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

Phase 3

• Conditions: Sars-cov-2
• Interventions: Drug: Xagrotin; Drug: Green tea

• Registration Number: NCT05222425
• Lead Sponsor: Biomad AS

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.

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 Timeline

• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-17
• Study Start: 2022-06-01
• Primary Completion: 2022-10-15
• Study Completion: 2022-12-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Xagrotin	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.
Placebo group	Green tea	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.

Primary Outcome Measures

Name	Time	Method
Mortality	30 days	Number of Participants who die by day 30 after the enrollment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Directorate of health of Sulaimani, Iraq -KRG; 🇮🇶 Sulaymaniyah, Iraq