Treatment of Covid-19 With a Herbal Compound, Xagrotin

Covid19 Clinical Trial

Official title:

Treatment of Early-Stage Covid-19 With a Herbal Compound, Xagrotin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05017493
• Other study ID #: 02-032021-SULXAG/NO
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 1, 2020
• Est. completion date: February 8, 2021

Study information

• Verified date: November 2021
• Source: Biomad AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 661
• Est. completion date: February 8, 2021
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Combination Product:
• Xagrotin
A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care

Locations

Country	Name	City	State
Iraq	Directorate of health of Sulaimani, Iraq -KRG	Sulaymaniyah

Sponsors (2)

Lead Sponsor	Collaborator
Biomad AS	Directorate of health of Sulaimani, Iraq -KRG

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Number of Participants who died by day 30 after the enrollment	30 days
Secondary	Duration of Disease From Beginning of Treatment	Number of days the patient has experienced the symptoms	30 days
Secondary	Hospitalization	Number of participants who have been hospitalized for Covid-19	30 days
Secondary	Duration of Hospitalization When Occurred	Days the participants were hospitalized	30 days