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Trial - NCT05371288


Column Value
Trial registration number NCT05371288
Full text link
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Jeein Kim

Contact
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

jeeink2@hs.uci.edu

Registration date
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

2022-05-12

Recruitment status
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Feb. 8, 2023, 4 a.m.
Source : ClinicalTrials.gov

inclusion criteria: • patients with positive covid testing (ab, rt pcr) and mild-severe symptoms based on covid symptom list

Exclusion criteria
Last imported at : Feb. 8, 2023, 4 a.m.
Source : ClinicalTrials.gov

• history of a severe sulfa sensitivity (i.e., anaphylaxis, stevens johnson syndrome), allergy to meat products and/or gelatin (alpha gal allergy) and/or a history of an allergic or adverse reaction to nac, alpha lipoic acid and/or gsh.

Number of arms
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

University of California, Irvine

Inclusion age min
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

50

primary outcome
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Assess Changes in Symptoms of Post-Acute Sequelae of COVID (PASC);Change in Quality of Life Using SF-36 Survey;Change in Time to Clinical Recovery (TTCR);COVID Severity of Symptoms Questionnaire

Notes
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

Phase 1

Arms
Last imported at : May 13, 2022, 7 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2481, "treatment_name": "Alpha lipoic acid+glutathione+n-acetylcysteine", "treatment_type": "Vitamins and dietary supplements+others pharmacological treatment+respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2482, "treatment_name": "Multivitamin", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}]