Investigating the Role of 13cis Retinoic Acid in the Treatment of COVID-19 and Enhancement of Its Spike Protein Based Vaccine Efficacy and Safety.

NCT04730895 | Unknown Phase 1 DMC

• 1 other identifier: COVID vaccine
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigating the role of 13cis retinoic acid in the treatment of COVID-19 and enhancement of Its spike protein based vaccine efficacy and safety.

Conditions

Covid19 Vaccine

Outcome Measures

Primary Outcomes (5)

• Assess the efficacy of the candidate oral and aerosolized isotretinoin for providing complete protection against COVID-19 in adults aged 18 years and older.

  Occurrence of COVID-19 infection

  Time Frame: Study duration (12 months from last dose donation ) ]

• Assess the safety of the candidate spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine in adults aged 18 years and older.

  Occurrence of expected serious side effects throughout the study duration and in the duration of followup: 1. Generation of Autoantibodies against host ACE2 2. Platelets aggregation 3. Thrombosis 4. Lung damage and fibrosis 5. Sexual problems 6. Neurological problems

  Time Frame: Study duration (24 months from last vaccination) ]

• Assess the efficacy of the candidate vaccine spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine for providing complete protection against COVID-19 in adults aged 18 years and older.

  Occurrence of COVID-19 infection

  Time Frame: Study duration (12 months from last dose donation ) ]

• Assess the efficacy of the candidate spike protein based vaccine such as ChAdOx1 nCoV-19 combined with oral and aerosolized isotetinoin in adults aged 18 years and older. for providing complete protection against COVID-19

  Occurrence of COVID-19 infection

  Time Frame: Study duration (12 months from last dose donation ) ]

• Assess the safety of the candidate spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine in combination with oral or aersolized 13 cis retinoic acid in adults aged 18 years and older.

  Occurrence of expected serious side effects throughout the study duration and in the duration of followup: 1. Generation of Autoantibodies against host ACE2 2. Platelets aggregation 3. Thrombosis 4. Lung damage and fibrosis 5. Sexual problems 6. Neurological problems

  Time Frame: Study duration (24 months from last vaccination) ]

Secondary Outcomes (11)

• Assess efficacy of the candidate oral and aerosolized isotretinoin against COVID-19

  Time Frame: Study duration (12 months from last dose donation ) ]

• Assess efficacy of the candidate spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine against COVID-19

  Time Frame: Study duration (12 months from last dose donation ) ]

• Assess safety of the candidate spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine combined with oral and aerosolized isotetinoin in vaccinated participants

  Time Frame: Study duration (48 months from last vaccination) ]

• Assessment the expression of MDAP-5 , RIG-1 , IFN1, TLR3 and IFN1 in Isotretinoin treated participants in comparison with vaccinated participants with spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine

  Time Frame: Study duration (12 months from last dose donation ) ]

• Absolute lymphocyte counts (CD4,CD8 and CD25+FOXP3+ Regulatory T cells ) in Isotretinoin treated participants in comparison with vaccinated participants with spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine

  Time Frame: Study duration (12 months from last dose donation ) ]

Study Arms (5)

Oral 13 cis retinoic acid

EXPERIMENTAL

The participants will receive 13 cis retinoic acid (0.5 mg/kg/day in 2 divided doses orally for 14 days . All subjects were encouraged to complete the full course of treatment and common side effects were explained. Side effects and compliance will be documented.

Drug: Oral 13 cis retinoic acid

Aerosolized 13 cis retinoic acid

EXPERIMENTAL

The participants will receive Aerosolized 13 cis retinoic acid in gradual in 2 divided doses increases froms 0.2 mg/kg/day to 4 mg/kg/day as inhaled 13 cis retinoic acid therapy for 14 days. All subjects were encouraged to complete the full course of treatment and common side effects were explained. Side effects and compliance will be documented.

Drug: Aerosolized 13 cis retinoic acid

13 cis retinoic acid doses orally in combination with spike protein based vaccine

EXPERIMENTAL

The participants will receive 13 cis retinoic acid (0.5 mg/kg/day in 2 divided doses orally for 14 days and also, participants will receive two doses of spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine in deltoid of non-dominant arm, 28 days apart. Participants will have 15 routine visits over a 24 month period.All subjects were encouraged to complete the full course of treatment and common side effects were explained. Side effects and compliance will be documented

Combination Product: 13 cis retinoic acid doses orally in combination with spike protein based vaccine

Aerosolized 13 cis retinoic acid in combination with spike protein based vaccine

EXPERIMENTAL

The participants will receive Aerosolized 13 cis retinoic acid in gradual in 2 divided doses increases froms 0.2 mg/kg/day to 4 mg/kg/day as inhaled 13 cis retinoic acid therapy for 14 days and also, participants will receive two doses of 5-7.5x10\^10 vp spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine in deltoid of non-dominant arm, 28 days apart. Participants will have 15 routine visits over a 24 month period.All subjects were encouraged to complete the full course of treatment and common side effects were explained. Side effects and compliance will be documented

Combination Product: Aerosolized 13 cis retinoic acid in combination with spike protein based vaccine

spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine

SHAM COMPARATOR

The participants will receive two doses of 5-7.5x10\^10 vp spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine in deltoid of non-dominant arm, 28 days apart. Participants will have 15 routine visits over a 24 month period.All subjects were encouraged to complete the full course of treatment and common side effects were explained. Side effects and compliance will be documented

Biological: Biological: spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine

Interventions

Oral 13 cis retinoic acid DRUG

Dose of 0.5 mg/kg/day in 2 divided doses orally for 14 days

Oral 13 cis retinoic acid

Aerosolized 13 cis retinoic acid DRUG

Dose of Aerosolized 13 cis retinoic acid in gradual in 2 divided doses increases froms 0.2 mg/kg/day to 4 mg/kg/day

Aerosolized 13 cis retinoic acid

13 cis retinoic acid doses orally in combination with spike protein based vaccine COMBINATION_PRODUCT

Dose of 13 cis retinoic acid (0.5 mg/kg/day in 2 divided doses orally for 14 days and also, participants will receive two doses of 5-7.5x10\^10 vp spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine in deltoid of non-dominant arm, 28 days apart

13 cis retinoic acid doses orally in combination with spike protein based vaccine

Aerosolized 13 cis retinoic acid in combination with spike protein based vaccine COMBINATION_PRODUCT

Dose of Aerosolized 13 cis retinoic acid in gradual in 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day for 14 days and also, participants will receive two doses of 5-7.5x10\^10 vp spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine in deltoid of non-dominant arm, 28 days apart

Aerosolized 13 cis retinoic acid in combination with spike protein based vaccine

Biological: spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine BIOLOGICAL

Dose of 5-7.5x10\^10vp of spike protein based vaccine such as ChAdOx1 nCoV-19 in deltoid of non-dominant arm, 28 days apart

spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 18-40 years.
• Increased risk of SARS-CoV-2 infection
• Medically stable

You may not qualify if:

• Confirmed or suspected immunosuppressive or immunodeficient state
• Prior or concomitant vaccine therapy for COVID-19
• significant disease, disorder, or finding
• Hypercholesterolemia
• Hypertriglyceridemia
• Liver disease
• Renal disease
• Sjögren syndrome
• Pregnancy
• Lactation
• Depressive disorder
• Body mass index less than 18 points or higher than 25 points
• Contraindications for hormonal contraception or intrauterine device.
• Autoimmune diseases A history of organ, bone marrow or hematopoietic stem cell transplantation
• Patients receiving anti-hcv treatment

Sponsors & Collaborators

• Kafrelsheikh University: lead

MeSH Terms

Interventions

Isotretinoin; ChAdOx1 nCoV-19

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines

Study Officials

• Mahmoud Elkazzaz, M.Sc in Biochemistry

  Facculty of Science, Damietta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Elkazzaz, M.Sc in Biochemistry

CONTACT

00201090302015; mahmoudramadan2051@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Science, Damietta University

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: January 29, 2021
• Study Start: July 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2023
• Last Updated: June 2, 2021

Record last verified: 2021-05