RECOVERY (SIM01)
Trial question
What is the role of SIM01 in patients with post-acute COVID-19 syndrome?
Study design
Single center
Double blinded
RCT
Population
Characteristics of study participants
65.0% female
35.0% male
N = 463
463 patients (303 female, 160 male).
Inclusion criteria: patients with post-acute COVID-19 syndrome according to the US CDC criteria.
Key exclusion criteria: immunocompromised state; pregnancy or lactation; unable to receive oral fluids; gastrointestinal surgery in the 30 days before randomization.
Interventions
N=232 SIM01 (an oral synbiotic preparation of 10 billion CFUs in sachets BID for 6 months).
N=231 placebo (vitamin C PO BID for 6 months).
Primary outcome
Alleviation of fatigue at 6 months
63%
43%
63.0 %
47.3 %
31.5 %
15.8 %
0.0 %
SIM01
Placebo
Significant
increase ▲
NNT = 5
Significant increase in alleviation of fatigue at 6 months (63% vs. 43%; OR 2.337, 95% CI 1.54 to 3.55).
Secondary outcomes
Significant increase in alleviation of memory loss at 6 months (42% vs. 27%; OR 1.983, 95% CI 1.27 to 3.09).
Significant increase in alleviation of difficulty in concentration at 6 months (62% vs. 39%; OR 2.644, 95% CI 1.69 to 4.14).
Significant increase in alleviation of gastrointestinal upset at 6 months (70% vs. 54%; OR 1.995, 99% CI 1.3 to 3.05).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with post-acute COVID-19 syndrome according to the US CDC criteria, SIM01 was superior to placebo with respect to alleviation of fatigue at 6 months.
Reference
Raphaela I Lau, Qi Su, Ivan S F Lau et al. A synbiotic preparation (SIM01) for post-acute COVID-19 syndrome in Hong Kong (RECOVERY): a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2023 Dec 7:S1473-3099(23)00685-0.
Open reference URL