I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
QuantumLeap Healthcare Collaborative · COVID-19
Phase 2
Active, not recruiting
1,500
2026-03
Evidence dashboardStudies since 2020Updated Jul 31, 2026
AviptadilClinical Trials.
A source-linked view of every Aviptadil study in the current snapshot—status, phase, enrollment, results, publications, locations and changes over time.
- Total trials
- 9
- Recruiting
- 0
- Completed
- 4
- Terminated
- 2
- Results posted
- 3
- Average enrollment
- 369
- Countries
- 3
- Highest phase
- Phase 3
Largest indexed study
1,500 participants · NCT04488081 →Developer / research origin
Multiple
Evidence summary
Activity is not efficacy.
Aviptadil appears in 9 indexed studies: 0 recruiting, 4 completed and 3 with registry results posted. The highest registered development stage in this snapshot is Phase 3. These counts measure registry activity; they do not establish that Aviptadil is safe or effective.
Review the design, endpoints, population, protocol changes, statistical analysis and publications before drawing conclusions.
Current studies
Recruiting or active
Completed studies
Finished records
Stopped studies
Withdrawn or terminated
NCT IDStudyPhase / statusEnrollmentUpdated
NCT IDStudyPhase / statusEnrollmentUpdated
ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19
National Institute of Allergy and Infectious Diseases (NIAID) · Covid19
Phase 3
Completed
473
2025-10
Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)
National Institute of Allergy and Infectious Diseases (NIAID) · Covid19
Phase 3
Completed
471
2025-10
Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure
APR Applied Pharma Research s.a. · Critical COVID-19 With Respiratory Failure · Acute Respiratory Distress Syndrome (ARDS)
Phase 2 / Phase 3
Completed
203
2023-07
A Clinical Study Evaluating Inhaled Aviptadil on COVID-19
Centurion Pharma · Covid19
Phase 2
Completed
80
2023-06
NCT IDStudyPhase / statusEnrollmentUpdated
Inhaled ZYESAMI (Aviptadil Acetate) for Treatment of Severe COVID-19
APR Applied Pharma Research s.a. · SARS-CoV 2 · COVID
Phase 3
Withdrawn
0
2026-05
Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS
Prof. Dr. Jörg Leuppi · Covid19 · Corona Virus Infection
Phase 2
Terminated
83
2024-01
Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19
APR Applied Pharma Research s.a. · SARS-CoV 2 · COVID
Phase 2 / Phase 3
Terminated
144
2023-02
Full study index
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9 matching studies
Last registry update first
Latest publications
Follow the paper trail.
PMID 35667714 ↗Files DC, Matthay MA, Calfee CS, Aggarwal NR, Asare AL, Beitler JR, Berger PA, Burnham EL, Cimino G, Coleman MH, Crippa A, Discacciati A, Gandotra S, Gibbs KW, Henderson PT, Ittner CAG, Jauregui A, Khan KT, Koff JL, Lang J, LaRose M, Levitt J, Lu R, McKeehan JD, Meyer NJ, Russell DW, Thomas KW, Eklund M, Esserman LJ, Liu KD; ISPY COVID Adaptive Platform Trial Network; undefined. I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations. BMJ Open. 2022 Jun 6;12(6):e060664. doi: 10.1136/bmjopen-2021-060664.Linked from NCT04488081PMID 40462830 ↗Mabrey FL, Martin TR, Calfee CS, Liu KD, LaCombe B, Brown-Swigart L, Discacciati A, Eklund M, Heckbert SR, Matthay MA, Esserman L, Wurfel MM. Anti-CD14 treatment in patients with severe COVID-19: Clinical and biological effects in a Phase 2 randomized open-label adaptive platform clinical trial. CHEST Crit Care. 2025 Mar;3(1):100117. doi: 10.1016/j.chstcc.2024.100117. Epub 2024 Dec 9.Linked from NCT04488081PMID 39592213 ↗Pomponio R, Peterson RA, Owusu M, Slaughter S, Melgar S, Jolley SE, Burnham EL. Phosphatidylethanol measures in patients with severe COVID-19-associated respiratory failure identify a subset with alcohol misuse. Alcohol Clin Exp Res (Hoboken). 2025 Jan;49(1):165-174. doi: 10.1111/acer.15495. Epub 2024 Nov 26.Linked from NCT04488081PMID 36883141 ↗I-SPY COVID Consortium. Report of the first seven agents in the I-SPY COVID trial: a phase 2, open label, adaptive platform randomised controlled trial. EClinicalMedicine. 2023 Apr;58:101889. doi: 10.1016/j.eclinm.2023.101889. Epub 2023 Mar 3.Linked from NCT04488081PMID 34473343 ↗Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.Linked from NCT04488081PMID 37348524 ↗Brown SM, Barkauskas CE, Grund B, Sharma S, Phillips AN, Leither L, Peltan ID, Lanspa M, Gilstrap DL, Mourad A, Lane K, Beitler JR, 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, O'Mahony DS, Manian P, Awori Hayanga JW, Wortmann GW, Tomazini BM, Miller RF, Jensen JU, Murray DD, Bickell NA, Zatakia J, Burris S, Higgs ES, Natarajan V, Dewar RL, Schechner A, Kang N, Arenas-Pinto A, Hudson F, Ginde AA, Self WH, Rogers AJ, Oldmixon CF, Morin H, Sanchez A, Weintrob AC, Cavalcanti AB, Davis-Karim A, Engen N, Denning E, Taylor Thompson B, Gelijns AC, Kan V, Davey VJ, Lundgren JD, Babiker AG, Neaton JD, Lane HC; ACTIV-3b/Therapeutics for Severely Ill Inpatients with COVID-19 (TESICO) Study Group. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial. Lancet Respir Med. 2023 Sep;11(9):791-803. doi: 10.1016/S2213-2600(23)00147-9. Epub 2023 Jun 19.Linked from NCT04843761PMID 36695483 ↗Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.Linked from NCT04843761PMID 34825704 ↗Tsiatis AA, Davidian M, Holloway ST. Estimation of the odds ratio in a proportional odds model with censored time-lagged outcome in a randomized clinical trial. Biometrics. 2023 Jun;79(2):975-987. doi: 10.1111/biom.13603. Epub 2021 Dec 17.Linked from NCT04843761
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