Utilizing the Crosstalk Among Aerosolized Phenformin , Methylene Blue, Photodynamic Therapy , Zinc and Potassium for Treating Severe COVID-19 Infection and Its Inflammatory Complication
COVID-19
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
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
- A history of renal failure (unless recovered for at least 6 months), lactic acidosis, recurrent or severe hypoglycemia.
- A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Other uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Allergic to experimental drugs and patients have the following conditions:
- Medical records of cirrhosis
- Myocardial infarction, developed after the patient was included in the study, but before the intervention
- bleeding, developed after the patient was included in the study, but before the intervention
- connection to artificial lung ventilation developed after the patient was included in the study, but before the intervention
- Active infection, or chronic or persistent infection that might worsen with immunosuppressive treatment (e.g., HIV, hepatitis B virus, hepatitis C virus, tuberculosis [TB])
- Liver disease
- Renal disease
- 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
- The competent physician considered it inappropriate to participate in the study
Sites / Locations
- Ministry of health.First health cluster ,Riaydh
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Combination Therapy plus Standard therapy
Standard Therapy
Methylene Blue 1 mg/kg water solution. Participants will orally receive Methylene Blue solution of 1 mg/kg concentration one time if any. After 3 hours of Methylene Blue administration irradiation of chest using 650 nm laser source with 18 J/cm^2 energy dose will be performed. Patients will be administered study medication (Inhaled 100-150 mg phenformin per day; or, if broken into 3 doses/day, 30-50 mg/dose. this dose well be once daily for 5 days, for a maximum of 7 days for those who remain hospitalized. Patients will receive an Enriched Grape Juice containing 234.5 mmol microcrystalline KCl (a total of 6000 mg of K in 2 EGJ, but split into 2 intakes daily) Patients received will receive Zinc gluconate capsule 15 mg x 2 per day during 14 days
Infected patients will receive the standard therapy for COVID-19 for 14 days