Treatment of Covid-19 With a Herbal Compound, Xagrotin

• Sponsor: Biomad AS (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05017493
• Collaborator: Directorate of health of Sulaimani, Iraq -KRG (Other)
• Enrollment: 661
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.3
• Patients Per Site Per Month: 90.6

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 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Combination Product: Xagrotin	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 661 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Early-Stage Covid-19 With a Herbal Compound, Xagrotin
• Actual Study Start Date: Jul 1, 2020
• Actual Primary Completion Date: Dec 7, 2020
• Actual Study Completion Date: Feb 8, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Mortality [30 days]

   Number of Participants who died 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 and Older
• 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:

• 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

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
• Directorate of health of Sulaimani, Iraq -KRG

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Nov 30, 2021
• Statistical Analysis Plan - Nov 30, 2021

More Information

Publications

None provided.

• Responsible Party: Biomad AS
• ClinicalTrials.gov Identifier: NCT05017493
• Other Study ID Numbers: 02-032021-SULXAG/NO
• First Posted: Aug 24, 2021
• Last Update Posted: Dec 2, 2021
• Last Verified: Nov 1, 2021

• 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
• Additional relevant MeSH terms: COVID-19

Study Results

Participant Flow

Recruitment Details	All adult patients in an outpatient setting who were confirmed as coronavirus patients were eligible to be included in the study.
Pre-assignment Detail	Age 18 or higher, Newly diagnosed (no longer than 10 days), PCR or clinically confirmed Covid-19

Arm/Group Title	Treatment Arm	Control Arm
Arm/Group Description	Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19. Xagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care	Patients in the Control arm received the standard of care for Covid19.
Period Title: Overall Study
STARTED	483	178
Treatment & Care	483	178
Follow up	483	178
Mortality Check	483	178
COMPLETED	361	178
NOT COMPLETED	122	0

Baseline Characteristics

Arm/Group Title	Treatment Arm	Control Arm	Total
Arm/Group Description	Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19. Xagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care	Patients in the Control arm received the standard of care for Covid19.	Total of all reporting groups
Overall Participants	483	178	661
Age (Count of Participants)
<=18 years	23 4.8%	5 2.8%	28 4.2%
Between 18 and 65 years	397 82.2%	150 84.3%	547 82.8%
>=65 years	63 13%	23 12.9%	86 13%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.9 (17.16)	44.297 (17.16)	44.1 (17.16)
Sex: Female, Male (Count of Participants)
Female	212 43.9%	91 51.1%	303 45.8%
Male	271 56.1%	87 48.9%	358 54.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	483 100%	178 100%	661 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Iraq	483 100%	178 100%	661 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm	Control Arm
Arm/Group Description	Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19. Xagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care	Patients in the Control arm received the standard of care for Covid19.
Measure Participants	361	178
Number [participants]	2 0.4%	10 5.6%

2. Secondary Outcome

Title	Duration of Disease From Beginning of Treatment
Description	Number of days the patient has experienced the symptoms
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm	Control Arm
Arm/Group Description	Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19. Xagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care	Patients in the Control arm received the standard of care for Covid19.
Measure Participants	361	178
Mean (Standard Deviation) [Days]	9.9 (5.5)	18.1 (9.5)

3. Secondary Outcome

Title	Hospitalization
Description	Number of participants who have been hospitalized for Covid-19
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm	Control Arm
Arm/Group Description	Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19. Xagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care	Patients in the Control arm received the standard of care for Covid19.
Measure Participants	361	178
Number [Participatnts]	11	57

4. Secondary Outcome

Title	Duration of Hospitalization When Occurred
Description	Days the participants were hospitalized
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm	Control Arm
Arm/Group Description	Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19. Xagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care	Patients in the Control arm received the standard of care for Covid19.
Measure Participants	361	178
Mean (Standard Deviation) [Days]	5.56 (4.94)	5.5 (3.42)

Adverse Events

Time Frame	30 Days
Arm/Group Title	Treatment Arm		Control Arm
Arm/Group Description	Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19. Xagrotin: A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care		Patients in the Control arm received the standard of care for Covid19.
All Cause Mortality
	Treatment Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/483 (0.4%)		10/178 (5.6%)
Serious Adverse Events
	Treatment Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/483 (0.2%)		10/178 (5.6%)
Blood and lymphatic system disorders
Xagrotin	1/483 (0.2%)	1	10/178 (5.6%)	10
Other (Not Including Serious) Adverse Events
	Treatment Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	113/483 (23.4%)		15/178 (8.4%)
Gastrointestinal disorders
Diarrhea	113/483 (23.4%)	113	15/178 (8.4%)	15
Flatulence	113/483 (23.4%)	113	15/178 (8.4%)	15

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

All PIs discuss or publish the results only according to a prior agreement with the sponsor.