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.

Recruiting at 3 trial locations

Overseen By Mahmoud R Mahmoud, M.Sc of Biochemistry

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Amr kamel khalil Ahmed

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 3 weeks

10000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mahmoud Elkazzaz, M.Sc of Biochemistry

Principal Investigator

Faculty of Science, Damietta university

Tamer Haydara, Ass/Prof of Internal medicine

Principal Investigator

Faculty of Medicine Kafrelshiekh university

Eligibility Criteria

Inclusion Criteria

adults 18 yrs or older patients

confirmed case (+ve PCR)

recovered/discharged (2 -ve PCR)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive aerosolized retinoic acid and Vitamin D therapy for post COVID-19 anosmia

3 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

2 visits (in-person)

Treatment Details

Interventions

• Aerosolized 13 cis retinoic acid plus Vitamin D
• Aerosolized All trans retinoic acid
• Aerosolized All trans retinoic acid plus Vitamin D
• Placebo/Control
• Standard therapy

Participant Groups

Group I: Aerosolized All trans retinoic acid and Vitamin D Experimental Treatment 1 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 D Experimental Treatment 1 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 therapy Placebo Group 1 Intervention

Standard therapy

Who Is Running the Clinical Trial?

Amr kamel khalil Ahmed

Lead Sponsor

Trials

2

Recruited

10,000+

Kafrelsheikh University

Lead Sponsor

Trials

184

Recruited

146,000+

Ministry of Health, Saudi Arabia

Collaborator

Trials

29

Recruited

43,500+

Foshan University Laboratory of Emerging Infectious Disease Institute of Translational Medicine , Jilin University China

Collaborator

Trials

1

Recruited

10,000+

Montefiore Health System and Albert Einstein College of Medicine, Newyork, United States of America (USA)

Collaborator

Trials

1

Recruited

10,000+

Faculty of Science, Kafrelsheikh University, Egypt.

Collaborator

Trials

1

Recruited

10,000+