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Macrolide Antibiotic
Study to Evaluate Safety and Efficacy of Carrimycin for Treatment of Severe Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients
Phase 3
Waitlist Available
Research Sponsored by Shenyang Tonglian Group CO., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (day -4 to day -1) days 3, 7, 10, 14 and 28 after treatment
Awards & highlights
Pivotal Trial
Summary
This trial is testing carrimycin in hospitalized patients with severe COVID-19 to see if it can help fight the virus and improve their condition.
Eligible Conditions
- COVID-19
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (day -4 to day -1) days 3, 7, 10, 14 and 28 after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day -4 to day -1) days 3, 7, 10, 14 and 28 after treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to patient not requiring supplemental oxygen up to 28 days after randomisation
Secondary study objectives
Change from baseline in respiratory rate
Change from baseline in temperature
Changes from baseline in sequential organ failure assessment (SOFA) score
+9 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CarrimycinExperimental Treatment1 Intervention
Patients will receive oral dose of 400 mg carrimycin once-daily and SOC for 14 days.
Group II: PlaceboPlacebo Group1 Intervention
Patients will receive oral dose of Placebo once-daily and SOC for 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carrimycin
2019
Completed Phase 1
~10
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Who is running the clinical trial?
Shenyang Tonglian Group CO., LtdLead Sponsor
1 Previous Clinical Trials
520 Total Patients Enrolled
1 Trials studying COVID-19
520 Patients Enrolled for COVID-19