Isotretinoin in Treatment of COVID-19
Кључне речи
Апстрактан
Опис
The study is a randomized interventional comparative Phase III trial. The duration of the trial for each subject is expected to be 3 months. The duration for each individual subject includes one-month study treatment and 3 months follow-up time. Recruitment of subjects will start in April 2020.
150 adult male and female patients with positive COVID-19 diagnosis and fulfilling the below outlined inclusion criteria will be enrolled into the study. Trial population will consist of both genders.
Name of tested drug: Isotretinoin. All consenting adult patients having confirmed COVID-19 will be recruited and randomly and blindly allocated in a 1:1:1 ratio to the following arms:
Group (1): 50 patients will receive isotretinoin 0.5 mg/kg/day for one month or until viral clearance.
Group (2): 50 patients will receive standard therapy for COVID-19 (Paracetamol 500 mg /6h, Hydroxychloroquine 500 mg/ 12h, Oseltamivir 150 mg /12 h for 5 days, Azithromycin 1 gm first day then 500 mg/day for 1st line or Clarithromycin 500 mg/12 h for 7-14 days, Ascorbic acid 500 mg/12 h and Cyanocobalamin IV once daily plus Lopinavir 400mg/Ritonavir 100 mg caps 2 capsules twice daily in severe cases).
Group (3): 50 patients will receive standard therapy for COVID-19 + isotretinoin 0.25 mg/kg/day for one month or until viral clearance.
Inclusion Criteria:
- Clinical and laboratory diagnosis of COVID-19.
- Age range 18-40
Exclusion Criteria:
• Have the following conditions:
1. Hypercholesterolemia
2. Hypertriglyceridemia
3. Liver disease
4. Renal disease
5. Sjögren syndrome
6. Pregnancy
7. Lactation
8. Depressive disorder
9. Contraindications for hormonal contraception or intrauterine device.
Датуми
| Последња верификација: | 03/31/2020 |
| Фирст Субмиттед: | 04/20/2020 |
| Предвиђена пријава послата: | 04/21/2020 |
| Прво објављено: | 04/23/2020 |
| Послато последње ажурирање: | 04/21/2020 |
| Последње ажурирање објављено: | 04/23/2020 |
| Стварни датум почетка студије: | 04/20/2020 |
| Процењени датум примарног завршетка: | 05/31/2020 |
| Предвиђени датум завршетка студије: | 08/31/2020 |
Стање или болест
Интервенција / лечење
Drug: Isotretinoin Only Product in Oral Dose Form
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| Active Comparator: Isotretinoin 13 cis retinoic acid 0.5 mg/kg/day in 2 divided doses orally for one month | |
| Sham Comparator: Standard COVID-19 therapy Paracetamol 500 mg /6h, Hydroxychloroquine 500 mg/ 12h, Oseltamivir 150 mg /12 h for 5 days, Azithromycin 1 gm first day then 500 mg/day for 1st line or Clarithromycin 500 mg/12 h for 7-14 days, Ascorbic acid 500 mg/12 h and Cyanocobalamin IV once daily plus Lopinavir 400mg/Ritonavir 100 mg caps 2 capsules twice daily in severe cases | |
| Active Comparator: Standard COVID-19 therapy+ isotretinoin Paracetamol 500 mg /6h, Hydroxychloroquine 500 mg/ 12h, Oseltamivir 150 mg /12 h for 5 days, Azithromycin 1 gm first day then 500 mg/day for 1st line or Clarithromycin 500 mg/12 h for 7-14 days, Ascorbic acid 500 mg/12 h and Cyanocobalamin IV once daily plus Lopinavir 400mg/Ritonavir 100 mg caps 2 capsules twice daily in severe cases) plus 13 cis retinoic acid 0.5 mg/kg/day in 2 divided doses orally forone month. |
Критеријуми
| Узраст подобан за студирање | 18 Years До 18 Years |
| Полови подобни за студирање | All |
| Прихвата здраве волонтере | да |
| Критеријуми | Inclusion Criteria: - Clinical and laboratory diagnosis of COVID-19. - Age range 18-40 Exclusion Criteria: 1. Hypercholesterolemia 2. Hypertriglyceridemia 3. Liver disease 4. Renal disease 5. Sjögren syndrome 6. Pregnancy 7. Lactation 8. Depressive disorder 9. Contraindications for hormonal contraception or intrauterine device. |
Исход
Примарне мере исхода
1. Clinical clearance [14-30 day]
Остале мере исхода
1. Laboratory clearance [14-30 day]
