Trial ChiCTR2000029851
Publication Zhong M, medRxiv, 2020 (preprint)
Dates: 01feb2020 to 01mar2020
Funding: Private (None. Acknowledgement: We thank Mr. Huirong Zhang from YAOPHARMA CO., LTD,for the donation of ?-Lipoic acid used in this study)
Conflict of interest: No

Methods
RCT
Blinding: single blinding
Location : Single center / China
Follow-up duration (days): 30
Inclusion criteria1. Patients diagnosed with critically ill COVID-19. It complies with the COVID-19 Critical and Critical Diagnostic Standards, namely "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5); 3. Sign written informed consent. Patients who cannot sign informed consent must obtain informed consent from the independent authorized nurse.
Exclusion criteria1. Patients who are participating in other clinical trials; 2. Pregnant or breastfeeding women; 3. There are other life-threatening diseases such as cancer; 4. Expected survival time <24 hours; 5. Patients who are allergic to ALA or similar drugs (B vitamins), and intolerant to the recommended dosage of ALA in the past; 6. A history of immune system diseases or diseases closely related to the immune system
Interventions
Treatment
alfa-Lipoic acid (1200mg)Co-Intervention: SC
Duration : 7 days
Control
Placebo
Duration : 7 days
Participants
Randomized
17 participants (n1=8 / n2= 9)
Characteristics of participants
N=17
Mean age : NR
13 males
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=8 Critical: n=9
Primary outcome
In the register
NR
In the report
SOFA Score
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated

NR
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to all available versions of the published/pre-print article, the study registry was used in data extraction and risk of bias assessment. The study did not achieve the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. Regarding the outcomes Adverse events and Serious adverse events, it is unclear whether the method of measuring the outcome adverse events was appropriate (Quote: "No unexpected drugs-related adverse events occurred during the trial.")