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

Biomad

Status and phase: Unknown; Phase 3

Conditions: Sars-cov-2

Treatments: Drug: Xagrotin; Drug: Green tea

Study type: Interventional

Funder types: Industry

Identifiers

NCT05222425

03-022022-FA3XAG/NO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,000 participants in 3 patient groups, including a placebo group

Treatment group

Experimental group

Description:

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.

Treatment:

Drug: Xagrotin

Control group

No Intervention group

Description:

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

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Green tea