ribavirin for inhalation solution / Generic mfg. - LARVOL DELTA

Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever (clinicaltrials.gov) - P=N/A | N=30 | Enrolling by invitation | Sponsor: U.S. Army Medical Research and Development Command | Recruiting ➔ Enrolling by invitation

Enrollment status • Hematological Disorders • Infectious Disease

Treatment of Hemorrhagic Fever With Ribavirin (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: U.S. Army Medical Research and Development Command | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Jul 2023 ➔ Jul 2027 | Trial primary completion date: Apr 2023 ➔ Apr 2026

Enrollment closed • Trial completion date • Trial primary completion date • Hematological Disorders • Nephrology • Renal Disease

Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: U.S. Army Medical Research and Development Command | Trial completion date: Dec 2022 ➔ Dec 2028 | Trial primary completion date: Oct 2022 ➔ Oct 2027

Trial completion date • Trial primary completion date • Hematological Disorders • Infectious Disease

Pembrolizumab With or Without Elbasvir/Grazoprevir and Ribavirin in Treating Patients With Advanced Refractory Liver Cancer (clinicaltrials.gov) - P2 | N=12 | Completed | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Aug 2023 | Trial primary completion date: Dec 2022 ➔ Aug 2023

Metastases • Trial completion • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Liver Cancer • Oncology • Solid Tumor

Ribavirin aerosol in hospitalized adults with respiratory distress and COVID-19: An open-label trial. (PubMed, Clin Transl Sci) - "This trial evaluated the potential of ribavirin inhalation solution (ribavirin aerosol) to reduce COVID-19 disease severity in adults with confirmed SARS-CoV-2 infection and a diagnosis of respiratory distress...No deaths were considered related to study treatment. These data provide preliminary evidence that ribavirin aerosol may be an efficacious treatment for respiratory distress in adults with COVID-19."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Treatment of Hemorrhagic Fever With Ribavirin (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: U.S. Army Medical Research and Development Command | Trial completion date: Jul 2022 ➔ Jul 2023 | Trial primary completion date: Apr 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Hematological Disorders • Nephrology • Renal Disease

Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: U.S. Army Medical Research and Development Command | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Aug 2021 ➔ Oct 2022

Trial completion date • Trial primary completion date • Hematological Disorders • Infectious Disease

Pembrolizumab With or Without Elbasvir/Grazoprevir and Ribavirin in Treating Patients With Advanced Refractory Liver Cancer (clinicaltrials.gov) - P2 | N=12 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | N=30 ➔ 12 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Enrollment change • Trial primary completion date • Gastrointestinal Cancer • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Liver Cancer • Oncology • Solid Tumor

Safety, Tolerability, and Pharmacokinetics of Inhaled Virazole Administered Via Air-Jet Nebulizer in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Bausch Health Americas, Inc.

New P1 trial

A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma (clinicaltrials.gov) - P1; N=3; Terminated; Sponsor: Weill Medical College of Cornell University; N=15 ➔ 3; Recruiting ➔ Terminated; low accrual

Enrollment change • Trial termination • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Oncology • BCL2 • CCND1

Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis (clinicaltrials.gov) - P3; N=9; Terminated; Sponsor: University of Colorado, Denver; Active, not recruiting ➔ Terminated; Study stopped due to low accrual and availability of other treatment options

Clinical • Trial termination • Fibrosis • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation

Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19 (clinicaltrials.gov) - P1; N=51; Completed; Sponsor: Bausch Health Americas, Inc.; Recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease

Ribavirin Aerosol in the Treatment of SARS-CoV-2: A Case Series. (PubMed, Infect Dis Ther) - "Five hospitalized patients with COVID-19 (confirmed by positive tests for SARS-CoV-2) received treatment with ribavirin for inhalation solution (ribavirin aerosol) as part of a compassionate use program...Ribavirin aerosol appears to be efficacious in the treatment of patients with COVID-19. A controlled trial of ribavirin aerosol is ongoing and will provide additional data across a broader patient population."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19 (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Bausch Health Americas, Inc.; N=50 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19 (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Bausch Health Americas, Inc.; Trial completion date: Apr 2021 ➔ Aug 2021; Trial primary completion date: Apr 2021 ➔ Aug 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19 (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Bausch Health Americas, Inc.; Trial primary completion date: Apr 2021 ➔ Jul 2021; Not yet recruiting ➔ Recruiting; Trial completion date: Apr 2021 ➔ Jul 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever (clinicaltrials.gov) - P=N/A; N=30; Recruiting; Sponsor: U.S. Army Medical Research and Development Command; Trial completion date: Jun 2021 ➔ Dec 2021; Trial primary completion date: Aug 2020 ➔ Aug 2021

Clinical • Trial completion date • Trial primary completion date • Hematological Disorders • Infectious Disease

Treatment of Hemorrhagic Fever With Ribavirin (clinicaltrials.gov) - P2; N=50; Not yet recruiting; Sponsor: U.S. Army Medical Research and Development Command; Trial completion date: Jul 2021 ➔ Jul 2022; Initiation date: Jun 2020 ➔ Jun 2021; Trial primary completion date: Apr 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Hematological Disorders • Nephrology

Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19 (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Bausch Health Americas, Inc.; Initiation date: Nov 2020 ➔ Feb 2021

Clinical • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19 (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Bausch Health Americas, Inc.; Initiation date: Nov 2020 ➔ Feb 2021

Clinical • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma (clinicaltrials.gov) - P1; N=15; Recruiting; Sponsor: Weill Medical College of Cornell University; Trial completion date: Jun 2020 ➔ Jun 2021; Trial primary completion date: Jun 2020 ➔ Jun 2021

Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Oncology • BCL2 • CCND1

Use of ribavirin in viruses other than hepatitis C. A review of the evidence. (PubMed, Enferm Infecc Microbiol Clin) - "However, there are other diseases in which it could be of benefit and it has the advantage of being suitable for oral, intravenous and inhaled administration. We conducted a review of the indications of the main drug agencies (Spanish, European and American) and other possible indications, mainly haemorrhagic fevers and coronavirus."

Journal • Hepatitis C Virus • Hepatology • Novel Coronavirus Disease

Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19 (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Bausch Health Americas, Inc.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Pembrolizumab With or Without Elbasvir/Grazoprevir and Ribavirin in Treating Patients With Advanced Refractory Liver Cancer (clinicaltrials.gov) - P2; N=30; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Dec 2019 ➔ Dec 2022; Trial primary completion date: Dec 2019 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatitis C Virus • Hepatocellular Cancer • Infectious Disease • Liver Cancer • Oncology • Solid Tumor

Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19 (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Bausch Health Americas, Inc.; Initiation date: Apr 2020 ➔ Sep 2020

Clinical • Trial initiation date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases