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

NCT ID: NCT05222425

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-12-07

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.

Conditions

Sars-cov-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Xagrotin

Intervention Type: DRUG

A herbal compound

Control group

Patients in the Control arm received the standard of care for sars-cov-2.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: PLACEBO_COMPARATOR

Green tea

Intervention Type: DRUG

Normal green tea

Interventions

Xagrotin

A herbal compound

Intervention Type: DRUG

Green tea

Normal green tea

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomad AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Directorate of health of Sulaimani, Iraq -KRG

Sulaymaniyah, , Iraq

Countries

Iraq

Central Contacts

Dana Omer, PhD

Role: CONTACT

danaomar1979@gmail.com

+9647701586707

Other Identifiers

03-022022-FA3XAG/NO

Identifier Type: -

Identifier Source: org_study_id