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

NCT05222425
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Phase
Phase 3
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Recruitment status
Unknown
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Participants
3,000
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Lead sponsor
Biomad AS
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Start date
2022-06-01
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Number of sites
1
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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.
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Short title
Treatment of Non-severe Covid-19 Outpatients With Xagrotin, Phase 3
clinicaltrials.gov
Official title
Treatment of Non-severe SARS-CoV-2 Outpatients With Herbal Compound Xagrotin, Phase 3
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Unknown
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Phase
Phase 3
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Study type
Interventional
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Completion date
2022-12-07
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First posted
2022-02-03
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Registry last updated
2022-03-17
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Primary completion date
2022-10-15
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Start date
2022-06-01
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Participants
3,000
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Participant count basis
Estimated
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Planned participants
3,000
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Protocol amendments
2
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Biomad AS
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05222425
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ClinicalTrials.gov ID
NCT05222425
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Mortality

    Timeframe: 30 days

    Number of Participants who die by day 30 after the enrollment

  1. Duration of Disease From Beginning of Treatment

    Timeframe: 30 days

    Number of days the patient has experienced the symptoms

  2. Hospitalization

    Timeframe: 30 days

    Number of participants who have been hospitalized for Covid-19

  3. Duration of Hospitalization When Occurred

    Timeframe: 30 days

    Days the participants were hospitalized

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No

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

  • Coronavirus patients admitted to medical centers for hospitalization and receive medical treatment and necessary care in medical centers
Sources for eligibility
clinicaltrials.gov

  • Directorate of health of Sulaimani, Iraq -KRGSulaymaniyah, Iraq
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)