Vitamin A Mist for Loss of Smell

Not currently recruiting at 4 trial locations

Overseen By Mahmoud R Mahmoud, M.Sc of Biochemistry

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Amr kamel khalil Ahmed

Must not be taking: Nasal steroids

Disqualifiers: Pregnancy, Severe COVID-19, Hypercholesterolemia, Hypertriglyceridemia, others

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

Compensation: Varies

Number of Visits: 2

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if aerosolized retinoic acid, a form of Vitamin A, can help restore the sense of smell lost due to COVID-19. Participants will receive various forms of retinoic acid, sometimes combined with Vitamin D, to identify the most effective treatment. The trial seeks individuals who have recovered from COVID-19 but still experience a loss or reduction in their sense of smell. This study could provide a new method to address the lingering effects of COVID-19 on smell. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, and this research seeks to understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes patients using nasal steroid sprays or irrigations. It's best to discuss your specific medications with the trial team.

What is the safety track record for these treatments?

Research shows that retinoic acid in spray form might help treat loss of smell caused by COVID-19. This treatment aids in repairing and growing smell receptors and cells in the nose. Retinoic acid, a type of Vitamin A, plays a role in fixing and growing these cells.

Past patients have generally found retinoic acid to be safe. It is also used for some skin conditions, where it is usually safe, though some people might experience mild side effects like dryness or irritation. These side effects often occur with higher doses or when taken orally or applied to the skin.

Researchers are exploring whether combining retinoic acid with Vitamin D enhances the treatment's effectiveness. Vitamin D is known to be safe and often supports bone health and the immune system.

This clinical trial is in an advanced stage, indicating that earlier studies have shown some evidence of safety. However, participants should discuss potential risks and benefits with the study team. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for COVID-19-related loss of smell because they present a unique approach using aerosolized retinoic acid. Unlike standard treatments that may focus on supportive care or wait-and-see approaches, these treatments directly target the molecular pathways involved in the smell function by delivering retinoic acid, a potent vitamin A derivative, directly to the nasal passages. This method could potentially speed up recovery by addressing retinoic acid insufficiency, a novel target in anosmia treatment. Additionally, combining retinoic acid with vitamin D might enhance the overall therapeutic effect, offering a new avenue for those struggling to regain their sense of smell post-COVID-19.

What evidence suggests that this trial's treatments could be effective for COVID-19 anosmia?

Research suggests that a mist form of retinoic acid, a type of Vitamin A, might help treat the loss of smell caused by COVID-19. Studies have shown that it can improve the function of key proteins and cells in the nose needed for smelling. In this trial, participants will receive either Aerosolized 13 cis retinoic acid with Vitamin D or Aerosolized All trans retinoic acid with Vitamin D to test their effectiveness in restoring the sense of smell. Researchers are evaluating both forms for their potential to support the growth of smell-related nerve cells. These findings offer hope for those experiencing a loss of smell after COVID-19. ^{1 2 3 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

Inclusion Criteria

adults 18 yrs or older patients

confirmed case (+ve PCR)

recovered/discharged (2 -ve PCR)

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10297121/

Post-COVID-19 Anosmia and Therapies: Stay Tuned for New ... Aerosolized retinoic acid may have an effective role in treating post-COVID-19 anosmia through upregulating ACE2 and STRA6 and regenerating OSNs ...

2. reaganudall.org reaganudall.org/clinical-trial/investigating-potential-role-aerosolized-retinoic-acid-potent-vitamin-metabolite

Investigating the Potential Role of Aerosolized Retinoic Aerosolized retinoic acidwill have an effective role in treating post COVID-19 anosmia (loss of smell) viaupregulating ACE2, STRA 6 and regenerating of ...

3. researchgate.net researchgate.net/publication/359118791_13_cis_retinoic_acid_improved_the_outcomes_of_COVID-19_patients_A_randomized_clinical_trial

13 cis retinoic acid improved the outcomes of COVID-19 ... ... Aerosolized retinoic acid may have an effective role in treating post-COVID-19 anosmia through upregulating ACE2 and STRA6 and regenerating OSNs expressing ...

4. medrxiv.org medrxiv.org/content/10.1101/2022.03.05.22271959.full

13 cis retinoic acid improved the outcomes of COVID-19 ... All patients who received 13 cis retinoic acid noticed a high improvement (P<0.001), and the mean value for clinical improvement was 16.3±4.5 ...

5. researchgate.net researchgate.net/publication/371110408_Post-COVID-19_Anosmia_and_Therapies_Stay_Tuned_for_New_Drugs_to_Sniff_Out

Post-COVID-19 Anosmia and Therapies: Stay Tuned for ... The drug therapies that appear more effective and promising are PEA-LUT and Cerebrolysin. The other interesting drugs are 13-cis-retinoic acid ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0142042

Post COVID-19 Anosmia (Loss of Smell) (DBCOND0142042) Investigating the Potential Role of Aerosolized Retinoic Acid, a Potent Vitamin A Metabolite for Treating COVID-19 Anosmia and Retinoic Acid Insufficiency .

7. mdpi.com mdpi.com/2079-9721/11/2/79/review_report

Post-COVID-19 Anosmia and Therapies: Stay Tuned for ... ... 13 cis retinoic acid);. Response 28: the sentence was entirely rewritten:”They evaluated the administration of dexamethasone 6 mg/day per os ...