Status:
UNKNOWN
Aerosol Combination Therapy of All-trans Retinoic Acid and Isotretinoin as A Novel Treatment for Inducing Neutralizing Antibodies in COVID -19 Infected Patients Better Than Vaccine : An Innovative Treatment
Lead Sponsor:
Kafrelsheikh University
Collaborating Sponsors:
New Damietta University Hospital
Conditions:
COVID-19
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Aerosol Combination therapy of All-trans retinoic acid and Isotretinoin as A novel Treatment for Inducing Neutralizing Antibodies in COVID -19 Infected Patients better than vaccine : An innovative Tre...
Detailed Description
This is a Phase 2, , randomized (1:1:1), placebo-controlled, 2-weeks, proof-of-concept study to evaluate the safety and tolerability as well as the mechanistic effect of oral administration of potent ...
Eligibility Criteria
Inclusion
- Adult SARI patients with 2019-ncov infection confirmed by PCR; Absolute value of lymphocytes \< 0. 6x 109/L; Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 \< 200 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP\>=5cmH2O))
Exclusion
- Age \< 18 Pregnant Allergic to experimental drugs and patients have the following conditions:
- 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
- Permanent blindness in one eye
- History of iritis, endophthalmitis, scleral inflammation or retinitis 15-90 days of retinal detachment or eye surgery
- The competent physician considered it inappropriate to participate in the study
- HIV infection or other immunodeficiency or with an absolute neutrophil count ≤1.0 × 109/L
- Abnormal liver biochemistry (alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase) \>1.5 × upper limit of normal or total bilirubin \> upper limit of normal (unless Gilbert's disease with normal conjugated bilirubin)
- Any of the following laboratory abnormalities are present at baseline:
- Platelet count \<150×109/L
- Serum albumin ≤ 3.5 g/dL
- INR ≥1.2
- CPK ≥ ULN.
- Significant liver fibrosis as evidenced by Fibrosis-4 (FIB-4) score \>3.25
- History of hypersensitivity to retinoic acid or any of its excipients or the class of neutrophil elastase inhibitors Known hypersensitivity to medications used in the study procedures (e.g. midazolam, fentanyl, and lidocaine for bronchoscopy)
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04396067
Start Date
October 1 2020
End Date
December 1 2020
Last Update
October 27 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.