COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCTs071200048

Takeshi Tanaka

ttakeshi@nagasaki-u.ac.jp

2020-10-29

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

1: 20 years old or older at the time of informed consent2:gender:both3:inpatient and outpatient4:Confirmed infection with SARS-Cov-25:Patient with mild or moderate patients with COVID-19 according to Clinical Management of Patients with COVID-19, a guide for front-line healthcare workers version3.06:can provide signed informed consent

1: asymptomatic or severe SARS-CoV-2 positive patients2: Known history of porphyria, hemochromatosis or Viral hepatitis3: Patients with serious renal, hepatic, or cardiac disease etc.4: Patients who have lung disease that potentially become severe COVID-19 and who have poorly controlled hypertension and diabetes mellitus5: Pregnant or possibly pregnant women, lactating women, and women who desire to become pregnant during the study period 6:Patients participating in other clinical (human) trials7:Patients who have photosensitivity8:Patients who have alcoholism or severe mental disorder9:Demonstrate hypersensitivity to 5-aminolevulinic phosphoric acid or sodium ferrous citrate10:Patients who received COVID-19 approved drugs, excluding steroids, after the onset of COVID-19 symptoms11:Patients who received off-label use drugs available in Japan, excluding steroids, listed in the COVID-19 clinical guide after the onset of COVID-19 symptoms (including cases where they are used for purposes other than the treatment of COVID-19)12:Other patients judged to be inappropriate for the study by the attending physician

2

Izumikawa Koichi

20

100

Japan

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

50

Changes in SARS-CoV-2 viral load; changes in clinical symptom and safety of 5-ALA/SFC

Phase 2

[{"arm_notes": "", "treatment_id": 4, "treatment_name": "5-ala/sfc", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]