Treatment of Non-severe Covid-19 Outpatients With Xagrotin, Phase 3

Sars-cov-2 Clinical Trial

Official title:

Treatment of Non-severe SARS-CoV-2 Outpatients With Herbal Compound Xagrotin, Phase 3

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05222425
• Other study ID #: 03-022022-FA3XAG/NO
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2022
• Est. completion date: December 7, 2022

Study information

• Verified date: March 2022
• Source: Biomad AS
• Contact: Dana Omer, PhD
• Phone: +9647701586707
• Email: danaomar1979[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 7, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Sars-cov-2

Intervention

Drug:
• Xagrotin
A herbal compound
• Green tea
Normal green tea

Locations

Country	Name	City	State
Iraq	Directorate of health of Sulaimani, Iraq -KRG	Sulaymaniyah

Sponsors (1)

Lead Sponsor	Collaborator
Biomad AS

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Number of Participants who die by day 30 after the enrollment	30 days
Secondary	Duration of Disease From Beginning of Treatment	Number of days the patient has experienced the symptoms	30 days
Secondary	Hospitalization	Number of participants who have been hospitalized for Covid-19	30 days
Secondary	Duration of Hospitalization When Occurred	Days the participants were hospitalized	30 days