Treatment of Covid-19 With a Herbal Compound, Xagrotin
Treatment of Early-Stage Covid-19 With a Herbal Compound, Xagrotin
1 other identifier
interventional
661
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 covid19
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2021
CompletedFirst Submitted
Initial submission to the registry
April 4, 2021
CompletedFirst Posted
Study publicly available on registry
August 24, 2021
CompletedResults Posted
Study results publicly available
December 2, 2021
CompletedDecember 2, 2021
November 1, 2021
5 months
April 4, 2021
September 21, 2021
November 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality
Number of Participants who died by day 30 after the enrollment
30 days
Secondary Outcomes (3)
Duration of Disease From Beginning of Treatment
30 days
Hospitalization
30 days
Duration of Hospitalization When Occurred
30 days
Study Arms (2)
Treatment arm
EXPERIMENTALPatients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.
Control arm
NO INTERVENTIONPatients in the Control arm received the standard of care for Covid19.
Interventions
A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care
Eligibility Criteria
You may qualify if:
- Age 18 or higher
- Newly diagnosed (no longer than 10 days)
- PCR or clinically confirmed Covid-19
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biomad ASlead
- Directorate of Health of Sulaimani, Iraqcollaborator
Study Sites (1)
Directorate of health of Sulaimani, Iraq -KRG
Sulaymaniyah, Iraq
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Dara Omer
- Organization
- Hiwa Hospital - KRG
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2021
First Posted
August 24, 2021
Study Start
July 1, 2020
Primary Completion
December 7, 2020
Study Completion
February 8, 2021
Last Updated
December 2, 2021
Results First Posted
December 2, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share