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

Treatment of Non-severe SARS-CoV-2 Outpatients With Herbal Compound Xagrotin, Phase 3

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sars-cov-2
• Intervention / Treatment: Drug: Xagrotin; Drug: Green tea

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 3000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dana Omer, PhD; Phone Number: +9647701586707; Email: danaomar1979@gmail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (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:

• Coronavirus patients admitted to medical centers for hospitalization and receive medical treatment and necessary care in medical centers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment group; 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.	Drug: Xagrotin; A herbal compound
NO_INTERVENTION: Control group; Patients in the Control arm received the standard of care for sars-cov-2.
PLACEBO_COMPARATOR: Placebo group; 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.	Drug: Green tea; Normal green tea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Number of Participants who die 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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2022
• Primary Completion (ANTICIPATED): October 15, 2022
• Study Completion (ANTICIPATED): December 7, 2022

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (ACTUAL): February 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: sars-cov-2
• Other Study ID Numbers: 03-022022-FA3XAG/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