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NCT Number: NCT05017493

Treatment of Covid-19 With a Herbal Compound, Xagrotin

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Directorate of health of Sulaimani, Iraq -KRG

Sulaymaniyah, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xagrotin

Combination Product

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

Primary outcomes

  1. Mortality

    Time frame: 30 days

    Number of Participants who died by day 30 after the enrollment

Secondary outcomes

  1. Duration of Disease From Beginning of Treatment

    Time frame: 30 days

    Number of days the patient has experienced the symptoms

  2. Hospitalization

    Time frame: 30 days

    Number of participants who have been hospitalized for Covid-19

  3. Duration of Hospitalization When Occurred

    Time frame: 30 days

    Days the participants were hospitalized

Sponsors and collaborators

Lead sponsor

Biomad AS

Industry

Collaborators

  • Directorate of Health of Sulaimani, Iraq

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Aug 24, 2021
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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