Efficacy of Sunlight Activated Synthetic Porphyrin in COVID-19 Infected Patients (SnPPIX)
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:
- History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers. Cancer free for less than 5 years.
- Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever is longer.
- Serum ferritin > 500 ng/ml or who have received IV iron within 28 days of screening, or currently being treated with oral iron.
- Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- Regular use of drugs of abuse and/or positive findings on urinary drug screening.
- Subjects who are severely physically or mentally incapacitated and who, in the opinion of investigator, are unable to perform the subjects' tasks associated with the protocol.
- Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.
- Subjects with history of photosensitivity or active skin disease, which, in the opinion of the investigator could increase the risk of photosensitivity.
- Subjects with abnormal baseline liver tests or hepatitis serologies that suggest active infection.
- Liver disease
- Renal disease
- Known hypersensitivity or previous anaphylaxis to SnPP and Sulfonated porphyrins
Sites / Locations
- Kafr El-sheikh University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
5 mg SnPP dose plus sunlight exposure
7mg SnPP dose plus sunlight exposure
9 mg SnPP dose plus sunlight exposure
5mg TPPS dose plus sunlight exposure
placebo
7 subjects with COVID-19 infection and Serum ferritin < 500 ng/ml will receive a single dose of 5 mg of Stannous Protoporphyrin and They will be exposed to sunlight one hours every day for 14 days
7 subjects with COVID-19 infection and Serum ferritin < 500 ng/ml will receive a single dose of 7 mg of Stannous Protoporphyrin and They will be exposed to sunlight two hours every day for 14 days
7 subjects with COVID-19 infection and Serum ferritin < 500 ng/ml will receive a single dose of 9 mg of Stannous Protoporphyrin and They will be exposed to sunlight three hours every day for 14 days
7 subjects with COVID-19 infection and Serum ferritin < 500 ng/ml will receive a single dose of 5 mg of sulfonatoporphyrin(TPPS), and They will be exposed to sunlight two hours every day for 14 days
No intervention