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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 28 days
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new spray medicine, AMP5A, for hospitalized adults with severe COVID-19 lung issues. The spray aims to reduce inflammation and improve breathing.
Eligible Conditions
- COVID-19
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of patients able to maintain peripheral capillary oxygen saturation (SpO2) of >93% without oxygen support at Day 15.
Secondary study objectives
All-cause mortality
Changes of chest x-ray, and computerized tomography (CT) scan
Changes of clinical status (9-point ordinal scale)
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Low Dose of Active DrugExperimental Treatment1 Intervention
80 patients will be randomly assigned to low dose, take active drug BID.
Group II: Low Dose Placebo ControlExperimental Treatment1 Intervention
80 patients will be randomly assigned to Low dose placebo, take the placebo BID.
Group III: High Dose of Active DrugExperimental Treatment1 Intervention
160 patients will be randomly assigned to high dose, take the active drug BID.
Group IV: High Dose Placebo ControlExperimental Treatment1 Intervention
80 will be randomly assigned to high dose placebo, take the placebo BID.
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Who is running the clinical trial?
Techfields IncLead Sponsor
1 Previous Clinical Trials
225 Total Patients Enrolled
Chongxi Yu, Ph.DStudy ChairTechfields Inc
1 Previous Clinical Trials
225 Total Patients Enrolled
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