Treatment of Covid-19 With a Herbal Compound, Xagrotin

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Combination product: Xagrotin

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 Type: Interventional
• Enrollment (Actual): 661
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iraq
  • Sulaymaniyah, Iraq
    • Directorate of health of Sulaimani, Iraq -KRG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19.	Combination product: Xagrotin; A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care
No Intervention: Control arm; Patients in the Control arm received the standard of care for Covid19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Number of Participants who died by day 30 after the enrollment	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Disease From Beginning of Treatment	Number of days the patient has experienced the symptoms	30 days
Hospitalization	Number of participants who have been hospitalized for Covid-19	30 days
Duration of Hospitalization When Occurred	Days the participants were hospitalized	30 days

Collaborators and Investigators

• Sponsor: Biomad AS
• Collaborators: Directorate of health of Sulaimani, Iraq -KRG

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): December 7, 2020
• Study Completion (Actual): February 8, 2021

Study Registration Dates

• First Submitted: April 4, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): December 2, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 02-032021-SULXAG/NO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No