Covid19Phase 1/2NCT05017493
Treatment of Covid-19 With a Herbal Compound, Xagrotin
A Phase 1/2 study testing Xagrotin in people with Covid19, 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 were recruited (n=361). Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Xagrotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 661 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jul 2020to 8 Feb 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 or higher
- Newly diagnosed (no longer than 10 days)
- PCR or clinically confirmed Covid-19
Who cannot join
- Severe pulmonary disease
- Severe cardiovascular disease
- Severe hepatic disease
- Severe renal disease
- Diabetes mellitus type one
- Metabolic acidosis
Show all 11Show fewer
- Oxygen saturation <70%
- Pregnancy
- Breast feeding
- Concomitant treatment with anticoagulation drugs
- Concomitant treatment with CYP3A4 medicines with narrow therapeutic window
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Early-Stage Covid-19 With a Herbal Compound, Xagrotin
This is an interventional, multi-center, randomized study. Adults with confirmed covid-19 disease not more than 10 days before enrollment date were recruited (n=361). Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome.
Read the detailed description
This is an interventional, multi-center, randomized study that has been performed in an outpatient setting (n=361). Adults with confirmed covid-19 disease not more than 10 days before enrollment date were recruited. Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. Adverse events were registered.
- Conditions
- Covid19
- Being tested
- Xagrotin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XagrotinCombination product
A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19. Receives: Combination Product: Xagrotin |
| Control arm | No intervention | Patients in the Control arm received the standard of care for Covid19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Number of Participants who died 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 posted24 Aug 2021
- Study start1 Jul 2020
- Primary completion7 Dec 2020
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomad AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Directorate of Health of Sulaimani, Iraq
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017493
- Sponsor's protocol ID
- 02-032021-SULXAG/NO
- Status last verified
- Nov 2021
- First submitted
- 4 Apr 2021
- Last updated
- 2 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Early-Stage Covid-19 With a Herbal Compound, Xagrotin
- ClinicalTrials.gov ID
- NCT05017493
- Acronym / sponsor ID
- 02-032021-SULXAG/NO
- Conditions
- Covid19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- Biomad ASIndustry (pharma, biotech, devices)
- Collaborators
- Directorate of Health of Sulaimani, Iraq
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Posted 2 Dec 2021
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 were recruited (n=361). Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome.
Detailed description
This is an interventional, multi-center, randomized study that has been performed in an outpatient setting (n=361). Adults with confirmed covid-19 disease not more than 10 days before enrollment date were recruited. Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. Adverse events were registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Combination Product: XagrotinPatients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19. |
| Control arm | No intervention | –Patients in the Control arm received the standard of care for Covid19. |
Who may qualify
- Ages
- 18 years and older
- 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 (11 listed)
- Severe pulmonary disease
- Severe cardiovascular disease
- Severe hepatic disease
- Severe renal disease
- Diabetes mellitus type one
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 group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care | Combination product | Treatment arm |
Primary outcome
Mortality
Time frame: 30 days
Number of Participants who died 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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 1/2 study testing Xagrotin in people with Covid19, 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 11 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 2 Dec 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 2 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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 2 Dec 2021.