Treatment of Covid-19 With a Herbal Compound, Xagrotin

Biomad

Status and phase: Completed; Phase 2; Phase 1

Conditions: Covid19

Treatments: Combination Product: Xagrotin

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05017493

02-032021-SULXAG/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 were recruited (n=361). Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome.

Full description

This is an interventional, multi-center, randomized study that has been performed in an outpatient setting (n=361). Adults with confirmed covid-19 disease not more than 10 days before enrollment date were recruited. Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. Adverse events were registered.

Enrollment: 661 patients

Sex: All

Ages: 18+ 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

• Severe pulmonary disease
• Severe cardiovascular disease
• Severe hepatic disease
• Severe renal disease
• Diabetes mellitus type one
• Metabolic acidosis
• Oxygen saturation <70%
• Pregnancy
• Breast feeding
• Concomitant treatment with anticoagulation drugs
• Concomitant treatment with CYP3A4 medicines with narrow therapeutic window

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

661 participants in 2 patient groups

Treatment arm

Experimental group

Description:

Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.

Treatment:

Combination Product: Xagrotin

Control arm

No Intervention group

Description:

Patients in the Control arm received the standard of care for Covid19.