Exploratory examination of Efficacy and safety of functional food included 5-aminolevulinic phosphoric acid/sodium ferrous citrate on COVID-19

JRCT ID: jRCTs071200048

Registered date:29/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 04/02/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Administration of 5-ALA/SFC

Outcome(s)

• Primary Outcome: Changes in SARS-CoV-2 viral load, changes in clinical symptom and safety of 5-ALA/SFC
• Secondary Outcome: number of days to SARS-CoV-2 negative is achieved, changes in laboratory assessment, changes in SpO2 and PaO2, changes in chest CT image, days to leaving O2 administration (Only patient with O2 administration), Safety assessment, days to discharge, ratio of change for severity from mild to moderate or severe and from moderate to severe,number of days until fevers disapperas(37.0 degrees or less)(Only cases excceds 37.0 degrees on Day1),Amount of change in body temperature(Only cases excceds 37.0 degrees on Day1)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1: 20 years old or older at the time of informed consent
2:gender:both
3:inpatient and outpatient
4:Confirmed infection with SARS-Cov-2
5: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 version3.0
6:can provide signed informed consent

Exclude criteria

1: asymptomatic or severe SARS-CoV-2 positive patients
2: Known history of porphyria, hemochromatosis or Viral hepatitis
3: 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 mellitus
5: 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) trials
7:Patients who have photosensitivity
8:Patients who have alcoholism or severe mental disorder
9:Demonstrate hypersensitivity to 5-aminolevulinic phosphoric acid or sodium ferrous citrate
10:Patients who received COVID-19 approved drugs, excluding steroids, after the onset of COVID-19 symptoms
11: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

Related Information

• Primary Sponsor: Izumikawa Koichi
• Source(s) of Monetary Support: neopharma Japan Co., Ltd.