Treatment of Non-severe Covid-19 Outpatients With Xagrotin, Phase 3
Study Details
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 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
An interventional, multi-center, randomized study that will performe in an outpatient setting (n=1000). Adults with confirmed covid-19 disease not more than 10 days before enrollment date will be recruited. Patients in same condition who had treated with standard of care will randomly assign 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. Adverse events will be registered.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment group Patients in the Treatment arm receive Xagrotin extract 2 grams three times a day in combination to the standard of care for sars-cov-2. |
Drug: Xagrotin
A herbal compound
|
No Intervention: Control group Patients in the Control arm received the standard of care for sars-cov-2. |
|
Placebo Comparator: Placebo group Patients in the Treatment arm receive green tea 2 grams three times a day in combination to the standard of care for sars-cov-2. |
Drug: Green tea
Normal green tea
|
Outcome Measures
Primary Outcome Measures
- Mortality [30 days]
Number of Participants who die by day 30 after the enrollment
Secondary Outcome Measures
- Duration of Disease From Beginning of Treatment [30 days]
Number of days the patient has experienced the symptoms
- Hospitalization [30 days]
Number of participants who have been hospitalized for Covid-19
- Duration of Hospitalization When Occurred [30 days]
Days the participants were hospitalized
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 or higher
-
Newly diagnosed (no longer than 10 days)
-
PCR or clinically confirmed Covid-19
Exclusion Criteria:
- Coronavirus patients admitted to medical centers for hospitalization and receive medical treatment and necessary care in medical centers
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Directorate of health of Sulaimani, Iraq -KRG | Sulaymaniyah | Iraq |
Sponsors and Collaborators
- Biomad AS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 03-022022-FA3XAG/NO