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Investigating the Role of 13cis Retinoic Acid in the Treatment of COVID-19 and Enhancement of Its Spike Protein Based Vaccine Efficacy and Safety. (Isotretinoin)
Investigating the role of 13cis retinoic acid in the treatment of COVID-19 and enhancement of Its spike protein based vaccine efficacy and safety.
Details
| Lead sponsor | Kafrelsheikh University |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 360 |
| Start date | 2021-07 |
| Completion | 2023-12 |
Conditions
- Covid19 Vaccine
Interventions
- Oral 13 cis retinoic acid
- Aerosolized 13 cis retinoic acid
- 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
- Biological: spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine
Primary outcomes
- Assess the efficacy of the candidate oral and aerosolized isotretinoin for providing complete protection against COVID-19 in adults aged 18 years and older. — Time Frame: Study duration (12 months from last dose donation ) ]
Occurrence of COVID-19 infection - Assess the safety of the candidate spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine in adults aged 18 years and older. — Time Frame: Study duration (24 months from last vaccination) ]
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 - 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. — Time Frame: Study duration (12 months from last dose donation ) ]
Occurrence of COVID-19 infection - 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 — Time Frame: Study duration (12 months from last dose donation ) ]
Occurrence of COVID-19 infection - 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. — Time Frame: Study duration (24 months from last vaccination) ]
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