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VIP research

What published studies found for VIP: 7 papers, 7 in humans, with sample sizes and key results, plus 43 registered clinical trials.

B
Some human evidence
Why: IV aviptadil RCTs (461 and 196 patients) and a meta-analysis found no survival benefit in COVID-19 respiratory failure; one 80-patient inhaled RCT was positive.

Vasoactive intestinal peptide (synthetic form: aviptadil) has been tested in human trials, most prominently intravenously for COVID-19 respiratory failure, where the largest placebo-controlled trial (461 patients) and a meta-analysis found no survival benefit; a small 80-patient trial of inhaled aviptadil reported faster discharge. Smaller studies show short-lived lung-vessel relaxation when inhaled, and an aviptadil-phentolamine injection is used for erectile dysfunction in some countries.

✓ 2 positive✗ 2 negative~ 1 mixed? 2 inconclusive

In the largest IV trial, serious adverse events in the first 5 days were numerically but not significantly more frequent with aviptadil than placebo.

US compounding: Compounding allowed (Category 1). Vasoactive intestinal peptide is in 503A Category 1: pharmacies may compound it while FDA evaluates it. Status for every peptide.

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Reported side effects

Registered clinical trials

43 trials of VIP on ClinicalTrials.gov: 4 active, 27 completed, 7 with posted results. Registered trials include ones that haven't published yet.

TrialStatusPhasePeopleSponsor
I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill PatientsNCT04488081 · started 2020-07-31Active, not recruitingPhase 21,500QuantumLeap Healthcare Collaborative
Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)NCT06238713 · started 2024-01-08Recruiting–480Shanghai Changzheng Hospital
Video-feedback Intervention to Promote Racial-Ethnic Socialization Competency (VIP-RACE)NCT07055906 · started 2025-05-12Recruiting–110Penn State University
Study of VIP943 in Subjects With Advanced CD123+ Hematologic MalignanciesNCT06034275 · started 2023-09-13RecruitingPhase 136Vincerx Pharma, Inc.
Preventing Sexual Violence Through a Comprehensive, Peer-led InitiativeNCT03207386 · started 2017-02-27 · results postedCompleted–2,647University of New Hampshire
ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19NCT04843761 · started 2021-04-20 · results postedCompletedPhase 3473National Institute of Allergy and Infectious Diseases (NIAID)
Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)NCT06729606 · started 2021-04-20 · results postedCompletedPhase 3471National Institute of Allergy and Infectious Diseases (NIAID)
Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure DeviceNCT01858636 · started 2013-05 · results postedCompleted–235Abbott Medical Devices
Intravenous Aviptadil for Critical COVID-19 With Respiratory FailureNCT04311697 · started 2020-05-15 · results postedCompletedPhase 2, Phase 3203APR Applied Pharma Research s.a.
Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) SymptomsNCT03182738 · started 2016-11-16 · results postedCompleted–100Columbia University
Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek ImplantNCT05337696 · started 2022-05-10 · results postedTerminated–23Icahn School of Medicine at Mount Sinai
Evaluation of Values in Perspective (VIP) ProgramNCT04879342 · started 2021-05-15Completed–850University of Miami

All 43 VIP trials, with countries and recruiting status

Meta-analyses & systematic reviews

✗ Negativemeta-analysisIndian J Crit Care Med · 2025

Aviptadil Therapy in Acute Respiratory Distress Syndrome Patients: A Systematic Review and Meta-analysis.

n = 665 humansSystematic review and meta-analysis (random-effects)

Meta-analysis of 9 studies (2 RCTs, 7 case series; 665 ARDS patients): pooled RCT survival odds were unchanged vs placebo (OR 1.01); uncontrolled case series reported better oxygenation.

Key resultSurvival odds ratio aviptadil vs placebo 1.01 (95% CI: 0.72-1.42, p = 0.93); 48 of 54 patients (88.9%) survived in case series
Studied
Patients with acute respiratory distress syndrome treated with aviptadil
Compared with
Placebo (in the two RCTs)
Main outcome
Survival and oxygenation
Sample
9 studies (2 RCTs, 7 case series), 665 patients, 361 received aviptadil
Authors' conclusion
Aviptadil may have a physiological role in improving oxygenation and reducing inflammation in ARDS, but current evidence does not show a significant survival benefit; larger RCTs are needed.
Limitations
Only two RCTs; most data from case series.
PubMed 41368449DOIFree full text

Human studies

✗ Negativehuman RCTLancet Respir Med · 2023

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

n = 473 humansRandomised, placebo-controlled trial (TESICO), 2 × 2 factorial for aviptadil and remdesivirPrimary outcome at day 90; aviptadil infused daily for 3 days

TESICO trial in 461 ICU patients with COVID-19 respiratory failure: IV aviptadil did not improve 90-day recovery (OR 1.11, p=0.54); mortality was 38% vs 36% on placebo, and early serious adverse events were numerically more frequent (63% vs 56%, p=0.10).

Key resultOdds ratio for better category with aviptadil vs placebo 1·11 (95% CI 0·80-1·55; p=0·54); 90-day mortality 38% vs 36% (hazard ratio 1·04, 95% CI 0·77-1·41; p=0·78)
Studied
Hospitalised adults with COVID-19 acute hypoxaemic respiratory failure at 28 US sites
Compared with
Matched saline placebo
Main outcome
Six-category ordinal outcome at day 90 (home and off oxygen through death)
Sample
473 enrolled; 471 randomized to aviptadil or placebo (461 in modified ITT); 87 to remdesivir comparison
Authors' conclusion
Aviptadil did not significantly improve clinical outcomes up to day 90 compared with placebo in COVID-19 respiratory failure.
Limitations
Aviptadil trial stopped for futility; remdesivir comparison underpowered (87 participants).
PubMed 37348524DOIFree full text
~ Mixedhuman RCTCrit Care Med · 2022

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

n = 196 humansMulticenter placebo-controlled randomized trial; 3 days of IV aviptadil60 days

Trial in 196 patients with critical COVID-19 respiratory failure: 3 days of IV aviptadil did not meet the primary endpoint (alive and free of respiratory failure at day 60), though a secondary analysis showed 2-fold higher odds of survival; no drug-related serious adverse events.

Key resultPrimary endpoint not significant (OR, 1.6; 95% CI, 0.86-3.11); survival OR 2.0 (95% CI 1.1-3.9, p = 0.035)
Studied
Patients with COVID-19 respiratory failure at ten US hospitals
Compared with
Placebo
Main outcome
Alive and free from respiratory failure at day 60
Sample
196 patients randomized 2:1
Authors' conclusion
The primary end point was not met, but the authors conclude aviptadil improves likelihood of survival from respiratory failure at day 60 and has an acceptable safety profile.
Limitations
Primary end point not significant; survival and subgroup results are secondary/subgroup findings.
PubMed 36044317DOIFree full text
✓ Positivehuman RCTMed Princ Pract · 2025

Inhaled Aviptadil Is a New Hope for Recovery of Lung Damage due to COVID-19.

n = 80 humansMulticenter randomized, double-blind, placebo-controlled trial (1:1), added to standard care30 days to discharge; CT follow-up to day 28

Multicenter double-blind randomized trial of inhaled aviptadil vs placebo in 80 hospitalized COVID-19 patients: mean time to discharge 7.8 vs 10 days (p=0.049) and greater CT improvement at day 28 (p=0.028); small trial, in contrast with the negative IV trials.

Key resultMean time to discharge 7.8 vs 10 days (p = 0.049); death rate 5.1% vs 12.2%
Studied
Hospitalized adults with COVID-19 pneumonia at 9 centers
Compared with
Placebo
Main outcome
Time from hospitalization to discharge within 30 days
Sample
80 hospitalized adults with COVID-19
Authors' conclusion
The authors conclude inhaled aviptadil is well tolerated and can be a supplementary intervention to hasten respiratory recovery in COVID-19 pneumonia.
Limitations
Small trial with borderline p-value on the primary endpoint; mortality difference not tested in the abstract.
PubMed 39870064DOIFree full text
? Inconclusivehuman trialEur Respir J · 2008

Inhalation of vasoactive intestinal peptide in pulmonary hypertension.

n = 20 humansSingle-dose acute haemodynamic study during right-heart catheterisation; inhaled aviptadil 100 microgSingle dose

Single 100-microgram inhaled dose in 20 patients with pulmonary hypertension: a small, temporary pulmonary vasodilation and improved stroke volume, with no side effects; longer-term effects untested.

Key resultSix patients had a pulmonary vascular resistance reduction of >20%
Studied
Patients with pulmonary arterial hypertension (nine), PH in lung disease (eight) or chronic thromboembolic PH (three)
Main outcome
Haemodynamics, blood gases and safety
Sample
20 patients with pulmonary hypertension
Authors' conclusion
The pulmonary vasodilating effect was modest and short-lived without side-effects; further studies are needed, including higher doses and chronic treatment.
Limitations
Single dose, no control group, 20 patients.
PubMed 18978135DOI
✓ Positivehuman observationalJ Sex Med · 2025

Intracavernosal injection of aviptadil and phentolamine for refractory erectile dysfunction.

n = 308 humansRetrospective single-center analysis of aviptadil plus phentolamine (AvP) intracavernosal injectionEfficacy at 3 months; mean follow-up 13.3 months

Retrospective study of men with erectile dysfunction who failed or could not tolerate alprostadil injections: aviptadil plus phentolamine injection worked in 76% of those with pain and 36% of those with treatment failure; facial flushing in 22.5%, priapism in 0.3%.

Key result182 men (59%) found AvP effective; efficacy 76% in the pain group vs 36% in the failed-dose group (P < .0001)
Studied
Men with refractory erectile dysfunction who had pain with or failed maximal-dose alprostadil injection
Compared with
None (comparison of pain group vs failed-dose group)
Main outcome
Resumption of penetrative sexual activity
Sample
308 men included
Authors' conclusion
AvP is an effective, well-accepted second-line option for men who failed most nonsurgical treatments for ED.
Limitations
Retrospective design, no control group and no validated instruments to assess erectile function; combination with phentolamine.
PubMed 40192471DOI
? Inconclusivehuman observationalIndian J Crit Care Med · 2024

Effect of Aviptadil, a Novel Therapy, on Clinical Outcomes of Patients with Viral-related Severe ARDS: A Retrospective Observational Study.

n = 6 humansRetrospective observational study; aviptadil infusion for 3 days plus conventional treatment3-day infusion

Retrospective single-center series of severe viral ARDS patients given aviptadil: oxygenation and chest X-ray scores improved over 3 days with no adverse effects noted; no control group.

Key resultPaO2 rose from 54.32 to 68.4 (p-value < 0.004); S/F ratio from 149 to 336 (p-value < 0.003)
Studied
Patients with severe viral-related ARDS in the ICU
Compared with
Before vs after treatment (no control group)
Main outcome
Oxygenation (SpO2, PaO2, S/F ratio), radiological clearance
Sample
6 patients with severe ARDS among 68 viral pneumonia ICU admissions
Authors' conclusion
Aviptadil improved clinical outcomes in severe viral ARDS without adverse effects in this small retrospective series.
Limitations
Only 6 patients; retrospective, no control group.
PubMed 38510776DOIFree full text

Verdicts are judged on each paper's own main outcome; grades run from A (strong human evidence) to D (little or none). Details are read from the abstracts, and figures are reproduced only from openly licensed full texts. Not medical advice.