A Phase 1/2 interventional study of Xagrotin in Covid19, sponsored by Biomad AS. Completed at 1 site in Iraq. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-02.
Sponsored by Biomad AS · Phase 1/2, Interventional, and Treatment
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 661 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Biomad AS is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.
Combination Product: Xagrotin
Patients in the Control arm received the standard of care for Covid19.
A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care
Mortality
Number of Participants who died by day 30 after the enrollment
Time frame: 30 days
Duration of Disease From Beginning of Treatment
Number of days the patient has experienced the symptoms
Time frame: 30 days
Hospitalization
Number of participants who have been hospitalized for Covid-19
Time frame: 30 days
Duration of Hospitalization When Occurred
Days the participants were hospitalized
Time frame: 30 days
All adult patients in an outpatient setting who were confirmed as coronavirus patients were eligible to be included in the study.
| Milestone | Treatment Arm | Control Arm |
|---|---|---|
| Started | 483 | 178 |
| Treatment & care | 483 | 178 |
| Follow up | 483 | 178 |
| Mortality check | 483 | 178 |
| Completed | 361 | 178 |
| Not completed | 122 | 0 |
| Withdrew: Withdrawal by subject | 26 | 0 |
| Withdrew: Physician decision | 15 | 0 |
| Withdrew: Protocol violation | 81 | 0 |
Number of Participants who died by day 30 after the enrollment
| participants | Treatment Arm | Control Arm |
|---|---|---|
| Mortality | 2 | 10 |
Number of days the patient has experienced the symptoms
| Days | Treatment Arm | Control Arm |
|---|---|---|
| Duration of Disease From Beginning of Treatment | 9.9 ± 5.5 | 18.1 ± 9.5 |
Number of participants who have been hospitalized for Covid-19
| Participatnts | Treatment Arm | Control Arm |
|---|---|---|
| Hospitalization | 11 | 57 |
Days the participants were hospitalized
| Days | Treatment Arm | Control Arm |
|---|---|---|
| Duration of Hospitalization When Occurred | 5.56 ± 4.94 | 5.5 ± 3.42 |
Collected over 30 Days. Non-serious events are listed at a 2.3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm | 2/483 (0.4%) | 1/483 (0.2%) | 113/483 (23.4%) |
| Control Arm | 10/178 (5.6%) | 10/178 (5.6%) | 15/178 (8.4%) |
| Event | Treatment Arm | Control Arm |
|---|---|---|
| XagrotinBlood and lymphatic system disorders | 1/483 | 10/178 |
| Event | Treatment Arm | Control Arm |
|---|---|---|
| DiarrheaGastrointestinal disorders | 113/483 | 15/178 |
| FlatulenceGastrointestinal disorders | 113/483 | 15/178 |
Both paitients who received and NOT received Xagrotin
| Age, Categorical(Participants) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| <=18 years | 23 | 5 | 28 |
| Between 18 and 65 years | 397 | 150 | 547 |
| >=65 years | 63 | 23 | 86 |
| Age, Continuous(years) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 43.9 ± 17.16 | 44.297 ± 17.16 | 44.1 ± 17.16 |
| Sex: Female, Male(Participants) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Female | 212 | 91 | 303 |
| Male | 271 | 87 | 358 |
| Race (NIH/OMB)(Participants) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 483 | 178 | 661 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Iraq | 483 | 178 | 661 |
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Plan to share: No
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Biomad AS