Treatment of Non-severe Covid-19 Outpatients With Xagrotin, Phase 3
Treatment of Non-severe SARS-CoV-2 Outpatients With Herbal Compound Xagrotin, Phase 3
1 other identifier
interventional
3,000
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2022
Shorter than P25 for phase_3
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
First Submitted
Initial submission to the registry
February 1, 2022
CompletedFirst Posted
Study publicly available on registry
February 3, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2022
CompletedMarch 17, 2022
March 1, 2022
5 months
February 1, 2022
March 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
Number of Participants who die 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 (3)
Treatment group
EXPERIMENTALPatients 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 INTERVENTIONPatients in the Control arm received the standard of care for sars-cov-2.
Placebo group
PLACEBO COMPARATORPatients in the Treatment arm receive green tea 2 grams three times a day in combination to the standard of care for sars-cov-2.
Interventions
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:
- Coronavirus patients admitted to medical centers for hospitalization and receive medical treatment and necessary care in medical centers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biomad ASlead
Study Sites (1)
Directorate of health of Sulaimani, Iraq -KRG
Sulaymaniyah, Iraq
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2022
First Posted
February 3, 2022
Study Start
June 1, 2022
Primary Completion
October 15, 2022
Study Completion
December 7, 2022
Last Updated
March 17, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share