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A multicenter, randomized controlled trial for the efficacy and safety of Alpha lipoic acid (iv) in the treatment of patients of severe novel coronavirus pneumonia (COVID-19)

A multicenter, randomized controlled trial for the efficacy and safety of Alpha lipoic acid (iv) in the treatment of patients of severe novel coronavirus pneumonia (COVID-19)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029851
Enrollment
Unknown
Registered
2020-02-15
Start date
2020-02-19
Completion date
Unknown
Last updated
2020-02-25

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

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

control group:conventional therapy and placebo
Experience group:conventional therapy and ALA

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Severe patients diagnosed with novel coronavirus pneumonia (COVID-19); 2. Aged 35 years old to 74 years old; 3. Patients or authorized family members volunteered to participate in this study and signed informed consent. Note: Case definition: Severe NCP: Refer to the "New Coronavirus Pneumonia Diagnosis and Treatment Plan (Fifth Edition)" formulated by the National Health Commission.

Exclusion criteria

Exclusion criteria: 1. Involving in other drug clinical trial; 2. Pregnant or breastfeeding; 3. Presence of other serious diseases that may be life threatening, such as cancer; 4. Expected life is less than 24 hours; 5. Allergy to ALA or drugs of similar chemical classes (Vitamin B),previous history of intolerance to recommended target doses of alpha-LA; 6. diagnosed with diseases of immune system.

Design outcomes

Primary

MeasureTime frame
SOFA;

Secondary

MeasureTime frame
cure rate;All-cause mortality;Severity rate;

Countries

China

Contacts

Public ContactJunbo Ge

Zhongshan Hospital, Fudan University

jbge@zs-hospital.sh.cn+86-21-64041990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026