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Vitamin A Metabolite
Aerosolized 13 cis retinoic acid and Vitamin D for Anomia
Phase 4
Waitlist Available
Led By Amr Ahmed
Research Sponsored by Amr kamel khalil Ahmed
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 6 weeks after softgel initiation
Awards & highlights
Summary
This trial is testing a Vitamin A mist to help adults who lost their sense of smell due to COVID-19. The treatment works by repairing and regenerating the cells in the nose that detect smells.
Eligible Conditions
- Anomia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks after softgel initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks after softgel initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement of olfaction
Secondary outcome measures
Angiotensin-converting enzyme II (ACE2) expression in lungs and olfactory region
Frequency of adverse events and severe adverse events
Il-6 blood levels
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Aerosolized All trans retinoic acid and Vitamin DExperimental Treatment1 Intervention
Patients with Post COVID-19 Anosmia (Loss of Smell) will receive one dose daily of Aerosolized all trans retinoic acid in gradual 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled retinoic acid therapy for 3 weeks. Furthermore, the patients will receive Cholecalciferol(Vitamin D) Intramuscular injection of 600,000 units of Cholecalciferol for 2 doses given at week 0 and week 4
Group II: Aerosolized 13 cis retinoic acid and Vitamin DExperimental Treatment1 Intervention
Patients with Post COVID-19 Anosmia (Loss of Smell) will receive one dose daily of Aerosolized 13 cis retinoic acid in gradual 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled retinoic acid therapy for 3 weeks. Furthermore, the patients will receive Cholecalciferol(Vitamin D) Intramuscular injection of 600,000 units of Cholecalciferol for 2 doses given at week 0 and week 4
Group III: Standard therapyPlacebo Group1 Intervention
Standard therapy
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Who is running the clinical trial?
Amr kamel khalil AhmedLead Sponsor
1 Previous Clinical Trials
2 Total Patients Enrolled
Kafrelsheikh UniversityLead Sponsor
125 Previous Clinical Trials
123,394 Total Patients Enrolled
Ministry of Health, Saudi ArabiaOTHER_GOV
28 Previous Clinical Trials
33,498 Total Patients Enrolled
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