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

Sponsor
Biomad AS (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05222425
Collaborator
(none)
3,000
1
3
6.2
483.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
3000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Non-severe SARS-CoV-2 Outpatients With Herbal Compound Xagrotin, Phase 3
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Oct 15, 2022
Anticipated Study Completion Date :
Dec 7, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Mortality [30 days]

    Number of Participants who die by day 30 after the enrollment

Secondary Outcome Measures

  1. Duration of Disease From Beginning of Treatment [30 days]

    Number of days the patient has experienced the symptoms

  2. Hospitalization [30 days]

    Number of participants who have been hospitalized for Covid-19

  3. Duration of Hospitalization When Occurred [30 days]

    Days the participants were hospitalized

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Directorate of health of Sulaimani, Iraq -KRG Sulaymaniyah Iraq

Sponsors and Collaborators

  • Biomad AS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biomad AS
ClinicalTrials.gov Identifier:
NCT05222425
Other Study ID Numbers:
  • 03-022022-FA3XAG/NO
First Posted:
Feb 3, 2022
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Biomad AS

Study Results

No Results Posted as of Mar 17, 2022