Treatment of Covid-19 With a Herbal Compound, Xagrotin

Phase 1

Completed

• Conditions: Covid19
• Interventions: Combination Product: Xagrotin

• Registration Number: NCT05017493
• 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 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.

Detailed 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.

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2020-12-07
• Study Completion: 2021-02-08
• Study First Submitted: 2021-04-04
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-24
• Results First Submitted: 2021-09-21
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-30
• Last Update Submitted: 2021-11-30
• Results First Posted: 2021-12-02
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 661

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mortality	30 days	Number of Participants who died 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
Duration of Hospitalization When Occurred	30 days	Days the participants were hospitalized
Hospitalization	30 days	Number of participants who have been hospitalized for Covid-19

Trial Locations

Locations (1)

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