Status:
UNKNOWN
Efficacy of Sunlight Activated Synthetic Porphyrin in COVID-19 Infected Patients
Lead Sponsor:
Kafrelsheikh University
Conditions:
COVID-19
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
Efficacy of Sunlight Activated Synthetic Porphyrin in COVID-19 Infected Patients (SnPPIX) Mahmoud ELkazzaz(1),Rokia yousry abdelaziz sallam(2) \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\...
Detailed Description
Efficacy of Sunlight Activated Synthetic Porphyrin in COVID-19 Infected Patients (SnPPIX) Official Title: Efficacy of Based MRI Contrast Media Against Covid-19 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_...
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
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04371822
Start Date
August 1 2020
End Date
November 1 2020
Last Update
June 24 2020
Active Locations (1)
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1
Kafr El-sheikh University
Cairo, Kafr el-Sheikh Governorate, Egypt, 33511