Combination of Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP and Isotretinoin Could be Promising Treatment for COVID-19 Infection- and Its Inflammatory Complications
COVID
About this trial
This is an interventional treatment trial for COVID
Eligibility Criteria
Inclusion Criteria:
1.Laboratory diagnosis:
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 Criteria:
- Age <18 years; Age >80 years
- Pregnant or breast feeding woman
- Patient in other therapeutic clinical trial within 30 days before ICF
- Receive any other ACE inhibitors (ACEI), angiotensin-receptor blockers (ARB) treatment within 7 days before ICF
- Chronic immunosuppression: current autoimmune diseases or patients who received immunotherapy within 30 days before ICF
- Hematologic malignancy (lymphoma, leukemia, multiple myeloma)
- Other patient characteristics (not thought to be related to underlying COVID-19) that portend a very poor prognosis (e.g, severe liver failure, and ect)
- Known allergy to study drug or its ingredients related to renin-angiotensin system (RAS), or frequent and/or severe allergic reactions with multiple medications
- Other uncontrolled diseases, as judged by investigators
- Body weight ≥85 kg
- Hypercholesterolemia
- Hypertriglyceridemia
- Liver disease
- Renal disease
- Sjögren syndrome
- Pregnancy
- Lactation
- Depressive disorder
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Experimental: rbACE2 group plus Aerosolized Isotretinoin
No Intervention: Control group
rbACE2 0.4 mg/kg IV BID for 7 days (unblinded) plus 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
Standard of care; no placebo