Treatment of Covid-19 With a Herbal Compound, Xagrotin
Primary Purpose
Covid19
Status
Completed
Phase
Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
Xagrotin
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Age 18 or higher
- Newly diagnosed (no longer than 10 days)
- PCR or clinically confirmed Covid-19
Exclusion Criteria:
- Severe pulmonary disease
- Severe cardiovascular disease
- Severe hepatic disease
- Severe renal disease
- Diabetes mellitus type one
- Metabolic acidosis
- Oxygen saturation <70%
- Pregnancy
- Breast feeding
- Concomitant treatment with anticoagulation drugs
- Concomitant treatment with CYP3A4 medicines with narrow therapeutic window
Sites / Locations
- Directorate of health of Sulaimani, Iraq -KRG
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment arm
Control arm
Arm Description
Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.
Patients in the Control arm received the standard of care for Covid19.
Outcomes
Primary Outcome Measures
Mortality
Number of Participants who died by day 30 after the enrollment
Secondary Outcome Measures
Duration of Disease From Beginning of Treatment
Number of days the patient has experienced the symptoms
Hospitalization
Number of participants who have been hospitalized for Covid-19
Duration of Hospitalization When Occurred
Days the participants were hospitalized
Full Information
NCT ID
NCT05017493
First Posted
April 4, 2021
Last Updated
November 30, 2021
Sponsor
Biomad AS
Collaborators
Directorate of health of Sulaimani, Iraq -KRG
1. Study Identification
Unique Protocol Identification Number
NCT05017493
Brief Title
Treatment of Covid-19 With a Herbal Compound, Xagrotin
Official Title
Treatment of Early-Stage Covid-19 With a Herbal Compound, Xagrotin
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
February 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biomad AS
Collaborators
Directorate of health of Sulaimani, Iraq -KRG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
661 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Patients in the Control arm received the standard of care for Covid19.
Intervention Type
Combination Product
Intervention Name(s)
Xagrotin
Intervention Description
A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care
Primary Outcome Measure Information:
Title
Mortality
Description
Number of Participants who died by day 30 after the enrollment
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Duration of Disease From Beginning of Treatment
Description
Number of days the patient has experienced the symptoms
Time Frame
30 days
Title
Hospitalization
Description
Number of participants who have been hospitalized for Covid-19
Time Frame
30 days
Title
Duration of Hospitalization When Occurred
Description
Days the participants were hospitalized
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or higher
Newly diagnosed (no longer than 10 days)
PCR or clinically confirmed Covid-19
Exclusion Criteria:
Severe pulmonary disease
Severe cardiovascular disease
Severe hepatic disease
Severe renal disease
Diabetes mellitus type one
Metabolic acidosis
Oxygen saturation <70%
Pregnancy
Breast feeding
Concomitant treatment with anticoagulation drugs
Concomitant treatment with CYP3A4 medicines with narrow therapeutic window
Facility Information:
Facility Name
Directorate of health of Sulaimani, Iraq -KRG
City
Sulaymaniyah
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Covid-19 With a Herbal Compound, Xagrotin
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