NCT04327791 (COMBO 1) is a Phase 2, PHASE3 clinical trial of Baloxavir in Influenza, sponsored by Bassett Healthcare.

Who is sponsoring NCT04327791?

NCT04327791 is sponsored by Bassett Healthcare.

What drugs are being tested in NCT04327791?

Interventions in NCT04327791: Baloxavir, Placebos.

Is NCT04327791 still recruiting?

NCT04327791 is currently status unknown. Last updated 30 October 2023.

Last reviewed 2023-10-30 · How we verify

NCT04327791: COMBO 1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

COmbination Therapy With Baloxavir and Oseltamivir 1 for Hospitalized Patients With Influenza (The COMBO Trial 1)

Status unknown Phase 2, PHASE3 Last updated 30 October 2023

What this trial tests

Phase 2, PHASE3 trial testing Baloxavir in Influenza in 60 participants. Status unknown.

Timeline

3 April 2020

Primary endpoint
1 June 2024

1 June 2025

Quick facts

Lead sponsor	Bassett Healthcare
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	3 April 2020
Primary completion	1 June 2024
Estimated completion	1 June 2025
Sites	3 locations across United States

Drugs / interventions tested

Baloxavir (BALOXAVIR) — full drug profile →
Placebos — full drug profile →

Conditions studied

Influenza — all drugs for Influenza →

Sponsor

Bassett Healthcare — full company profile →

Who can join

18 and older, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, double-blind, placebo-controlled Phase 2-like, investigator-directed trial of hospitalized patients with laboratory confirmed influenza. Eligible and consented patients will be randomly assigned, in a 1:1 ratio, to one of two groups: Group 1, the combination treatment group (oseltamivir and baloxavir); Group 2, the standard treatment group (oseltamivir and placebo).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Baloxavir Marboxil: An Original New Drug against Influenza.
Dufrasne F. · · 2021 · cited 34× · PMID 35056085 · DOI 10.3390/ph15010028
Influenza antivirals and animal models.
Caceres CJ, Seibert B, Cargnin Faccin F, Cardenas-Garcia S, et al · · 2022 · cited 30× · PMID 35451200 · DOI 10.1002/2211-5463.13416
Repurposing Approved Drugs for Guiding COVID-19 Prophylaxis: A Systematic Review.
Andrade BS, Rangel FS, Santos NO, Freitas ADS, et al · · 2020 · cited 18× · PMID 33390967 · DOI 10.3389/fphar.2020.590598
Targeting BRF2 in Cancer Using Repurposed Drugs.
Rashidieh B, Molakarimi M, Mohseni A, Tria SM, et al · · 2021 · cited 12× · PMID 34359683 · DOI 10.3390/cancers13153778
Comparison of the efficacy and safety of baloxavir versus those of oseltamivir in pediatric patients with influenza: a meta-analysis.
Chen S, Hua L. · · 2025 · PMID 41229679 · DOI 10.3389/fmicb.2025.1672925

Verify or expand the search:

Other trials of Baloxavir

Trials testing the same drug.

NCT07314905 — Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp) · Phase 3 · not yet recruiting
NCT05648448 — A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza · Phase 2 · recruiting

Other recruiting trials for Influenza

Currently open trials in the same condition.

NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT07496450 — A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults · Phase 3 · recruiting
NCT07302256 — A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 1 · recruiting
NCT07431840 — Immune Defense Protein Impact On Respiratory Immune Outcomes · NA · recruiting
NCT07485855 — Influenza Vaccination Strategy for Patients With Hematologic Malignancy · Phase 3 · recruiting

Other Bassett Healthcare trials

Trials by the same sponsor.

NCT04474288 — The COVID-19 PUI Reality Check (CPRC) Study · completed
NCT04328012 — COVID MED Trial - Comparison Of Therapeutics for Hospitalized Patients Infected With COVID-19 · Phase 2, PHASE3 · terminated
NCT04245683 — Feasibility of Non-Operative Management of Rectal Cancer in a Rural Population · recruiting
NCT04180943 — Liposomal Bupivacaine Versus Bupivacaine for for Postoperative Pain Control in Shoulder Surgery · Phase 4 · completed
NCT03592082 — Use of Bismuth Subsalicylate in Clostridium Difficile Colitis · Phase 4 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04327791 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bassett Healthcare
Last refreshed: 30 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04327791.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing