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Treatment of Covid-19 With a Herbal Compound, Xagrotin

Primary Purpose

Covid19

Status

Completed

Phase

Phase 1

Locations

Iraq

Study Type

Interventional

Intervention

Xagrotin

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Directorate of health of Sulaimani, Iraq -KRG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment arm

Control arm

Arm Description

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

Patients in the Control arm received the standard of care for Covid19.

Outcomes

Primary Outcome Measures

Mortality

Number of Participants who died by day 30 after the enrollment

Secondary Outcome Measures

Duration of Disease From Beginning of Treatment

Number of days the patient has experienced the symptoms

Hospitalization

Number of participants who have been hospitalized for Covid-19

Duration of Hospitalization When Occurred

Days the participants were hospitalized

Full Information

NCT ID

NCT05017493

First Posted

April 4, 2021

Last Updated

November 30, 2021

Sponsor

Biomad AS

Collaborators

Directorate of health of Sulaimani, Iraq -KRG

1. Study Identification

Unique Protocol Identification Number

NCT05017493

Brief Title

Treatment of Covid-19 With a Herbal Compound, Xagrotin

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

December 7, 2020 (Actual)

Study Completion Date

February 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biomad AS

Collaborators

Directorate of health of Sulaimani, Iraq -KRG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

661 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment arm

Arm Type

Experimental

Arm Description

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

Arm Title

Control arm

Arm Type

No Intervention

Arm Description

Patients in the Control arm received the standard of care for Covid19.

Intervention Type

Combination Product

Intervention Name(s)

Xagrotin

Intervention Description

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

Primary Outcome Measure Information:

Title

Mortality

Description

Number of Participants who died by day 30 after the enrollment

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Duration of Disease From Beginning of Treatment

Description

Number of days the patient has experienced the symptoms

Time Frame

30 days

Title

Hospitalization

Description

Number of participants who have been hospitalized for Covid-19

Time Frame

30 days

Title

Duration of Hospitalization When Occurred

Description

Days the participants were hospitalized

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Directorate of health of Sulaimani, Iraq -KRG

City

Sulaymaniyah

Country

Iraq

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Treatment of Covid-19 With a Herbal Compound, Xagrotin

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