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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs071200048

Enrollment

Registered

2020-10-29

Start date

2021-02-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 COVID-19

Interventions

Administration of 5-ALA/SFC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Changes in SARS-CoV-2 viral load, changes in clinical symptom and safety of 5-ALA/SFC	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Contacts

Public ContactTakeshi Tanaka

Nagasaki University Hospital

ttakeshi@nagasaki-u.ac.jp+81-95-819-7731

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026