Trial Outcomes & Findings for Treatment of Covid-19 With a Herbal Compound, Xagrotin (NCT NCT05017493)

NCT ID: NCT05017493

Last Updated: 2021-12-02

Results Overview

Number of Participants who died by day 30 after the enrollment

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 661 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2021-12-02

Participant Flow

All adult patients in an outpatient setting who were confirmed as coronavirus patients were eligible to be included in the study.

Age 18 or higher, Newly diagnosed (no longer than 10 days), PCR or clinically confirmed Covid-19

Participant milestones

Measure	Treatment Arm 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	Control Arm Patients in the Control arm received the standard of care for Covid19.
Overall Study STARTED	483	178
Overall Study Treatment & Care	483	178
Overall Study Follow up	483	178
Overall Study Mortality Check	483	178
Overall Study COMPLETED	361	178
Overall Study NOT COMPLETED	122	0

Reasons for withdrawal

Measure	Treatment Arm 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	Control Arm Patients in the Control arm received the standard of care for Covid19.
Overall Study Withdrawal by Subject	26	0
Overall Study Physician Decision	15	0
Overall Study Protocol Violation	81	0

Baseline Characteristics

Treatment of Covid-19 With a Herbal Compound, Xagrotin

Baseline characteristics by cohort

Measure	Treatment Arm n=483 Participants 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	Control Arm n=178 Participants Patients in the Control arm received the standard of care for Covid19.	Total n=661 Participants Total of all reporting groups
Age, Categorical <=18 years	23 Participants n=5 Participants	5 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	397 Participants n=5 Participants	150 Participants n=7 Participants	547 Participants n=5 Participants
Age, Categorical >=65 years	63 Participants n=5 Participants	23 Participants n=7 Participants	86 Participants n=5 Participants
Age, Continuous	43.9 years STANDARD_DEVIATION 17.16 • n=5 Participants	44.297 years STANDARD_DEVIATION 17.16 • n=7 Participants	44.1 years STANDARD_DEVIATION 17.16 • n=5 Participants
Sex: Female, Male Female	212 Participants n=5 Participants	91 Participants n=7 Participants	303 Participants n=5 Participants
Sex: Female, Male Male	271 Participants n=5 Participants	87 Participants n=7 Participants	358 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	483 Participants n=5 Participants	178 Participants n=7 Participants	661 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Iraq	483 participants n=5 Participants	178 participants n=7 Participants	661 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Number of Participants who died by day 30 after the enrollment

Outcome measures

Measure	Treatment Arm n=361 Participants 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	Control Arm n=178 Participants Patients in the Control arm received the standard of care for Covid19.
Mortality	2 participants	10 participants

SECONDARY outcome

Timeframe: 30 days

Number of days the patient has experienced the symptoms

Outcome measures

Measure	Treatment Arm n=361 Participants 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	Control Arm n=178 Participants Patients in the Control arm received the standard of care for Covid19.
Duration of Disease From Beginning of Treatment	9.9 Days Standard Deviation 5.5	18.1 Days Standard Deviation 9.5

SECONDARY outcome

Timeframe: 30 days

Number of participants who have been hospitalized for Covid-19

Outcome measures

Measure	Treatment Arm n=361 Participants 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	Control Arm n=178 Participants Patients in the Control arm received the standard of care for Covid19.
Hospitalization	11 Participatnts	57 Participatnts

SECONDARY outcome

Timeframe: 30 days

Days the participants were hospitalized

Outcome measures

Measure	Treatment Arm n=361 Participants 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	Control Arm n=178 Participants Patients in the Control arm received the standard of care for Covid19.
Duration of Hospitalization When Occurred	5.56 Days Standard Deviation 4.94	5.5 Days Standard Deviation 3.42

Adverse Events

Treatment Arm

Serious events: 1 serious events

Other events: 113 other events

Deaths: 2 deaths

Control Arm

Serious events: 10 serious events

Other events: 15 other events

Deaths: 10 deaths

Serious adverse events

Measure	Treatment Arm n=483 participants at risk 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	Control Arm n=178 participants at risk Patients in the Control arm received the standard of care for Covid19.
Blood and lymphatic system disorders Xagrotin	0.21% 1/483 • Number of events 1 • 30 Days	5.6% 10/178 • Number of events 10 • 30 Days

Other adverse events

Measure	Treatment Arm n=483 participants at risk 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	Control Arm n=178 participants at risk Patients in the Control arm received the standard of care for Covid19.
Gastrointestinal disorders Diarrhea	23.4% 113/483 • Number of events 113 • 30 Days	8.4% 15/178 • Number of events 15 • 30 Days
Gastrointestinal disorders Flatulence	23.4% 113/483 • Number of events 113 • 30 Days	8.4% 15/178 • Number of events 15 • 30 Days

Additional Information

Dr. Dara Omer

Hiwa Hospital - KRG

Phone: +9647701586707

Email: mailto:danaomar1979@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee All PIs discuss or publish the results only according to a prior agreement with the sponsor.
• Publication restrictions are in place

Restriction type: OTHER