Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial.

Brown SM, Barkauskas CE, Grund B, Sharma S, Phillips AN, Leither L, Peltan ID, Lanspa M, Gilstrap DL, Mourad A, Lane K, Beitler JR and 38 more

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Serra AL, Garcia I, Almasri E, Fayed M, Hubel K, Harris ES, Middleton EA, Barrios MAG, Mathews KS, Goel NN, Acquah S, Mosier J, Hypes C, Salvagio Campbell E, Khan A, Hough CL, Wilson JG, Levitt JE, Duggal A, Dugar S, Goodwin AJ, Terry C, Chen P, Torbati S, Iyer N, Sandkovsky US, Johnson NJ, Robinson BRH, Matthay MA, Aggarwal NR, Douglas IS, Casey JD, Hache-Marliere M, Georges Youssef J, Nkemdirim W, Leshnower B, Awan O, Pannu S

The Lancet. Respiratory medicine19 Jun 2023Cited by 16 (Europe PMC)

PMID37348524PMCIDPMC10527239DOI10.1016/s2213-2600(23)00147-9PepBankPUB-37348524

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with COVID-19 acute hypoxaemic respiratory failure, intravenous aviptadil did not significantly improve the day 90 ordinal clinical outcome compared with placebo.
In plain wordsIn adults with COVID-19 and serious breathing failure, intravenous aviptadil did not improve recovery at day 90 compared with placebo.
Peptide
Vasoactive intestinal peptide (VIP, aviptadil)
Outcome
No significant changeSix-category ordinal clinical outcome at day 90
Study
n = 461
Comparator
Placebo
Analysis
Primary
Outcome group
Intensive care and hospital outcomes · Respiratory
Studied dose
Dose not stated · intravenous · 3 daysAs given in this study (human).
Measurements
Odds ratio
1.11 ratio
aviptadil vs placebo
Source sentences
Summary
The odds ratio (OR) for being in a better category of the primary efficacy endpoint for aviptadil versus placebo at day 90, from a model stratified by baseline disease severity, was 1·11 (95% CI 0·80-1·55; p=0·54).
2 context sentences(design, population, supporting numbers)
Summary · context
Hospitalised adult patients were eligible for the study if they had acute hypoxaemic respiratory failure due to confirmed SARS-CoV-2 infection and were within 4 days of the onset of respiratory failure.
Summary · context
Aviptadil was administered as a daily 12-h infusion for 3 days, targeting 600 pmol/kg on infusion day 1, 1200 pmol/kg on day 2, and 1800 pmol/kg on day 3.
Report a problemFND-3734852401
02HumanRandomized controlled trialSafety outcome
In adults with COVID-19 acute hypoxaemic respiratory failure, the combined primary safety outcome up to day 5 was not significantly different between intravenous aviptadil (63%) and placebo (56%).
In plain wordsIn adults with COVID-19 and serious breathing failure, serious safety events by day 5 were not clearly more common with aviptadil than with placebo.
Peptide
Vasoactive intestinal peptide (VIP, aviptadil)
Outcome
No significant changePrimary safety outcome up to day 5 (death, serious adverse event, organ failure, serious infection, grade 3-4 adverse event)
Study
n = 461
Comparator
Placebo
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · intravenous · 3 daysAs given in this study (human).
Measurements
Primary safety outcome
63%
aviptadil
Primary safety outcome
56%
placebo
Odds ratio
1.4 ratio
aviptadil vs placebo
Source sentences
Summary
The primary safety outcome of death, serious adverse events, organ failure, serious infection, or grade 3 or 4 adverse events up to day 5 occurred in 146 (63%) of 231 patients in the aviptadil group compared with 129 (56%) of 230 participants in the placebo group (OR 1·40, 95% CI 0·94-2·08; p=0·10).
2 context sentences(design, population, supporting numbers)
Summary · context
Hospitalised adult patients were eligible for the study if they had acute hypoxaemic respiratory failure due to confirmed SARS-CoV-2 infection and were within 4 days of the onset of respiratory failure.
Summary · context
Aviptadil was administered as a daily 12-h infusion for 3 days, targeting 600 pmol/kg on infusion day 1, 1200 pmol/kg on day 2, and 1800 pmol/kg on day 3.
Report a problemFND-3734852403
03HumanRandomized controlled trialEfficacy outcome
In adults with COVID-19 acute hypoxaemic respiratory failure, death up to day 90 was not significantly different with intravenous aviptadil (38%) than with placebo (36%).
In plain wordsIn adults with COVID-19 and serious breathing failure, about as many people died by day 90 with aviptadil as with placebo.
Peptide
Vasoactive intestinal peptide (VIP, aviptadil)
Outcome
No significant changeMortality up to day 90
Study
n = 461
Comparator
Placebo
Analysis
Secondary
Outcome group
Mortality · Whole body
Studied dose
Dose not stated · intravenous · 3 daysAs given in this study (human).
Measurements
Cumulative mortality
38%
aviptadil
Cumulative mortality
36%
placebo
Hazard ratio
1.04 ratio
aviptadil vs placebo
Source sentences
Summary
Up to day 90, 86 participants in the aviptadil group and 83 in the placebo group died. The cumulative percentage who died up to day 90 was 38% in the aviptadil group and 36% in the placebo group (hazard ratio 1·04, 95% CI 0·77-1·41; p=0·78).
3 context sentences(design, population, supporting numbers)
Summary · context
Mortality up to day 90 was a key secondary outcome.
Summary · context
Hospitalised adult patients were eligible for the study if they had acute hypoxaemic respiratory failure due to confirmed SARS-CoV-2 infection and were within 4 days of the onset of respiratory failure.
Summary · context
Aviptadil was administered as a daily 12-h infusion for 3 days, targeting 600 pmol/kg on infusion day 1, 1200 pmol/kg on day 2, and 1800 pmol/kg on day 3.
Report a problemFND-3734852402

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT04843761

ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19

National Institute of Allergy and Infectious Diseases (NIAID)n = 47320 Apr 2021 to 20 Nov 2022

Covid19

Trial page ClinicalTrials.govUpdated 24 Oct 2025

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
9 Oct 2026, 19:08 UTC
Study results updated
Version 1
9 Oct 2026, 12:40 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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