Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial
et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(23)00147-9, TESICO, Sep 2023
RCT 461 hospitalized patients with COVID-19-associated respiratory failure showing no significant difference in outcomes with aviptadil treatment.
Standard of Care (SOC) for COVID-19 in the study country,
the USA, is very poor with very low average efficacy for approved treatments1.
Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
|
risk of death, 6.0% higher, HR 1.06, p = 0.71, treatment 231, control 230, Kaplan-Meier, day 180.
|
|
risk of progression, 9.9% lower, OR 0.90, p = 0.54, treatment 231, control 230, inverted to make OR<1 favor treatment, 6-category ordinal outcome, day 90, RR approximated with OR.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Brown et al., 30 Sep 2023, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, median age 57.0, 87 authors, study period 21 April, 2021 - 24 May, 2022, TESICO trial.
Contact: samuel.brown@imail.org.
Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial
The Lancet Respiratory Medicine, doi:10.1016/s2213-2600(23)00147-9
Background: Aviptadil (vasoactive intestinal peptide) is a lung-protective neuropeptide and remdesivir is a nucleotide prodrug of an adenosine analog, both of which may improve outcomes for COVID-19 patients with acute hypoxemic respiratory failure. Methods: Daily 12-hour infusions of aviptadil or placebo for three successive days and daily infusions of remdesivir or placebo for up to 10 successive days were studied using a master protocol for adults hospitalized for COVID-19 with acute hypoxemic respiratory failure. Participants could be randomized to both study treatments in a 2×2 factorial design or to just one of the agents. For both treatment comparisons, the primary outcome, assessed at Day 90, was a 6-category ordinal outcome ranging from return to home with liberation from supplemental oxygen (recovery) for ≥77 days to death. Mortality through Day 90 was a key secondary outcome. The independent data and safety monitoring board recommended stopping the aviptadil trial on
Supplementary Material Refer to Web version on PubMed Central for supplementary material. Lancet Respir Med. Author manuscript; available in PMC 2024 September 01.
Author Manuscript
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Late treatment
is less effective
is less effective
