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

Phase 2

• Conditions: COVID-19

• Registration Number: JPRN-jRCTs071200048
• Lead Sponsor: Izumikawa Koichi

Brief Summary

o differences in changes in SARS-CoV-2 and changes in clinical symptom-scores were observed in the 14-day ingestion of 5-ALA/SFC for individuals with mild and moderate COVID-19 compared with non-consumption. The safety of 5-ALA/SFC was within the assumptions and adequately controlled for the adverse events that occurred.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-29
• Study Completion: 2021-08-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified