars-cov-2, run by Biomad AS at 1 site in Iraq.
Trial summary
This is an interventional, multi-center, randomized study. Adults with confirmed covid-19 disease not more than 10 days before enrollment date will be recruited (n=1000). Patients in same condition who get treated with standard of care will be randomly assigned to the control group (n=1000), and patients in same… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sars-cov-2
- What is being tested?
- Xagrotin and Green tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jun 2022to 7 Dec 2022
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or higher
- Newly diagnosed (no longer than 10 days)
- PCR or clinically confirmed Covid-19
Who cannot join
- Coronavirus patients admitted to medical centers for hospitalization and receive medical treatment and necessary care in medical centers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Non-severe SARS-CoV-2 Outpatients With Herbal Compound Xagrotin, Phase 3
This is an interventional, multi-center, randomized study. Adults with confirmed covid-19 disease not more than 10 days before enrollment date will be recruited (n=1000). Patients in same condition who get treated with standard of care will be randomly assigned to the control group (n=1000), and patients in same condition who get treated with standard of care will be randomly assigned to the placebo group (n=1000). The investigators analyze the effect of Xagrotin, and also investigate impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome.
Read the detailed description
An interventional, multi-center, randomized study that will performe in an outpatient setting (n=1000). Adults with confirmed covid-19 disease not more than 10 days before enrollment date will be recruited. Patients in same condition who had treated with standard of care will randomly assign to the control group (n=1000), and patients in same condition who get treated with standard of care will be randomly assigned to the placebo group (n=1000). The investigators analyze the effect of Xagrotin, and also investigate impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. Adverse events will be registered.
- Conditions
- Sars-cov-2
- Being tested
- Xagrotin, Green tea
- Keywords
- sars-cov-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XagrotinDrug
A herbal compound
Green teaDrug
Normal green tea
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients in the Treatment arm receive Xagrotin extract 2 grams three times a day in combination to the standard of care for sars-cov-2. Receives: Drug: Xagrotin |
| Control group | No intervention | Patients in the Control arm received the standard of care for sars-cov-2. |
| Placebo group | Placebo comparator | Patients in the Treatment arm receive green tea 2 grams three times a day in combination to the standard of care for sars-cov-2. Receives: Drug: Green tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Number of Participants who die by day 30 after the enrollment
Measured: 30 days
Secondary outcomes (3)
Duration of Disease From Beginning of Treatment
Number of days the patient has experienced the symptoms
Measured: 30 days
Hospitalization
Number of participants who have been hospitalized for Covid-19
Measured: 30 days
Duration of Hospitalization When Occurred
Days the participants were hospitalized
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Jun 2022 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion7 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-cov-2Studies 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
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomad AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222425
- Sponsor's protocol ID
- 03-022022-FA3XAG/NO
- Status last verified
- Mar 2022
- First submitted
- 1 Feb 2022
- Last updated
- 17 Mar 2022
- 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 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Non-severe SARS-CoV-2 Outpatients With Herbal Compound Xagrotin, Phase 3
- ClinicalTrials.gov ID
- NCT05222425
- Acronym / sponsor ID
- 03-022022-FA3XAG/NO
- Conditions
- Sars-cov-2
- Keywords
- sars-cov-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Biomad ASIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 7 Dec 2022 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an interventional, multi-center, randomized study. Adults with confirmed covid-19 disease not more than 10 days before enrollment date will be recruited (n=1000). Patients in same condition who get treated with standard of care will be randomly assigned to the control group (n=1000), and patients in same condition who get treated with standard of care will be randomly assigned to the placebo group (n=1000). The investigators analyze the effect of Xagrotin, and also investigate impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome.
Detailed description
An interventional, multi-center, randomized study that will performe in an outpatient setting (n=1000). Adults with confirmed covid-19 disease not more than 10 days before enrollment date will be recruited. Patients in same condition who had treated with standard of care will randomly assign to the control group (n=1000), and patients in same condition who get treated with standard of care will be randomly assigned to the placebo group (n=1000). The investigators analyze the effect of Xagrotin, and also investigate impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. Adverse events will be registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: XagrotinPatients in the Treatment arm receive Xagrotin extract 2 grams three times a day in combination to the standard of care for sars-cov-2. |
| Control group | No intervention | –Patients in the Control arm received the standard of care for sars-cov-2. |
| Placebo group | Placebo comparator | Drug: Green teaPatients in the Treatment arm receive green tea 2 grams three times a day in combination to the standard of care for sars-cov-2. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or higher
- Newly diagnosed (no longer than 10 days)
- PCR or clinically confirmed Covid-19
Key exclusion criteria (1 listed)
- Coronavirus patients admitted to medical centers for hospitalization and receive medical treatment and necessary care in medical centers
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 |
|---|---|---|
| XagrotinA herbal compound | Drug | Treatment group |
| Green teaNormal green tea | Drug | Placebo group |
Primary outcome
Mortality
Time frame: 30 days
Number of Participants who die by day 30 after the enrollment
3 secondary outcomes
Duration of Disease From Beginning of Treatment
Time frame: 30 days
Hospitalization
Time frame: 30 days
Duration of Hospitalization When Occurred
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Sars-cov-2
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
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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.
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 Xagrotin and Green tea in people with Sars-cov-2, run by Biomad AS at 1 site in Iraq.
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 1 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 17 Mar 2022. 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 Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dana Omer, PhD (+9647701586707, danaomar1979@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 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 17 Mar 2022.