Investigating the Potential Role of Aerosolized Retinoic Acid, a Potent Vitamin A Metabolite for Treating COVID-19 Anosmia and Retinoic Acid Insufficiency .A Novel Approach for Regaining Sense of Smell.

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 1 week after softgel initiation

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

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 ~ 1 week after softgel initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week after softgel initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week after softgel initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement of olfaction

Secondary study objectives

Modified Brief Questionnaire of Olfactory Dysfunction (mQOD-NS)

Sinonasal Outcomes Test

Sinonasal Outcomes Test (SNOT-22)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial 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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