HBOT in Long COVID (HOT-LoCO): Interim Safety Analysis of a Randomized, Placebo-Controlled Trial

Key Finding

In this ongoing double-blind RCT, 20 previously healthy Long COVID patients were randomized (HBOT vs. placebo). Primary endpoints are RAND-36 Physical Functioning (PF) and Role Physical (RP) at 13 weeks; secondary endpoints include the 6-minute walk test (6MWT).

In this interim safety analysis, no serious adverse events (SAEs) occurred. A total of 31 adverse events (AEs) were reported in 60% of participants, mostly cough or chest discomfort, generally mild and transient. The DSMB evaluated the safety profile as favorable.

At baseline, the cohort showed markedly impaired quality of life (PF 31.8 vs. norm 83.5, p<0.001) and reduced physical capacity (6MWT 442 m vs. 662 m, p<0.001). (BioMed Central)

Study Design & Protocol (Brief)

• Design: Randomized, placebo-controlled, double-blind, ongoing Phase II trial

• Primary endpoints: RAND-36 PF and RP at 13 weeks

• Secondary endpoints: objective functional tests (e.g., 6MWT, 30-sec chair stand), endothelial function (RHI)

• Safety endpoints: frequency and severity of AEs/SAEs; DSMB evaluation (PubMed)

Participants: n=20 (interim analysis) (BioMed Central)

Safety: 31 AEs, 0 SAEs; mostly cough & chest discomfort, transient, some possibly related to the intervention. DSMB judged overall safety as favorable (BioMed Central).

Registration: NCT04842448, EudraCT 2021-000764-30 (BioMed Central)

Interpretation (for readers)

This interim analysis primarily assessed safety and feasibility. Efficacy results will follow upon completion of the RCT. The markedly reduced baseline values highlight the significant clinical need in Long COVID. (BioMed Central)