The Use of IV Vasoactive Intestinal Peptide (Aviptadil) in Patients With Critical COVID-19 Respiratory Failure: Results of a 60-Day Randomized Controlled Trial.

Youssef JG, Lavin P, Schoenfeld DA, Lee RA, Lenhardt R, Park DJ, Fernandez JP, Morganroth ML, Javitt JC, Jayaweera D

Critical care medicine29 Aug 2022Cited by 19 (Europe PMC)

PMID36044317PMCIDPMC9555831DOI10.1097/ccm.0000000000005660PepBankPUB-36044317

Read at source PubMedAsk about this study

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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with COVID-19 respiratory failure, IV aviptadil did not significantly change the odds of being alive and free from respiratory failure at day 60 compared with placebo.
In plain wordsIn patients with COVID-19 respiratory failure, IV aviptadil did not clearly improve the chance of being alive and free of respiratory failure at day 60.
Peptide
Vasoactive intestinal peptide (VIP, aviptadil)
Outcome
No significant changeAlive and free from respiratory failure at day 60
Study
n = 196
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
1.6 ratio
aviptadil vs placebo
Source sentences
Summary
The primary end point (alive and free from respiratory failure at day 60) did not reach statistical significance (odds ratio [OR], 1.6; 95% CI, 0.86-3.11) for patients treated with Aviptadil when controlling for baseline ventilation status as prespecified in the protocol.
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 196 patients with COVID-19 respiratory failure.
Summary · context
Participants were randomized 2:1 to receive 3 days of IV Aviptadil or placebo.
Report a problemFND-3604431701
02HumanRandomized controlled trialEfficacy outcome
In patients with COVID-19 respiratory failure, IV aviptadil was linked to about twofold higher odds of survival at day 60 than placebo.
In plain wordsIn patients with COVID-19 respiratory failure, IV aviptadil gave higher odds of survival at day 60 than placebo.
Peptide
Vasoactive intestinal peptide (VIP, aviptadil)
Outcome
IncreaseSurvival at day 60
Study
n = 196
Comparator
Placebo
Outcome group
Mortality · Whole body
Studied dose
Dose not stated · intravenous · 3 daysAs given in this study (human).
Measurements
Odds ratio
2 ratio
aviptadil vs placebo
Source sentences
Summary
There was, however, a statistically significant two-fold odds of improved survival (OR, 2.0; 95% CI, 1.1-3.9) at 60 days ( p = 0.035).
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 196 patients with COVID-19 respiratory failure.
Summary · context
Participants were randomized 2:1 to receive 3 days of IV Aviptadil or placebo.
Report a problemFND-3604431702
03HumanRandomized controlled trialSafety outcome
In patients with COVID-19 respiratory failure, the authors report no drug-related serious adverse events with IV aviptadil.
In plain wordsIn patients with COVID-19 respiratory failure, the authors report no serious side effects that were linked to IV aviptadil.
Peptide
Vasoactive intestinal peptide (VIP, aviptadil)
Outcome
No significant changeDrug-related serious adverse events
Study
n = 196
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · intravenous · 3 daysAs given in this study (human).
Source sentences
Summary
Given the absence of drug-related serious adverse events
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 196 patients with COVID-19 respiratory failure.
Summary · context
Participants were randomized 2:1 to receive 3 days of IV Aviptadil or placebo.
Report a problemFND-3604431707
04HumanRandomized controlled trialEfficacy outcome
In patients with COVID-19 respiratory failure, the respiratory distress ratio improved significantly by day 3 with IV aviptadil.
In plain wordsIn patients with COVID-19 respiratory failure, a breathing measure improved by day 3 with IV aviptadil compared with placebo.
Peptide
Vasoactive intestinal peptide (VIP, aviptadil)
Outcome
Direction not reportedRespiratory distress ratio by day 3
Study
n: not reported in source
Comparator
Placebo
Outcome group
Intensive care and hospital outcomes · Respiratory
Studied dose
Dose not stated · intravenous · 3 daysAs given in this study (human).
Source sentences
Summary
There was significant improvement in respiratory distress ratio and reduced interleukin 6 cytokine release ( p = 0.02) by day 3
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 196 patients with COVID-19 respiratory failure.
Summary · context
Participants were randomized 2:1 to receive 3 days of IV Aviptadil or placebo.
Report a problemFND-3604431703
05HumanRandomized controlled trialMechanism
In patients with COVID-19 respiratory failure, IV aviptadil reduced interleukin 6 cytokine release by day 3 compared with placebo.
In plain wordsIn patients with COVID-19 respiratory failure, IV aviptadil lowered release of the inflammation signal interleukin 6 by day 3 compared with placebo.
Peptide
Vasoactive intestinal peptide (VIP, aviptadil)
Outcome
DecreaseInterleukin 6 release by day 3
Study
n: not reported in source
Comparator
Placebo
Outcome group
Inflammation markers · Immune and inflammation
Studied dose
Dose not stated · intravenous · 3 daysAs given in this study (human).
Source sentences
Summary
There was significant improvement in respiratory distress ratio and reduced interleukin 6 cytokine release ( p = 0.02) by day 3
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 196 patients with COVID-19 respiratory failure.
Summary · context
Participants were randomized 2:1 to receive 3 days of IV Aviptadil or placebo.
Report a problemFND-3604431704
06HumanRandomized controlled trialEfficacy outcome
In the subgroup of patients with COVID-19 respiratory failure on high-flow nasal oxygen at baseline, IV aviptadil raised the likelihood of reaching the primary end point.
In plain wordsIn patients with COVID-19 on high-flow nasal oxygen, IV aviptadil raised the chance of being alive and free from respiratory failure, in a subgroup analysis.
Peptide
Vasoactive intestinal peptide (VIP, aviptadil)
Outcome
IncreasePrimary end point in patients on high-flow nasal oxygen at baseline
Study
n: not reported in source
Comparator
Placebo
Outcome group
Intensive care and hospital outcomes · Respiratory
Studied dose
Dose not stated · intravenous · 3 daysAs given in this study (human).
Source sentences
Summary
Subgroup analysis identified a statistically significant likelihood of achieving primary end point among those treated with high-flow nasal oxygen at baseline ( p = 0.039).
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 196 patients with COVID-19 respiratory failure.
Summary · context
Participants were randomized 2:1 to receive 3 days of IV Aviptadil or placebo.
Report a problemFND-3604431705
07HumanRandomized controlled trialEfficacy outcome
In patients with COVID-19 respiratory failure on mechanical ventilation, IV aviptadil was linked to about 10-fold higher odds of survival than placebo.
In plain wordsIn patients with COVID-19 on mechanical ventilation, IV aviptadil gave higher odds of survival than placebo, in a subgroup.
Peptide
Vasoactive intestinal peptide (VIP, aviptadil)
Outcome
IncreaseSurvival in patients on mechanical ventilation
Study
n: not reported in source
Comparator
Placebo
Outcome group
Mortality · Whole body
Studied dose
Dose not stated · intravenous · 3 daysAs given in this study (human).
Source sentences
Summary
Subjects on mechanical ventilation also experienced a 10-fold increased odds of survival with drug versus placebo ( p = 0.031).
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 196 patients with COVID-19 respiratory failure.
Summary · context
Participants were randomized 2:1 to receive 3 days of IV Aviptadil or placebo.
Report a problemFND-3604431706

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 2/3Results postedNCT04311697

Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure

APR Applied Pharma Research s.a.n = 20315 May 2020 to 22 Feb 2021

Critical COVID-19 With Respiratory Failure · Acute Respiratory Distress Syndrome (ARDS) · Corona Virus Infection · Acute Lung Injury

Trial page ClinicalTrials.govUpdated 24 Jul 2023

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

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Terms as the source lists them.

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